March 24, 2022 

Dr. Robert Califf

Commissioner

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Dear Commissioner Califf: 

I wrote to you earlier this week regarding the Food and Drug Administration’s (FDA) 

failure to protect Americans from a heart pump device associated with over 3,000 deaths. I am 

now writing to request information about FDA’s delayed response in addressing contaminated 

infant formula now linked to five hospitalizations and two deaths. According to public reporting, 

FDA learned in September 2021 about contaminated formula produced at an Abbott Nutrition 

facility in Sturgis, Michigan, but failed to issue a public warning until February.1 Newly 

released FDA inspection reports show that Abbott Nutrition failed to maintain sanitary 

conditions and procedures at the plant for years. 2 FDA must do more to protect vulnerable 

infants from foodborne illnesses and warn their caregivers of potential dangers. 

FDA was first on notice of the contaminated formula in September 2021, when 

Minnesota health authorities alerted FDA that they had traced one infant’s Cronobacter 

sakazakii infection back to formula produced at the facility.3 Cronobacter sakazakii infections 

1 FDA Learned of Suspected Infant Formula Illness Four Months Before Recall, Politico (Feb. 18, 2022) 

(online at www.politico.com/news/2022/02/18/fda-infant-formula-illness-four-months-before-recall-00010226); 

Food and Drug Administration, FDA Warns Consumers Not to Use Certain Powdered Infant Formula Produced in 

Abbott Nutrition’s Facility in Sturgis, Michigan(online at www fda.gov/news-events/press-announcements/fdawarns-consumers-not-use-certain-powdered-infant-formula-produced-abbott-nutritions-facility) (accessed March 16, 

2022) (as of FDA’s February 17 announcement, formula was linked to four hospitalizations and was a potential 

cause of one death; on February 28, formula was linked to a fifth hospitalization and second death).

2 Plant Behind Abbott Baby Formula Recall Was Unsanitary, FDA Finds, CBS News (Mar. 23, 2022) 

(online at www.cbsnews.com/news/abbott-baby-formula-recall-fda-details/).

3 FDA Learned of Suspected Infant Formula Illness Four Months Before Recall, Politico (Feb. 18, 2022) 

(online at www.politico.com/news/2022/02/18/fda-infant-formula-illness-four-months-before-recall-00010226).
Dr. Robert Califf

Page 2 

are rare, but can lead to severe and life-threatening illnesses, including sepsis and meningitis.4 

When Cronobacter sakazakii causes meningitis, the mortality rate can be as high as 44%.5 

 

FDA inspected the Abbott facility in late September and noted unsanitary conditions at 

the plant, but did not issue a warning. 6 FDA received two more reports of Cronobacter 

sakazakii infections tied to the facility between September and December, and also received a 

complaint about a Salmonella Newport illness linked to the facility.7 FDA finally issued a 

warning to consumers on February 17, when Abbott voluntarily recalled the formula.8 As of 

February 17, FDA knew the Cronobacter sakazakii and Salmonella Newport infections had led 

to four hospitalizations and may have contributed to one death. On February 28, the Centers for 

Disease Control and Prevention announced a fourth Cronobacter sakazakii infection linked to 

the facility, which may have contributed to a second death.9

Between January 31 and March 18, 2022, FDA again inspected the facility. Shockingly, 

FDA found that the Abbott facility failed to maintain clean surfaces for handling formula. FDA 

also found a history of Cronobactersakazakii contamination at the plant, including eight such 

instances between 2019 and 2022.10 

FDA is tasked with protecting all Americans from life-threatening foodborne illness

outbreaks, but fell short in protecting vulnerable infants from contaminated formula. FDA must

do more to ensure no lives are lost, or babies sickened, due to delayed inspections and late

consumer warnings. 

4 Food and Drug Administration, FDA Investigation of Cronobacter Infections: Powdered Infant Formula 

(online at www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-and-salmonella-complaintspowdered-infant-formula-february-2022) (accessed Mar. 23, 2022).

5 Margaret Taylor et al., Two Cases of Cronobacter SakazakiiMeningitis in Infants(Sept. 2021) (online at 

https://journals.lww.com/pidj/Fulltext/2021/09000/Two_Cases_of_Cronobacter_Sakazakii_Meningitis_in.20.aspx).

6 Plant Behind Abbott Baby Formula Recall Was Unsanitary, FDA Finds, CBS News (Mar. 23, 2022) 

(online at www.cbsnews.com/news/abbott-baby-formula-recall-fda-details/).

7 FDA Learned of Suspected Infant Formula Illness Four Months Before Recall, Politico (Feb. 18, 2022) 

(online at www.politico.com/news/2022/02/18/fda-infant-formula-illness-four-months-before-recall-00010226). 

8 Id.; Food and Drug Administration, FDA Warns Consumers Not to Use Certain Powdered Infant Formula 

Produced in Abbott Nutrition’s Facility in Sturgis, Michigan (online at www fda.gov/news-events/pressannouncements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced-abbott-nutritions-facility) 

(accessedMarch 16, 2022); Food and Drug Administration, Company Announcement: Abbott Voluntarily Recalls 

Powder Formulas Manufactured at One Plant (Feb. 17, 2022) (online at www fda.gov/safety/recalls-marketwithdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant).

9 Food and Drug Administration, FDA Warns Consumers Not to Use Certain Powdered Infant Formula 

Produced in Abbott Nutrition’s Facility in Sturgis, Michigan (online at www fda.gov/news-events/pressannouncements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced-abbott-nutritions-facility) 

(accessedMarch 16, 2022). 

10 Plant Behind Abbott Baby Formula Recall Was Unsanitary, FDA Finds, CBS News (Mar. 23, 2022) 

(online at www.cbsnews.com/news/abbott-baby-formula-recall-fda-details/); Food and Drug Administration, FDA 

Investigation of Cronobacter Infections: Powdered Infant Formula (online at www fda.gov/food/outbreaksfoodborne-illness/fda-investigation-cronobacter-and-salmonella-complaints-powdered-infant-formula-february2022) (accessed Mar. 23, 2022).
Dr. Robert Califf

Page 3 

To assist the Subcommittee in its review of this matter, we request that you provide the 

following information by April 7, 2022: 

1. Why did FDA wait until February 17, 2022, to issue a warning to consumers not

to use certain powdered infant formula produced at the Abbott Nutrition facility in

Sturgis, Michigan?

2. What steps, if any, is FDA taking to ensure that it more quickly inspects facilities,

and issues consumer warnings, after reports of foodborne illnesses linked to

particular facilities?

We also request that you provide all documents and communications, from September 1, 

2021, to the present, by April 7, 2022, related to the following topics: 

1. Reports from Minnesota health authorities regarding Cronobacter sakazakii or

Salmonella Newport infections traced back to the facility; and

2. FDA’s steps to address the reported infections at the facility.

The Committee on Oversight and Reform is the principal oversight committee of the 

House of Representatives and has broad authority to investigate “any matter” at “any time” under 

House Rule X. An attachment to this letter provides additional instructions for responding to the 

Subcommittee’s request. Please contact Subcommittee staff at (202) 225-5051 if you have any 

questions about this request. 

Sincerely, 

__________________________

Raja Krishnamoorthi

Chairman 

Subcommittee on Economic and Consumer Policy

Enclosure

cc: The Honorable Michael Cloud, Ranking Member

Subcommittee on Economic and Consumer Policy
Responding to Oversight Committee Document Requests

1. In complying with this request, produce all responsive documents that are in your 

possession, custody, or control, whether held by you or your past or present agents, 

employees, and representatives acting on your behalf. Produce all documents that you 

have a legal right to obtain, that you have a right to copy, or to which you have access, as 

well as documents that you have placed in the temporary possession, custody, or control 

of any third party. 

2. Requested documents, and all documents reasonably related to the requested documents, 

should not be destroyed, altered, removed, transferred, or otherwise made inaccessible to 

the Committee.

3. In the event that any entity, organization, or individual denoted in this request is or has 

been known by any name other than that herein denoted, the request shall be read also to 

include that alternative identification.

4. The Committee’s preference is to receive documents in electronic form (i.e., CD, 

memory stick, thumb drive, or secure file transfer) in lieu of paper productions. 

5. Documents produced in electronic format should be organized, identified, and indexed 

electronically.

6. Electronic document productions should be prepared according to the following 

standards:

a. The production should consist of single page Tagged Image File (“TIF”), files 

accompanied by a Concordance-format load file, an Opticon reference file, and a 

file defining the fields and character lengths of the load file.

b. Document numbers in the load file should match document Bates numbers and 

TIF file names.

c. If the production is completed through a series of multiple partial productions, 

field names and file order in all load files should match.

d. All electronic documents produced to the Committee should include the following 

fields of metadata specific to each document, and no modifications should be 

made to the original metadata:

BEGDOC, ENDDOC, TEXT, BEGATTACH, ENDATTACH, PAGECOUNT,

CUSTODIAN, RECORDTYPE, DATE, TIME, SENTDATE, SENTTIME, 

BEGINDATE, BEGINTIME, ENDDATE, ENDTIME, AUTHOR, FROM, CC, 

TO, BCC, SUBJECT, TITLE, FILENAME, FILEEXT, FILESIZE, 

DATECREATED, TIMECREATED, DATELASTMOD, TIMELASTMOD, 
2 

INTMSGID, INTMSGHEADER, NATIVELINK, INTFILPATH, EXCEPTION, 

BEGATTACH.

7. Documents produced to the Committee should include an index describing the contents 

of the production. To the extent more than one CD, hard drive, memory stick, thumb 

drive, zip file, box, or folder is produced, each should contain an index describing its 

contents. 

8. Documents produced in response to this request shall be produced together with copies of 

file labels, dividers, or identifying markers with which they were associated when the 

request was served.

9. When you produce documents, you should identify the paragraph(s) or request(s) in the 

Committee’s letter to which the documents respond.

10. The fact that any other person or entity also possesses non-identical or identical copies of 

the same documents shall not be a basis to withhold any information.

11. The pendency of or potential for litigation shall not be a basis to withhold any 

information. 

12. In accordance with 5 U.S.C.§ 552(d), the Freedom of Information Act (FOIA) and any 

statutory exemptions to FOIA shall not be a basis for withholding any information. 

13. Pursuant to 5 U.S.C. § 552a(b)(9), the Privacy Act shall not be a basis for withholding 

information. 

14. If compliance with the request cannot be made in full by the specified return date, 

compliance shall be made to the extent possible by that date. An explanation of why full 

compliance is not possible shall be provided along with any partial production. 

15. In the event that a document is withheld on the basis of privilege, provide a privilege log 

containing the following information concerning any such document: (a) every privilege 

asserted; (b) the type of document; (c) the general subject matter; (d) the date, author, 

addressee, and any other recipient(s); (e) the relationship of the author and addressee to 

each other; and (f) the basis for the privilege(s) asserted. 

16. If any document responsive to this request was, but no longer is, in your possession, 

custody, or control, identify the document (by date, author, subject, and recipients), and 

explain the circumstances under which the document ceased to be in your possession, 

custody, or control.

17. If a date or other descriptive detail set forth in this request referring to a document is 

inaccurate, but the actual date or other descriptive detail is known to you or is otherwise 

apparent from the context of the request, produce all documents that would be responsive 

as if the date or other descriptive detail were correct.
3 

18. This request is continuing in nature and applies to any newly-discovered information. 

Any record, document, compilation of data, or information not produced because it has 

not been located or discovered by the return date shall be produced immediately upon 

subsequent location or discovery. 

19. All documents shall be Bates-stamped sequentially and produced sequentially. 

20. Two sets of each production shall be delivered, one set to the Majority Staff and one set 

to the Minority Staff. When documents are produced to the Committee, production sets 

shall be delivered to the Majority Staff in Room 2157 of the Rayburn House Office 

Building and the Minority Staff in Room 2105 of the Rayburn House Office Building. 

21. Upon completion of the production, submit a written certification, signed by you or your 

counsel, stating that: (1) a diligent search has been completed of all documents in your 

possession, custody, or control that reasonably could contain responsive documents; and 

(2) all documents located during the search that are responsive have been produced to the 

Committee.

Definitions

1. The term “document” means any written, recorded, or graphic matter of any nature 

whatsoever, regardless of how recorded, and whether original or copy, including, but not 

limited to, the following: memoranda, reports, expense reports, books, manuals, 

instructions, financial reports, data, working papers, records, notes, letters, notices, 

confirmations, telegrams, receipts, appraisals, pamphlets, magazines, newspapers, 

prospectuses, communications, electronic mail (email), contracts, cables, notations of any 

type of conversation, telephone call, meeting or other inter-office or intra-office 

communication, bulletins, printed matter, computer printouts, teletypes, invoices, 

transcripts, diaries, analyses, returns, summaries, minutes, bills, accounts, estimates, 

projections, comparisons, messages, correspondence, press releases, circulars, financial 

statements, reviews, opinions, offers, studies and investigations, questionnaires and 

surveys, and work sheets (and all drafts, preliminary versions, alterations, modifications, 

revisions, changes, and amendments of any of the foregoing, as well as any attachments 

or appendices thereto), and graphic or oral records or representations of any kind 

(including without limitation, photographs, charts, graphs, microfiche, microfilm, 

videotape, recordings and motion pictures), and electronic, mechanical, and electric 

records or representations of any kind (including, without limitation, tapes, cassettes, 

disks, and recordings) and other written, printed, typed, or other graphic or recorded 

matter of any kind or nature, however produced or reproduced, and whether preserved in 

writing, film, tape, disk, videotape, or otherwise. A document bearing any notation not a 

part of the original text is to be considered a separate document. A draft or non-identical 

copy is a separate document within the meaning of this term.

2. The term “communication” means each manner or means of disclosure or exchange of 

information, regardless of means utilized, whether oral, electronic, by document or 

otherwise, and whether in a meeting, by telephone, facsimile, mail, releases, electronic 
4 

message including email (desktop or mobile device), text message, instant message, 

MMS or SMS message, message application, or otherwise.

3. The terms “and” and “or” shall be construed broadly and either conjunctively or 

disjunctively to bring within the scope of this request any information that might 

otherwise be construed to be outside its scope. The singular includes plural number, and 

vice versa. The masculine includes the feminine and neutral genders. 

4. The term “including” shall be construed broadly to mean “including, but not limited to.” 

5. The term “Company” means the named legal entity as well as any units, firms, 

partnerships, associations, corporations, limited liability companies, trusts, subsidiaries, 

affiliates, divisions, departments, branches, joint ventures, proprietorships, syndicates, or 

other legal, business or government entities over which the named legal entity exercises 

control or in which the named entity has any ownership whatsoever. 

6. The term “identify,” when used in a question about individuals, means to provide the 

following information: (a) the individual’s complete name and title; (b) the 

individual’s business or personal address and phone number; and (c) any and all 

known aliases. 

7. The term “related to” or “referring or relating to,” with respect to any given subject, 

means anything that constitutes, contains, embodies, reflects, identifies, states, refers to, 

deals with, or is pertinent to that subject in any manner whatsoever. 

8. The term “employee” means any past or present agent, borrowed employee, casual 

employee, consultant, contractor, de facto employee, detailee, fellow, independent 

contractor, intern, joint adventurer, loaned employee, officer, part-time employee, 

permanent employee, provisional employee, special government employee, 

subcontractor, or any other type of service provider.

9. The term “individual” means all natural persons and all persons or entities acting on 

their behalf. 
U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

 May 11, 2022 

The Honorable Raja Krishnamoorthi 

Chairman

Subcommittee on Economic and Consumer Policy 

Committee on Oversight and Reform 

U.S. House of Representatives

Washington, DC 20515-6143 

Dear Chairman Krishnamoorthi:

Thank you for your letter of March 24, 2022, regarding the Food and Drug Administration’s 

(FDA or the Agency) investigation of consumer complaints and reports of infant illness related 

to products from Abbott Nutrition’s facility in Sturgis, Michigan. FDA shares your deep concern 

about needing to protect vulnerable infants from foodborne illnesses. The Agency is investigating 

this matter diligently, in collaboration with federal, state, and local partners, and we are taking 

numerous steps to help ensure that parents and caregivers have access to safe and nutritious 

infant formula, which is the only source of nutrition for many newborns and infants. We would 

welcome the opportunity to brief you or your staff on this issue.

We would like to provide information to help explain the events leading up to FDA issuing a 

consumer advisory on this matter in February 2022. On September 20, 2021, FDA was made 

aware of a Cronobacter infection in an infant that consumed powdered infant formula (PIF) 

produced at the Sturgis, Michigan facility. FDA received additional reports of Cronobacter

infections on November 17, 2021, December 1, 2021, and January 11, 2022. The Agency 

investigated each of the four consumer complaints, including analyzing product from consumers’ 

homes when available. FDA also notified Abbott Nutrition after receiving each complaint. 

As you know, the Centers for Disease Control and Prevention (CDC) receives reports on 

foodborne disease outbreaks from state, local, and territorial health departments. On average 

CDC receives two to four Cronobacter case reports annually. However, because Cronobacter is 

not a nationally notifiable condition, the four cases that came to our attention raised a concern. 

Further, the reported common exposure of each infant to PIF from one of the infant formula 

manufacturers serving the U.S. added to the Agency’s concern. Given these factors, FDA 

decided to initiate a for-cause inspection at the Sturgis, Michigan, facility. While inspectional 

planning was initiated in late 2021 with an anticipated inspection date in early January 2022, the 

inspection did not commence until January 31, 2022, due to COVID-19 positive employees at 

the facility. 

Over the course of the onsite inspection initiated in January 2022, the FDA inspection team 

observed significant operational deficiencies in the facility, which raised concerns regarding 

potential product contamination by Cronobacter or other pathogens. FDA investigators collected 

numerous product and environmental samples: 
Page 2 – The Honorable Raja Krishnamoorthi 

• Five environmental subsamples collected from the facility were positive for Cronobacter 

sakazakii; four were detected by FDA and one was detected through firm-initiated 

testing. The positive Cronobacter sakazakii environmental samples collected at the 

Sturgis, Michigan, facility have been analyzed using Whole Genome Sequencing, 

revealing five different strains of Cronobacter sakazakii. 

• Product samples collected by FDA at the facility were analyzed for Cronobacter by FDA 

and were found negative. 

As soon as the Agency received these positive sampling results in February 2022, we began 

conversations with the firm about issuing a voluntary recall. On February 17, 2022, we issued the 

public communication advising consumers not to use the affected products. 

More information on our findings from the inspection initiated in January 2022, as well as FDA 

inspections conducted in September 2019 and September 2021, are available in the FDA Form 

483s, available on online.1 The inspectional observations in these Form 483s do not constitute 

final FDA determinations of whether any condition was or is in violation of the Federal Food, 

Drug, and Cosmetic Act or any of its implementing regulations. The Agency is currently 

evaluating the 2022 inspectional findings in determining the appropriate next steps, including 

any regulatory actions. This remains an open investigation with many moving parts.

We take seriously our duty to prevent, if possible, and respond to foodborne illnesses. Once we 

complete the active investigation and response activities, we will conduct an evaluation of the 

Agency’s response to this incident and determine whether additional steps could be taken to 

ensure the maximum effectiveness of Agency programs and policies related to infant formula 

and special medical food complaints, illnesses, and recalls.

More broadly, and in the spirit of continuous improvement, we issued a Foodborne Outbreak 

Response Improvement Plan (FORIP) in December 2021, which will guide our efforts to

enhance the speed, effectiveness, coordination, and communication of outbreak investigations. 

One goal outlined in the FORIP is the development of performance measures across FDA’s 

foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory 

investigation activities. 

1 https://www.fda.gov/about-fda/office-regulatory-affairs/ora-foia-electronic-reading-room
Page 3 – The Honorable Raja Krishnamoorthi 

We appreciate your interest in this important issue and would be happy to discuss this issue 

further should you or your staff have any questions. 

Sincerely,

Kimberlee Trzeciak

Associate Commissioner 

 for Legislative Affairs

cc: The Honorable Michael Cloud, Ranking Member 

Subcommittee on Economic and Consumer Policy 
April 11, 2022 

The Honorable Robert M. Califf 

Commissioner of Food and Drugs 

U.S. Food and Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

Dear Commissioner Califf: 

I am deeply concerned about a new report into longstanding, significant delays and dysfunction 

across food safety efforts at the U.S. Food and Drug Administration (FDA). Americans rely on 

the FDA to ensure the food they are eating and feeding their families is safe. The FDA’s failure

over decades to regulate and enforce food safety standards, on issues ranging from bacteria in 

vegetables to arsenic in baby food, has put the health of Americans at risk. I am calling on you to 

make these issues a priority and take immediate action to ensure the FDA is doing all it can to 

fulfill all aspects of its mission to protect the health and safety of the American people.

According a recent media report based on over 50 interviews, the FDA’s food safety efforts have 

received little attention within the agency and have been beset by delays and management 

challenges for years.1 Despite overseeing nearly 80 percent of the American food supply, the 

FDA’s predominant focus, the investigation found, has been on drugs and devices, while food 

safety issues have not been prioritized by senior leadership. Over the last decade, the food safety 

program has languished with delays across inspections and the development and issuance of 

safety standards. As one former acting FDA Commissioner put it, the food program is “on the 

back burner” at the agency. Other officials described the program as “impossible,” “broken,” 

“byzantine,” and “a joke.” 

This report highlighted several delays in regulatory action that have endangered the public 

health. Over a decade after the Food Safety Modernization Act was implemented, the FDA has 

yet to issue safety standards required by the law, and hundreds of people have been sickened due 

to foodborne illness. Despite recognition within the agency of the danger of toxic elements in 

baby food, the FDA has not imposed strict safety standards, even as report after report has 

identified unacceptably high levels of lead, arsenic, mercury, cadmium, and other toxins in baby 

food. The agency has not even finalized long-term voluntary reduction targets for sodium in 

food, despite a recommendation to do so in 2010. 

I am further concerned by the agency’s failure to ensure timely inspections and recalls, which are 

critical for ensuring food is free of bacteria and other harmful contaminants. According to the 

1 https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/ 

1
report, the number of FDA food safety inspections has generally decreased over time. 

Inspections are also often delayed. For example, I have sought answers from both Abbott 

Nutrition and the FDA regarding potential bacterial contamination of Abbott’s infant formula, 

which has been associated with multiple hospitalizations and deaths.2 The FDA first received a 

report of these issues in September 2021, but failed to initiate an inspection of the manufacturing 

plant until January, before a voluntary recall in February.3 The FDA has since found serious 

sanitation issues at the facility.

4

 FDA inspections for facilities manufacturing other food products 

have also failed to identify the causes of bacteria in produce, and the agency has often waited 

months prior to issuing product recalls.5

These delays actively endanger the health and safety of the American people. Every year, 

approximately one in six Americans get sick and 3,000 die from foodborne diseases.6 Exposure 

to toxic metals and chemicals like arsenic, lead, and cadmium – especially for children – have 

been linked with a higher risk of serious illness, lifelong impairment, and death.7 The effects of 

poor nutrition are also significant. For example, a new analysis focused just on salt intake 

estimates the FDA’s delay in finalizing sodium targets in food may result in over 260,000 

deaths.8 

You have the opportunity to address these longstanding issues and reform the way FDA handles 

these longstanding food safety and nutrition issues. During your confirmation hearing, you 

committed to me you would “hit the ground running” and prioritize consumer and patient 

protection issues.9 I am calling on you to fulfill that promise and take immediate action to ensure 

the FDA’s food safety efforts are robust, timely, and effective in keeping the American people 

healthy and safe. 

In addition, I request the following information no later than April 25, 2022: 

1. What steps are you taking or planning to take to improve the FDA’s food safety efforts,

including the timeliness and rigor of regulatory and enforcement activities?

2. The recent news report highlights significant, years-long delays in addressing water used to

grow produce, toxic substances in baby food, and sodium levels in food. Has the FDA

assessed the causes of these delays? If so, please provide the results or findings of any such

assessment. If not, please explain why such assessments have not been conducted and if there

are any plans to do so.

3. The report indicates that an organizational change made under the Trump Administration

may have further hampered FDA’s food safety efforts. What steps, if any, are you

2 Letter from Senators Patty Murray and Bob Casey to Abbott Nutrition (Feb. 24, 2022); Briefing from FDA Staff 

(March 16, 2022).

3 https://www.politico.com/news/2022/02/18/fda-infant-formula-illness-four-months-before-recall-00010226 4 https://www.fda.gov/media/157073/download

5 https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/ 6 https://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html 7 https://www.consumerreports.org/food-safety/heavy-metals-in-baby-food-a6772370847/ 8 https://www.ahajournals.org/doi/abs/10.1161/HYPERTENSIONAHA.121.18475

9 https://www.help.senate.gov/imo/media/doc/Califf2.pdf

2
considering to ensure the FDA’s organizational structure supports timely and effective 

decision-making on food-related issues? 

4. For each year over the past ten years, how many:

a. Food safety inspections has the FDA conducted? Please provide a breakdown by

inspection type;

b. Food and food packaging samples did the FDA test for toxic elements? Please

provide a breakdown by food and packaging type. Please provide the results of any

such tests for any products intended for infants or young children.

Thank you for your attention to this matter. Please direct any correspondence pertaining to this 

request to Yelena Tsilker at Yelena_Tsilker@help.senate.gov. 

Sincerely,

Chair

U.S. Senator Committee on Health, Education, 

Labor, and Pensions

cc: Senator Richard Burr 

Ranking Member 

3
U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

May 24, 2022 

The Honorable Patty Murray 

Chair

Committee on Health, Education, Labor, and Pensions 

United State Senate

Washington, D.C. 20510 

Dear Chair Murray:

Thank you for your letter of April 11, 2022, requesting information related to the U.S. Food and 

Drug Administration’s (FDA or the Agency) Foods Program. Your questions are important for 

all Americans, for there is no more quintessential governmental function than ensuring the safety 

of the products our Foods Program oversees. 

Food safety and nutrition are critical priorities and central to our mission as an Agency. We take 

criticism seriously and acknowledge that, as we face challenges, we must strive for continuous 

improvement. Through our work, the Agency has been able to deliver on a number of major 

initiatives to advance food safety and nutrition policy over the past decade and has a bold vision 

to continue building upon these successes to further improve public health. However, we know 

there are areas where we must improve. For example, FDA and the Administration can and will 

do more to make our timelines as aggressive as possible, and we strive to accelerate our efforts to 

deliver the public health protection and oversight that American consumers expect from FDA. 

First, while perhaps not the primary focus of the questions in your letter, we would like to 

address FDA’s ongoing work to mitigate infant formula supply challenges in the U.S., an issue 

that is top of mind for the Agency and many Americans. FDA has and will continue to 

implement several important steps1

 to improve the supply of infant and specialty formula 

products in the U.S. Notably, on May 16, 2022, a consent decree of permanent injunction 

between the FDA and Abbott Nutrition, as well as three Abbott principals, was entered in the 

U.S. District Court for the Western District of Michigan. Under the consent decree, Abbott has 

agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility. 

The consent decree obliges Abbott to take actions that are expected to ultimately result in an 

increase of infant formula products, while ensuring that the company undertakes certain actions 

that would ensure safe powdered infant formula is produced at the facility. Additionally, also on 

May 16, FDA announced a guidance that outlines increased flexibilities regarding importation of 

certain infant formula products to further increase the availability of infant formula across the 

country while protecting the health of infants. The Agency is encouraging infant formula 

manufacturers worldwide to take advantage of these flexibilities. Ensuring the availability of 

safe, sole-source nutrition products like infant formula is of the utmost importance to FDA. We

1 https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-improve-supply-infant-andspecialty-formula-products
Page 2 – The Honorable Patty Murray 

have been working tirelessly to address and alleviate supply issues and will continue doing 

everything within our authority to ensure the production of safe infant formula products. 

As you know, the Foods Program has responsibility for a variety of areas, including ensuring the 

microbial and chemical safety of food, ensuring that consumers have access to information to 

make healthful food choices, and ensuring the safety of dietary supplements and cosmetics. 

FDA continues the critical work needed to fully implement the FDA Food Safety Modernization 

Act (FSMA) through additional rulemakings, guidance development, training, inspections, and 

other implementation activities. We have published eight foundational final rules and more than 

50 draft and final guidances to help transform our nation’s food safety system to a preventionoriented framework. Despite advancements in food safety over the past decade, rates of 

foodborne disease in the U.S have not changed significantly. To achieve our goal of bending the 

curve of foodborne illness, in 2020 we engaged with internal and external stakeholders to craft a 

vision for building on the progress made by FSMA while leveraging the use of new and 

emerging technologies and new approaches for a rapidly changing food system. The New Era of 

Smarter Food Safety (New Era) blueprint outlines FDA’s bold approach for improving our 

programs to effectively respond to rapid changes and emerging issues in the global food safety 

system. New Era is an essential next step toward fully realizing the benefits of FSMA’s 

prevention-oriented framework that translates into fewer foodborne illnesses.

A few recent accomplishments under the New Era initiative include: 

• Improving the speed, effectiveness, coordination, and communication of outbreak 

investigations through the Foodborne Outbreak Response Improvement Plan (FORIP), 

developed with input from Federal and State public health officials, industry, and 

consumer foodborne outbreak experts; 

• Detecting outbreaks and food safety issues earlier and with increased precision, including 

through our whole genome sequencing platform known as GenomeTrakr. Our work on 

GenomeTrakr has been a critically important paradigm shift in the control of foodborne 

illness; 

• Enhancing the safety of leafy greens by improving strategies for prevention of Shigatoxin producing E. coli (STEC), addressing knowledge gaps, and enhancing response 

activities by FDA and other entities under the Leafy Greens STEC Action Plan (LGAP). 

FDA continues to build on the original LGAP issued in 2020, making significant progress 

through collaborative action-oriented public-private partnerships; 

• Piloting artificial intelligence/machine learning projects to improve our ability to identify 

imported food products of public health concern; 

• Building stronger relationships with our state partners and trusted foreign partners to 

better coordinate our strategy and resources on targeting the highest-risk food safety 

issues through our mutual and systems recognition programs; and 

• Working towards establishing frameworks for tech-enabled source-to-table food 

traceability that will build on the foundations established through the FSMA Food 

Traceability rulemaking, which should be completed by November 2022. 
Page 3 – The Honorable Patty Murray 

Our understanding of the role nutrition plays in the lives of everyday Americans has also 

progressed throughout the years, and, over the past decade, we advanced multiple nutrition 

policies to reduce the burden of diet-related chronic disease through improved nutrition. For 

example, our actions updating the Nutrition Facts Label with added sugars for the first time, 

removing industrially produced trans fats from our food system, implementing menu labeling so 

consumers can access not just calorie information but additional written nutrition information 

like sodium when ordering foods from chain restaurants, and reducing sodium in the diet have 

the potential to prevent hundreds of thousands of diet-related premature deaths and illnesses in 

the coming years. Indeed, the World Health Organization has told FDA that our work on trans

fats and sodium is impactful in leading policies around the globe for healthier foods. 

Finally, our Closer to Zero initiative identifies actions the Agency is taking to reduce exposure to 

toxic elements from foods eaten by babies and young children to as low as possible. We have 

prioritized babies and young children because their smaller body sizes and metabolism make 

them more vulnerable to the harmful effects of these contaminants. And we have seen our 

science-based approach to setting action levels already producing results in driving down 

contaminant levels and reducing exposure. From 2012 to 2018, we saw a 29 percent reduction of 

inorganic arsenic levels in infant rice cereal because of our efforts in developing an action level. 

This reduced exposure is predicted to decrease adverse health effects—such as lowering the 

median estimated lung and bladder cancer cases from consumption of inorganic arsenic in infant 

rice cereal during the first year of life by 60 percent (1.11 to 0.44 cases/million).2

 In April 2021, 

we issued the Closer to Zero action plan and followed that up with a public meeting in October. 

At the one-year anniversary mark, we issued a draft guidance on action levels for lead in juices 

commonly consumed by children and partnered with the U.S. Department of Agriculture on a 

second Closer to Zero public meeting (April 27). We also anticipate soon releasing a guidance 

document on lead in food for babies and young children, which is in the final stages of 

Administration clearance. 

The Agency is proud of these initiatives and believes that all establish a firm foundation on 

which to build for future successes in ensuring the safety of food and helping Americans 

establish healthy eating patterns. As noted above, FDA can do better, and so we would welcome 

the opportunity to discuss both our successes and areas for improvement with you in greater 

detail and to partner with you and other Members of Congress on implementing solutions to 

improve our efforts. 

Your specific requests are restated below, in bold type, followed by the Agency’s response. 

1. What steps are you taking or planning to take to improve the FDA’s food safety 

efforts, including the timeliness and rigor of regulatory and enforcement activities?

While we have had a number of significant successes in our Foods Program, there are 

improvements to be made in FDA’s food safety efforts, and the Agency is committed to 

making them. We know that stakeholders deserve a higher level of transparency from the 

2 https://www.fda.gov/media/96071/download
Page 4 – The Honorable Patty Murray 

Agency in terms of Foods Program priorities. For example, advocacy and industry 

stakeholders alike have communicated that they appreciate the transparency of the Closer to 

Zero plan, the clearly defined deliverables and timelines, and the commitment to an iterative 

scientific approach, which are laid out on our Closer to Zero webpage.3 We are committed to 

delivering the public health protection and oversight that consumers expect from FDA, 

including by improving the timeliness and rigor of our regulatory and enforcement activities 

and regularly communicating Foods Program priorities, plans, and progress to stakeholders. 

However, there is no way around the simple fact that the program’s current capacity and 

resources are overwhelmed by the sheer magnitude of the responsibilities and the evergrowing and evolving industries FDA regulates. 

Staffing: FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is operating with 

essentially the same number of staff as it has for decades. But staffing is particularly 

worrisome in areas such as diet-related disease and long-term risks from chemical 

contaminants. CFSAN’s Office of Nutrition and Food Labeling operates with staffing equal 

to the number of teachers in an average Seattle high school.4

 The Foods Program would 

benefit if it had the agile hiring authorities that FDA’s medical product centers received in 

2016 under 21st Century Cures. Scientific experts in the Foods Program are reviewing food 

product and packaging innovations that will have population-wide impacts, often with data 

that is more limited than the clinical trial data that is available to review similar innovations 

in medical products. This requires increasing scientific, technical, statistical, and other 

expertise that FDA faces fierce competition to recruit. Modern hiring and pay authorities 

would enable the Foods Program to recruit and hire talented scientific staff with agility and 

speed on par with the private sector. These hiring authorities would be transformative for the 

Foods Program – FDA would be able to bring on the talent it needs to address the 

increasingly complex and exciting innovation in key program areas. We appreciate your 

leadership in including the expansion of the Cures hiring authorities in the FDA Safety and 

Landmark Advancements Act.5 

Resources: Unlike most FDA Centers that receive significant funding through user fees, 97 

percent of CFSAN’s budget comes from budget authority. This means CFSAN’s funding is 

not directly tied to the level of work it has relative to the scope of its mission, in contrast to 

most FDA Centers, which receive user fees and thus can scale up as the volume of incoming 

work increases. We appreciate the increased funding FDA received in the Consolidated 

Appropriations Act, 2022 and view it as a strong down payment for many of our critical 

initiatives. The President’s FY 2023 budget request looks to build on those investments and 

enable the Foods Program to improve health equity through nutrition and reducing exposure 

to harmful chemicals and toxins in food, while strengthening data-driven approaches to 

protecting consumers, allocating regulatory oversight resources based on risk, and improving 

FDA’s capacity to quickly respond to ongoing and evolving public health challenges in 

support of the Agency’s continued implementation of the New Era of Smarter Food Safety. 

While Congress invested additional resources for standing up FSMA, the rate of increased 

3 https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods 4 https://washingtonstatereportcard.ospi.k12.wa.us/ReportCard/ViewSchoolOrDistrict/101062

5 https://www.help.senate.gov/chair/newsroom/press/senators-murray-burr-release-legislation-to-support-fdaprograms-to-lower-costs-and-spur-innovation- 
Page 5 – The Honorable Patty Murray 

investment in FDA’s foods program has significantly lagged behind those made in FDA’s 

Center for Drug Evaluation and Research (see enclosure).

Again, FDA welcomes an opportunity to discuss these needs with you and work with you 

and other Members of Congress to help build capacity as we work to improve the timeliness 

and rigor of our Foods Program regulatory and enforcement activities to deliver oversight of 

foods on behalf of consumers. 

2. The recent news report highlights significant, years-long delays in addressing water 

used to grow produce, toxic substances in baby food, and sodium levels in food. Has 

the FDA assessed the causes of these delays? If so, please provide the results or 

findings of any such assessment. If not, please explain why such assessments have 

not been conducted and if there are any plans to do so.

First, FDA is taking steps to improve the timeliness of its food safety efforts. Although not 

formal evaluations, the Agency has identified several elements that, while not unique to these 

issues, influenced project timelines for the agricultural water proposed rule, setting levels for 

toxic elements in baby food, and sodium reduction targets. 

As with any complex, scientific issue, these three projects required research, analysis of data, 

and, in certain cases, engagement with the scientific community to inform decision-making 

and adjustments when new science emerged. Further, FDA’s regulations and guidances often 

require intra-governmental review processes to solicit feedback from various parts of the 

U.S. government. The feedback and insight of our government partners can help make our 

policies stronger and more comprehensive, but the reviews are outside of our control and 

often require significant time. Finally, but importantly, stakeholder input also is essential to 

ensure that policies we put into place are feasible to implement once established. If we do not 

take the time to make sure our policies can be enacted in real-world settings, then they will 

not be successful and the intended public health benefits will not be realized or unintended 

consequences could result. 

For example, regarding our sodium reduction targets, there were a myriad of considerations 

(e.g., potential food safety issues, advancements in food technology, adaptation of 

consumers’ palates) that required a thorough and thoughtful process. In particular, we did not 

take a “one size fits all” approach, but rather developed targets that are specifically tailored 

for 163 food categories based on their unique food safety and food technology 

considerations. In addition to packaged food targets, the sodium reduction guidance includes 

targets for restaurant foods, recognizing the need to reduce sodium broadly across the food 

supply in order for palates to adjust –an approach other countries are seeking to emulate. 

3. The report indicates that an organizational change made under the Trump 

Administration may have further hampered FDA’s food safety efforts. What steps, 

if any, are you considering to ensure the FDA’s organizational structure supports 

timely and effective decision-making on food-related issues? 




Page 10 – The Honorable Patty Murray 

In addition to the regulatory sampling noted above, FDA collects surveillance and 

research samples for food. Notably, the FDA Total Diet Study (TDS) monitors levels 

of contaminants (e.g., cadmium and lead) and nutrients (e.g., calcium and iron) in 

foods commonly eaten by people in the U.S. The ongoing nature of the TDS enables 

us to track trends in the average U.S. diet. The foods are bought at retail outlets 

throughout the U.S., prepared as consumed, and analyzed for elements both toxic 

and nutrient. We make these data publicly available, and the results from 1991 to 

2017 can be found on our website.6

 Results from 2018 to 2020 will be posted soon. 

Thank you again for your continued interest in this important matter. The work of the Foods 

Program is critical to FDA’s mission, and we are committed to our shared interest of advancing 

food safety and nutrition. We welcome the opportunity to discuss these areas with you and how 

we can continue to make improvements. 

 

Sincerely,

 

 Kimberlee Trzeciak

Associate Commissioner for 

 Legislative Affairs

6 https://www.fda.gov/food/total-diet-study/analytical-results-total-diet-study
Addendum: Comparison of CFSAN vs CDER funding FY11 – FY22

$815,488 $838,694 

$1,059,871 $1,097,515 $1,135,258 $1,189,531 $1,121,278 

$1,419,991 

$1,676,069 $1,734,667 $1,753,685 

$1,851,466 

$252,322 

$257,488 $266,060 $266,893 $280,480 $304,544 $307,619 $317,438 $335,244 $343,011 $344,655 $370,420 

 $-

 $200,000

 $400,000

 $600,000

 $800,000

 $1,000,000

 $1,200,000

 $1,400,000

 $1,600,000

 $1,800,000

 $2,000,000

FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 FY21 FY22

FY11 - 22 CDER/CFSAN Comparison - Enacted

Budget Authority and User Fees (in thousands)

CDER CFSAN Linear (CDER) Linear (CFSAN)

CDER

+127%

+$1B

CFSAN

+46.8%

+$118M

Enclosure
From: Ganter, Jack

To: Legislation

Subject: [EXTERNAL] baby formula shortage

Date: Thursday, May 5, 2022 9:43:20 PM

Attachments: image001.png

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CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you

recognize the sender and know the content is safe.

Good afternoon,

We have had several constituents reach out to us about the recent baby food shortage. My boss

would like to help in ANY way possible. Please let us know ASAP how our office can be beneficial.

‘It’s absolutely heartbreaking’: Jacksonville-area parents face worsening baby formula shortage

Happy to chat over the phone about this.

Thanks and look forward to hearing from you soon.

Jack Ganter

Health Legislative Assistant 

2432 Rayburn HOB | 202-225-5831

 
From: Moxley, Shera

To: Ganter, Jack

Cc: Goitom, Mahlet

Subject: RE: [EXTERNAL] baby formula shortage

Date: Monday, May 9, 2022 4:01:00 PM

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Hi Jack,

Good to chat with you earlier today. Here are the materials I mentioned I’d send you:

1. Here’s our webpage tracking the Abbott infant formula recall:

https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacterinfections-powdered-infant-formula-february-2022. Previous updates are all the way at the

bottom, from the initial investigation notice on February 17, 2022, and the voluntary recall

notice on February 20, through additional updates throughout February and March, including

our recent update (in the blue box) where we don’t object to Abbott releasing certain

specialty and metabolic formulas on a case-by-case basis. This section includes contact

information at Abbott for parents and caregivers to request products, and also the riskbenefit disclaimer I mentioned. Additional updates will be posted at this same location.

2. Links to the “483s,” inspection observations from inspections at Abbott’s Sturgis, Michigan,

facility on the following dates:

September 16-24, 2019: https://www.fda.gov/media/157319/download

September 20-24, 2021: https://www.fda.gov/media/157318/download,

https://www.fda.gov/media/157317/download (amended)

January 31 – March 18, 2022: https://www.fda.gov/media/157708/download
3. FDA’s FY 2023 A-19, “Preventing Food Shortages, Including Infant Formula and Certain

Medical Foods”: https://www.fda.gov/media/157194/download (page 6).

Additionally, I’ll keep you updated as FDA has new information to share on the Abbott infant formula

recall and related shortage issue. As I mentioned, we’re conducting an internal assessment of the

Abbott case, including the supply chain impacts, and we may identify additional ways to strengthen

FDA’s oversight of the infant formula and medical foods industry beyond what’s proposed in the A19 about supply chain/shortages.

Thanks, again, for your interest in helping resolve the supply chain issues and your support for

strengthening FDA’s authorities in the infant formula program.

Sincerely,

Shera Moxley

Shera A. Moxley, PhD

Congressional Affairs Specialist

Office of Legislation

Office of Policy, Legislation, and International Affairs

U.S. Food and Drug Administration

Tel: 240.402.1594

Mobile: 

shera.moxley@fda.hhs.gov

From: Ganter, Jack <Jack.Ganter@mail.house.gov> 

Sent: Monday, May 9, 2022 9:41 AM

To: Moxley, Shera <Shera.Moxley@fda.hhs.gov>

Subject: Re: [EXTERNAL] baby formula shortage

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you

recognize the sender and know the content is safe.

Yes, you can reach me at .

Look forward to chatting soon!

Jack Ganter

Health Legislative Assistant 

(b) (6) (b) (6)
2432 Rayburn HOB | 202-225-5831

 

From: "Moxley, Shera" <Shera.Moxley@fda.hhs.gov>

Date: Monday, May 9, 2022 at 9:36 AM

To: "Ganter, Jack" <Jack.Ganter@mail.house.gov>

Subject: RE: [EXTERNAL] baby formula shortage

Hi Jack,

If 1:30 today is still free for you, let me give you a call then. Does the 202-225-5831 number in your

signature work best?

Shera

From: Ganter, Jack <Jack.Ganter@mail.house.gov> 

Sent: Saturday, May 7, 2022 2:13 PM

To: Moxley, Shera <Shera.Moxley@fda.hhs.gov>

Subject: Re: [EXTERNAL] baby formula shortage

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you

recognize the sender and know the content is safe.

Hey Shera – appreciate the quick response. Sorry I wasn’t able to get to this until today.

I am free to chat this weekend and can talk on Monday as well. Below are some times that works for

me on Monday:

9am-10am

11am

1:30pm

3pm.

Thanks and look forward to hearing from you soon.

Jack Ganter

Health Legislative Assistant 

2432 Rayburn HOB | 202-225-5831
 

From: "Moxley, Shera" <Shera.Moxley@fda.hhs.gov>

Date: Friday, May 6, 2022 at 12:42 PM

To: "Ganter, Jack" <Jack.Ganter@mail.house.gov>

Subject: RE: [EXTERNAL] baby formula shortage

Hi Jack,

Thanks very much for your email about infant formula shortages.

I’d be happy to chat with you this afternoon to understand more specifically how Rep. Carter is

interested in helping.

I’m available this afternoon between 1:00-1:30, 2:30-3:00, and 4:00-5:00, at .

I look forward to speaking with you.

Sincerely,

Shera Moxley

Shera A. Moxley, PhD

Congressional Affairs Specialist

Office of Legislation

Office of Policy, Legislation, and International Affairs

U.S. Food and Drug Administration

Tel: 240.402.1594

Mobile: 

shera.moxley@fda.hhs.gov

From: Ganter, Jack <Jack.Ganter@mail.house.gov> 

Sent: Thursday, May 5, 2022 9:43 PM

To: Legislation <Legislation@fda.hhs.gov>

Subject: [EXTERNAL] baby formula shortage

(b) (6) (b) (6)
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you

recognize the sender and know the content is safe.

Good afternoon,

We have had several constituents reach out to us about the recent baby food shortage. My boss

would like to help in ANY way possible. Please let us know ASAP how our office can be beneficial.

‘It’s absolutely heartbreaking’: Jacksonville-area parents face worsening baby formula shortage

Happy to chat over the phone about this.

Thanks and look forward to hearing from you soon.

Jack Ganter

Health Legislative Assistant 

2432 Rayburn HOB | 202-225-5831

 
CHARLES E GRASSLEY

Pres dent pro te

WASHINGTON DC 2051

Reply to:

135 Hart Senate Office Buildi

Washington DC 20510–

(202) 224–3744

www.grassley.senate.gov

721 Federal Buildi

210 Walnut Stree

Des Moine, IA 50309

(515) 288–1145

111 7th Avenue, SE, Box

Suite 6800

Cedar Rapid, IA 52401

(319) 363–6832

Reply to:

120 Federal Buildi

320 6th Stre

Sioux City,IA 51101–1

(712) 233–1860

210 Waterloo Buildin

531 Commercial S

Waterloo,IA 50701–5

(319) 232–6657

201 West 2nd Stre

Suite 720

Davenport IA 52801–

(563) 322–4331

307 Federal Buildi

8 South 6th Str

Council Bluffs IA 51501–

(712) 322–7103

PRTED

Co-Chairma

INTERN

Ranking Member,

United States Senate

AG

B

May10, 2022

The Honorable Robert M. Califf

Commissioner 

U.S. Food and Drug Administration 

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Dear Commissioner Califf, 

I am writing with concern about the current shortage of infant formula in Iowa, and nationwide. 

Access to a steadfast, nutritional food supply is critical for all Americans, especially children. As 

supply chain shortages continue to impact families, I ask that the FDA prioritize our nation’s 

critical need for infant formula and do what the agency can to ease the shortages. 

As you likely know, supplies of infant formula have significantly decreased over the last few 

months. At the end of April, out-of-stock formula percentage increased to 40%, leading many 

retail stores to limit consumer purchases of formula. Further, in six states including Iowa, more 

than half of all baby formula was completely sold out during the week of April 24th. While the 

most common use of formula is feeding infants, many children and adults who are fed through 

feeding tubes also rely on formula for all of their nutrition. This is a staple that cannot be 

substituted. 

With inflation at a 40 year high, Americans are already experiencing strain and adversity when 

they make trips to their local grocery stores. Many families in Iowa and across the U.S. rely on 

formula, but current supply chain issues and high prices are forcing low and middle income 

Americans to stretch their dollars and their formula even further. Shortages are also causing 

families to turn to unsafe methods of feeding their babies, such as making homemade formula or 

adding extra water to a bottle to stretch their supply. These makeshift methods of making up for a 

lack of supply in stores can be deadly. 

I recognize the impact the COVID-19 pandemic and decreased workforce capacity has had on 

our supply chains. However, it is imperative that Americans have access to food that infants and 

others need to survive. It is the utmost importance to our families across the country that a 

May 11, 2022

The Honorable Joseph R. Biden, Jr.

President of the United States

The White House

1600 Pennsylvania Avenue NW

Washington, DC 20500

The Honorable Robert M. Califf, M.D., MACC

Commissioner 

Food and Drug Administration 

10903 New Hampshire Avenue

Silver Spring, MD 20903

President Biden and Dr. Califf:

We write to you about concerns over the nationwide shortage of baby formula and your 

failure to meaningfully address this ongoing crisis. Parents are understandably frustrated and 

scared by this shortage. In fact, the formula shortage has reached crisis levels in recent weeks. 

The share of baby formula “out of stock across the U.S. hit 40 percent on April 24” and a “total of 

26 states have out of stock rates of 40 to 50 percent.”1 Notably, CVS, Walgreens, and Target are 

among the stores putting limits on how much formula customers can buy at one time.2

Additionally, there is concern over how this may impact parents participating in the Special 

Supplemental Nutrition Program for Women, Infants, and Children (WIC), who rely on the 

program’s supply of baby formula for their infant’s nutritional needs. 

According to Datasembly, baby formula shortages were at 23 percent in January 2022 

“and have continued to worsen, showing [out of stock] levels now at 31% as of April 2022.”3 

Further, Ben Reich, the CEO of Datasembly, said a combination of “inflation, supply chain 

shortages, and product recalls have brought an unprecedented amount of volatility for baby 

formula” and that he expects “to continue to see the baby formula category being dramatically 

1 Rob Wile, 40 percent of America’s baby formula supplies are out of stock, NBC News (May 9, 2022), available at 

https://www.cnbc.com/2022/05/09/40-percent-of-americas-baby-formula-supplies-are-out-of-stock html

2 Rachel Paula Abrahamson and Elise Sole, Everything you need to know about the baby formula shortage, Today 

(Feb. 9, 2022), available at https://www.today.com/parents/parents/everything-need-know-baby-formula-shortagercna15613?icid=canonical_related

3 Business Wire, Datasembly Data Reveals 31% Out-Of-Stock Rate in April 2022 for Baby Formula; Up 11% 

Compared to November 2021, (Apr. 13, 2022), available at 

https://www.businesswire.com/news/home/20220413005974/en/Datasembly%E2%80%99s-Data-Reveals-31-Outof-Stock-Rate-in-April-2022-for-Baby-Formula-Up-11-Compared-to-November-2021
Letter to President Biden and Dr. Califf

Page 2

affected by these conditions.”4 Mr. Reich warns that baby formula “will continue to demonstrate 

higher than average out-of-stock levels.”5

Parents across the country are struggling to keep up with this nationwide shortage of baby 

formula. This problem worsened in February 2022 when, Abbott Nutrition, a manufacturer of 

infant formula, voluntarily recalled formula produced in its Sturgis, Michigan facility following 

reports of infant hospitalizations and death. The facility was subsequently shut down pending an 

investigation by the FDA and enhanced testing. Since then, a link has not been established 

between the formula produced at the facility and the sickened infants. 

On April 29, 2022, the FDA announced that it did not object to Abbott Nutrition 

releasing specialty and metabolic formulas produced at the Sturgis facility on a case-by-case 

basis. Yet, the FDA has still not cleared the facility to resume the vast majority of its infant 

formula production. The prolonged shutdown of the Sturgis facility without any public backup 

plan by the administration has greatly exacerbated the current shortage.

Baby formula shortages are an urgent problem that must be addressed immediately. This 

new problem is compounded by the historic inflation caused by the Biden administration that is 

already burdening families. The office of the U.S. Surgeon General states that families typically 

spend $1,200 to $1,500 on infant formula in the first year.6

Just yesterday, the FDA announced a number of steps it will take in an attempt to 

“improve supply of infant and specialty formula products.”7 However, this announcement comes 

far too late, as parents struggle to find formula for their babies. House Republicans call on the 

administration to do more to help parents across this country. This issue is a matter of life and 

death, and it is time this administration treats it with the appropriate urgency it deserves. 

Accordingly, to assist us in our oversight, please provide the following by May 18, 2022:

1. Please explain the meaning of FDA’s April 29, 2022, update, and if FDA expects its 

non-objection to help mitigate the supply shortage? If so, how is it expected to 

mitigate the shortage? Please explain how long the additional testing is expected to 

take and what the timeline is for reopening Abbott’s Sturgis, Michigan facility. 

2. With respect to the steps FDA recently announced, please answer the following:

a. How will these steps meaningfully increase supply?

b. When does the agency expect to see a supply increase, particularly in states 

experiencing significant shortages?

4

Id. 

5

Id. 

6 Office of Surgeon General, Breastfeeding: Surgeon General’s Call to Action Fact Sheet, available at

https://www.hhs.gov/surgeongeneral/reports-and-publications/breastfeeding/factsheet/index html

7 FDA, FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products, (May 10, 2022), 

available at https://content.govdelivery.com/accounts/USFDA/bulletins/317391e
Letter to President Biden and Dr. Califf

Page 3

c. Please identify what and the number of specific “reviews” and “certificates” 

in the regulatory process you are “expediting” to increase supply.

d. Please explain how you will exercise discretion on “minor labeling issues” to 

increase supply?

e. Are there any additional steps the FDA is considering?

3. What is FDA’s understanding of what is causing the shortage of infant formula?

4. How did FDA account for infant formula supply impacts from the recalls?

5. What action is FDA taking to track the shortage?

6. What action is FDA taking related to the resolution of any issues resulting in the 

temporary closure of the facility in Sturgis, MI?

7. What outreach has the administration performed to hospital pediatric units to 

determine if they have enough baby and specialty formula in reserve for emergency 

situations?

8. What data is available regarding whether non-infants who rely on specialty formula 

are having any adverse reactions to currently available formula?

9. What formula production facilities are available beyond U.S. borders, and to what 

extent have these facilities been impacted by transit bottlenecks due to COVID 

lockdowns?

Please also provide a briefing for the Minority staff of the Energy and Commerce 

Committee after sending your written response. If you have any questions, please contact the 

Minority Committee staff at (202) 225-3641. Thank you for your attention to this request. 

Sincerely,

 

Cathy McMorris Rodgers Brett Guthrie

Republican Leader Republican Leader

Committee on Energy and Commerce Subcommittee on Health

Committee on Energy and Commerce 
Letter to President Biden and Dr. Califf

Page 4

H. Morgan Griffith Fred Upton 

Republican Leader Member of Congress

Subcommittee on Oversight and Investigations

Committee on Energy and Commerce

 

Tim Walberg Michael C. Burgess, M.D.

Member of Congress Member of Congress

Steve Scalise Robert E. Latta

Member of Congress Member of Congress

David B. McKinley Gus M. Bilirakis

Member of Congress Member of Congress 

Bill Johnson Billy Long

Member of Congress Member of Congress

Larry Bucshon, M.D. Markwayne Mullin

Member of Congress Member of Congress

Richard Hudson Earl L. “Buddy” Carter

Member of Congress Member of Congress

Letter to President Biden and Dr. Califf

Page 6

Darrell Issa Virginia Foxx

Member of Congress Member of Congress

Vern Buchanan Doug Lamborn

Member of Congress Member of Congress

Rob Wittman Blaine Luetkemeyer

Member of Congress Member of Congress

Tom McClintock Glenn “GT” Thompson

Member of Congress Member of Congress

Eric A. “Rick” Crawford Mo Brooks

Member of Congress Member of Congress

Bob Gibbs Bill Huizenga

Member of Congress Member of Congress

Steven M. Palazzo Austin Scott

Member of Congress Member of Congress
Letter to President Biden and Dr. Califf

Page 7

Andy Barr Doug LaMalfa

Member of Congress Member of Congress

Ann Wagner Jackie Walorski

Member of Congress Member of Congress

Brad R. Wenstrup, D.P.M Roger Williams

Member of Congress Member of Congress

Jason Smith Rick Allen

Member of Congress Member of Congress

Tom Emmer Garret Graves

Member of Congress Member of Congress

Glenn Grothman John Katko

Member of Congress Member of Congress

Barry Loudermilk John R. Moolenaar

Member of Congress Member of Congress
Letter to President Biden and Dr. Califf

Page 8

Dan Newhouse Elise Stefanik

Member of Congress Member of Congress

David G. Valadao Drew Ferguson

Member of Congress Member of Congress

Brian Fitzpatrick Mike Gallagher

Member of Congress Member of Congress

Clay Higgins John H. Rutherford

Member of Congress Member of Congress

Ralph Norman Ben Cline

Member of Congress Member of Congress

Anthony Gonzalez Mark E. Green, M.D.

Member of Congress Member of Congress

Michael Guest Dusty Johnson

Member of Congress Member of Congress
Letter to President Biden and Dr. Califf

Page 9

Guy Reschenthaler John Rose

Member of Congress Member of Congress

Pete Stauber William R. Timmons, IV

Member of Congress Member of Congress

Jeff Van Drew Michael Waltz

Member of Congress Member of Congress

Gregory F. Murphy, M.D. Claudia Tenney

Member of Congress Member of Congress

Cliff Bentz Kat Cammack

Member of Congress Member of Congress

Andrew S. Clyde Michelle Fischbach

Member of Congress Member of Congress

Bob Good Diana Harshbarger

Member of Congress Member of Congress
Letter to President Biden and Dr. Califf

Page 10

Yvette Herrell Jake LaTurner

Member of Congress Member of Congress

Nancy Mace Tracey Mann

Member of Congress Member of Congress

Peter Meijer Mariannette J. Miller-Meeks, M.D.

Member of Congress Member of Congress

Blake Moore August Pfluger

Member of Congress Member of Congress

Maria Elvira Salazar Beth Van Duyne

Member of Congress Member of Congress

Carol D. Miller Daniel Webster

Member of Congress Member of Congress

Vicky Hartzler Andrew R. Garbarino

Member of Congress Member of Congress

U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Robert Aderholt 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Aderholt: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Robert Aderholt 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Robert Aderholt 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Robert Aderholt 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Robert Aderholt 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Robert Aderholt 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Rick Allen 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Allen: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Rick Allen 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Rick Allen 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Rick Allen 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Rick Allen 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Rick Allen 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Kelly Armstrong 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Armstrong: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Kelly Armstrong 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Kelly Armstrong 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Kelly Armstrong 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Kelly Armstrong 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Kelly Armstrong 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Andy Barr 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Barr: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Andy Barr 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Andy Barr 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Andy Barr 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Andy Barr 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Andy Barr 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Cliff Bentz 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Bentz: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Cliff Bentz 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Cliff Bentz 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Cliff Bentz 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Cliff Bentz 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Cliff Bentz 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Jack Bergman 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Bergman: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Jack Bergman 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Jack Bergman 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Jack Bergman 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Jack Bergman 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Jack Bergman 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Stephanie Bice 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Bice: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Stephanie Bice 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Stephanie Bice 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Stephanie Bice 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Stephanie Bice 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Stephanie Bice 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Gus Bilirakis 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Bilirakis: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Gus Bilirakis 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Gus Bilirakis 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Gus Bilirakis 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Gus Bilirakis 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Gus Bilirakis 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Bill Johnson 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Johnson: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Bill Johnson 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Bill Johnson 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Bill Johnson 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Bill Johnson 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Bill Johnson 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Kevin Brady 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Brady: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Kevin Brady 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Kevin Brady 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Kevin Brady 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Kevin Brady 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Kevin Brady 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Mo Brooks 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Brooks: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Mo Brooks 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Mo Brooks 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Mo Brooks 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Mo Brooks 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Mo Brooks 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Vernon Buchanon 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Buchanon: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Vernon Buchanon 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Vernon Buchanon 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Vernon Buchanon 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Vernon Buchanon 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Vernon Buchanon 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Larry Bucshon 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Bucshon: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Larry Bucshon 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Larry Bucshon 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Larry Bucshon 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Larry Bucshon 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Larry Bucshon 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Michael Burgess 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Burgess: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Michael Burgess 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Michael Burgess 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Michael Burgess 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Michael Burgess 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Michael Burgess 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Ken Calvert 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Calvert: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Ken Calvert 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Ken Calvert 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Ken Calvert 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Ken Calvert 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Ken Calvert 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Kat Cammack 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Cammack: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Kat Cammack 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Kat Cammack 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Kat Cammack 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Kat Cammack 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Kat Cammack 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Buddy Carter 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Carter: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Buddy Carter 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Buddy Carter 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Buddy Carter 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Buddy Carter 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Buddy Carter 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Ben Cline 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Cline: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Ben Cline 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Ben Cline 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Ben Cline 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Ben Cline 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Ben Cline 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Andrew Clyde 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Clyde: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Andrew Clyde 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Andrew Clyde 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Andrew Clyde 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Andrew Clyde 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Andrew Clyde 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Rick Crawford 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Crawford: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Rick Crawford 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Rick Crawford 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Rick Crawford 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Rick Crawford 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Rick Crawford 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Dan Crenshaw 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Crenshaw: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Dan Crenshaw 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Dan Crenshaw 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Dan Crenshaw 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Dan Crenshaw 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Dan Crenshaw 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable John Curtis 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Curtis: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable John Curtis 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable John Curtis 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable John Curtis 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable John Curtis 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable John Curtis 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Jeff Duncan 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Duncan: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Jeff Duncan 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Jeff Duncan 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Jeff Duncan 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Jeff Duncan 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Jeff Duncan 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Neal Dunn 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Dunn: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Neal Dunn 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Neal Dunn 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Neal Dunn 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Neal Dunn 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Neal Dunn 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Dusty Johnson 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Johnson: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Dusty Johnson 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Dusty Johnson 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Dusty Johnson 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Dusty Johnson 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Dusty Johnson 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Tom Emmer 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Emmer: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Tom Emmer 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Tom Emmer 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Tom Emmer 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Tom Emmer 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Tom Emmer 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Drew Ferguson 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Ferguson: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Drew Ferguson 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Drew Ferguson 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Drew Ferguson 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Drew Ferguson 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Drew Ferguson 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Michelle Fischbach 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Fischbach: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Michelle Fischbach 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Michelle Fischbach 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Michelle Fischbach 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Michelle Fischbach 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Michelle Fischbach 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Brian Fitzpatrick 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Fitzpatrick: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Brian Fitzpatrick 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Brian Fitzpatrick 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Brian Fitzpatrick 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Brian Fitzpatrick 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Brian Fitzpatrick 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Virginia Foxx 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Foxx: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Virginia Foxx 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Virginia Foxx 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Virginia Foxx 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Virginia Foxx 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Virginia Foxx 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Michael Gallagher 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Gallagher: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Michael Gallagher 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Michael Gallagher 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Michael Gallagher 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Michael Gallagher 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Michael Gallagher 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Andrew Garbarino 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Garbarino: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Andrew Garbarino 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Andrew Garbarino 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Andrew Garbarino 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Andrew Garbarino 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Andrew Garbarino 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Mike Garcia 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Garcia: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Mike Garcia 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Mike Garcia 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Mike Garcia 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Mike Garcia 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Mike Garcia 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Garret Graves 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Graves: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Garret Graves 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Garret Graves 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Garret Graves 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Garret Graves 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Garret Graves 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Bob Gibbs 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Gibbs: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Bob Gibbs 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Bob Gibbs 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Bob Gibbs 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Bob Gibbs 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Bob Gibbs 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Louie Gohmert 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Gohmert: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Louie Gohmert 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Louie Gohmert 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Louie Gohmert 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Louie Gohmert 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Louie Gohmert 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Anthony Gonzalez 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Gonzalez: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Anthony Gonzalez 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Anthony Gonzalez 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Anthony Gonzalez 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Anthony Gonzalez 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Anthony Gonzalez 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Robert Good 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Good: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Robert Good 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Robert Good 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Robert Good 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Robert Good 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Robert Good 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Mark Green 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Green: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Mark Green 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Mark Green 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Mark Green 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Mark Green 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Mark Green 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

May 24, 2022 

The Honorable H. Morgan Griffith

Ranking Member 

Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations 

U.S. House of Representatives 

Washington, DC 20515 

Dear Ranking Member Griffith: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below.

Update on Current Situation

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable H. Morgan Griffith

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them.

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week.

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable H. Morgan Griffith

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall.

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

• Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas.
Page 4 – The Honorable H. Morgan Griffith

• Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs.

• Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

• Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

• Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance tomanufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

• Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records.

• Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

• Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers.

• Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care
Page 5 – The Honorable H. Morgan Griffith

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist.

Stakeholder Outreach

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable H. Morgan Griffith

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future.

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term.

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely,

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak - S

Trzeciak -S Date: 2022.05.24

17:09:34 -04'00'

Kimberlee Trzeciak 

Associate Commissioner

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Glenn Grothman 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Grothman: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Glenn Grothman 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Glenn Grothman 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Glenn Grothman 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Glenn Grothman 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Glenn Grothman 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Michael Guest 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Guest: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Michael Guest 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Michael Guest 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Michael Guest 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Michael Guest 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Michael Guest 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

May 24, 2022 

The Honorable Brett Guthrie 

Ranking Member 

Committee on Energy and Commerce 

Subcommittee on Health

U.S. House of Representatives 

Washington, DC 20515 

Dear Ranking Member Guthrie: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below.

Update on Current Situation

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Brett Guthrie

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them.

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week.

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Brett Guthrie

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall.

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

• Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas.
Page 4 – The Honorable Brett Guthrie

• Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs.

• Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

• Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

• Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance tomanufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

• Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records.

• Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

• Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers.

• Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care
Page 5 – The Honorable Brett Guthrie

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Brett Guthrie

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future.

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term.

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely,

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak - S

Trzeciak -S Date: 2022.05.24

17:09:34 -04'00'

Kimberlee Trzeciak 

Associate Commissioner

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Diana Harshbarger 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Harshbarger: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Diana Harshbarger 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Diana Harshbarger 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Diana Harshbarger 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Diana Harshbarger 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Diana Harshbarger 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Vicky Hartzler 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Hartzler: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Vicky Hartzler 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Vicky Hartzler 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Vicky Hartzler 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Vicky Hartzler 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Vicky Hartzler 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Yvette Herrell 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Herrell: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Yvette Herrell 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Yvette Herrell 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Yvette Herrell 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Yvette Herrell 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Yvette Herrell 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Clay Higgins 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Higgins: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Clay Higgins 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Clay Higgins 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Clay Higgins 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Clay Higgins 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Clay Higgins 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Richard Hudson 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Hudson: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Richard Hudson 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Richard Hudson 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Richard Hudson 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Richard Hudson 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Richard Hudson 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Bill Huizenga 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Huizenga: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Bill Huizenga 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Bill Huizenga 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Bill Huizenga 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Bill Huizenga 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Bill Huizenga 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Darrell Issa 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Issa: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Darrell Issa 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Darrell Issa 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Darrell Issa 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Darrell Issa 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Darrell Issa 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable John Joyce 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Joyce: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable John Joyce 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable John Joyce 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable John Joyce 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable John Joyce 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable John Joyce 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable John Katko 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Katko: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable John Katko 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable John Katko 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable John Katko 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable John Katko 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable John Katko 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Doug LaMalfa 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative LaMalfa: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Doug LaMalfa 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Doug LaMalfa 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Doug LaMalfa 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Doug LaMalfa 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Doug LaMalfa 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Doug Lamborn 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Lamborn: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Doug Lamborn 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Doug Lamborn 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Doug Lamborn 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Doug Lamborn 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Doug Lamborn 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Robert Latta 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Latta: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Robert Latta 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Robert Latta 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Robert Latta 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Robert Latta 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Robert Latta 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Jake LaTurner 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative LaTurner: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Jake LaTurner 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Jake LaTurner 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Jake LaTurner 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Jake LaTurner 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Jake LaTurner 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Debbie Lesko 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Lesko: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Debbie Lesko 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Debbie Lesko 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Debbie Lesko 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Debbie Lesko 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Debbie Lesko 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Billy Long 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Long: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Billy Long 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Billy Long 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Billy Long 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Billy Long 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Billy Long 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Barry Loudermilk 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Loudermilk: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Barry Loudermilk 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Barry Loudermilk 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Barry Loudermilk 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Barry Loudermilk 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Barry Loudermilk 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Frank Lucas 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Lucas: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Frank Lucas 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Frank Lucas 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Frank Lucas 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Frank Lucas 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Frank Lucas 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Blaine Luetkemeyer 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Luetkemeyer: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Blaine Luetkemeyer 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Blaine Luetkemeyer 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Blaine Luetkemeyer 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Blaine Luetkemeyer 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Blaine Luetkemeyer 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Nancy Mace 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Mace: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Nancy Mace 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Nancy Mace 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Nancy Mace 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Nancy Mace 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Nancy Mace 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Tracey Mann 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Mann: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Tracey Mann 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Tracey Mann 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Tracey Mann 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Tracey Mann 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Tracey Mann 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Tom McClintock 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative McClintock: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Tom McClintock 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Tom McClintock 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Tom McClintock 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Tom McClintock 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Tom McClintock 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable David McKinley 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative McKinley: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable David McKinley 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable David McKinley 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable David McKinley 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable David McKinley 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable David McKinley 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

May 24, 2022 

The Honorable Cathy McMorris Rodgers 

Republican Leader

Committee on Energy and Commerce 

U.S. House of Representatives 

Washington, DC 20515 

Dear Ranking Member Rodgers: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below.

Update on Current Situation

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Cathy McMorris Rogers

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them.

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week.

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Cathy McMorris Rogers

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall.

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

• Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas.
Page 4 – The Honorable Cathy McMorris Rogers

• Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs.

• Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

• Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

• Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance tomanufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

• Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records.

• Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

• Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers.

• Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care
Page 5 – The Honorable Cathy McMorris Rogers

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Cathy McMorris Rogers

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future.

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term.

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely,

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak - S

Trzeciak -S Date: 2022.05.24

17:09:34 -04'00'

Kimberlee Trzeciak 

Associate Commissioner

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Peter Meijer 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Meijer: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Peter Meijer 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Peter Meijer 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Peter Meijer 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Peter Meijer 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Peter Meijer 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Mariannette Miller-Meeks 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Miller-Meeks: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Mariannette Miller-Meeks 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Mariannette Miller-Meeks 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Mariannette Miller-Meeks 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Mariannette Miller-Meeks 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Mariannette Miller-Meeks 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Carol Miller 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Miller: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Carol Miller 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Carol Miller 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Carol Miller 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Carol Miller 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Carol Miller 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable John Moolenaar 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Moolenaar: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable John Moolenaar 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable John Moolenaar 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable John Moolenaar 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable John Moolenaar 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable John Moolenaar 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Blake Moore 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Moore: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Blake Moore 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Blake Moore 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Blake Moore 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Blake Moore 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Blake Moore 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Markwayne Mullin 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Mullin: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Markwayne Mullin 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Markwayne Mullin 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Markwayne Mullin 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Markwayne Mullin 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Markwayne Mullin 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Gregory Murphy 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Murphy: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Gregory Murphy 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Gregory Murphy 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Gregory Murphy 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Gregory Murphy 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Gregory Murphy 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Dan Newhouse 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Newhouse: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Dan Newhouse 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Dan Newhouse 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Dan Newhouse 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Dan Newhouse 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Dan Newhouse 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Ralph Norman 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Norman: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Ralph Norman 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Ralph Norman 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Ralph Norman 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Ralph Norman 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Ralph Norman 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Steven Palazzo 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Palazzo: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Steven Palazzo 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Steven Palazzo 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Steven Palazzo 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Steven Palazzo 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Steven Palazzo 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Gary Palmer 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Palmer: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Gary Palmer 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Gary Palmer 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Gary Palmer 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Gary Palmer 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Gary Palmer 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Greg Pence 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Pence: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Greg Pence 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Greg Pence 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Greg Pence 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Greg Pence 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Greg Pence 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable August Pfluger 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Pfluger: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable August Pfluger 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable August Pfluger 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable August Pfluger 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable August Pfluger 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable August Pfluger 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Guy Reschenthaler 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Reschenthaler: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Guy Reschenthaler 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Guy Reschenthaler 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Guy Reschenthaler 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Guy Reschenthaler 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Guy Reschenthaler 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable John Rose 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Rose: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable John Rose 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable John Rose 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable John Rose 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable John Rose 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable John Rose 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable John Rutherford 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Rutherford: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable John Rutherford 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable John Rutherford 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable John Rutherford 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable John Rutherford 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable John Rutherford 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Maria Salazar 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Salazar: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Maria Salazar 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Maria Salazar 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Maria Salazar 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Maria Salazar 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Maria Salazar 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Sam Graves 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Graves: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Sam Graves 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Sam Graves 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Sam Graves 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Sam Graves 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Sam Graves 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Steve Scalise 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Scalise: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Steve Scalise 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Steve Scalise 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Steve Scalise 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Steve Scalise 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Steve Scalise 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Austin Scott 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Scott: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Austin Scott 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Austin Scott 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Austin Scott 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Austin Scott 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Austin Scott 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Mike Simpson 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Simpson: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Mike Simpson 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Mike Simpson 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Mike Simpson 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Mike Simpson 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Mike Simpson 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Jason Smith 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Smith: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Jason Smith 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Jason Smith 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Jason Smith 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Jason Smith 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Jason Smith 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Peter Stauber 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Stauber: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Peter Stauber 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Peter Stauber 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Peter Stauber 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Peter Stauber 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Peter Stauber 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Elise Stefanik 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Stefanik: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Elise Stefanik 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Elise Stefanik 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Elise Stefanik 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Elise Stefanik 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Elise Stefanik 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Chris Stewart 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Stewart: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Chris Stewart 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Chris Stewart 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Chris Stewart 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Chris Stewart 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Chris Stewart 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Claudia Tenney 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Tenney: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Claudia Tenney 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Claudia Tenney 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Claudia Tenney 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Claudia Tenney 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Claudia Tenney 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable GT Thompson 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Thompson: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable GT Thompson 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable GT Thompson 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable GT Thompson 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable GT Thompson 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable GT Thompson 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable William Timmons 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Timmons: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable William Timmons 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable William Timmons 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable William Timmons 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable William Timmons 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable William Timmons 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Fred Upton 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Upton: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Fred Upton 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Fred Upton 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Fred Upton 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Fred Upton 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Fred Upton 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable David Valadao 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Valadao: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable David Valadao 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable David Valadao 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable David Valadao 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable David Valadao 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable David Valadao 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Jeff Van Drew 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Van Drew: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Jeff Van Drew 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Jeff Van Drew 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Jeff Van Drew 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Jeff Van Drew 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Jeff Van Drew 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Beth Van Duyne 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Van Duyne: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Beth Van Duyne 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Beth Van Duyne 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Beth Van Duyne 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Beth Van Duyne 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Beth Van Duyne 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Ann Wagner 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Wagner: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Ann Wagner 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Ann Wagner 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Ann Wagner 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Ann Wagner 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Ann Wagner 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Tim Walberg 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Walberg: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Tim Walberg 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Tim Walberg 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Tim Walberg 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Tim Walberg 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Tim Walberg 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Jackie Walorski 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Walorski: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Jackie Walorski 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Jackie Walorski 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Jackie Walorski 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Jackie Walorski 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Jackie Walorski 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Michael Waltz 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Waltz: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Michael Waltz 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Michael Waltz 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Michael Waltz 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Michael Waltz 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Michael Waltz 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Daniel Webster 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Webster: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Daniel Webster 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Daniel Webster 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Daniel Webster 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Daniel Webster 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Daniel Webster 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Brad Wenstrup 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Wenstrup: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Brad Wenstrup 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Brad Wenstrup 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Brad Wenstrup 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Brad Wenstrup 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Brad Wenstrup 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Roger Williams 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Williams: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Roger Williams 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Roger Williams 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Roger Williams 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Roger Williams 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Roger Williams 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

w ww.fda.gov

May 24, 2022 

The Honorable Rob Wittman 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Wittman: 

Thank you for your letter of May 11, 2022, cosigned by several of your colleagues, to the Food 

and Drug Administration (FDA or the Agency) regarding the shortage in the availability of infant 

formula. Ensuring that parents and caregivers have access to safe and nutritious infant formula is 

of utmost importance to the Agency. FDA remains committed to closely monitoring the 

availability of all types of infant formula and is working diligently to support the supply of infant 

formula products using all of its available tools. As requested in your letter, Agency staff are 

available to discuss our infant formula supply chain monitoring and mitigation efforts, as well as 

additional tools that would be helpful to prevent, monitor, and mitigate any future infant formula 

shortages. 

The infant formula supply chain is controlled by a small number of producers who have a 

handful of manufacturing facilities – which means that any perturbation or cause for a facility to 

halt production will lead to disruption in supply. Further, FDA would need both additional 

authorities and resources to create a robust supply chain monitoring program for this critical 

product, which serves as the sole source of nutrition for infants. Despite this, FDA has taken 

aggressive steps to intervene and bolster infant formula supplies due to Abbott’s voluntary recall 

of infant formula on February 17, 2022. 

FDA believes that the safe restart of production at Abbott, the increased production of other 

manufacturers, and the arrival of additional products under FDA’s recently issued infant formula 

flexibility guidance – all working in concert together – will steadily improve availability on store 

shelves over the coming days and weeks. FDA will keep your offices closely updated on this. 

Your letter raises questions that fall into four broad areas, which we address below. 

Update on Current Situation 

Increasing the availability of safe infant formula is of the utmost importance to FDA. We are 

doing everything in our power as part of the all-of-government efforts to ensure there is adequate 

product available wherever and whenever parents and caregivers need it. FDA began alerting 

federal partners and stakeholders about potential supply disruptions even before Abbott 

voluntarily recalled product. Just after, FDA reached out to infant formula manufacturers to seek
Page 2 – The Honorable Rob Wittman 

more supply chain insight and to increase production. FDA has since met regularly with federal 

partners and worked with stakeholders to mitigate supply disruptions and bolster supply. FDA 

has also leveraged IRI data to monitor in-stock rates of formula and has been working to get 

more of the right formulas to the right places where families, parents, and caregivers need them. 

Importantly, on May 16, 2022, a consent decree of permanent injunction between FDA and 

Abbott Nutrition, as well as three Abbott principals, was entered in the U.S. District Court for the 

Western District of Michigan. FDA sought a negotiated consent decree with Abbott because 

FDA lost confidence in the firm’s food safety culture, but also knew that a rapid restart of 

production at Sturgis was critical to address the supply of specialty metabolic formulas, amino 

acid formulas, and regular formulas. Under the consent decree, Abbott has agreed to take 

corrective actions following the FDA inspection of its Sturgis facility. The consent decree 

obliges Abbott to take actions that are expected to ultimately result in an increase of infant 

formula products, while also ensuring that the company undertakes actions that would ensure 

safe powdered infant formula is produced at the facility. When the company decides to restart 

production at this facility, it must conform with the provisions of the consent decree and meet 

FDA food safety standards. If contamination is identified, the company must notify FDA, 

identify the source of the problem and conduct a root-cause investigation before resuming 

production. Under the consent decree, Abbott Nutrition is required to retain an independent 

expert to review the Sturgis facility’s operations to ensure compliance with the law. The consent 

decree also includes requirements for testing products, as well as the implementation of a 

sanitation plan, environmental monitoring plan, and employee training programs. Abbott has 

been aware of the sanitation and equipment issues that the firm needed to correct since FDA 

closed the inspection and issued a 483 to the firm on March 18, 2022. FDA is in close touch 

with Abbott, and we are eagerly awaiting the firm to resume production. 

Also on May 16, FDA announced a guidance that outlines increased flexibilities regarding 

importation of certain infant formula products to further increase the availability of infant 

formula across the country while protecting the health of infants. The Agency is encouraging 

infant formula manufacturers worldwide to take advantage of these flexibilities. Within the first 

days following this announcement, we received multiple requests and hope that more companies 

seeking to take advantage of these flexibilities will submit information for FDA to quickly 

evaluate whether the product can be used safely and whether it provides adequate nutrition. We 

have already issued two enforcement discretion letters – and hope to issue more soon. The 

information that will help us review these requests expeditiously includes labeling, information 

on nutritional adequacy and safety testing, and information about facility inspection history. The 

Agency is prioritizing submissions for products that can demonstrate the safety and nutritional 

adequacy and have the largest volume of product available and/or those who can get product 

onto U.S. shelves the quickest. FDA has also worked with federal partners to airlift additional 

amino acid and hypoallergenic hydrolyzed formula from Nestle facilities in Europe; the amino 

acid formulas arrived in Indiana on May 22, 2022, and the hydrolyzed formula is expected to 

arrive later this week. 

FDA also has been in discussions with formula manufacturers and suppliers regarding additional 

supply throughout our response, and infant formula manufacturers are all reporting that they are 

producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of 
Page 3 – The Honorable Rob Wittman 

their infant formula available to consumers by approximately 50 percent in March and April and 

Reckitt is supplying more than 30 percent more product year to date. 

This increased production is now evident in increased infant formula sales. According to data 

from Information Resources Inc. (IRI), national infant formula sales by volume for the month of 

April were up more than 13 percent compared to the month prior to the recall and national infant 

formula sales by unit for the month of April are also up by more than 5 percent compared to the 

month prior to the recall. 

While some data suppliers have reported lower in-stock rates, the most complete data sets 

available from IRI are showing nearly 80 percent in-stock rates at the week ending May 15. This 

means that if a local supermarket normally carries 50 different infant formula products, an 80 

percent in-stock rate would translate to 40 of those 50 product types being available. 

What the sales volume data and in-stock rates tell us is that while there is more product being 

sold, it may be of less variety than prior to the recall. With increased production by other 

manufacturers, additional import actions, and the potential for Abbott Nutrition’s Sturgis facility 

to resume production in the near-term, FDA expects supply to continue to steadily improve in the 

coming days and weeks. 

FDA Actions to Date 

The United States was facing infant formula supply chain stress even before the Abbott Nutrition 

recall that began on February 17, 2022, due to pandemic-related issues (worker absenteeism due 

to COVID-19, labor challenges, ingredient shortages, and logistical bottle necks). Thus, even 

prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition 

Sturgis facility, FDA was working to address supply chain issues associated with the pandemic, 

including those impacting the infant formula industry. Specifically, FDA was in communication 

with infant formula manufacturers and the Infant Nutrition Council of America (INCA) before 

the recall to discuss supply chain challenges and seek out real time feedback of the status of the 

marketplace. Additionally, during the pandemic and still ongoing, FDA has been working with 

manufacturers to review, as expeditiously as possible, their data submissions related to minor 

changes, mostly in ingredients and packaging, in their products stemming from supply chain 

issues which helps to alleviate any unnecessary disruptions to the supply that might otherwise 

have occurred. 

To help increase the current supply of infant formula, FDA is leveraging all of the tools at its 

disposal. The Agency continues to take several significant actions, including: 

 Meeting regularly with major infant formula manufacturers to better understand their 

capacity to increase production of various types of infant formulas and medical 

foods. The infant formula industry is working to maximize their production to meet 

new demands. Efforts already underway by several infant formula manufacturers 

include optimizing processes and production schedules to increase product output, as 

well as prioritizing product lines that are of greatest need, particularly the specialty 

formulas. 
Page 4 – The Honorable Rob Wittman 

 Helping manufacturers bring safe product to the market by expediting review of 

notifications of manufacturing changes that will help increase supply, particularly in 

the case of the specialized formulas for medical needs. 

 Monitoring the status of the infant formula supply by using the Agency’s 21 

Forward food supply chain continuity system, combined with external data (more 

information below). 

 Compiling data on trends for in-stock rates at both national and regional levels to 

help understand whether the right amount of infant formula is available in the right 

locations, and if not, where it should go. 

 Expediting the necessary certificates to allow for flexibility in the movement of 

already permitted products from abroad into the U.S. Currently, FDA has reviewed 

and expedited two USDA export certificates which helped to bring additional infant 

formula into the U.S. market. After the publication of the guidance to manufacturers 

of infant formula about temporary enforcement discretion, we expect that number to 

grow. 

 Offering a streamlined import entry review process for certain products coming from 

foreign facilities with favorable inspection records. 

 Exercising enforcement discretion on minor labeling issues (e.g., product labeled 

“Not for Individual Sale” or product with the incorrect manufacturing location 

identified, while other tracking and contact information is correct) for both domestic 

and imported products to help increase volume of product available as quickly as 

possible. 

 Reaching out to retailer stakeholder groups to request that their members consider 

placing purchase limits on some products in order to protect infant formula 

inventories for all consumers. 

 Worked to prioritize the release of metabolic and amino acid formulas produced at 

the Sturgis facility and asked Abbott to develop a process to provide access in 

critical conditions. Abbott Nutrition has allowed individuals needing urgent, lifesustaining supplies of certain specialty and metabolic formulas to access these 

formulas on a case-by-case basis that have been on hold at its Sturgis facility (more 

information below). 

FDA understands that availability of specialty products such as amino acid-based specialty 

formulas and metabolic products continues to be of concern. In fact, FDA prioritized the 

metabolic products stored at the Sturgis facility and agreed with Abbott to exclude them from the 

recall given they serve as a sole source of nutrition for infants with rare diseases and disorders, 

and we knew there were limited or no alternatives available. FDA asked Abbott to develop a 

process to release these products, and Abbott is allowing their case-by-case release in consult 

with healthcare providers. The risk of not having certain specialty and metabolic products 

available could significantly worsen underlying medical conditions, and in some cases, pose lifethreatening risks for individuals who rely on these products. In these circumstances, the benefit 

of allowing caregivers, in consultation with their healthcare providers, to access these products 

may outweigh the potential risk of bacterial infection. FDA is working to ensure health care 
Page 5 – The Honorable Rob Wittman 

provider associations and stakeholders understand information about the risks and benefits of 

pursuing this product. 

Meanwhile, these products have been an area of focus for discussions with other manufacturers 

that make comparable products. As a result of the recall and work with FDA, other 

manufacturers have increased production of comparable product lines and in some cases 

expedited the importation of these products where they exist. 

Stakeholder Outreach 

In addition to frequent calls with infant formula manufacturers domestically and abroad, FDA 

has been in communication with the families, health care providers, and other Department of 

Health and Human Services (HHS) programs affected by the infant formula shortage. We are 

partnering with the United States Department of Agriculture’s Food and Nutrition Service (FNS) 

to monitor the impact of the recall on the Special Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Program. FDA has also been in communication and working with 

associations of healthcare professionals such as the American Academy of Pediatrics, the 

American Society of Pediatric Nephrology, and Genetic Metabolic Dietitians International to 

identify possible alternatives to the affected formulas and provide information that may be 

helpful to their members in working with individual parents and caregivers. FDA has also been 

in communication with support and advocacy groups for individuals with inherited metabolic 

disorders regarding Abbott’s program to provide limited release of its specialty formulas for such 

conditions on a case-by-case basis for individuals in dire need. These additional stakeholder 

groups include the Society of Inherited Metabolic Disorders and the Maple Syrup Urine Disease 

Family Support Group. 

Supply Chain Monitoring 

Monitoring the supply of infant formula availability has been key to informing our response and 

helping the Agency focus on the areas of greatest need. FDA is monitoring the availability of 

infant formula products using a data analytics platform called 21 Forward, combined with 

external data. 21 Forward was developed during the pandemic to provide a comprehensive, databacked understanding of how the pandemic is impacting all nodes in the food supply chain, from 

producers and growers to grocery stores. Although originally designed to address the broader 

food supply during the pandemic, the Agency has adapted it for monitoring and supporting infant 

formula supplies by adding additional data sets to provide more frequent and granular 

information about infant formula product availability and sales. Combining these various sources 

of data has provided FDA with as full a picture as possible on the current and future status of 

supply. 

This information has helped guide numerous discussions with industry on how to increase 

production of various types of infant formulas and medical foods. Manufacturers’ efforts are 

already underway to maximize production to meet demand, including optimizing production 

lines and packaging to increase capacity; prioritizing product lines that are of greatest need 

(particularly for specialty formulas); expanding hours of operation for manufacturing facilities; 

and expediting the importation of product produced at facilities located abroad. 
Page 6 – The Honorable Rob Wittman 

Strengthening data tool sets at FDA and in other agencies is critical to enhancing infant formula 

supply chain resiliency. We need a sustainable mechanism for infant formula supply chain 

monitoring to allow us to better identify and address existing and future potential supply chain 

disruptions. However, funding for 21 Forward expires in September 2022, and our external data 

purchases are short-term. FDA is interested in exploring options to continue this program into 

the future. 

The wide-reaching impacts of a recall from a single infant formula manufacturing facility 

underscores the risks and vulnerabilities in the supply chain. Building resiliency across the infant 

formula supply chain will better-enable us to withstand any future disruptions without a 

significant breakdown in supply. To this end, we are exploring additional mechanisms to 

incentivize flexibility and redundancy of the infant formula supply chain infrastructure to 

increase resiliency in the infant formula industry over the long-term. 

We also have identified legislative changes in the President’s fiscal year (FY) 2023 budget 

request that would provide new tools to help FDA prevent or mitigate shortages of infant 

formula and essential medical foods. Our proposal would require firms to notify FDA of 

anticipated significant interruptions in the supply of infant formula or essential medical foods, 

which would allow the Agency to receive timely and accurate information about likely or 

confirmed shortages in the U.S. marketplace, better enabling us to take steps that promote the 

continued availability of these important foods, which often are a sole source of nutrition. In 

light of the current situation, we have also begun considering what additional tools would be 

helpful to prevent, monitor, and mitigate any future infant formula shortages. We would be 

happy to discuss with you or your staff once we have more information available. 

We understand the stress and anxiety that this shortage is causing parents and caregivers. 

We’re working with industry 24/7 to do all that we can so that consumers can find the 

products they need, where they shop, and when they need them. We will keep your offices 

closely updated as we continue our actions to bolster the supply of formula, and hope to work 

with you on additional tools that will allow FDA to do more. An identical response has been 

sent to your cosigners. 

Sincerely, 

Digitally signed by

Kimberlee R. Kimberlee R. Trzeciak ‐ S

Trzeciak ‐S Date: 2022.05.24

17:09:34 ‐04'00'

Kimberlee Trzeciak 

Associate Commissioner 

for Legislative Affairs
May 17, 2022 

Robert M. Califf, M.D. 

Commissioner 

Food and Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

Dear Commissioner Califf, 

Parents and families across the country are feeling the effects of the shortage of infant formula. 

Infant formula is a critical tool in ensuring that children’s nutritional needs are met. The Centers 

for Disease Control and Prevention report that only 25.8% of infants are exclusively breastfed by 

the time they are 6 months old. Without access, parents are left with few options to keep their 

children healthy. My home state of Oregon is facing a 34% out-of-stock rate, resulting in severe 

consequences from price gouging to milk banks not being able to serve low-income families. As 

the Food and Drug Administration (FDA) encourages the importation of infant formula from 

outside the United States and the domestic distribution of formula produced for export, I urge 

you to swiftly provide guidance to manufacturers that would assist them as they look at this 

temporary pathway. 

The monopoly that the three major manufacturers have on the current market has led us to this 

current moment. Consistent with the Biden-Harris Administration’s efforts to promote 

competition in the American economy, allowing more producers to enter the market will ease 

shortages and make the market more competitive. I recently heard from a local manufacturer, 

Cascadia Nutrition, who produces infant formula that meets quality standards at an FDAapproved facility in the United States but because they have not undergone clinical trials, they 

can only distribute this product internationally. They are among a number of smaller 

manufacturers who have the production capability and supply to meet the current needs. 

In the wake of the FDA’s announcement, expedited guidance could provide clarity for those 

companies that seek to domestically distribute product manufactured for export. If there is 

product produced in the United States and safely consumed by children abroad, it is my view that 

it should also be able to be distributed in the United States. Smaller companies that do not have 
the resources to undergo clinical testing but adhere to the same quality metrics as larger 

companies should not be penalized at this critical moment and, more importantly, neither should 

our communities. The FDA must work with these manufacturers to utilize their sorely-needed 

supply in accordance with applicable laws and regulations. 

Thank you for your consideration. 

Sincerely, 

Earl Blumenauer 

Member of Congress 
May 18, 2022

VIA ELECTRONIC TRANSMISSION

The Honorable Robert Califf, M.D.

Commissioner

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, M.D. 20993

Dear Commissioner Califf: 

Thank you for your efforts to ensure food safety at the Food and Drug Administration (FDA). For 

decades, the FDA has been the gold standard for approving and regulating medical products and 

food. Yet this year, the actions of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN)

has raised questions regarding its ability to fulfill its core oversight responsibilities. The safety of,

and access to, infant formula should be among CFSAN’s highest priorities, as this food is vital for 

the growth and development of infants. To this end, we write to request a response from FDA on its 

activities that may have contributed to the exacerbated infant formula shortages and specific 

questions in the following paragraphs. It is our responsibility as U.S. Senators to do everything with 

our authority to hold the FDA accountable and legislate in areas that will enable the agency to meet 

the expectations of the American people. 

Our hearts and prayers are with the parents and their families whose babies tragically died due to 

infant formula bacterial contamination. We understand and want to support the FDA in thoroughly 

evaluating all reported and potential infant formula contaminations. However, based on the timeline

and where we are today, it is unclear as to why nearly three months have gone by and the FDA has

failed to expeditiously conduct and conclude its investigation. On February 17, Abbott Nutrition 

initiated a proactive, voluntary recall of three of its powdered formulas manufactured at their facility 

in Michigan following four consumer complaints of potential Cronobacter bacteria contamination.

1

 

1 Abbott, Abbott Voluntarily Recalls Powder Formulas Manufactured at One Plant, February 17, 2022, 

https://abbott mediaroom.com/2022-02-17-Abbott-Voluntarily-Recalls-Powder-Formulas-Manufactured-at-One-Plant. See also 

U.S. Food and Drug Administration, Company Announcement: Abbott Voluntarily Expands Recall of Powder Formulas 

Manufactured at One Plant, February 17, 2022, https://www fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbottvoluntarily-recalls-powder-formulas-manufactured-one-plant.
The following day, FDA warned consumers not to use these products.2 On April 15, the U.S. Centers 

for Disease Control and Prevention concluded the bacteria isolated from two of the sick infants and 

the Michigan facility had no connection. And as of last week, no connection has been found, yet the 

facility remains idle.3, 4

We are also concerned as to why FDA leadership failed to be proactive in mitigating the shortage 

crisis parents are now facing. The COVID-19 pandemic revealed many vulnerabilities across all 

sectors of industry, and our food supply chain was woefully unprepared to handle challenges here 

and from foreign partners. Infant formula supplies at local grocery stores were relatively stable for 

the first half of 2021. The out-of-stock percentage started to climb steadily in the later half and 

continued to worsen throughout this year.5 Abbott Nutrition’s voluntary recall exacerbated the 

shortage, and yet no policies were taken to mitigate the sharp increases to the current out-of-stock 43 

percent the Administration is now scrambling to address. It’s also concerning that FDA and key 

officials in the Administration did not anticipate this crisis or take action within days following 

Abbott Nutrition’s voluntary recall considering the company holds 48.1 percent of the U.S. market in 

infant formula.6

Families are getting to the brink of pursuing unsafe and potentially dangerous options to feed their 

infants including homemade infant formula. And physicians are, once again, running defense on 

misinformation due to a lack of federal action to get the word out on safe alternatives.7, 8, 9In 

addition, the shortage will trickle into other federal agencies, diverting and stretching resources from 

other crises like illicit fentanyl. In April, the U.S. Customers and Border Protection (CBP) seized 

$30,000 worth of unapproved infant formula across 17 shipments at the Philadelphia, Pennsylvania 

port of entry.10

Based on the timeline, it is unclear why federal health agencies have not been able to complete this 

investigation in a more expeditious manner or plan ahead to mitigate this additional supply chain 

disruption. Therefore we respectfully request your responses to the following questions:

1. The manufacturing facility in Michigan is segmented where manufacturing designated areas 

are required to adhere to specific safety and infection control standards. The facility also 

 

2 Kansas Department of Health and Environment, KDHE & FDA warn consumers not to use select Similac, Alimentum & 

EleCare powdered infant formula, February 18, 2022, https://www.kdhe.ks.gov/CivicAlerts.aspx?AID=147. 

3 Abbott, Press Release: Abbott Provides Infant Formula Update, May 11, 2022, 

https://www.abbott.com/corpnewsroom/nutrition-health-and-wellness/abbott-update-on-powder-formula-recall html. 

4 U.S. Centers for Disease Control and Prevention, Cronobacter and Powdered Infant Formula Investigation, accessed May 12, 

2022 (updated May 12, 2022), https://www.cdc.gov/cronobacter/outbreaks/infant-formula html. 

5 Datasembly, Nation-wide Out-Of-Stock is now at 43% for the week ending May 8th, May 10, 2022, 

https://datasembly.com/news/out-of-stock-rate-in-april-2022-copy/. 

6

IBISWorld, Industry Report: Infant Formula Manufacturing, by Jack Curran, August 2020, https://www.ibisworld.com/unitedstates/market-research-reports/infant-formula-manufacturing-industry/. 

7 The New York Times, Why Doctors Don’t Recommend Homemade Baby Formula, by Catherine Pearson, May 11, 2022, 

https://www.nytimes.com/2022/05/11/well/homemade-baby-formula.html. 

8 KAKE ABC, Homemade infant formula can be dangerous. Experts share how to feed your baby through the shortage, by 

Madeline Holcombe, May 11, 2022, https://www.kake.com/story/46472922/homemade-infant-formula-can-be-dangerousexperts-share-how-to-feed-your-baby-through-the-shortage.

9 Bloomberg, Parents Are Trying Homemade Baby Formula. Doctors Say They Shouldn’t, by Allison Nicole Smith and Kelsey 

Butler, May 12, 2022, https://www.bloomberg.com/news/articles/2022-05-12/why-parents-making-homemade-infant-formulashould-beware-of-serious-health-risks. 

10 U.S. Customs and Border Protection (CBP), Philadelphia CBP Seizes Nearly 600 Cases of Infant Formula Unapproved for 

Import to the United States, April 5, 2021, https://www.cbp.gov/newsroom/local-media-release/philadelphia-cbp-seizes-nearly600-cases-infant-formula-unapproved. 
maintains areas that are administrative and do not directly handle manufacturing or exposure 

of open products. Please describe the areas in which the FDA has taken samples and how 

many samples were taken that would empirically validate the results of the investigation. In 

your explanation, please also include the expected timeline for each task and if CFSAN has 

met its obligations.

2. As noted in the paragraph above, the CDC concluded that the samples taken did not match 

the bacteria in the facility. How does the FDA partner with other agencies at the federal, 

state, and/or local level to expedite investigations to forestall potential supply chain crises? 

To what extent do other agencies or organizations advance or hinder a timely investigation?

3. Why has it taken more than three months to complete the obligations required to finalize a 

safety inspection?

4. At what point did the FDA alert the White House of the bacteria and the product recall?

5. Did the FDA, along with the White House, have a strategic plan in place to mitigate formula

shortages? If yes, please provide a brief description, date of implementation, actions the 

agency has taken, and expected timelines to enable manufacturers to produce, process and 

deliver food during supply chain disruptions. 

6. Did or has the FDA made any recommendations to the White House about what actions the 

agency can take to prepare or handle the shortage? 

7. The manufacturing facility in Sturgis, Michigan is the only Abbott plant to produce 

specialized formula for infants with metabolic disorders. How is the FDA going to work with 

Abbott and other formula manufacturers to ensure that the special medical needs of infants 

can be met?

8. Abbott Nutrition, along with other infant formula manufacturers, have registered domestic 

and foreign sites to manufacture infant formula for interstate commerce in the U.S. Abbott 

Nutrition’s facility in Ireland is an FDA-registered facility. It also has several other facilities 

in the Netherlands, Spain, and France that manufacture infant formula. What steps has FDA 

taken to increase importation by accrediting more manufacturing facilities overseas?

9. At what point was the White House made aware that these importation options were available 

to ease the strain on domestic capacity?

10. Whose decision was it to ease these requirements on formula from foreign manufacturers?

11. In White House press briefings last week, the Press Secretary and others within the Biden

Administration appeared to blame Abbott Nutrition for the deaths and shortages, despite the 

fact that the investigation is not concluded.11, 12 Did the FDA state to the White House that 

Abbott Nutrition was responsible for the illnesses or deaths? 

The shortage, felt by all families in need, is disproportionately impacting vulnerable populations. As 

you know, Medicaid is a major source of coverage for low-income vulnerable populations including 

pregnant women, infants, and children. In 2020, Medicaid covered 42 percent of births.13 In addition, 

 

11 The Hill, White House goes on defense on baby formula shortage, by Alex Gangitano, May 13, 2022, 

https://thehill.com/news/administration/3487765-white-house-goes-on-defense-on-baby-formula-shortage/. 

12 The Hill, Buttigieg points blame at Abbott for baby formula shortage, by Monique Beals, May 15, 2022, 

https://thehill.com/news/administration/3489439-buttigieg-points-blame-at-abbott-for-baby-formula-shortage/.

13 March of Dimes, Health Insurance/Income, 

https://www.marchofdimes.org/peristats/data?reg=99&top=11&stop=154&lev=1&slev=1&obj=18. 

Thom Tillis Cindy Hyde-Smith

U.S. Senator U.S. Senator

John Thune James Lankford

U.S. Senator U.S. Senator

Steve Daines Ted Cruz

U.S. Senator U.S. Senator

Roy Blunt John Kennedy

U.S. Senator U.S. Senator