TESTIMONY

OF

SUSAN T. MAYNE, Ph.D.

DIRECTOR

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)

FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE

SUBCOMMITTEE ON HEALTH CARE AND FINANCIAL SERVICES 

COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY

U.S. HOUSE OF REPRESENTATIVES

“FDA OVERSIGHT PART II: RESPONSIBILITY FOR THE INFANT FORMULA 

SHORTAGE”

May 11, 2023 

RELEASE ONLY UPON DELIVERY
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INTRODUCTION

Chairwoman McClain, Chairman Comer, Ranking Member Porter, Ranking Member Raskin, 

and members of the Subcommittee, thank you for inviting me to testify about the Food and Drug 

Administration’s (FDA’s or the Agency’s) work on infant formula. FDA is committed to doing 

everything we can within our authorities to help avoid future supply shortages and ensure parents 

and caregivers have access to an abundant supply of safe and nutritious infant formula. To that 

end, we are taking significant actions to continually strengthen our own operations and working 

across the government to optimize supply chains and access, while holding industry accountable.

BACKGROUND

The United States has one of the safest food supplies in the world. Most people in the United 

States eat their food without having to give much thought to safety and without encountering any

safety issues, which reflects the effectiveness of our current food safety system. Indeed, 

independent experts have recognized the U.S. food supply as being among the safest in the 

world. For example, The Economist publishes an annual report that measures the Global Food 

Security Index (GFSI), which considers food affordability, availability, quality and safety, and 

sustainability and adaptation, across 113 countries. In the 2022 GFSI Report, the United States 

received its highest ranking for the “food quality and safety” category—ranking third in the 

world in this category behind Canada and Denmark.1 The report states this ranking is supported 

by the United States’ score of 100 percent on several indicators in this category, including food 

safety and nutritional standards.

2 Further, the report notes that the United States has moved up 25 

positions for the food safety indicator since 2012 and is now tied for first.

At the same time, we recognize that our system is not perfect. FDA is an important part of the 

food quality and safety system of the United States, as we regulate about 78 percent of the food 

supply. Our job as regulators is to follow the science, set standards, and then verify that industry 

is doing their part to meet those standards. Other key parts of the nation’s food quality and safety 

system include the producers and manufacturers of our food. They are on the frontline, with the 

ultimate responsibility of safeguarding the safety, quality and availability of our nation’s food. 

As a nation, we all suffer when they do not meet that responsibility, as illustrated by last year’s

infant formula recall and shutdown of Abbott Nutrition’s Sturgis, Michigan facility. These 

actions were taken following several reports of Cronobacter infections in infants who had 

reportedly consumed powdered infant formula from that facility, a confidential disclosure 

document from a whistleblower who worked there, and egregious findings from an FDA 

inspection. 

Shortly after the voluntary recall by Abbott and associated Sturgis facility shutdown, parents and 

caregivers began experiencing shortages of infant formula products. FDA worked with Abbott, 

other infant formula manufacturers, and federal partners to address the shortage. Since 2022, 

FDA has engaged in several actions to address the issues identified and distill key lessons 

learned, as outlined in more detail below. In addition, FDA engaged in two reviews of the 

1 See “United States,” Global Food Security Index 2022, ECONOMIST IMPACT, available at 

https://impact.economist.com/sustainability/project/food-security-index/explore-countries/united-states. 2 See id.
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Agency’s infant formula response: an internal review of the Abbott recall and a comprehensive 

external evaluation of the Human Foods Program by the Reagan-Udall Foundation (RUF). Based 

on these reviews and the lessons learned from 2022, the Agency is committed to taking actions 

to strengthen our own operations, to work with our federal partners to optimize supply chains 

and access to safe and nutritious infant formula, and to hold industry accountable to ensure a safe 

and reliable infant formula supply.

LESSONS LEARNED 

FDA has reflected on the Abbott recall and infant formula shortage, and we would like to share 

with the Subcommittee some of the key lessons learned. 

First, there are additional actions that the infant formula industry needs to take to ensure the 

safety of the food they produce. FDA has reviewed conditions during recent inspections of 

powdered infant formula manufacturers and has identified numerous areas for improvement 

across the industry. We outlined these areas in a March 8, 2023, letter to infant formula 

manufacturers, packers, distributors, exporters, importers, and retailers, which was a call to 

action for all members of the infant formula industry to help better protect our most vulnerable 

population. Among other things, FDA is urging industry to evaluate established systems of 

production and in-process controls and to ensure that appropriate controls are implemented at 

any point, step, or stage in the production process where control is necessary to prevent 

adulteration of infant formula.3 While FDA has a regulatory role in setting safety standards and

verifying compliance, industry bears the responsibility to produce to the highest possible 

standards and maintain their facilities so recalls and shutdowns are minimized.

Second, the U.S. infant formula market is concentrated, and the high concentration in the infant 

formula industry means any interruption could have outsized market effects. There are only three 

major domestic producers of infant formula—only two of which produce specialized medical 

formulas. This means that any potential disruption—whether it be a recall or a natural disaster—

can, and did, place outsized stress on the infant formula supply. This is why the first lesson 

learned is so critical: one important way to prevent future shortages in such a concentrated 

industry is through a stronger focus on food safety.

Third, the Abbott recall was not the only contributor to the formula shortage. The infant formula 

supply was already under strain due to labor and supply chain challenges associated with the 

COVID-19 pandemic and the conflict in Ukraine, which decreased access to crucial formula 

ingredients. The situation was also exacerbated by a lack of meaningful risk management plans 

from manufacturers to prepare for unforeseen manufacturing or supply chain disruptions, often 

making it difficult or impossible to switch production of specific formulas to different lines or 

plants in the near-term to respond to these disruptions. Furthermore, lower volume and less 

variety of formula on store shelves contributed to consumer purchasing behavior, which can be 

driven by media exposure. Specifically, with regard to the infant formula shortage, there was a 

3 See “March 8, 2023, Letter to Infant Formula Manufacturers, Packers, Distributors, Exporters, Importers, and 

Retailers,” FOOD AND DRUG ADMINISTRATION, available at https://www.fda.gov/media/166044/download.
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large spike in infant formula purchases which peaked in May 2022 and contributed to increased 

draw down of formula inventories and further depleted product that was in the supply chain.4

 

Fourth, extensive data gaps surrounding Cronobacter and associated infections exist, including 

epidemiology, genomics, and prevalence of contamination in varying environments. This is 

largely due to the fact that the vast majority of states do not require Cronobacter infection to be 

reported to state health departments. Also, Cronobacter infection is not a nationally notifiable 

condition unlike many illnesses caused by foodborne pathogens, meaning that states are also not 

reporting most cases to the Centers for Disease Control and Prevention (CDC). CDC and FDA 

do receive some notifications of Cronobacter infection outside of the process used for most other 

foodborne pathogens that are nationally notifiable. Further, Cronobacter bacteria are commonly 

found in a number of environments, including in homes, and since infections are seemingly rare, 

the source of infections is not well understood. With limited reporting of an infection that is 

seemingly rare, public health agencies have extremely limited data in libraries of genomic 

sequences of these pathogens compared with foodborne pathogens like Salmonella. Robust 

genomic data libraries are needed to maximize the ability to definitively link clinical samples to 

their source and to identify repeat sources of clinical illnesses.

Finally, FDA’s internal evaluation of agency activities and decision-making, as well as the

external, independent evaluation of FDA’s Human Foods Program convened by the RUF, 

highlight the need for operational improvements within FDA. We support the findings of these 

evaluations and are actively working to implement their recommendations.

PATH FORWARD

FDA Actions

FDA is committed to doing everything within our authorities to ensure the safety and availability 

of infant formula. For instance, when the infant formula shortage became apparent in 2022, FDA 

sought to provide relief by enabling available, safe, and nutritious products to enter the U.S. 

market by temporarily exercising enforcement discretion, on a case-by-case basis, for certain 

infant formula requirements.5 Twelve manufacturers brought their infant formula products into 

the U.S. market under this flexibility.

6 In September 2022, FDA issued an Infant Formula

Transition Plan guidance that outlines a path for interested firms marketing products in the 

United States under the exercise of enforcement discretion. The path outlined in the guidance

aims to bring those products into compliance with U.S. requirements to facilitate longer-term 

4 See “Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market,” FOOD AND DRUG 

ADMINISTRATION, pg. 5, available at https://www.fda.gov/media/166520/download. 5 See “Guidance for Industry: Infant Formula Enforcement Discretion Policy,” FOOD AND DRUG ADMINISTRATION, 

May 2022, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidanceindustry-infant-formula-enforcement-discretion-policy. 6

See “Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies,” FOOD AND DRUG 

ADMINISTRATION, available at https://www.fda.gov/food/infant-formula-guidance-documents-regulatoryinformation/enforcement-discretion-manufacturers-increase-infant-formula-supplies.
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availability and help diversify manufacturers providing products in the U.S. market.7 As a result, 

the number of manufacturers providing formula to the U.S. market has doubled. These 

flexibilities, combined with increased production from existing manufacturers, have resulted in

in-stock rates returning to levels that exceed the levels before the recall.

8

We have also made many operational improvements at FDA in response to recommendations in 

the internal review and the RUF report. To highlight a few since the Abbott recall, FDA has:

• Engaged in a broad, Agency-wide effort to reorganize and strengthen the Human Foods 

Program;

• Revised the internal consumer complaint procedure to strengthen the escalation process, 

thus better defining when certain consumer complaints need to be escalated to the most 

senior officials;

• Expanded and significantly improved a required infant formula training course for 

investigators to ensure every infant formula inspection is robust, thorough, and focused

on the most critical aspects of the infant formula manufacturing process;

• Initiated hiring for key positions to support the new Office of Critical Foods that is 

required to be established under the Food and Drug Omnibus Reform Act, including a 

Chief Critical Foods Officer and a critical foods investigator cadre specializing in infant 

formula and medical foods using recently expanded hiring authorities under the 21st

Century Cures Act;

• Met our infant formula inspectional targets, including inspecting all infant formula 

facilities, both domestic and foreign, annually;

• Strengthened our risk-based approach to the timing and periodicity of infant formula 

facility inspections, helping to minimize any possible disruptions to the supply chain; and

• Strengthened our compliance oversight by holding more regulatory meetings, inspecting 

facilities at greater frequencies, conducting more environmental and product testing

during those inspections, adding more expert analysis to the complaint review process, 

and enhancing our review of firms’ sanitation records, resulting in smaller, more targeted 

recalls. 

We are also committed to advancing the science of Cronobacter sakazakii. On November 15, 

2022, FDA published an outline of our Strategy to Help Prevent Cronobacter sakazakii Illnesses 

Associated with Consumption of Powdered Infant Formula to explore options for strengthening 

food safety throughout the product’s lifecycle. This prevention strategy is intended to help limit 

or prevent contamination, recalls, and any possible illnesses associated with adulterated 

powdered infant formula.9

 

7 See “Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion,” FOOD AND 

DRUG ADMINISTRATION, Sept. 2022, available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-industry-infant-formula-transition-plan-exercise-enforcement-discretion. 8 See supra n.4. 9 See “Outline of FDA’s Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of 

Powdered Infant Formula,” FOOD AND DRUG ADMINISTRATION, available at https://www.fda.gov/food/new-erasmarter-food-safety/outline-fdas-strategy-help-prevent-cronobacter-sakazakii-illnesses-associated-consumptionpowdered.
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Since February 2022, the Agency has had ongoing and extensive engagement with the infant 

formula industry to identify and implement opportunities to strengthen preventive control 

practices and engage on the development and refinement of the prevention strategy moving 

forward. FDA food safety experts have engaged with industry, state, international, and other 

partners to explore environmental factors that may contribute to contamination in facilities; 

review issues related to specific foodborne hazards to identify potential mitigation measures or 

knowledge gaps; review regulations to identify provisions that may be strengthened; identify 

prevention measures that can be taken to reduce future incidences of foodborne illness; and 

expand our understanding of food safety issues and limit recurrences of underlying root causes 

responsible for contamination. 

FDA food safety experts have advanced a charge through the National Advisory Committee on 

Microbiological Criteria for Foods (NACMCF) to gain scientific insight on possible industry and 

public health interventions to address Cronobacter infections associated with powdered infant 

formula. We have engaged with the Council of State and Territorial Epidemiologists (CSTE) and 

CDC about elevating reporting for Cronobacter infection in infants less than 1 year of age to a 

nationally notifiable disease.

We appreciate the resources and authorities recently granted to us by Congress in the Fiscal Year

(FY) 2023 Consolidated Appropriations Act, including, as noted earlier, the creation of a new 

office for oversight, coordination, and facilitation of activities related to critical foods such as 

infant formula. We are working to implement new authorities and to leverage new resources, 

including requiring that manufacturers of infant formula notify FDA of discontinuances and 

interruptions in supply that could lead to a meaningful disruption of the supply chain, enhancing

our IT systems to streamline review processes, and working with the National Academies of 

Sciences, Engineering, and Medicine on a study of the U.S. infant formula market and 

comparison with the European Union to examine and report on challenges in the supply, market 

competition, and regulation of infant formula in the United States. We are also actively 

improving our staffing through the hiring enhancements expanded under the 21st Century Cures 

Act and have hired additional infant formula staff. The Agency has also posted hiring 

announcements for several key positions, including for the Deputy Commissioner for Human 

Foods and the Chief Critical Foods Officer. Lastly, in March 2023, we released the Immediate 

National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, which outlines

immediate actions FDA took to address the infant formula shortage and details the Agency’s

plans for improving the resiliency of the infant formula supply, while noting multiple issues 

beyond the purview of FDA.

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We believe these actions are important steps forward, but additional resources and authorities are 

still needed to help FDA effectively prevent disruptions in the infant formula supply chain and 

ensure the safety of these products. Importantly, the President’s FY 2024 Budget includes $21.4 

million in new funding to improve surveillance and monitoring of adverse events; refine 

laboratory methods for detecting certain bacteria; and hire additional staff and experts to increase 

review capacity and stay current on innovation within the industry and the evolving science of 

infant nutrition. FDA is also seeking statutory changes through the FY 2024 budget request to 

require that, among other things, manufacturers report to FDA final product positive test results 

10 See generally supra n.4.
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for relevant pathogens, conduct more frequent environmental monitoring in their facilities to 

identify relevant pathogens, and maintain the results of such testing for FDA inspection, either in 

person or remotely. Such changes would better enable FDA to work with firms in real time to 

resolve issues around product positive findings, provide much-needed data about contamination 

prevalence and pathogen genomics, and help ensure that infant formula is being produced under 

the safest possible conditions.

Industry Responsibility

I would like to emphasize that manufacturers of infant formula are in the best position to prevent 

future recalls and shortages. FDA does not make food; we set safety standards and verify that 

industry is meeting them. It is industry’s responsibility to produce safe food and infant formula, 

and these companies must do more to prevent contamination of their facilities and products. 

Over the past year, while we have not encountered any other facilities that approach the 

conditions that we found in our January 2022 inspection of Abbott’s Sturgis facility, we have 

seen certain common issues at other firms. In our March 8, 2023, letter to industry, we translated 

our findings into a call to action to urge manufacturers to consider ways to better control water in 

plants; perform more frequent environmental monitoring for Cronobacter; conduct the most 

robust root cause analyses possible; embrace the latest science and technology, including whole 

genome sequencing when food safety problems occur; and strengthen supply chain controls for 

health hazards. By encouraging industry to deal more aggressively with issues when they are 

smaller, we seek to avoid facing a situation like the one with Abbott where there was a large 

recall and months of facility shutdown to correct conditions.

As we make our own operational improvements outlined above, I want to be clear that the 

Agency intends to take more actions: more inspections; more actions toward industry aimed at 

improving the safety of their production practices; more communications like our letter to 

industry; and other targeted actions, so that if recalls become necessary, they are smaller. These 

actions are intended to recalibrate an entire industry, drive safety forward, and challenge industry 

to be more preventive.

However, there is no regulatory or enforcement action that we can take that will be faster or 

more effective than having a firm take the most appropriate food safety actions before product 

ever leaves their doors. That is why our March 8, 2023, letter to industry asked firms to 

voluntarily notify us as soon as they have detected a product positive—because that is how we 

can make a real change, working with firms before product leaves their facilities, obviating the 

need for a recall. 

The need for our call to action is exemplified by events that occurred in the months prior to 

issuance. Two firms—Perrigo and Reckitt—released infant formula product into the market 

without fully evaluating the intervening sanitation breaks before and after the production of the 

implicated product.11 If Perrigo and Reckitt had notified FDA at the time the positive samples

11 See e.g., “Perrigo Announces Voluntary Recall of Limited Quantity of Gerber® Good Start® SootheProTM 

Powdered Infant Formula,” available at https://www.fda.gov/safety/recalls-market-withdrawals-safetyalerts/perrigo-announces-voluntary-recall-limited-quantity-gerberr-good-startr-sootheprotm-powdered-infant; 
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were found, we could have worked with the firms to assess the potential impact of the findings 

on other product and to affirm that the appropriate steps were being taken to ensure that no 

potentially contaminated product entered the market. 

Thankfully, compared to the Abbott recall and the temporary closure of the Sturgis facility, the 

recent recalls were much narrower in scope, only impacting a few weeks of product with no 

additional facility closures. Nevertheless, these recalls highlight the need for industry to do more 

to find Cronobacter in the production environment through environmental monitoring, 

performing root cause analyses if product contamination occurs, and using that information to 

prevent future contamination.

We encourage Congress to also examine the current state of the infant formula industry, 

including voluntary compliance with actions to improve the safety of infant formula laid out in 

our letter to industry, efforts to improve and modernize manufacturing facilities and equipment, 

and compliance with the supply disruption notification requirements included in the FY 2023

Consolidated Appropriations Act. 

All of Government Approach 

FDA is a food safety agency and works to support improved nutrition, including for our youngest 

consumers. As such, the Agency has limited authority and ability to impact market concentration 

and monitor supply chains in real time in the way that industry can. We are working to do all we 

can within our authorities and with our partners to prevent future shortages, but recognize there 

are other factors affecting the market that are beyond our control. FDA continues to engage with 

agency partners and other stakeholders as they pursue efforts to improve the infant formula 

supply chain, and we are committed to providing support to any efforts which may benefit infant

health and nutrition in the United States.

CLOSING

Last year’s infant formula shortage reflected an industry failure to produce infant formula in a 

sanitary way, putting FDA in the difficult situation of recommending a voluntary recall of certain 

products, knowing that there would be supply chain ramifications. Avoiding this situation in the 

future will require not only the actions by FDA that I have highlighted in my testimony, but also 

action from the infant formula industry, other U.S. government (USG) partners, and Congress. 

We appreciate our interactions with industry, stakeholders, and our USG partners, which have all 

contributed to improvements in the supply of safe infant formula. It will take continued 

cooperation among all the players and additional authorities and resources to help us achieve our 

vision for a modernized regulatory approach to infant formula safety, contributing to an infant 

formula supply with greater resilience to withstand any future challenges.

We look forward to working with you all to make this a reality.

“Reckitt Recalls Two Batches of Prosobee 12.9 oz Simply Plant Based Infant Formula Because of Possible Health 

Risk,” available at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/reckitt-recalls-two-batchesprosobee-129-oz-simply-plant-based-infant-formula-because-possible.