1

March 2023

The U.S. Food and Drug Administration’s 

Immediate National Strategy to Increase the 

Resiliency of the U.S. Infant Formula Market
2

Introduction

Between September 2021 and January 2022, the U.S. Food and Drug Administration received 

information about four cases of illness or death in infants who consumed powdered infant formula. 

After learning that each of these infants consumed powdered infant formula products manufactured 

by Abbott Nutrition in Sturgis, Michigan, and initiating an investigation at the facility that revealed 

insanitary conditions, the FDA warned consumers not to use certain products manufactured at this 

facility. On February 17, 2022, Abbott Nutrition issued a voluntary recall of certain infant formula products 

manufactured in Sturgis, Michigan, and temporarily ceased production. The recall was voluntarily 

expanded on February 28, 2022, by Abbott Nutrition to cover additional products. While necessary 

to safeguard public health, the recall and pause in production further stressed a supply chain already 

strained by the COVID-19 pandemic and preceding market concentration issues. A shortage of these 

products created hardships for parents and caregivers who rely on infant and specialty formulas to feed 

their babies, as well as loved ones with certain metabolic disorders. 

FDA had concerns about the resiliency of the supply chains for infant formula and medical foods 

beginning in the first days of the COVID-19 pandemic, given that the pandemic stressed ingredient 

and packaging supply chains used in infant formula as well as the labor and manufacturing sectors. 

The concentration of production in the industry, lack of robust risk management plans by major 

manufacturers, and lack of statutory authority to ensure FDA insight into production challenges left the 

infant formula market in the United States vulnerable to issues that could stress or disrupt the supply 

chain – be it a major recall, natural disaster, or labor shortage. 

There are numerous factors that led to the shortages encountered with infant formula in 2022. This 

Immediate National Strategy collects what we have observed, describes immediate actions taken to 

address the situation, and details what we plan to do to further help improve the resiliency of the infant 

formula market, while noting additional issues that need to be addressed beyond the purview of FDA. 

This initial strategy represents a first step toward issuing, with input from the National Academy of 

Science, Engineering and Medicine (NASEM), a long term national strategy to improve preparedness 

against infant formula shortages by outlining methods to improve information-sharing, recommending 

measures for protecting the integrity of the infant formula supply chain and preventing contamination, 

outlining methods to incentivize new infant formula manufacturers to increase supply, and recommending

other necessary authorities to gain insight into the supply chain and risk for shortages.
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Table of Contents

Introduction...........................................................................................................................................2

Assessing Contributing Factors to the Shortage.............................................................................. 4

Acute Contributing Factors..................................................................................................................... 4

Market Contributing Factors...................................................................................................................6

Factors that Led to Market Concentration.........................................................................................9

Work Over the Past Year in Response to the Infant Formula Shortage........................................ 11

Strategy to Increase the Resiliency of the U.S. Infant Formula Market........................................ 18

Providing Education and Communication Materials for Parents, Caregivers, 

and Medical Providers..........................................................................................................................22

Appendix: FDA Fact Sheet.................................................................................................................24
4

Assessing Contributing Factors to the Shortage

The infant formula shortage in 2022 was caused by multiple factors and influenced by others. The 

immediate factors leading to the shortage were in part a result of long-standing circumstances that 

had shaped the production of infant formula over the years. At a time when the COVID-19 pandemic 

had already strained supply chains for many consumer products, the infant formula industry was 

particularly vulnerable to disruption.

Most acutely, the combination of insanitary conditions in the Abbott Nutrition Sturgis, Michigan 

facility, the significant reliance on this single facility for both routine and critical specialty formulas, 

the firm’s lack of capacity for back-up production of specialty formulas, and inadequacy of 

redundancy plans for production of powdered formula, created a “perfect storm” resulting in the 

supply chain disruption in 2022 that 

affected the entire U.S. market. 

Acute Contributing Factors

• On February 17, 2022, Abbott Nutrition 

voluntarily recalled over 7 million pounds 

of powdered infant formula products 

from retail shelves manufactured in 

Sturgis, Michigan, and temporarily ceased 

production at the facility. The recall was 

voluntarily expanded on February 28, 2022, 

to cover additional products. (Figure 1.)
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• Lower volume and less variety on the shelves contributed to abnormal purchasing behavior that 

has been called “panic buying” or “pantry loading” in the business literature, which can be driven by 

media exposure. Specifically, with regard to the infant formula shortage this phenomenon peaked in 

May 2022 and contributed to increased draw down of formula inventories. (Figure 2.)

• Although Abbott Nutrition was able to 

resume production initially on June 4, 

2022, under a consent decree entered on 

May 16, 2022, their operations were shut 

down again due to flooding on June 13, 

2022; operations did not resume again 

until July 1, 2022. Abbott Nutrition did 

not announce it was resuming routine 

formula production until August 26, 

2022—following some “stops and starts” 

in production. 

• The COVID-19 pandemic and the 

Ukraine/Russia conflict exposed and 

amplified the fragility of supply chains 

in general, straining raw materials/

ingredients, labor, packaging, 

transportation, and other resources 

across all supply chains.
6

Market Contributing Factors

• Infant formula supply is highly concentrated in a small number of manufacturers, which means that 

if there is a problem in production in one company, the overall supply can be significantly affected. In 

2022, four companies controlled 99 percent of the infant formula market. (Figure 3.)

• In addition, the dominant manufacturers rely on relatively few manufacturing facilities that account 

for a significant amount of their production. For example, prior to the February 2022 recall, the 

Sturgis facility produced 40 percent of Abbott’s powdered infant formula for the domestic market.

• Lack of competition means there is less incentive for investment in excess or improved 

manufacturing infrastructure or innovation in the marketplace.

• The U.S. market has never experienced a triple shock like it did with the COVID-19 pandemic, a 

large-scale voluntary recall, and the shutdown of a major manufacturing facility due to insanitary 

conditions of the Sturgis plant. This situation was subsequently further exacerbated by an additional 

closure following a major flood. As a result of these events affecting one of the largest producers 

of infant formula in the U.S., the industry was not prepared with appropriate risk management 

strategies to cope with shifting market conditions.

• With the reliance on “just in time” production methodology, there is insufficient excess capacity 

built into finished product, ingredient, labor, or packaging supply chains and only a modest inventory 

of finished product is maintained (e.g., 4-8 weeks of safety stocks). Although finished product is 

shelf stable (with nutrients eroding over 18-24 months after production), the costs associated with 

storing ingredients or finished product are considerable, and the recent shortage exhausted any 

safety stocks that manufacturers had on hand. 
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• Due to the specialized nature of different infant formula recipes (e.g., unique ingredients such as 

amino acids or allergen concerns), production is not quickly or easily shifted to a new location or 

even a different process flow within the same facility. Instead, ingredients, packaging, and labor 

decisions are planned well in advance of final production, with limited ability to shift those resources. 

Additionally, some manufacturers utilize the same facility for multiple products or brands, which adds 

complexity to the overall supply chain. 

• These issues are all magnified when looking at specialty infant formulas, which include medically 

necessary amino acid-based, extensively hydrolyzed, and specially formulated metabolic infant 

formula products for infants and individuals with medical conditions, who often rely on these 

formulas as their sole source of nutrition. There is a smaller number of manufacturers, facilities, and 

facility lines (which often need to be dedicated to avoid cross-contamination with other ingredients) 

that produce specialty infant formulas. Since the number of infants needing these products is lower, 

these specialty products are typically produced less often and in lower volumes. Because some 

specialty formula also does not provide higher profit margins, firms have even fewer incentives to 

make large capital investments.
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• The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) serves nearly 

7 million people, including nearly 2 million infants. Over half of the infant formula sold in the U.S. is 

purchased through WIC. Since 1989, Congress has required WIC state agencies to operate a costcontainment system for infant formula, which states are meeting through a competitive bidding 

process for formula contracts. Contracts are awarded to the manufacturer offering the highest 

discount on wholesale prices. This can pose challenges for non-contract manufacturers to gain 

market share in any given state. This 1989 reform has resulted in billions of dollars in savings for 

WIC and allowed the program to provide necessary benefits to serve every eligible infant, child, and 

pregnant, postpartum, or breastfeeding woman.

• The 1989 cost-containment reform helped ensure that every WIC-eligible family could access 

nutritious foods and infant formula. While the current system has allowed the program to serve 

eligible families in a cost-effective way, the reforms the U.S. Department of Agriculture (USDA) is 

undertaking, discussed later in this report, are an important step towards building more resilience 

into the system to protect the health and safety of American infants. (Figure 4.)
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Factors that Led to Market Concentration

The structure of the current U.S. market for infant formula was not radically different in 2022 

than it had been in recent years. Rather, multiple factors, which have been in place for decades, 

have shaped the infant formula market into the one we have today. As we evaluate each of the 

contributing factors to the shortage, it is helpful to take a step back to understand the underlying 

forces that consolidated the infant formula market and any levers, within the government or 

otherwise, that may be able to ease that concentration. There are a variety of factors that keep new 

firms from easily entering or gaining a meaningful share of the market: 

• The production of infant formula is a highly specialized process with substantial up-front capital 

investments needed to enter the market. Because of the large capital investments needed, a large 

volume of product and substantial market share are necessary to recover these costs and remain 

viable. Thus, potential entrants may be deterred because of high start-up costs, fixed retail prices, 

and difficulty gaining a substantial market share. 

• To ensure formulas are safe and nutritionally adequate for our most vulnerable consumers, all 

manufacturers must produce infant formula in accordance with the Federal Food, Drug, and 

Cosmetic Act, including Current Good Manufacturing Practices (CGMP) for Human Food and 

CGMPs for Infant Formula; however, it can be challenging for a new firm to meet the relevant premarket and post-market requirements for producing infant formula, especially if they do not have 

access to the same level of legal, food safety, or nutritional resources as their more established 

counterparts. 
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• According to a recent analysis, the U.S. has 

historically produced more infant formula than 

it traditionally consumes, thereby reducing the 

need for imported formula. Indeed imports 

prior to 2022 represented less than one percent 

of the total volume of infant formula sold in 

the U.S. Infant formula products are subject 

to a base tariff rate of nearly 15 percent, and 

an effective rate of about 25 percent. Tariff 

rates are dependent on country-by-country 

agreements and established tariff rate quotas 

(TRQs), meaning the tariff rate will increase 

once an agreed upon volume of product 

is shipped into the U.S. These TRQs are 

designed to prevent a sudden surge in imports 

from disrupting U.S. domestic infant formula 

production, but they can also increase the 

cost of imported infant formula in the event of 

unexpected need and might have contributed 

to the decision of foreign manufacturers not to 

enter the U.S. market.
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Work Over the Past Year in Response to the 

Infant Formula Shortage

To address the supply chain crisis following the recall of infant formula product from Abbott’s Sturgis 

facility and the subsequent shutdown of the facility, FDA engaged our United States Government 

partners and external stakeholders when it became clear FDA would recommend a recall of products 

produced at Sturgis. FDA also worked closely with all major infant formula manufacturers to mitigate 

supply disruption. However, at the time FDA lacked authority, resources, and staff specifically 

dedicated to predicting, detecting, and responding to supply chain issues for infant formula, 

although we had requested authority to do so since 2020.1 

Specifically, FDA:

• Negotiated a consent decree with Abbott Nutrition, which was entered by the U.S. District Court for 

the Western District of Michigan on May 16, 2022. This consent decree requires Abbott to take steps 

necessary to safely produce infant formula in close coordination with FDA and under our oversight of

its manufacturing and food safety processes.

• Ensured that Abbott, in consultation with FDA, held, and did not discard, any specialty and 

metabolic products not released into commerce, reviewed batch records and developed enhanced 

sampling schemes, and worked to make these products available on a case-by-case basis to 

consumers in need.

• Worked with major domestic infant formula producers to increase formula production to 

compensate for decreased Abbott Nutrition output, frequently communicated and shared data with 

manufacturers on production levels and potential supply chain issues, prioritized reviews related to 

before first processing changes to help maintain infant formula supply, and emphasized the critical 

importance of redundancies in infant formula supply chains, especially for specialty products.

1

For a more complete update of all activities related to infant formula, not just improving the resiliency of the supply chain, see 

Appendix: FDA Fact Sheet.
12

• Worked with suppliers of raw and packaging materials, including through the Defense Production 

Act (DPA), to prioritize the needs of infant formula manufacturers. To date, the FDA and U.S. 

Department of Health and Human Services (HHS) Administration for Strategic Preparedness and 

Response (ASPR) DPA- Emergency Response Authorities (ERA) Office have helped to resolve 

over 62 raw material related constraints and leveraged priority rating authorities in three instances 

when required to ensure prioritization and timely delivery of purchase orders to infant formula 

manufacturers.

• Leveraged the 21 Forward system built during the COVID-19 pandemic to better understand 

supply chain issues and enhanced its functionality by populating it with infant formula data 

voluntarily provided by infant formula manufacturers. FDA then enhanced 21 Forward using external 

data to analyze production levels, in-stock rates, and sales of infant formula to understand the 

rapidly evolving market for infant formula.

- Received and analyzed production data from top manufacturers for early signals of supply

 chain issues, to track production projections/goals and progress towards production level

 recovery. (Figure 6.)
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- Monitored sales data to assess whether sales volumes track recovery of demand and sales

 of infant formula after the recall. (Figure 7.)

- Monitored in-stock rates to track proxy measures for the recovery of product volume and

 variety on store shelves.2 (Figure 8.)

2

In-stock rates measure the availability of product variety usually found on store shelves, but do not capture volume available The data 

for in-stock rates, when coupled with the production and sales volume data, show that both the variety of products on store shelves 

and volume available improved in the second half of 2022.
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- Developed these data into a proof-of-concept model to forecast near-future events and

 possible supply disruptions, allowing us to anticipate and preemptively respond to potential

 supply chain challenges.

• Met regularly with USDA to share information and analyses on the supply of infant formula. In 

addition to these meetings and information sharing, USDA performed the following actions:

- Following Abbott Nutrition’s voluntary infant formula recall due to insanitary conditions at

 its Sturgis, Michigan manufacturing plant, USDA worked to ensure that safe and nutritious

 infant formula was available to every WIC family that needed it. In the immediate wake of the

 recall, USDA Food and Nutrition Service (FNS) provided guidance to WIC state agencies

 and, within days, offered flexibilities including waivers to help them respond to the impacts

 of the recall.

- USDA helped ensure that WIC participants could continue to access formula during times

 of crisis. USDA has taken action to require WIC state agencies to include a provision in 

 future infant formula rebate contracts to include remedies in the event of an infant formula

 recall, including how an infant formula manufacturer would protect against disruption to

 program participants in the state.

- USDA ensured WIC state agencies were prepared for future supply chain disruptions. USDA

 worked with WIC state agencies to have disaster plans in place, including identifying 

 methods to provide infant formula during a supply chain disruption, disaster, or 

 emergency period. 

- USDA increased transparency with the goal of promoting competition in WIC infant 

 formula bids. To procure infant formula rebate contracts, WIC state agencies solicit bids

 from infant formula manufacturers to provide a rebate for infant formula. To ensure all

 manufacturers have the information they need to compete for state contracts and to support
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 any new qualified companies in the market, USDA established a dedicated webpage

 for state bid solicitations for infant formula, similar to actions called for on a bipartisan basis

 in Congress.

• FDA also engaged with multiple other U.S. Government partners that have the specialized supply 

chain authorities, expertise, and influence to build immediate flexibility and relief into the infant 

formula supply chain, and we supported temporary policies designed to alleviate the shortage. This 

included (Figure 9.): 

- Supporting HHS to mobilize Operation Fly Formula to arrange for emergency transport

 of large volumes of formula from outside the U.S. at the peak of the crisis. Between May and

 September 2022, HHS helped facilitate over 70 Operation Fly Formula shipments from

 Europe, Asia, and North America that imported over 6 million pounds of infant formula

 (equivalent to nearly 100 million 8-oz bottle equivalents) into the United States.

- Collaborating and communicating regularly with USDA, U.S. Digital Service, and the HHS

 Supply Chain Control Tower on analyses and tracking of infant formula products in different 

 parts of the supply chain, including production, distribution, and retail.

- Working with HHS ASPR to help ensure the timely availability of raw materials, when

 applicable, and participating in FDA-led weekly calls with manufacturers.

• Successfully worked with Congress, leading to new requirements for firms to notify FDA of a 

permanent discontinuance or interruption in the supply of infant formula and to write and implement 

redundancy risk management plans, including mechanisms to mitigate impacts of supply disruption 

through alternative production sites, alternative suppliers, stockpiling of inventories, and other 

means.

• Worked with the U.S. Department of State and USDA to identify foreign manufacturers of infant 

formula with immediate capacity to export regular and specialty formulas to the U.S. under FDA’s 

exercise of enforcement discretion and followed up with the manufacturers to provide additional 
2021 2022

12

14

10

 8

 6

 4

 2

0

Source: U.S. Food and Drug Administration

Firms

Figure 10.

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information regarding enforcement discretion, and to better understand their manufacturing 

processes, capacity, and formulations.

- Issued the Infant Formula Enforcement

 Discretion Policy: Guidance for Industry

 to describe considerations for firms and

 formulas entering the market

 temporarily under FDA’s exercise of

 enforcement discretion, then

 subsequently issuing the Guidance

 for Industry: Infant Formula Transition

 Plan for Exercise of Enforcement

 Discretion to outline a path for

 interested firms marketing products

 in the U.S. under the exercise of

 enforcement discretion to bring

 those products into compliance with

 U.S. requirements to facilitate 

 longer-term availability in the market.

 (Figure 10.)

- Issued Draft Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to

 Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological

 Quality of Protein, relating to a key component of a new infant formula submission. 

- Hosted multiple webinars in autumn 2022 to support infant formula firms interested in

 marketing their products in the U.S., including those marketing as part of the transition

 plan and new market entrants more generally. Topics of the webinars included: the Infant

 Formula Transition Plan guidance, FDA’s requirements and recommendations for new infant

 formula submissions, PER studies, and Growth Monitoring Studies (GMS). 

- Developed webpages about the new, imported formulas that were entering the market

 under FDA’s exercise of enforcement discretion, with information about how to safely switch

 to those formulas, if needed.

• Published an Outline of FDA’s 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 future 

illnesses associated with adulterated powdered infant formula. FDA has met with numerous infant 

formula producers to actively engage on the development and refinement of this strategy moving 

forward.

- Advanced a charge through the USDA, Food Safety and Inspection Service’s National

 Advisory Committee on Microbiological Criteria for Foods (NACMCF) to gain scientific

 insight on the prevalence, pathogenesis, possible industry and public health interventions,

 and food safety messaging to address Cronobacter infections associated with powdered

 infant formula (PIF). NACMCF will convene in FY2023 through its current authorized 2-year

 tenure to review current science, define research gaps, and make recommendations to

 advance PIF safety.
Help Prevent Cronobacter Illness:

Prepare and Store Powdered Infant Formula Safely 

In most cases, it is safe to mix powdered infant formula following manufacturer’s instructions. But if your baby is less 

than 2 months old, was born prematurely, or has a weakened immune system, you may want to take the following 

extra steps to prepare your formula with hot water (at least 158°F/70°C) to help protect against Cronobacter:

Use prepared infant formula within 1 hour from start of feeding and within 2 hours of preparing it.

the entire bottle of formula, throw away leftover formula.

If you do not plan to start feeding your baby with the prepared formula right away, refrigerate it immediately.

Use refrigerated formula within 24 hours. If you can’t remember how long you have kept formula in the refrigerator, it is safer 

to throw it out than to feed it to your baby. For more information visit www.cdc.gov/cronobacter

Clean work surfaces, such as 

countertops and sinks with soap 

and water, or use a disinfectant 

wipe or paper towel sprayed with 

cleaning product. Do not place 

feeding items directly in the sink, 

because germs in sinks or drains 

could contaminate these items.

Add the exact amount of formula 

listed on the container.

Boil water and let it cool for 

about 5 minutes.

If you plan to use the prepared 

formula right away, cool the formula 

to body temperature to ensure it 

is not too hot before feeding your 

baby. Run the prepared, capped 

bottle under cool water or place 

it into an ice bath. Do not let the 

cooling water get into the bottle or 

on the nipple.

Pour the water into a clean 

bottle or feeding cup.

Before feeding the baby, test the 

formula’s temperature by putting 

a few drops on the inside of your 

wrist. It should feel warm, not hot.

Wash hands with soap and water 

before preparing infant formula.

Carefully shake the capped bottle 

rather than stirring the mixture.

Figure 12.

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- Engaged with the Council of State &

 Territorial Epidemiologists (CSTE) and

 Centers for Disease Control and Prevention

 (CDC) about elevating reporting for

 Cronobacter infection in infants less than

 1 year of age to a nationally notifiable

 disease.

- Engaged with NASEM to examine and issue

 a report (expected in 2024) on challenges

 in the supply, market competition, and

 regulation of infant formula in the U.S.

- In March 2023, as part of the prevention

 strategy work, the FDA sent a letter to the

 powdered infant formula industry to share

 current safety information and call on the

 industry to take prompt action to improve

 processes and programs for the protection

 of our most vulnerable population.

• Conducted health fraud investigations related to 

domestic and foreign infant formula manufacturers 

who had not provided the required premarket 

notification to FDA before introducing or delivering 

for introduction into interstate commerce any new 

infant formula.

• Worked in collaboration with HHS to develop and 

distribute education and communication materials

for consumers to ensure they had the latest 

information to manage during the shortage, 

such as how to locate safe alternative formulas. 

(Figure 11.)

• Created content to highlight the importance of 

safe handling practices and the mechanisms for 

reducing the risk of Cronobacter sakazakii infection 

during infant formula preparation. (Figure 12.)
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Strategy to Increase the Resiliency of the U.S. 

Infant Formula Market

FDA will continue using its authorities to help increase the resiliency of the U.S. infant formula market 

by working with manufacturers to ensure that they implement robust redundancy and risk-monitoring 

plans; supporting entry and competition in the domestic infant formula market; monitoring supply 

metrics and identifying potential signs of production issues; sustaining regular communication 

with infant formula manufacturers and retailers to share information and data; and building upon 

collaboration with U.S. Government partners to reduce the number of disruptions in the future and 

mitigate any impacts.

Specifically, FDA is working to:

• Conduct surveillance food safety inspections of all infant formula manufacturers at least annually 

and use remote regulatory assessments, as needed. 

• Significantly expand and improve infant formula training for investigators and other appropriate 

staff to ensure every infant formula inspection is robust, thorough, and focused on the most critical 

aspects of the infant formula manufacturing process. 

• Continue collaborating with major infant formula producers and retailers, including:

- Communicating with manufacturers and continuing to receive information about production 

 levels, raw materials, and distribution.

- Issuing the Infant Formula Transition Plan guidance, which outlines a path for interested

 firms marketing products in the U.S. under the exercise of enforcement discretion to bring

 these products into compliance with U.S. requirements to facilitate longer-term availability of

 these products in the U.S. 
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- Supporting infant formula manufacturers trying to access the U.S. market through the

 provision of information (such as on the PER rat bioassay studies and the infant GMS) to

 help them make new infant formula submissions and ensure the submissions are complete

 and meet our requirements, enabling a shorter review timeline. 

- Sharing, especially with the specialty infant formula industry, the new requirement to have

 redundancy risk management plans and the critical importance of identifying and/or creating

 redundancies in their supply chains, including mechanisms to mitigate impacts of supply

 disruption through alternative production sites, alternative suppliers, stockpiling of

 inventories, and other means.

- Communicating with major infant formula producers on mandatory reporting of potential

 shortages of product, raw materials, and ingredients, and the critical importance of specialty

 infant formula supply chains.

- Enhancing technical assistance to those considering entering the U.S. infant formula market,

 in particular smaller businesses. 

• Monitor the infant formula supply and supply chain to assess general market health and current 

and future demand and identify potential signs of production challenges by:

- Continuing to receive and analyze production data from current major manufacturers, as

 made available on a continuing basis to FDA, for early signals of supply chain disruptions,

 tracking whether production projections and goals will meet estimated demand, and tracking

 progress towards production goals. 

- Monitoring in-stock rates to track proxy measures for product volume and variety, as well

 as sales data, to track whether sales volumes are commensurate with estimated demand for

 infant formula.
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- Developing additional models and metrics to monitor and assess ongoing infant formula

 market health and resilience, including a forecasting model as a part of predictive analysis

 for near future events and supply disruptions.

- Monitoring state-level data (as data permit) to assess any state-level problems with infant

 formula supplies.

- Examining supply chains to assess critical points (e.g., raw materials constraints).

• Engage with U.S. Government partners to address immediate infant formula needs, in particular, 

where those partners are able to influence the infant formula supply chain outside of FDA’s control 

and build long-term resiliency into the infant formula supply chains. For example, considering 

whether tariffs play a role in market diversification, and evaluating support for the construction of 

new and updated facilities for manufacturing infant formula. 

• Engage with USDA to support resiliency and adequate reserve planning through the administration 

of the WIC program. For example, USDA is: 

- Taking additional steps to ensure that the families who rely on the WIC program have safe

 and reliable infant formula options even in an emergency, in light of the crisis and new

 authority provided through the bipartisan Access to Baby Formula Act, in July 2022. 

- Supporting WIC state agencies in prioritizing resources and developing a separate disaster

 plan for the distribution of specialty formula for infants with health conditions. Disaster plan

 actions might include how WIC agencies will coordinate with health care centers to manage

 the supply of specialty formula or an integrated plan for WIC retailers to share information

 about infant formula stock with WIC to support a formula locater.
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- Testing and launching online shopping for infant formula for WIC participants. WIC

 participants may not currently use their benefits to purchase infant formula or other food

 items online. This can make it more challenging for families to find formula if their local

 stores are not carrying it. As part of the White House’s National Strategy on Hunger, Nutrition

 and Health USDA will use funds from the American Rescue Plan to expand online shopping

 in WIC. In FY 2022, FNS awarded approximately $10 million in grants to improve the WIC

 shopping experience, including planning efforts for online shopping, and subsequent rounds

 of funding are planned for FYs 2023 and 2024. USDA also has proposed rulemaking

 to address regulatory barriers to online shopping and to expand the types of stores eligible

 to participate in the program. 

• Complete reviews of pending infant formula submissions from firms seeking access to the 

U.S. market (those marketing as part of the transition plan as well as new market entrants more 

generally).

• Develop policies to promote infant formula market health and diversification, including measures to 

support redundancy planning and promote entry and competition. 

• Design and promote policies from U.S. Government partners that support breastfeeding as well as 

infant and maternal health. 

• Refine, in consultation with industry and other stakeholders, the Strategy to Help Prevent 

Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula to 

improve the overall safety of infant formula and minimize the potential for disruptions in the supply 

chain. 
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• Receive new scientific data from the NACMCF charge, and stand ready to implement and 

operationalize any new insights that may be used to improve the food safety, detection methods, or 

resiliency of the infant formula supply chain. 

• Work with the NASEM to understand their analysis on challenges in the supply of infant formula in 

the U.S. and incorporate their findings into an updated, long-term national strategy to increase the 

resiliency of the U.S. infant formula market. 

• Analyze methods and approaches for potential international harmonization of regulatory 

requirements for infant formula to determine whether doing so could increase resiliency in supply 

and market competition. 

• Use expanded hiring authorities under the 21st Century Cures Act to support infant formula work 

and work to implement new infant formula authorities provided for in the Food and Drug Omnibus 

Reform Act of 2022. 

• Create a new Office of Critical Foods responsible for oversight, coordination, and activities related 

to critical foods, which is defined to include infant formula and medical foods. 

• Expedite review of premarket submissions for new infant formula products to mitigate or prevent 

shortages.

Providing Education and Communication Materials for Parents, Caregivers, and 

Medical Providers

There’s nothing as important to families as the health and safety of their babies. As the country 

faced the powdered infant formula recall in February 2022 and the subsequent formula shortage, we 

understood that families had many questions regarding access, availability, and safety. Throughout 

the infant formula shortage, FDA and HHS have worked together to develop and distribute materials 

for consumers. However, even with FDA’s recent efforts to improve consumer education related to 

infant formula, more can be done.
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Specifically, FDA is working to: 

• Consolidate, reorganize, and translate our educational materials on FDA.gov in the coming months 

to improve accessibility for all families. As part of this effort, we will also be evaluating how we can 

incorporate related consumer information for safely feeding infants, such as the information found on 

CDC’s infant and toddler nutrition pages and breastfeeding webpage.

• Coordinate with USDA’s WIC program to distribute our consumer education materials. 

• Enhance and leverage our partnerships with health care providers and professionals, particularly 

infant care professionals, to further build our consumer education program. For example, during 

the infant formula shortage, the FDA partnered with the American Academy of Pediatrics and built 

relationships with other medical groups and societies including the metabolic dietitians practice 

group and support groups for individuals with metabolic disorders. The FDA will continue to work 

with these groups, while also exploring new opportunities to partner with other healthcare providers 

and facilities to enhance and promote our consumer education regarding the safe use of infant 

formula.
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Appendix: FDA Fact Sheet

Status Update March 2023

FDA’s Infant Formula Response Activities 

Since the Abbott infant formula recall in February 2022, the U.S. Food and Drug Administration (FDA or the Agency) 

and U.S. Government partners have been working to expand consumer access to infant formula products, while also 

ensuring that these products meet the agency’s safety, nutrition, and quality standards. As we emerged from the acute 

crisis, the agency conducted numerous reviews including an evaluation of the agency’s infant formula response and the 

Reagan-Udall foundation’s Evaluation of the FDA’s Human Foods Program (conducted at FDA’s request) to identify areas 

for improvement within the Agency. While work continues on all fronts, the FDA is committed to transparency. Below is 

an update on actions the FDA has taken, and those underway, to strengthen the safety and resiliency in the supply of 

nutritious infant formula. 

Safety of Infant Formula

• In 2022, FDA conducted 34 inspections of foreign and domestic facilities that produce infant formula (including some 

that also produce medical foods), meeting FDA’s inspection targets for FY22. Appropriate follow up actions were taken 

as warranted. Importantly, FDA had set targets to inspect facilities that produce infant formula annually, even prior to a 

requirement to do so established in the Food and Drug Omnibus Reform Act of 2022. 

• In November 2022, FDA released a draft outline of a strategy to prevent Cronobacter sakazakii illnesses associated with 

the consumption of powdered infant formula. This outline was intended to guide discussions with stakeholders over the 

next several months as FDA further developed the strategy. 

- FDA conducted meetings with infant formula manufacturers throughout January and February 2023 to

 discuss the strategy, learn more about what industry is doing to enhance safety, and hear their ideas for

 prevention.

- In March 2023, as part of the prevention strategy work, FDA sent a letter to the powdered infant formula

 industry to share current safety information and call on the industry to take prompt action to improve processes

 and programs for the protection of our most vulnerable population.

• In November 2022, the FDA advanced a charge through the U.S. Department of Agriculture (USDA) Food Safety and 

Inspection Service’s 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.

• Initiated engagement with the Council of State & Territorial Epidemiologists (CSTE) and Centers for Disease Control 

and Prevention (CDC) about elevating reporting for Cronobacter infection in infants less than 1 year of age to a nationally 

notifiable disease.

• FDA has expanded the availability of education materials to help consumers better understand Cronobacter 

risks associated with powdered infant formula and the steps they can take at home to help minimize any potential 

contamination. 

• FDA continues to work with Abbott Nutrition under the consent decree entered by the U.S. District Court for the 

Western District of Michigan on May 16, 2022. This consent decree requires Abbott to take the steps necessary to safely 

produce infant formula in close coordination with FDA and under our oversight of its manufacturing and food safety 

processes.
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Resiliency in the Supply of Nutritious Infant Formula

• At the height of the supply challenges, FDA staff worked daily with clinicians and hospitals to address crucial issues of 

specialty and medically necessary formula supply for infants with serious metabolic diseases who were dependent on 

highly specialized formulas. 

• FDA supported our colleagues at HHS to mobilize Operation Fly Formula to arrange for emergency air transport of large 

volumes of formula at the peak of the crisis.

• FDA worked with Customs and Border Protection (CBP) to implement legislation that provided temporary relief for 

infant formula importers from tariffs during the latter half of 2022.

• FDA has helped to expand access to infant formula by temporarily exercising enforcement discretion, on a case-bycase basis, for certain infant formula requirements. Twelve manufacturers have brought various infant formula products 

into the U.S. market under FDA’s exercise of enforcement discretion, doubling the number of firms suppling product to 

the U.S. market from 2021 to 2022.

- FDA conducted an expedited review of certain food safety and nutrition records associated with the firms and

 products prior to issuing letters of enforcement discretion.

- FDA also adjusted import screening criteria to help facilitate the immediate importation of millions of pounds of

 infant formula and infant formula base powder (an ingredient used in producing infant formula products). 

• FDA also issued the Infant Formula Transition Plan for Exercise of Enforcement Discretion guidance that outlines a path 

for interested firms marketing products in the U.S. under the exercise of enforcement discretion to bring those products 

into compliance with U.S. requirements to facilitate longer-term supply resiliency in the U.S. market.

- During October and November 2022, FDA hosted a four-part webinar series to provide detailed information

 about the transition plan for infant formulas marketed under the exercise of enforcement discretion and to

 address questions. 

• FDA has leveraged 21 Forward, a tool that was built to help track supply chain shortages during the COVID-19 

pandemic, to now inform ongoing work to track and anticipate supply disruptions across the infant formula supply chain. 

The platform uses data provided to the agency voluntarily by infant formula manufacturers.

- FDA staff continue to meet regularly with infant formula manufacturers to discuss current and forecasted

 production and to identify potential distribution issues. 

• The Agency coordinated with colleagues in the U.S. Department of Health and Human Services (HHS) Administration 

for Strategic Preparedness and Response (ASPR) Defense Production Act (DPA) Office to leverage their capabilities 

and authority to identify and provide appropriate support to resolve raw material constraints on ingredients needed to 

manufacture formula – including through technical assistance and DPA authorities when needed. 

Operational Improvements

• FDA has revised its internal consumer complaint procedure to strengthen the escalation process to better define when 

certain consumer complaints need to be escalated to senior officials. This change involves rapid escalation of reports of 

serious illness or death to the highest levels of the agency and specifically addresses triggers for any hospitalization or 

death involving an infant.

• FDA has significantly expanded and improved a required infant formula online training course for investigators and 

other appropriate staff to ensure every infant formula inspection is robust, thorough, and focused on the most critical 

aspects of the infant formula manufacturing process. 

• The Office of Regulatory Affairs (ORA) has significantly expanded the agency’s capacity to analyze samples of infant 

formula by adding two laboratories with the capacity to test for Cronobacter, partnering with state laboratories with 

existing capabilities, and enhancing its system for prioritizing sample analysis. 

• FDA staff who conduct or support inspections of powdered infant formula manufacturers attended an interactive inperson powdered infant formula inspection workshop with specific training on conducting infant formula inspections in 

January 2023. The workshop provided critically relevant and timely inspectional information for investigators and other 
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appropriate staff, including updates from lessons learned during previous inspections. 

• In February 2023, CFSAN issued a schedule with instructions for improved routine surveillance inspections and 

sampling to be conducted at domestic and foreign infant formula and medical food facilities in fiscal year (FY) 2023. 

These instructions, issued to FDA investigators, included numerous modifications that incorporate lessons learned 

during inspections conducted in FY22 and address feedback from internal and external stakeholders.

- In 2022, prior to FDA’s evaluation of the infant formula response, CFSAN began amending its instructions to

 ORA related to inspections of infant formula and medical food facilities. The changes provided additional

 considerations for environmental sampling, a renewed focus on the supply chain requirements under the

 Preventive Controls for Human Food Rule, and scheduling adjustments to minimize potential supply chain

 disruptions. 

• CFSAN’s Office of Nutrition and Food Labeling has increased its staff by 66 percent to better facilitate infant formula 

reviews.

New Authorities 

While FDA has taken actions to improve access to safe and nutritious infant formula, there also has been widespread 

recognition that new authorities, provided by Congress, could help to build a lasting foundation for a more resilient infant 

formula supply in the U.S. The FDA is currently designing implementation plans for new authorities received in the Food 

and Drug Omnibus Reform Act of 2022, including:

• Creating a new Office of Critical Foods responsible for oversight, coordination, and activities related to critical foods, 

which is defined as infant formula and medical foods. 

• Expediting review of premarket infant formula submissions if an infant formula shortage has been identified.

• Mandating critical foods manufacturers to notify FDA of a permanent discontinuance or interruption that is likely to lead 

to a meaningful disruption in infant formula supply.

• Requiring critical foods manufacturers to develop, maintain and implement, as appropriate, redundancy risk 

management plans to identify and evaluate risks to the supply of the critical food, such as infant formula, and ways to 

mitigate such risks.

• Issuing guidance to support new infant formula submissions.

• Exploring pathways to harmonize international regulatory requirements for infant formula.

• Notifying Congress of infant formula recalls.

• Working with relevant federal agencies to work together to develop a National Strategy on Infant Formula to address 

infant formula supply chain resiliency and provide education and communication for parents and caregivers. 

• Engaging with the National Academy of Science, Engineering and Medicine to examine and report on challenges in the 

supply, market competition, and regulation of infant formula in the U.S. 

FDA also received expanded hiring authorities under the 21st Century Cures Act to recruit additional staff to, among 

other things, support the infant formula work underway and implement new infant formula authorities provided for in the 

Food and Drug Omnibus Reform Act of 2022. 

FDA is also seeking additional authority through the FY24 budget request to require that, among other things, 

manufacturers report to FDA final product positive test results 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. The combination of these new authorities would empower the FDA to work with 

firms in real time to resolve issues around product positive findings and better assure the safety of product entering the 

market.

The FDA appreciates the continued collaboration with the infant formula industry, retailers, educators, and 

federal partners to strengthen the resiliency and safety of infant formula in the United States.
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