FDA Steps to Tighten Infant Formula Safety (2023)

Table of Contents

1. What the FDA Did
2. Background: The 2022 Recall and Shortage
3. What Cronobacter Is and Why Powdered Formula Matters
4. The March 2023 Letter to Industry
5. Five Problem Areas the FDA Reported From Inspections
6. The August 2023 Warning Letters
7. The September 2023 Compliance Program
8. Other 2023 Steps the FDA Reported
9. What the FDA Told Parents and Caregivers
10. What These Actions Do Not Do
11. Dates and Status as of 18 October 2026
12. How the 2023 Steps Fit Earlier and Later Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the FDA Did

The 2023 actions were three separate documents, none of them a new regulation:

• 8 March 2023 — a letter to industry. The FDA constituent update of that day says the agency “sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula 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.” The letter was signed by the Commissioner of Food and Drugs and the director of the FDA’s Center for Food Safety and Applied Nutrition, and was released with a one-page “Table of Actions” summarizing it.
• 30 August 2023 — three warning letters. An FDA news release announced warning letters to three infant formula manufacturers “for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations,” reflecting inspections of their facilities over the previous several months.
• 28 September 2023 — an updated compliance program. The FDA’s page for formula manufacturers says that in September 2023 the agency “updated its infant formula compliance program to outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities related to the oversight of infant formula.” The program document (Compliance Program 7321.006) gives 28 September 2023 as its date of issuance.

A check of the Federal Register through 18 October 2026 found no Federal Register notice for any of the three. The Federal Register is the U.S. government’s daily journal of rules and notices, and a rule proposed there gets a public docket, a numbered file of the documents and comments. These 2023 steps were issued directly by the FDA as a letter, enforcement letters and an internal program document, so they have no rulemaking docket.

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2. Background: The 2022 Recall and Shortage

The March 2023 letter opens with the events that led to it: “In late 2021 and early 2022, a series of Cronobacter spp. illnesses among infants in the U.S. was associated with feeding a certain brand of powdered infant formula.” The FDA’s inspection of the plant “revealed the presence of Cronobacter spp. within the production environment, as well as other insanitary conditions, leading to a nationwide recall,” and the letter says the recall and the temporary shutdown of the plant were “a major contributing factor to the infant formula shortage experienced across the U.S. in 2022.”

The FDA’s summary of its Cronobacter prevention strategy adds detail. Between September 2021 and February 2022 the agency received complaints about four cases of illness or death in infants who had consumed powdered formula made at the same facility. The inspection found five different strains of Cronobacter sakazakii inside the plant. Those samples did not genetically match the isolates from the two sick infants for whom whole genome sequencing results were available, and the two infants’ isolates did not match each other. The FDA writes that it “was unable to determine whether the infants became sick from the firm’s product or contamination by other means,” but that the findings “raised serious concerns about the safety of the powdered infant formula and other products produced at this facility.” On 17 February 2022 the FDA warned consumers not to use certain products from the plant, and the manufacturer recalled them and paused production the same day.

In November 2022 the FDA published an outline of its strategy to help prevent Cronobacter sakazakii illnesses linked to powdered formula. Its stated goals were to broaden scientific knowledge of the germ, improve oversight of formula production, and improve communication with industry, consumers and public health partners. The FDA presents the March 2023 letter and the review of its compliance program as parts of that strategy, and the August warning-letter release places its action in the same effort.

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3. What Cronobacter Is and Why Powdered Formula Matters

The FDA describes Cronobacter sakazakii as “a pathogen found naturally in the environment that can enter manufacturing facilities and home environments on hands, shoes, and other contaminated surfaces.” It is “especially good at surviving in dry foods, like powdered infant formula, powdered milk, herbal teas, and starches.” For most people it is harmless, “but it can be life threatening for infants younger than two months, infants who are born prematurely, and for infants who have weakened immune systems.”

The 2023 compliance program gives more background:

• The germ family. The genus Cronobacter has seven species; C. sakazakii is the one most often linked to illness. The program states that infections in infants “can be deadly, with case-fatality rates ranging from 10% to 80%,” and that infants without underlying conditions born at full term have also had invasive infections.
• Why powder is different. Liquid formulas “typically undergo processing to make them commercially sterile, but powder infant formula is not sterile.” For that reason the program names two germs for testing in powdered formula: Cronobacter and Salmonella.
• How the germs persist in plants. Both organisms survive drying well and are hard to kill with heat once dehydrated. They thrive where a dry area gets wet from time to time, through wet cleaning or a leaking pipe, valve or roof, and then takes a day or more to dry. Such hidden “niche” spots can be hard to reach and can shelter germs from routine cleaning.

The FDA’s strategy page notes that the Centers for Disease Control and Prevention (CDC) typically receives 2 to 4 reports a year of severe Cronobacter infections in infants, and that public health investigations have mainly linked these to contamination while formula is being prepared, not in the factory.

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4. The March 2023 Letter to Industry

The constituent update says the letter followed two months of regular meetings between FDA food-safety staff and powdered formula manufacturers to develop the prevention strategy, and reflected “the information we gained through these interactions and the latest available science.” The FDA’s strategy page dates those meetings to January and February 2023.

Under the heading “Call to Action,” the letter asks firms to:

1. evaluate their system of production and in-process controls, covering every stage “from the receipt and acceptance of the raw materials, ingredients, and components through the storage and distribution of the finished product,” and make sure controls are in place under 21 CFR 106.6(c) wherever they are needed to prevent adulteration;
2. ensure full compliance with the infant formula rule (21 CFR part 106, which covers good manufacturing practice, quality control, quality factors, records and reports, and notifications) and the general food-safety rule for human food (21 CFR part 117);
3. consider the concerns in the letter when evaluating their controls and taking corrective actions; and
4. follow the existing requirement, in 21 CFR 106.150, to notify the FDA of an adulterated or misbranded infant formula any time product has left the facility.

“CFR” is the Code of Federal Regulations, the collected body of federal rules; points 1, 2 and 4 restate obligations that already existed. The new element was a voluntary request: “FDA asks that firms voluntarily notify the Agency any time a product sample is found to be positive for Cronobacter spp. or Salmonella, even if the affected lot(s) have not been distributed.” The FDA’s current page for manufacturers says these reports go to the FDA inspections division for the region where the plant is located.

The letter closes by noting that, while it focuses on observations the FDA found concerning, “the Agency also observed many procedures and practices that were performed in compliance with the applicable regulations.”

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5. Five Problem Areas the FDA Reported From Inspections

The letter draws on routine inspections, for-cause inspections that followed consumer complaints, and other contacts with manufacturers. It lists five “areas for improvement across the infant formula industry”:

• Water in dry production areas. In several inspections the FDA saw water during production in areas meant to stay dry, from roof and building leaks, leaking equipment and condensation. Some firms did not record these events. Equipment cleaned with “clean-in-place” procedures, which pour large amounts of water over surfaces, was not always shown to be fully dried before production restarted, and these cleanings were being done more often than before.
• Environmental monitoring. Some firms tested plant surfaces mainly for a broad bacterial family, Enterobacteriaceae, rather than for Cronobacter itself. The FDA wrote that it is “not aware of sufficient data demonstrating a correlation” between the two, and that its own investigators recovered Cronobacter from surfaces where firms were testing only for the broader group. The letter “encourages the direct testing for Cronobacter spp. at some frequency” in the processing environment.
• Corrective action after a positive test. Some plants cleaned suspected surfaces immediately after a positive product sample and only then took samples, which limited their ability to find the source. The FDA encouraged sampling before sanitizing during a root cause investigation. It wrote that “the only adequate remediation for food contact surfaces contaminated by a bacterial pathogen is the application of a sanitizing treatment” such as heat or chemicals, and that dry-cleaning methods (vacuuming, brushing, sweeping) “have not proven effective” at removing pathogens. It also “strongly recommends” whole genome sequencing, a lab method that reads a germ’s full genetic code, to trace any pathogen found; some plants had more than one strain of Cronobacter.
• Supply-chain controls. Some formula is made by dry-blending ingredients that receive no germ-killing step at the formula plant. The FDA found that manufacturers’ supplier programs did not always fully characterize the pathogen risk at the supplier’s facility, and wrote that such suppliers are “an extension of the infant formula manufacturing process.”
• All relevant biological hazards. The FDA reminded industry that Salmonella and Clostridium botulinum, the germ behind infant botulism, have also been historically associated with powdered formula, and that it had followed up complaints about all three. The letter notes that federal rules define an infant as a person not more than 12 months old, and encourages firms to address these risks in powdered drinks for children aged 12 to 36 months as well.

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6. The August 2023 Warning Letters

The 30 August 2023 news release states that the three warning letters “reflect findings from FDA inspections of these facilities over the last several months.” At each inspection the FDA had issued inspectional observations and overseen the firm as it recalled product “potentially contaminated with Cronobacter sakazakii”; the recalls took place in December 2022, February 2023 and March 2023.

The release explains what a warning letter asked of these firms. The FDA was issuing them “as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens.” The firms “must, among other things, thoroughly conduct root cause investigations and perform subsequent cleaning and sanitation activities,” and also need to evaluate their cleaning and sanitation practices before releasing product. Each company had 15 working days to tell the FDA what corrective actions it was taking. The FDA said it would judge those actions when reviewing the responses and at its next inspection of each plant.

The acting director of the FDA’s Center for Food Safety and Applied Nutrition was quoted: “The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage.” He described the letters as “a reflection of this enhanced oversight.”

The release also stated that the FDA was “not aware of any distributed product where contamination was confirmed,” believed the recalls had removed the potentially contaminated batches, and, because the letters were not tied to any current recall, did “not anticipate any impact to the availability of infant formula on the market.” The individual warning letters are posted on fda.gov under the firms’ names and are not linked here.

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7. The September 2023 Compliance Program

A compliance program is the FDA’s written instruction set for its own staff. Program 7321.006, “Infant Formula Program – Inspection, Sample Collection and Examination,” says it “provides instructions and tools for FDA investigators, laboratory analysts, and compliance officers.” The version now posted gives 28 September 2023 as its date of issuance and records pen-and-ink changes made on 5 August 2025, so the details below describe the program as currently posted.

Its stated objectives include:

• an annual inspection of every domestic and foreign plant making infant formula for the U.S. market;
• samples of finished formula at each domestic plant during the annual inspection, tested for nutrients (liquid and powder) and for germs (powder only);
• environmental sampling once a year at each domestic powdered-formula plant, tested for both Cronobacter and Salmonella, “if there are no significant adverse supply-chain implications”;
• more sampling of foreign-made formula at the U.S. border; and
• documenting significant findings and starting regulatory action where warranted.

The program also summarizes infant formula provisions of the Food and Drug Omnibus Reform Act of 2022 (FDORA), a law passed by Congress. As the program describes them, FDORA requires the FDA to inspect each domestic and foreign formula manufacturer every calendar year, to notify Congress within 24 hours after a formula recall begins, and to reinspect in a timely way where needed; it also requires recalling manufacturers to submit a plan to find and fix the root cause, and requires formula firms to keep risk management plans for threats to supply. The March constituent update had noted that Congress “recently added new requirements for manufacturers aimed at mitigating supply chain disruptions through mandatory shortage notifications and risk management plans.”

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8. Other 2023 Steps the FDA Reported

The August news release and the FDA’s strategy page (content current as of 20 September 2023) list further work during the year:

• A notifiable disease. The FDA, with the CDC, supported the Council of State and Territorial Epidemiologists’ decision to add invasive Cronobacter infections in infants under one year old to the Nationally Notifiable Conditions List, the list of diseases health departments report nationally. According to the FDA’s strategy page, the vote passed on 29 June 2023, with notification to take effect at the beginning of 2024, decided state by state.
• Staff. The FDA said it had begun hiring for a dedicated cadre of infant formula investigators and for a new Office of Critical Foods.
• More meetings and training. Further FDA–industry meetings were held in May 2023. A training workshop for FDA investigators was completed in early 2023, and the required online infant formula course for investigators was expanded.
• Testing authority. The strategy page says the FDA was evaluating testing requirements for finished product and continued to work with Congress to seek legal authority to, among other things, require firms to notify the agency of any product testing positive for Cronobacter. In 2023 that notification remained the voluntary request made in the March letter.
• Research. The FDA reported working with the National Advisory Committee on Microbiological Criteria for Foods on knowledge gaps, including how common Cronobacter contamination is in powdered formula on the U.S. market.
• Supply. The release reported U.S. formula in-stock rates “at 85% or higher since the beginning of 2023.”

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9. What the FDA Told Parents and Caregivers

With the warning letters, the FDA stated that it “does not advise parents and caregivers to discard or avoid purchasing any particular infant formula at this time.”

The same release passed on preparation guidance. It cites the CDC as recommending, for babies under 2 months old, born prematurely or with weakened immune systems, ready-to-feed liquid formula where possible, because liquid formula “is made to be sterile (without germs).” For powdered formula in these groups, the release describes extra steps: heating water to at least 158°F (70°C) “to help protect against Cronobacter,” adding the powder and mixing, then cooling to body temperature (98.6°F) before feeding. It adds that some metabolic and specialty formulas carry package warnings against heating above 100°F because nutrients can be lost, and points to manufacturers’ instructions for those products. These are the FDA’s and CDC’s statements; decisions about feeding a particular infant belong with the infant’s clinician.

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10. What These Actions Do Not Do

• The March letter is not a rule. It restates existing legal requirements and adds a voluntary request; reporting a positive sample from product that never left the plant was not made mandatory by it.
• The warning letters are not recalls. The FDA said they were not tied to any current recall, that it knew of no distributed product with confirmed contamination, and that it expected no effect on supply.
• No formula was declared unsafe to use. The FDA did not advise discarding or avoiding any particular formula.
• They do not settle the 2022 illnesses. The FDA’s own account says it could not determine whether the infants in the 2022 cases became sick from the plant’s product or from contamination by other means.
• The compliance program is written for the FDA’s own staff. It describes itself as instructions and tools for investigators, laboratory analysts and compliance officers; the requirements on manufacturers are those of the FD&C Act and the regulations it summarizes, such as 21 CFR parts 106, 107 and 117.

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11. Dates and Status as of 18 October 2026

• November 2022: outline of the FDA’s Cronobacter prevention strategy published.
• January–February 2023: regular FDA meetings with powdered formula manufacturers.
• 8 March 2023: letter and Table of Actions sent to the powdered formula industry.
• May 2023: further FDA–industry meetings.
• 29 June 2023: the Council of State and Territorial Epidemiologists’ vote on making invasive infant Cronobacter infections nationally notifiable, as reported by the FDA.
• 30 August 2023: warning letters to three infant formula manufacturers; 15 working days to respond.
• 28 September 2023: updated infant formula compliance program issued (pen-and-ink changes 5 August 2025).

Status as of 18 October 2026: none of these was a rule, so there is nothing to finalize, stay or withdraw. The FDA’s page for formula manufacturers (content current as of 13 July 2026) still lists the March 2023 letter, with its voluntary request to report Cronobacter or Salmonella positives, and the September 2023 compliance program among its current safety steps, and the compliance program remains posted with its 2025 changes. A check of the Federal Register through 18 October 2026 found no document that changes the status of the 2023 steps; the later Federal Register items on formula are new, separate actions (section 12). The outcome of the three warning letters is not reported in the documents used here.

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12. How the 2023 Steps Fit Earlier and Later Actions

The FDA’s manufacturer page groups the 2023 steps with other responses to “the infant formula supply disruption that followed” the 2022 recall. Earlier, in fall 2022, the FDA provided a pathway for domestic and foreign makers to add new formulas to the U.S. market “through an initial exercise of enforcement discretion”; the page says this added 12 new infant formula products.

Later actions listed on the same page and in the Federal Register:

• 4 December 2024: draft guidance on notifying the FDA when a manufacturer permanently stops or interrupts making an infant formula in a way likely to disrupt supply, a requirement for “critical foods” such as formula (89 FR 96261, Docket No. FDA-2024-D-1334).
• January 2025: the FDA’s Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, and draft guidance on sanitation programs and corrective actions after pathogen contamination for low-moisture ready-to-eat foods, including powdered formula (90 FR 1052, 7 January 2025, Docket No. FDA-2024-D-2604). The comment period was reopened until 28 July 2025 (90 FR 22675); no final version appears in the Federal Register through 18 October 2026.
• March 2025: “Operation Stork Speed,” which began a review of infant formula nutrients and more testing of formula and ingredients for spore-forming germs such as Clostridium botulinum and Bacillus cereus; a request for information on nutrient requirements followed on 14 May 2025 (90 FR 20475, Docket No. FDA-2025-N-1134).
• December 2025: a letter reminding industry, especially retailers, of their responsibilities to carry out recalls effectively, with particular attention to infant formula.
• 13 July 2026: a letter to the formula industry on risks to consider when selecting ingredients and ingredient sources for powdered formula.

A different kind of formula contamination, by a spore-forming germ that pasteurization does not kill, is reported on the site’s page on the 2025 infant botulism outbreak linked to powdered formula. A formula failure caused by a missing nutrient rather than a germ is described on the page on the 2003 Israeli soy formula thiamine-deficiency outbreak. Other 2023 FDA actions on foods for babies and children include the warning on probiotics for preterm infants and the investigation of lead in cinnamon applesauce pouches.

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13. Primary Documents

1. U.S. Food and Drug Administration (2023). FDA Calls for Enhanced Safety Measures in Letter to Powdered Infant Formula Industry. Constituent Update, 8 March 2023 — fda.gov constituent update
2. U.S. Food and Drug Administration (2023). Letter to infant formula manufacturers, packers, distributors, exporters, importers and retailers calling for enhanced safety measures, 8 March 2023 (PDF) — fda.gov letter
3. U.S. Food and Drug Administration (2023). FDA Sends Call to Action to Infant Formula Industry: Table of Actions, March 2023 (PDF) — fda.gov Table of Actions
4. U.S. Food and Drug Administration (2023). FDA Issues Warning Letters to Three Infant Formula Manufacturers. News release, 30 August 2023 — fda.gov news release
5. U.S. Food and Drug Administration. Compliance Program 7321.006, Infant Formula Program – Inspection, Sample Collection and Examination. Date of issuance 28 September 2023; pen-and-ink changes 5 August 2025 (PDF) — fda.gov compliance program
6. U.S. Food and Drug Administration. Summary of FDA’s Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula. Content current as of 20 September 2023 — fda.gov strategy summary
7. U.S. Food and Drug Administration. Information for Infant Formula Manufacturers and Retailers. Content current as of 13 July 2026 — fda.gov manufacturer page
8. Food and Drug Administration, HHS (2024). Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Availability. Federal Register 89:96261, 4 December 2024. Docket No. FDA-2024-D-1334 — FR Doc. 2024-28230
9. Food and Drug Administration, HHS (2025). Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability. Federal Register 90:1052, 7 January 2025. Docket No. FDA-2024-D-2604 — FR Doc. 2024-31528; comment period reopened, 90 FR 22675, 29 May 2025 — FR Doc. 2025-09653
10. Food and Drug Administration, HHS (2025). Infant Formula Nutrient Requirements; Request for Information. Federal Register 90:20475, 14 May 2025. Docket No. FDA-2025-N-1134 — FR Doc. 2025-08419

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Key Research Papers

1. Strysko J, Cope JR, Martin H, Tarr C, Hise K, Collier S, Bowen A (2020). Food safety and invasive Cronobacter infections during early infancy, 1961-2018. Emerging Infectious Diseases 26(5):857-865 — PubMed PMID: 32310746
2. Haston JC, Miko S, Cope JR, McKeel H, Walters C, Joseph LA, Griswold T, Katz LS, Andújar AA, Tourdot L, Rounds J, Vagnone P, Medus C, Harris J, Geist R, Neises D, Wiggington A, Smith T, Im MS, Wheeler C, Smith P, Carleton HA, Lee CC (2023). Cronobacter sakazakii infections in two infants linked to powdered infant formula and breast pump equipment - United States, 2021 and 2022. MMWR Morbidity and Mortality Weekly Report 72(9):223-226 — PubMed PMID: 36862586
3. Chauhan R, Tall BD, Gopinath G, Azmi W, Goel G (2023). Environmental risk factors associated with the survival, persistence, and thermal tolerance of Cronobacter sakazakii during the manufacture of powdered infant formula. Critical Reviews in Food Science and Nutrition 63(33):12224-12239 — PubMed PMID: 35838158
4. Osaili T, Forsythe S (2009). Desiccation resistance and persistence of Cronobacter species in infant formula. International Journal of Food Microbiology 136(2):214-220 — PubMed PMID: 19720413
5. Norberg S, Stanton C, Ross RP, Hill C, Fitzgerald GF, Cotter PD (2012). Cronobacter spp. in powdered infant formula. Journal of Food Protection 75(3):607-620 — PubMed PMID: 22410240
6. Hunter CJ, Bean JF (2013). Cronobacter: an emerging opportunistic pathogen associated with neonatal meningitis, sepsis and necrotizing enterocolitis. Journal of Perinatology 33(8):581-585 — PubMed PMID: 23538645

The first paper is a CDC review of invasive Cronobacter infections in infants reported over nearly six decades; the second is a 2023 CDC report of two infant cases investigated with whole genome sequencing. The third and fourth review how the germ survives drying and persists in formula plants, the problem behind several of the FDA’s 2023 inspection concerns. The last two are general reviews of Cronobacter in powdered formula and of the illnesses it causes in newborns.

PubMed Topic Searches

1. PubMed: Cronobacter and powdered infant formula
2. PubMed: Cronobacter sakazakii infections in infants
3. PubMed: Salmonella and powdered infant formula

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Connections

• FDA Actions of 2023
• FDA and Regulation
• Infant Botulism Outbreak Linked to Powdered Formula (2025)
• Lead Action Levels for Baby Food (2025)
• 2003 Soy Formula Thiamine-Deficiency Outbreak
• Bacterial Illnesses
• Bacteria
• Salmonella
• Probiotics for Preterm Infants Warning (2023)
• Lead in Cinnamon Applesauce Pouches (2023)
• Cantaloupe Salmonella Outbreak (2023)
• Sesame Becomes the Ninth Major Allergen (2023)

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