FDA Flexibilities to Ease the Infant Formula Shortage (2022)

Table of Contents

1. What the FDA Did on May 16, 2022
2. Why the FDA Acted: The 2022 Shortage
3. What Manufacturers Were Asked to Send
4. How Products Were Judged Case by Case
5. Letters of Enforcement Discretion
6. Import Screening, Air Shipments and Tariff Relief
7. The September 30, 2022 Transition Plan
8. What the Flexibilities Did Not Do
9. Dates and Legal Status as of October 18, 2026
10. How It Fits Earlier and Later FDA Infant Formula Actions
11. Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

1. What the FDA Did on May 16, 2022

The FDA’s page “Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies” states that on May 16, 2022 the agency “issued a guidance to manufacturers of infant formula to announce the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula.” The document was titled “Guidance for Industry: Infant Formula Enforcement Discretion Policy” (May 2022, final, Docket No. FDA-2022-D-0814); the guidance record lists the FDA’s Human Foods Program as the issuing office.

Enforcement discretion means that the FDA chooses, for a period and under conditions it sets, not to take enforcement action over particular requirements that a product does not meet. The law and the regulations themselves do not change. A guidance document is the FDA’s statement of how it intends to apply the law; the May 2022 guidance record states that its contents “do not have the force and effect of law and are not meant to bind the public in any way.”

The FDA described the purpose in these words: the action “was designed to increase infant formula supplies in the United States, while protecting the health of infants, for whom infant formula is often the sole source of nutrition during a critical period of growth and development.” According to the guidance record, it was meant to explain the factors the FDA would weigh in deciding whether to allow the introduction into interstate commerce, “including importation,” of formula “that is safe and nutritionally adequate, but that may not comply with all statutory and regulatory requirements,” and to tell manufacturers what information to send.

The guidance record states that it was “implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate,” citing section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 10.115(g)(2), and that it was “implemented immediately, but it remains subject to comment.” It was to remain in effect until November 14, 2022, and the FDA wrote that it would “evaluate whether any extension is necessary.”

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2. Why the FDA Acted: The 2022 Shortage

The FDA’s enforcement-discretion page gives the background in one sentence: a voluntary recall by one of the largest U.S. formula manufacturers in February 2022 “and subsequent voluntary cease in production at their Sturgis facility, combined with the overall strains on supply chains experienced during the COVID-19 pandemic, created concerns about the availability of certain types of infant formula.” The recall followed an FDA investigation of infant Cronobacter infections linked to powdered formula from that Michigan plant.

The FDA’s December 2023 status update on its infant formula response describes the period that followed. “At the height of the supply challenges,” it says, 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.”

On the same day the guidance was issued, May 16, 2022, the U.S. District Court for the Western District of Michigan entered a consent decree of permanent injunction between the FDA and the manufacturer of the recalled formula; the FDA’s outbreak page says that under it the firm would take corrective actions at the plant. That court order is reported on the recall and plant shutdown page.

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3. What Manufacturers Were Asked to Send

Under the May guidance, a manufacturer that wanted the FDA to consider enforcement discretion for a formula had to supply information about it. The FDA’s enforcement-discretion page lists what was sought:

• a list of all nutrients and their amounts, as well as the ingredients;
• a copy of the product label and a description of the packaging;
• current or anticipated inventory of the formula;
• microbiological testing results;
• the facility’s inspection history.

The guidance record gives the FDA’s estimate of the paperwork burden: about 24 hours per response, under Office of Management and Budget (OMB) control number 0910-0256. The record notes that a person “is not required to respond to” a collection of information unless it displays a currently valid OMB control number.

The FDA’s September 30, 2022 constituent update says that “many manufacturers” sent detailed information about particular formulas, and that the FDA reviewed “the products’ nutritional adequacy and safety, microbiological testing results, labeling information and details about the manufacturing facility’s food safety production practices and inspection history.” The December 2023 status update describes this as “an expedited review of certain food safety and nutrition records associated with the firms and products prior to issuing letters of enforcement discretion.”

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4. How Products Were Judged Case by Case

The FDA’s page gives two examples of how it drew the line:

• A labeling difference that would likely qualify. For a formula “with a label that did not list the nutrients in the order required, but that otherwise meets applicable requirements,” the FDA said it would likely find enforcement discretion appropriate.
• A nutrient difference that might not. “In contrast, an infant formula with meaningful differences in required nutrients might not have been an appropriate candidate for enforcement discretion.”

Some label requirements were treated as safety matters rather than formalities. The FDA wrote that “Certain labeling requirements, such as the clear identification of any allergens present in the product or adequate instructions for safe product preparation and use, are connected to food safety and were considered carefully in evaluating requests for enforcement discretion.”

The FDA’s outbreak page from the same period lists a resource titled “Tips for Preparing Imported Infant Formula” among its materials for consumers; the content of that resource was not reviewed for this page.

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5. Letters of Enforcement Discretion

The FDA put its decisions in writing to each manufacturer. The FDA’s outbreak page, in its May 26, 2022 update, reports that on May 24, 2022 the FDA announced that it “will exercise enforcement discretion with respect to specific infant formula products to increase infant formula supplies in the United States,” and that its list of companies receiving enforcement discretion “will be updated on a regular basis.”

The September 30, 2022 constituent update confirms that, based on its reviews, the FDA “has issued letters of enforcement discretion related to the marketing of specific infant formula products in the United States through November 14, 2022.” The letters covered specific, named products.

The December 2023 status update gives the overall count: “Twelve firms that manufacture infant formula have brought various infant formula products into the U.S. market under FDA’s exercise of enforcement discretion; this increased the number of firms supplying product to the U.S. market from 2021 to 2022.”

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6. Import Screening, Air Shipments and Tariff Relief

The guidance was one of several steps. The December 2023 status update lists others the FDA took or supported in its response:

• Import screening. The FDA “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).”
• Emergency air transport. The 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.” The operation was run by the Department of Health and Human Services (HHS); the FDA describes its own role only as support.
• Tariff relief. The 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.”
• Supply tracking. The FDA used a data platform first built to track supply shortages during the COVID-19 pandemic to track and anticipate disruptions across the infant formula supply chain, using data that manufacturers provide voluntarily, and FDA staff met regularly with manufacturers about current and forecast production.
• Raw materials. The FDA coordinated with the HHS Administration for Strategic Preparedness and Response’s Defense Production Act office to help resolve shortages of ingredients needed to make formula, “including through technical assistance and DPA authorities when needed.”

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7. The September 30, 2022 Transition Plan

As the November 14, 2022 end date approached, the FDA issued a second guidance, “Infant Formula Transition Plan for Exercise of Enforcement Discretion: Guidance for Industry.” The FDA announced it in a constituent update on September 30, 2022, and its notice of availability was published in the Federal Register on October 6, 2022 (87 FR 60689; Docket No. FDA-2022-D-0814). The Federal Register is the U.S. government’s daily publication of rules and official notices; a docket is the public file in which an action’s documents and comments are kept.

The constituent update describes the plan as “a pathway for manufacturers of infant formula under enforcement discretion to market infant formula products that may not currently comply with specific FDA requirements while they work toward meeting those requirements.” Its terms, as the FDA documents give them:

• Extension to January 6, 2023. Enforcement discretion for the products named in the FDA’s letters was extended until January 6, 2023, “with further extensions possible for firms that express interest in and take steps toward the lawful marketing of such products in the United States.”
• Letter of intent by December 5, 2022. Manufacturers marketing products under enforcement discretion “would need to send to the FDA by Dec. 5, 2022, a letter of intent to pursue compliance with all regulatory requirements.”
• New letters. The FDA would evaluate each letter of intent and, where appropriate, issue a new letter of enforcement discretion by January 6, 2023, to continue its discretion while the manufacturer worked to bring its products into full compliance.
• A recommended timetable. The guidance “provides a recommended timetable for the actions manufacturers will be taking to achieve compliance with all requirements that apply to their products.”

The FDA gave two reasons. The update says the disruption, “caused in part by the temporary shutdown of a major infant formula manufacturing facility, has demonstrated the need to create a more resilient U.S. supply for infant formula products and help avoid future shortages.” It adds that “continued product availability is desirable for infants who started on a specific formula during the shortage and now are accustomed to that formula as an essential source of nutrition.” The Federal Register abstract states that the guidance was issued “to protect public health by helping to stabilize the supply of infant formula in the United States and to maintain a consistent supply of a variety of infant formula products.”

The same notice announced that a related collection of information had been submitted to OMB under the Paperwork Reduction Act of 1995, with FDA requesting immediate emergency approval and written comments on the collection due by November 7, 2022. During October and November 2022, according to the status update, the FDA hosted a four-part webinar series on the transition plan for manufacturers.

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8. What the Flexibilities Did Not Do

• They did not change the law or the regulations. The U.S. requirements for infant formula stayed in place; the May guidance states that its contents “do not have the force and effect of law.” The FDA chose, for a time, not to enforce certain requirements for named products.
• They were not blanket permission. Each product was judged case by case on the information its manufacturer supplied, and formulas with “meaningful differences in required nutrients” might not qualify.
• They did not set aside safety-related labeling. Allergen identification and instructions for safe preparation and use were, in the FDA’s words, “connected to food safety and were considered carefully.”
• They were not meant to be permanent. The May policy was set to end on November 14, 2022, and the transition plan was a path toward “full compliance” with all U.S. requirements, not a lasting exemption.
• They did not end the review. Under the transition plan, the FDA continued to review manufacturers’ deliverables, which the December 2023 status update lists as including protein efficiency ratio rat bioassay studies, growth monitoring studies and requests for exemptions, as well as new infant formula submissions.

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9. Dates and Legal Status as of October 18, 2026

• February 2022: a major manufacturer’s voluntary recall of certain powdered formula, followed by a halt in production at its Michigan plant.
• May 16, 2022: the FDA issues “Infant Formula Enforcement Discretion Policy,” implemented immediately (Docket No. FDA-2022-D-0814).
• May 24, 2022: the FDA announces enforcement discretion for specific formula products and begins a regularly updated list of companies receiving it.
• September 30, 2022: the FDA issues the transition-plan guidance.
• October 6, 2022: notice of availability in the Federal Register (87 FR 60689).
• November 7, 2022: comment deadline on the related information collection.
• November 14, 2022: end date of the May 2022 policy; letters issued under it ran through this date.
• December 5, 2022: deadline for manufacturers’ letters of intent to pursue full compliance.
• January 6, 2023: extended end of enforcement discretion for products in the letters, with further extensions possible under the transition plan.
• December 2023: the FDA’s status update reports eight firms taking part in the transition plan.
• July 15, 2025: the expected date for new infant formula submissions in the FDA’s current transition-plan table.

Status as of October 18, 2026: the May 2022 policy has ended; the transition plan’s products remain under FDA review. The May 2022 guidance, in the FDA’s words, “was in effect until November 14, 2022.” Its successor, the transition plan, is the path the remaining products have followed. In December 2023 the FDA reported that eight firms were taking part in the transition plan “to bring their formula products into compliance with all U.S. requirements for infant formula.” The FDA’s enforcement-discretion page (content current as of November 25, 2025) now lists six manufacturers that took part in the transition plan, each marked as having made a new infant formula submission to the FDA by the expected date of July 15, 2025. The FDA documents found for this page do not state whether any of those submissions has been completed or accepted.

A check of the Federal Register through October 18, 2026 found no document that withdraws or replaces the transition-plan guidance. The later documents filed under the same docket, FDA-2022-D-0814, are notices about information collections submitted to OMB (March 27, 2023, 88 FR 18146; September 29, 2023, 88 FR 67303) and lists of OMB approvals. No separate Federal Register notice for the May 2022 guidance itself was found.

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10. How It Fits Earlier and Later FDA Infant Formula Actions

The flexibilities sit between the 2022 recall that caused the shortage and a series of later steps described in the FDA documents and Federal Register records:

• February–May 2022. The FDA investigation of infant Cronobacter infections, the recall and the plant shutdown, ending in the May 16, 2022 consent decree (reported here).
• May–September 2022. The enforcement-discretion policy and the transition plan reported on this page.
• November 2022. The FDA releases a strategy to help prevent Cronobacter sakazakii illnesses linked to powdered formula and gives the National Advisory Committee on Microbiological Criteria in Foods a charge on possible interventions, according to the December 2023 status update.
• February 10, 2023. Draft guidance on protein efficiency ratio (PER) rat bioassay studies, used to show that a new infant formula supports “the quality factor of sufficient biological quality of protein” (88 FR 8868; Docket No. FDA-2022-D-2424). The status update names PER studies and growth monitoring studies among the deliverables firms owe under the transition plan.
• March 2023. The FDA issues its Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, which, according to the status update, describes immediate actions the FDA took during the shortage and its plans for the market, “while noting multiple issues that are beyond the purview of the FDA.” A Long-Term National Strategy followed.
• 2023. A letter to the powdered formula industry and warning letters to three formula manufacturers, reported on the 2023 infant formula safety page.
• December 4, 2024. Draft guidance on notifying the FDA of a permanent discontinuance or interruption in the manufacture of infant formula (89 FR 96261; Docket No. FDA-2024-D-1334). Its abstract explains that a manufacturer of a critical food, which includes infant formula, must notify the FDA of such a discontinuance or interruption when it is likely to lead to a meaningful disruption in the U.S. supply.
• May 14, 2025. A request for information to begin a review of infant formula nutrient requirements, “in part, to continue to ensure the nutritional adequacy of infant formula sold in the United States” (90 FR 20475; Docket No. FDA-2025-N-1134).
• May 22, 2026. The final PER guidance, which “finalizes the approach presented in the draft guidance issued in 2023” (91 FR 30318).

The December 2023 status update also reports that the FDA contracted with the National Academies of Sciences, Engineering, and Medicine for two independent studies: one on supply, market competition and regulation of infant formula in the United States, and one on possible alternatives to the PER and growth monitoring studies that the current regulations prescribe. A separate 2025 formula-related outbreak is reported on the 2025 infant botulism outbreak page. Among other 2022 actions, the FDA also used enforcement discretion in its N-acetyl-L-cysteine supplement policy.

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11. Primary Documents

1. U.S. Food and Drug Administration. Guidance for Industry: Infant Formula Enforcement Discretion Policy. Final guidance, May 2022. Docket No. FDA-2022-D-0814. Guidance record on fda.gov, listed under the title above in the FDA guidance documents database (not linked here).
2. U.S. Food and Drug Administration. Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies. Program page, content current as of November 25, 2025 — fda.gov enforcement discretion page
3. U.S. Food and Drug Administration. FDA to Continue Providing Flexibility to Infant Formula Manufacturers Under Certain Conditions to Stabilize Supplies. Constituent update, September 30, 2022 — fda.gov constituent update
4. Food and Drug Administration, HHS (2022). Infant Formula Transition Plan for Exercise of Enforcement Discretion: Guidance for Industry; Availability. Notice of availability. Federal Register 87 FR 60689, October 6, 2022. Docket No. FDA-2022-D-0814 — FR Doc. 2022-21794
5. U.S. Food and Drug Administration. Status Update on FDA’s Infant Formula Response Activities. December 2023 update, content current as of August 20, 2024 — fda.gov status update
6. U.S. Food and Drug Administration. FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022). Outbreak investigation page, updates of May 17 and May 26, 2022, content current as of August 1, 2022 — fda.gov outbreak investigation page
7. Food and Drug Administration, HHS (2023). Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements. Notice. Federal Register 88 FR 18146, March 27, 2023. Docket No. FDA-2022-D-0814 — FR Doc. 2023-06249
8. Food and Drug Administration, HHS (2023). Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Draft Guidance for Industry; Availability. Notice of availability. Federal Register 88 FR 8868, February 10, 2023. Docket No. FDA-2022-D-2424 — FR Doc. 2023-02836
9. 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. Notice of availability. Federal Register 89 FR 96261, December 4, 2024. Docket No. FDA-2024-D-1334 — FR Doc. 2024-28230
10. Food and Drug Administration, HHS (2025). Infant Formula Nutrient Requirements; Request for Information. Notice. Federal Register 90 FR 20475, May 14, 2025. Docket No. FDA-2025-N-1134 — FR Doc. 2025-08419
11. Food and Drug Administration, HHS (2026). Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry; Availability. Notice of availability. Federal Register 91 FR 30318, May 22, 2026. Docket No. FDA-2022-D-2424 — FR Doc. 2026-10284
12. Public docket FDA-2022-D-0814 — regulations.gov FDA-2022-D-0814

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Key Research Papers

1. Fenske GJ, Brown B, Oryang D, Pouillot R, Van Doren JM (2026). Dynamics of the U.S. 2022 Infant Formula Shortage and Recovery as Measured by In-stock Rates, Sales, and Household Experiences. Journal of Food Protection 89(5):100743 — PubMed PMID: 41786291
2. Harrigan PB, Misyak SA, Volpe SL, Hedrick VE, Kim M, Zheng S, Schenk T (2025). Policy changes to US federal infant feeding laws and regulations from 2014-2023: evidence that the 2022 infant formula shortage had a narrow policy impact. Health Affairs Scholar 3(6):qxaf096 — PubMed PMID: 40520237
3. Sheehan MD, Orenstein D, Addisu L, Patil S, Kuehn D (2025). Practice changes and infant health risks during the 2022 infant formula shortage: Results of a US healthcare provider survey. Nutrition in Clinical Practice 40(2):475-483 — PubMed PMID: 39358888
4. James-Davis L, Drumm C, Krick J, Vereen R (2024). Impact of the 2022 Infant Formula Shortage on Neonatal Intensive Care Units. Breastfeeding Medicine 19(11):881-884 — PubMed PMID: 39207249
5. Cernioglo K, Smilowitz JT (2023). Infant feeding practices and parental perceptions during the 2022 United States infant formula shortage crisis. BMC Pediatrics 23(1):320 — PubMed PMID: 37355589
6. Kalaitzandonakes M, Ellison B, Coppess J (2023). Coping with the 2022 infant formula shortage. Preventive Medicine Reports 32:102123 — PubMed PMID: 36798794
7. Warren CM, Gupta RS, Nowak-Wegrzyn A (2023). The 2022 US infant formula shortage: Perspectives on a nutritional crisis. Annals of Allergy, Asthma & Immunology 130(4):427-428 — PubMed PMID: 36681273

The first paper measures the course of the 2022 shortage and its recovery through store in-stock rates, sales and household experiences. The second reviews changes to U.S. federal infant feeding laws and regulations from 2014 to 2023. The third and fourth report on clinicians’ practice changes and on neonatal intensive care units during the shortage. The fifth and sixth survey how parents and households fed infants and coped during the shortage, and the last is a short perspective on the shortage as a nutritional crisis.

PubMed Topic Searches

1. PubMed: infant formula shortage
2. PubMed: infant formula supply chain
3. PubMed: infant formula regulation

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Connections

• FDA Actions of 2022
• FDA and Regulation
• FDA Investigation and Recall at a Major Infant Formula Plant (2022)
• FDA Steps to Tighten Infant Formula Safety (2023)
• Infant Botulism Outbreak Linked to Powdered Formula (2025)
• Milk
• NAC Supplement Enforcement Discretion (2022)
• Food Traceability Final Rule (2022)
• Frozen Lentil Crumbles Illnesses (2022)

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