GUIDANCE DOCUMENT

Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion September 2022

Final

Docket Number:: FDA-2022-D-0814
Issued by:: Guidance Issuing Office

Center for Food Safety and Applied Nutrition

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FDA plays a critical role in ensuring the safety and nutritional adequacy of infant formula in the United States. We work to ensure that infant formula sold in the United States meets the required safety and nutritional standards specified in section 412 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and in FDA’s implementing regulations at 21 CFR parts 106 and 107. Given recent events precipitating a critical shortage of infant formula in the United States, FDA is issuing this guidance document 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.[1] Continued product availability is an issue of particular significance for infants who started on a specific formula during the shortage and have come to rely on such formula as an essential source of nutrition.[2]

The current period of supply shortage and disruption caused by, among other things, the temporary shutdown of a major infant formula manufacturing facility, has demonstrated the need for FDA to support the availability of an adequate supply of safe and nutritionally adequate infant formula, create a more resilient U.S. supply for infant formula products, and help avoid the future risk of lack of access to a sole source of nutrition for a vulnerable population. To help meet these goals, FDA intends to temporarily exercise enforcement discretion for certain manufacturers of infant formula that continue to introduce into interstate commerce (including through importation) infant formula products that may not comply with certain statutory and regulatory requirements if: (1) such manufacturers market these products consistent with a letter of enforcement discretion relating to information provided under our “Infant Formula Enforcement Discretion Policy: Guidance for Industry” issued May 2022 (May 2022 Enforcement Discretion Guidance),[3] which remains in effect until November 14, 2022; and (2) such manufacturers take specific actions to achieve compliance with the statutory and regulatory requirements applicable to their products. This guidance document will help infant formula manufacturers meet the regulatory requirements applicable to these products while ensuring continued access to formulas that are currently fulfilling the needs of infants consuming such products. This guidance is intended to advise infant formula manufacturers marketing products in accordance with letters of enforcement discretion issued under the May 2022 Enforcement Discretion Guidance about: (1) the type of information to provide to FDA; and (2) our timing expectations related to such information, if they would like us to consider the exercise of enforcement discretion with respect to infant formula products that are safe and nutritionally adequate, but that may not comply with all statutory and regulatory requirements, during the period described below. FDA expects that all infant formula products will comply with all applicable U.S. requirements by the end of the enforcement discretion period.

This guidance also allows FDA to refocus resources on reviewing product and manufacturer information submitted in accordance with FDA regulations prior to the May 2022 Enforcement Discretion Guidance. Infant formula manufacturers that submitted packages to FDA pursuant to the May 2022 Enforcement Discretion Guidance but that did not receive enforcement discretion letters may continue to seek FDA review in accordance with FDA regulations.

This guidance document will remain in effect until October 18, 2025, and we will evaluate whether any extension is necessary before that date. We will give public notice if we determine that an extension is warranted.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA guidances means that something is suggested or recommended, but not required.

This guidance is being 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. This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not appropriate (see section 701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance is being implemented immediately, but it remains subject to comment in accordance with our good guidance practices.

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[1] This guidance has been prepared by the Office of Nutrition and Food Labeling and the Office of Regulations and Policy in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

[2] See, e.g., 79 FR 7933 at 8026 (Feb. 10, 2014).

[3] Consistent with the policies described in the May 2022 Enforcement Discretion Guidance, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy, certain manufacturers have submitted information to FDA to substantiate the safety and nutritional adequacy of specific infant formula products and have been marketing such products under FDA’s exercise of enforcement discretion.

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All written comments should be identified with this document's docket number: FDA-2022-D-0814.