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GUIDANCE DOCUMENT

Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula December 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-1334

Docket Number:
FDA-2024-D-1334
Issued by:
Guidance Issuing Office
Human Foods Program

Section 424(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350m(a)(1)) requires manufacturers of a critical food[1] to notify FDA of a permanent discontinuance in the manufacture or an interruption of the manufacture of a critical food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption.

The notification requirements apply to all manufacturers (foreign and domestic) that manufacture critical foods for sale in the United States, regardless of manufacturer size or market share.  This guidance discusses the notification requirements under section 424(a)(1) of the FD&C Act as they pertain to infant formula,[2] as well as FDA’s interpretation of key terms in the statute and provides recommendations for the content of and procedures for submitting such notifications.  These recommendations are informed by FDA’s recent experience involving manufacturer interruptions of these products and our work to improve the resiliency of the infant formula market.  This guidance covers all infant formulas, including those that are also medical foods (i.e., exempt infant formulas[3]).  FDA intends to continue gathering data regarding the market(s) for other types of critical food to help inform guidance related to those products.  Although this guidance is specific to infant formula, manufacturers of other types of critical foods are still required to comply with section 424 of the FD&C Act.    

In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance documents 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 guidance documents means that something is suggested or recommended, but not required.

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Related Resources

[1] This guidance has been prepared by the Office of Surveillance, Strategy, and Risk Prioritization; the Office of Critical Foods; and the Office of Policy, Regulations, and Information in the Human Foods Program at the U.S. Food and Drug Administration.

[2] Section 201(ss) of the FD&C Act (21 U.S.C. 321(ss)) defines a “critical food” as a food that is (1) an infant formula or (2) a medical food as defined in section 5(b)(3) of the Orphan Drug Act [21 U.S.C. 360ee(b)(3)].

[3] Section 201(z) of the FD&C Act (21 U.S.C. 321(z)) defines “infant formula” as a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.

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