Original Post
MAY 2022
Download the Final Guidance Document
Docket Number: FDA–2022–D–0814
Issued by: Center for Food Safety and Applied Nutrition
We are issuing this guidance document to help increase the supply of infant formula in the United States. FDA intends to temporarily exercise enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements and is seeking information from manufacturers regarding the safety and nutritional adequacy of their products. This guidance document is intended to:
- explain factors that FDA intends to consider in making case-by-case determinations about whether to exercise enforcement discretion to allow the introduction into interstate commerce (including importation) of infant formula that is safe and nutritionally adequate, but that may not comply with all statutory and regulatory requirements; and
- advise infant formula manufacturers about the type of information to provide to FDA, if they would like FDA to consider whether to exercise enforcement discretion with regard to particular products.
This guidance document will remain in effect until November 14, 2022, and we will evaluate whether any extension is necessary. We will give public notice when the period of enforcement discretion ends.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA guidance means that something is suggested or recommended, but not required.
This guidance is being issued to help increase the supply of infant formula in the United States. This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (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 the Agency’s good guidance practices.
Related Resources
- Infant Formula Guidance Documents & Regulatory Information
- Imports & Exports Guidance Documents & Regulatory Information
- Fact Sheet: Helping Families Find Formula During the Infant Formula Shortage
- Questions & Answers for Consumers Concerning Infant Formula
- FDA Advises Parents and Caregivers to Not Make or Feed Homemade Infant Formula to Infants
- FDA Investigation of Cronobacter Infections: Powdered Infant Formula
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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–2022–D–0814.
