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GUIDANCE DOCUMENT

Guidance for Industry: Labeling of Infant Formula March 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2013-S-0610
Issued by:
Guidance Issuing Office
Human Foods Program

The Food and Drug Administration (“FDA” or “we”) is publishing this reminder to infant formula manufacturers and distributors (“you”) about certain labeling requirements for infant formula products. While this guidance provides information about the labeling requirements for infant formula products generally, we are concerned particularly about the number of infant formula products that bear the same or similar statements of identity but are different in composition or intended use. We have also noticed an increased use of nutrient content claims that render products misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance provides information that can help you understand and comply with relevant labeling requirements.

This guidance does not provide an exhaustive list of all regulations covering the labeling of infant formula. We encourage you to review your product labels to ensure they comply with FDA’s regulations, especially—but not limited to—the regulations discussed in this guidance. We also encourage you to refer to our guidance documents at www.fda.gov/FoodGuidances for additional information.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s 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. 

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All written comments should be identified with this document's docket number: FDA-2013-S-0610.

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