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GUIDANCE DOCUMENT

Guidance for Industry: Labeling of Infant Formula August 2016

Final

Guidance for Industry: Labeling of Infant Formula

Issued by:
Guidance Issuing Office
Office of Nutrition and Food Labeling

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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Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.