Guidance for Industry: Labeling of Infant Formula


How to Comment

Submit 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 document.


For questions and additional copies, please contact us at:

Office of Nutrition and Food Labeling
Food Labeling and Standards Staff, HFS-820
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
(Tel) 240-402-2371 

Contains Nonbinding Recommendations

September 2016

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 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.

Download the Guidance for Industry (PDF 139KB)

Page Last Updated: 09/16/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English