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GUIDANCE DOCUMENT

Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling September 2016

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2016-D-2241
Issued by:
Guidance Issuing Office
Office of Nutrition and Food Labeling

This guidance document describes the type and quality of evidence that the Food and Drug Administration (FDA or we) recommends infant formula manufacturers and distributors have to substantiate claims about effects on the structure or function of the body (“structure/function claims”) made on the label and in other labeling of nonexempt and exempt infant formulas. 

The purpose of this guidance document is to help infant formula manufacturers and distributors making structure/function claims to comply with the statutory requirement that all claims in food labeling must be truthful and not misleading under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(a)(1)).

FDA regulates infant formula under the FD&C Act.  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.”  FDA regulations in Title 21 of the Code of Federal Regulations (21 CFR) define the term “infant” as “a person not more than 12 months old” (21 CFR 106.3).  Although human milk is the recommended source of nutrition for infants (Ref. 1), infant formula nonetheless provides the sole source of nutrition for many infants during a vulnerable period of life when diet plays a critical role in affecting long-term growth and development.

Download the Draft Guidance

More Infant Formula Guidance Documents & Regulatory Information


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-2016-D-2241.