Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling


How to Comment

The comment period opens September 9, 2016.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit comments by February 21, 2017.

Submit electronic comments on to docket number FDA-2016-D-2241 

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 docket number FDA-2016-D-2241.

Contains Nonbinding Recommendations
Draft-Not for Implementation

September 2016

This guidance is being distributed for comment purposes only.

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Download the Draft Guidance for Industry(PDF: 94KB)

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