Summary of FDA’s Draft Guidance on Structure/Function Claims in Conventional Foods, Specifically Infant Formula Labels and Labeling

For the first time, the Food and Drug Administration (FDA) issued draft guidance on the substantiation of structure/function (SF) claims in the labeling of bp_comp_woman_reading_labelconventional foods, specifically infant formula. (FDA has previously released guidance on the substantiation of SF claims in dietary supplement labeling.) FDA considers a SF claim as a claim about an effect on the normal structure or function of the human body, for example a claim describing the role of an infant formula constituent intended to affect normal structure or function; FDA defines “constituent” as “substances that are inherent components of a product as well as those that are added ingredients.” Such claims do no need preapproval by FDA when labeling conventional foods or dietary supplements. While specifically targeted toward SF claims for infant formula, FDA suggested that the draft guidance will represent FDA’s current thinking on this topic for all conventional foods when finalized.
The draft guidance outlines the type and quality of evidence recommended for infant formula manufacturers and distributors to substantiate SF claims. Compared to dietary supplements the scope of SF claims for conventional foods is more narrow. While dietary supplements can make SF claims relating to both nutritive and non-nutritive effects on the structure or function of the body, SF claims on conventional foods should relate to “articles consumed primarily for taste, aroma, or nutritive value.”  Similar to food additives for conventional foods, infant formula manufacturers must establish the safety of constituents before adding them to their products. FDA is recommending manufacturers use the same “competent and reliable scientific evidence” substantiation standard developed by the Federal Trade Commission (FTC), since FDA and FTC have overlapping jurisdiction over infant formula products, exclusively overseeing safety and primarily overseeing labeling, and primarily overseeing advertisements for infant formula products, respectively. Specifically for infant formula, FDA and FTC consider competent and reliable scientific evidence to be findings from well-designed and controlled intervention studies in an appropriate population of U.S. infants receiving an appropriate formula matrix with and without the constituent of interest, including all relevant studies. This means manufacturers shouldn’t pick and choose which studies they want to use to substantiate their claim, leaving out studies with findings not in their interest.
When determining if adequate evidence exists to substantiate a SF claim, FDA is suggesting manufacturers and distributors consider evidence-based systematic reviews to assess the strength of the evidence. To substantiate SF claims in infant formula labeling, manufacturers should rely on infant feeding intervention studies, specifically randomized, double blind, and parallel-controlled trials. While manufacturers and distributors could use results from observational studies, research synthesis studies and animal and in vitro studies, results from these and other study designs should not be used to substantiate a SF claim in infant formula labeling, but only to provide supportive evidence.  FDA considers the following factors important when establishing whether a study and its findings would support “competent and reliable scientific evidence”:

  • What are the individual study’s strengths and weaknesses, including the quality of the study and the peer review?

  • When more than one study exists, do the studies with the highest quality suggest a certain outcome and what do most studies suggest or find?

  • Does the totality of the evidence support the proposed claim?

  • Do study designs with limited utility to substantiate a SF claim provide supportive evidence for a claim?

Manufacturers and distributors interested in making SF claims on infant formula and other conventional foods should provide comments on the draft guidance. Comments on the guidance should be submitted by November 8 and may be submitted here: