FDA issues Draft Guidance Concerning Substantiation Needed to Support Structure/Function Claims Made in Infant Formula Labeling. 

• In an increasingly competitive marketplace, infant formula manufacturers are incentivized to make product claims that capture consumers’ attention.  “Structure/function” claims have become popular with infant formula products – these are statements about the effect of a product or its constituents on the normal structure or function of the body. An example of a structure/function claim in infant formula labeling is a statement that the formula “supports digestion.”  FDA requires that such claims be truthful and not misleading, meaning that the claim needs to be adequately substantiated.

• On September 9, FDA announced the availability of its first draft guidance for industry entitled, “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling,” which describes the type and quality of evidence that FDA recommends infant formula manufacturers and distributors have to substantiate structure/function claims in infant formula labels and labeling.  81 FR 62509 (September 9, 2016).  In short, the draft guidance recommends that structure/function claims for infant formula should be substantiated with information that meets the “competent and reliable evidence” standard, consistent with Federal Trade Commission’s (FTC’s) and FDA’s approach for the substantiation of structure/function claims for dietary supplements.  Of note, the draft guidance also suggests that infant formula manufacturers consider conducting clinical research trials on infants to substantiate assertions of how their products actually function in an infant’s body, but indicates that non-infant studies would also be adequate if the mechanism of action is well-established and the data indicate no difference between infants and adults.

• FDA asks that comments be submitted by November 8, 2016 to ensure that they are considered as the Agency works on the final version of the guidance.  Although manufacturers of all dietary supplements and food (including infant formula) have always had an obligation to support their products’ claims, the development of a specific guidance document may result in additional scrutiny of structure/function claims on infant formula labels.  As a result, infant formula manufacturers should make sure they are comfortable that their products’ claims are adequately supported.