As previously covered here, on September 9, 2016, FDA announced the availability of its first draft guidance for industry entitled, “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling,” which describes the type and quality of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).

Today, FDA announced that it has reopened the comment period for this draft guidance in response to requests for additional time to submit comments.  The comment period will reopen on November 21, 2016 for 90 days.

Food and dietary supplement manufacturers have always had an obligation to adequately substantiate their products’ claims.  The development of a specific guidance document for infant formula structure/function claims, however, may result in additional scrutiny of such claims on infant formula labels.  Complying with FDA’s thinking on what constitutes adequate substantiation will help infant formula manufacturers defend against potential challenges (regulatory or otherwise) to their structure/function claims.  In this regard, industry should consider taking advantage of this additional time to provide their input on and help shape the final version of FDA’s guidance document for infant formula structure/function claims.