Dietary Supplements | Claims Substantiation (FTC)

The Food Drug and Cosmetic Act (FDCA) and FDA regulations require that all claims related to dietary supplement labels and labeling (including Internet websites and other marketing or promotional materials) have adequate substantiation supporting the claim. Adequate substantiation means that a dietary supplement distributor or manufacturer has, at the time the claim is made, competent and reliable scientific evidence about the benefits and safety of dietary supplements and other health-related products. The evidence must support the truthfulness and non-misleading nature of the beneficial product claim. This standard applies to dietary supplement labeling claims relating to nutritional deficiency and supplementation, structure or function labeling or marketing claims, and to general health and well-being claims. The Federal Trade Commission (FTC) has primary jurisdiction over advertisements and marketing for dietary supplements and it has its own policy relating to substantiating dietary supplement marketing claims, particularly on the Internet.

Although the adequate substantiation standard belongs primarily to the FTC and its jurisdiction, FDA applies a standard for the substantiation of dietary supplement claims that is consistent with the FTC’s. Through facility establishment inspections, import inspections and examinations, and Internet website reviews and evaluations, FDA makes certain that dietary supplements are properly labeled and do not make implied or explicit drug disease claims. FDA works closely with the FTC to enforce the relevant FDA labeling regulations and FTC advertising regulations related to all dietary supplement marketing. These two agencies work in concert to regulate labeling (including Internet marketing sites) and advertising claims associated with dietary supplements and other products.

Very often companies marketing dietary supplements may have some scientific evidence about a particular ingredient in a dietary supplement, and then attempt to claim that the final formulation (which happens to contain that ingredient) is able to deliver the same beneficial effect as the ingredient. This is usually not an acceptable approach without including certain very specific disclaiming language regarding the nature of the evidence and the ingredient to which it directly applies.

It is clear that regulatory guidance and assistance from, LLC, with its experience interpreting dietary supplement labels, marketing and Internet claims, shines the light on The Way Through FDA and FTC claims substantiation, labeling, and marketing regulations governing dietary supplements. Many foreign and domestic dietary supplement manufacturers and distributors turn to, LLC on a weekly basis to review new dietary supplement products, new dietary ingredients, new marketing language, and new dietary supplement labels. Let, LLC help your company successfully enter and compete in the U.S. dietary supplement market.