·         All label, labeling, and advertising claims should be reviewed by legal counsel with expertise in FDA/FTC regulations.

·         Adequately evaluate the clinical research and literature on individual ingredients and ideally on the product as a whole. ONLY use claims that are substantiated with competent and reliable scientific evidence in the dosage range of the product.

          Always consider the number of studies, the type of studies (ideally human), quality of studies [# of participants, double-blind, placebo controlled], relevance of studies [same formulation, additional ingredients, route of administration]), and other negative findings/totality of the evidence.

         Avoid relying on animal or in-vitro studies unless the claim is qualified to reflect the limitation.

         Testimonials or personal experiences are not considered as substantiation.

         Keep a binder or file with all of the studies and/or literature used to substantiate product claims.

         Ensure all claims are phrased in “structure/function” language and that no express or implied disease claims are being made. Websites not only help sell product but also help the agencies to review claims from the comfort of their office.

         Subscribe to FDA warning letters notification e-mails and other industry sources to stay abreast of the latest enforcement priorities.

         Advertising claims based solely on traditional use should be crafted in a way to avoid the implication that the product has been scientifically evaluated for efficacy. Historical use should be documented.

         Avoid claims that, if unfounded, could present a substantial safety risk.

         Avoid claims that could lead consumers to forgo treatments or to self-medicate for serious conditions.

         Third-party literature can be a very effective tool if used correctly. To minimize risk it should be reviewed by legal counsel prior to its use in marketing.

         Understand the difference between puffery (subjective claims that cannot be proven true or false) and deceptive (objective) claims. Avoid making objective claims that cannot be scientifically substantiated.

         A disclaimer cannot cure a deceptive claim.

         Consider getting expert letters on substantiation especially for “grey” claims to minimize risk.