Bayer prevails over FTC in case addressing claim substantiation for dietary supplements.

• In the dietary supplement advertising area, the Federal Trade Commission (FTC) takes enforcement action where companies lack “competent and reliable scientific evidence” to substantiate marketing claims.  In 2014, the FTC initiated civil contempt proceedings against Bayer related to claims for a probiotic supplement, alleging that the company violated a 2007 consent decree by making unsubstantiated claims about the product’s role in alleviating gastrointestinal symptoms.  During the ensuing trial, the FTC opined that the “competent and reliable scientific evidence” required to support Bayer’s claims necessitated a randomized controlled trial (RCT), i.e., the “gold standard” for claims in the pharmaceutical area.
• The U.S. District Court for the District of New Jersey has ruled in Bayer’s favor, finding that the company made appropriate structure-function claims (rather than disease claims) and that one government expert’s opinion was insufficient to establish the requirement that only an RCT could substantiate the claims.
• Particularly because a win for the government in this case could have imposed RCTs as the new minimum requirement to substantiate structure-function claims, Bayer’s victory is being hailed as a positive outcome for the food and supplement industry.