CRN outlines industry impact in enforcing 'rigid' substantiation standard

WASHINGTON — The Council for Responsible Nutrition on Wednesday filed a second amicus brief in response to a motion by the U.S. Department of Justice on behalf of the Federal Trade Commission. The brief addresses a motion by the U.S. Department of Justice on behalf of the FTC, with respect to Bayer Healthcare’s advertising claims for a probiotic supplement. 

 

In October, CRN argued that by requiring multiple randomized, placebo-controlled and double-blind human clinical trials using the specific product for which the claims are made and are performed in the population at which the claims are directed, the FTC is invoking “a rigid standard for the substantiation of non-disease claims made about dietary supplements that is a significant departure from the current well-established, consistent and flexible federal regulatory regime upon which the entire dietary supplement industry has long relied.”

 

The second brief offers further insight into the implications for the whole industry and urges the court to reject the government’s novel legal standard for the substantiation of dietary supplement claims that contravenes Congressional intent and departs from longstanding agency guidance and industry practice.