Washington, D.C., September 12, 2014—In response to a contempt motion filed by the United States Department of Justice, on behalf of the Federal Trade Commission, against marketer of probiotic dietary supplement, Phillips’ Colon Health, the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, issued the following statement:
Statement by Steve Mister, president & CEO, CRN:
“We are disappointed and dismayed by the motion filed by the Justice Department on behalf of the Federal Trade Commission (FTC) to require multiple drug-like randomized controlled trials (RCTs) for a dietary supplement product that has been substantiated as safe and beneficial. This action by the agency is an assault on the principle of evidence-based nutrition, and is inconsistent with the current requirements under the law, which we are poised to defend with force for our industry.
Under the law, dietary supplements are held to a high standard of ‘competent and reliable scientific evidence.’ In order to make a structure/function claim, which is not a disease claim, a company must have legitimate and reputable scientific literature in support of its claim. However, the ‘competent and reliable scientific evidence’ standard in the law has long recognized that a variety of rigorous and robust scientific studies can fulfill that requirement. Structure/function claims have never been held solely to the multiple RCT standard that the FTC now seeks to impose through this enforcement activity. Requiring these claims to be supported by multiple RCTs, without regard for other credible methods of analysis, would hold dietary supplements to unreasonable, inflexible, and pharmaceutical-like standards, which contradicts how dietary supplements are defined and regulated under the law.
It is a truly sad day when government chooses to reprimand the responsible industry meeting legal requirements. The FTC’s mandate to protect consumers would be better served by using the FTC’s limited resources to target rogue companies who break the law by making outrageous, unsubstantiated claims to treat or cure serious disease, rather than over-reaching its authority, and making unreasonable and unlawful demands on those companies who play by the rules.”