The Council for Responsible Nutrition (CRN) submitted a Citizen Petition to the U.S. Federal Trade Commission requesting clarification on certain aspects of its Health Products Compliance Guidance which it issued in January.
 
CRN’s submission details concerns the association has with the FTC’s guidance, which the association argues misrepresents the state of the law on advertising substantiation for dietary supplements and food.
 
Specifically, CRN noted that there is no clear requirement that randomized, controlled clinical trials are needed to make “health benefit” claims for dietary supplements or food, and there is no explicit requirement for full product testing versus testing of active ingredients.
 
CRN also argued that, contrary to the guidance document, professionals like nutrition researchers, nutritionists, and pharmacologists can be scientific experts to assess claim substantiation for dietary supplements and food.
 
The new guidance fails to align with the policy around claims Congress created to distinguish dietary supplements and foods from drugs, and erroneously suggests that foods and supplements could be marketed with disease claims if supported by randomized, controlled trials, CRN said.
 
“In simple terms, the FTC’s new guidance discourages the dissemination of truthful nutrition information because it constructs a impression that RCTs are required for general well-being and structure/function claims, with no flexibility for the consideration of other forms of reliable evidence,” CRN said in a statement. “It is not a solution to say companies should commission RCTs for all nutritional support claims out of an abundance of caution, because such studies are not always the most appropriate form of scientific evidence to demonstrate the general health effects of dietary ingredients. CRN provided numerous examples of where RCTs would, at most, have shown the effects of deficiency of a nutrient, and could be unethical given the necessity of many nutrients to human health.”
 
The requirement to possess a randomized, controlled clinical study before making so-called “health benefit” claims is so stringent that it exceeds the current standards for drug approval, noted Megan Olsen, senior VP and general counsel at CRN.
 
“The FTC can no more change court precedent through guidance than it can, through guidance, convert ‘competent and reliable scientific evidence’ from a factual standard to a legal requirement for RCTs,” Olsen said. As a matter of law, FTC can’t impose a uniform standard requiring specific types of studies, or even require clinical studies at all, Olsen said. FTC has already failed to convince courts in several cases that high-level randomized, controlled trial (RCT) support is needed to make structure/function claims.
 
“Our hope is to work with FTC to develop guidance that isn’t overly burdensome on industry, while ensuring that Americans receive information about supplements that is sensible, scientifically sound and useful,” Olsen said.