Washington D.C.—The Council for Responsible Nutrition (CRN) filed a petition with the Federal Trade Commission (FTC). CRN is requesting FTC clarify certain aspects of its new new Health Products Compliance GuidanceAs WholeFoods Magazine has reported, in December 2022, the FTC Bureau of Consumer Protection issued this revised version of its business guidance for health products, which represents a "substantial" update to the 1998 guide Dietary Supplements: An Advertising Guide For Industry.

Background: FTC's New Business Guidance for Marketers & Sellers of Health Products

CRN said the guidance misrepresents the state of the law with respect to advertising substantiation for dietary supplements and food.

Concerns CRN has with FTC's guidance:

  • There is no bright-line requirement for randomized, controlled trials (RCTs) before making "health benefit" claims for dietary supplements or food;
  • There is no requirement for full product testing versus testing of certain ingredients;
  • Professionals like nutrition researchers, nutritionists, and pharmacologists can be suitable scientific experts to assess claim substantiation for dietary supplements and food; and
  • The guidance fails to align with the claims regimes Congress created for dietary supplements and food, versus drugs. CRN said it erroneously suggests that marketers of supplements and food may lawfully use disease claims if supported by randomized clinical trials.

In simple terms, CRN explained: "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 stressed that saying companies should commission RCTs for all nutritional support claims out of an abundance of caution is not the solution. Why? "Such studies are not always the most appropriate form of scientific evidence to demonstrate the general health effects of dietary ingredients." CRN made its point by providing 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.

No legal requirement

“There is no legal requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements or food. Such a requirement would even exceed the current standard for drug approval,” said CRN Senior VP and General Counsel Megan Olsen, who along with Katie Bond, Partner, Keller and Heckman, discuss CRN's Citizen's Petition in greater depth here.

As Olsen explained, FTC is relying heavily on statements that suggest “bright line” requirements for randomized clinical trials. And, while “there is definitely a place” in the substantiation regime for those types of studies, FTC needs to consider the type of claim being made and develop guidance that allows for flexibility.  “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 added.  

CRN explained that, as a matter of law, FTC cannot impose a one-size-fits-all standard that requires specific types of clinical studies or even requiring clinical studies at all. In addition, CRN contends, FTC failed to convince courts in several cases that dietary supplement structure/function claims require the high level of RCT support the agency is now advancing in its new guidance. 

Looking forward, Olsen said: “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.”

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