September 30, 2014

FTC Seeks to Elevate Requirements Necessary to Demonstrate Competent and Reliable Scientific Evidence for Structure/Function Claims

In a recent development, the FTC filed a motion in the United States District Court for the District of New Jersey, seeking to enforce an order entered in 2007 in United States v. Bayer Corporation. The order prohibited Bayer from making unsubstantiated claims for any dietary supplement it promotes or sells. This motion came in response to structure/function claims Bayer made related to Bayer's Phillips' Colon Health probiotic. The FTC seeks to impose strict criteria for fulfilling the requirement that structure/function claims be substantiated by competent and reliable scientific evidence.

Structure/function claims apply to dietary supplements. These claims state the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or characterize the documented mechanism by which a supplement acts to maintain such structure or function. Structure/function claims cannot be made regarding diseases.

The 2007 order requires that before a claim about the performance or efficacy of any dietary supplement is made, Bayer must possess "competent and reliable scientific evidence" to support its claims. The FTC's recent motion alleges that in its advertising campaign for Phillip's Colon Health, Bayer makes express and implied claims about the benefits, performance and efficacy of Phillips' Colon Health, without the requisite "competent and reliable scientific evidence" for its claims. The actual court order defines this as "tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results." However, the FTC seeks to hold Bayer to an even higher standard, arguing that Bayer cannot establish the requisite "competent and reliable scientific evidence" without having conducted human clinical trials that are: (1) randomized; (2) placebo-controlled; (3) double-blind; (4) using the product for which the claims are made; (5) performed in the population the claims are directed towards; and (6) using validated methods to assess the claimed benefits. The FTC alleges that Bayer has not conducted human clinical trials that meet these requirements.

The Council for Responsible Nutrition (CRN) issued a statement expressing strong dissent from the FTC's position, noting that this standard for "competent and reliable scientific evidence" advanced by the FTC is too narrow in defining what tests and research are acceptable and diverges from the variety of rigorous scientific studies that have, until now, been accepted to fulfill the requirement. Requiring multiple, drug-like randomized controlled trials would impose an unreasonably high standard. CRN notes that "[s]tructure/function claims have never been held solely to the multiple [randomized control test] standard that the FTC now seeks to impose," and this elevated standard "would hold dietary supplements to unreasonable, inflexible, and pharmaceutical-like standards."

If the FTC is successful in imposing this new, more rigorous standard for dietary supplements, manufacturers of these supplements should be aware of the impact this could have on their claims and be wary of relying on tests and studies that do not comply with the test now outlined by the FTC. Manufacturers may now be required to do more in depth, human clinical trials to meet these requirements.

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