Does FTC Require Two Clinical Studies for Structure-Function Claims?


Searching for trends in recent FTC consent orders and related motions

News of last week’s FTC motion of contempt against Bayer Corp. for alleged unsubstantiated structure/function claims for its Phillips’ Colon Health probiotic product drew protest from many in the dietary supplements industry. It’s an ongoing criticism of the agency over the last several years for what many feel is a growing emphasis on requiring substantiation exclusively in the form of randomized clinical trials (RCTs), while ignoring other types of scientific evidence demonstrating effect and benefit.

“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,” Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), said to the press.

While FTC has always required that companies have “competent and reliable scientific evidence” to back their structure/function claims, the agency stunned the supplements industry back in 2010 when, in cases involving Iovate Health Sciences and Nestlé, FTC consent orders not only instructed the companies to have “competent and reliable scientific evidence” to support any claims henceforth, but ordered both companies to get any future related claims preapproved by FDA and specified that scientific evidence means “at least two adequate and well-controlled human clinical studies.”

At the time, a senior FTC staff attorney, Michelle Rusk, said that while the agency was making efforts to make consent orders more specific, the agency was also considering requirements on a case-by-case basis.

Four years later, what do FTC’s consent orders actually show? Has the agency indeed steadily raised requirements for dietary supplement substantiation?

Recent consent orders indicate that the agency is indeed broadly looking for well-controlled human clinical trials. But, unlike in the Nestlé case, for instance, the agency is no longer dictating the number of studies required.

Does this mean that requirements have actually gotten better for supplement firms? One expert believes so.

“There may be a silver lining to this cloud,” said John E. Villafranco, a partner in the advertising and marketing practice at Kelley Drye & Warren LLP (Washington, DC). He says that the FTC may actually be applying the “competent and reliable scientific evidence” standard with more care.

In the Bayer case, “the FTC’s position, as argued in its motion, is more measured than it has been in previous cases, where the FTC asserted broadly that the law requires RCTs for any health-related claim. It appears that the FTC has reconsidered what the 'competent and reliable scientific evidence' standard means and concluded that it does not mean randomized, double-blind, placebo-controlled trials in every instance where a health benefit claim is made. And that is a good thing.”

Villafranco points out another trend, however-one that all in the supplements industry should heed. Weight-management companies may actually face a higher bar, as FTC actions show the agency generally requiring weight-management companies to substantiate claims with two clinical trials, whereas other types of structure/function claims may require just one trial.

Still, all supplement companies should expect that the FTC will require at least one clinical trial.

But don't take our word for it. Take a look at some of the FTC's most notable cases. Let us know if you agree with our analysis. (Thanks to John E. Villafranco and Kelley Drye & Warren LLP for their assistance.)




Jennifer Grebow
Nutritional Outlook magazine


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