Reversing Prior Losses, FTC Scores a Win in its RCT Crusade

As I have written before (see past posts at, it is no secret that the Federal Trade Commission’s substantiation policy on health claims, including for dietary supplements, is that the only acceptable form of substantiation is a randomized, placebo-controlled human clinical trial (“RCT” for short).  While the FTC’s might enables it to impose this stringent and expensive requirement on companies that are forced to settle for financial or other practical reasons, its policy has met with mixed success in the courts.  In FTC v. POM Wonderful, for example, the U.S. Court of Appeals for the District of Columbia, while affirming an RCT requirement for disease treatment (drug) claims, reversed an FTC mandate of two RCTs, and held that for non-disease health claims, the more flexible traditional standard of “competent and reliable scientific evidence” applies.  As defined by the FTC, that means:

tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have 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.

Courts have disagreed on the meaning of this standard, and whether it can be reasonably interpreted to require an RCT, as the FTC has argued.  In U.S. v Bayer, an FTC contempt action against Bayer for failing to have “competent and reliable scientific evidence” for probiotic claims, as required by a prior consent order, the FTC argued that the standard required an RCT, which Bayer didn’t have, thus placing it in violation of its order. The court rejected the FTC’s argument and contempt motion on several grounds.  First, the Dietary Supplement Health & Education Act of 1994 (“DSHEA”) does not require RCTs.  DSHEA does not impose a stringent “drug-level” RCT substantiation standard for dietary supplements, but only that supplement claims be “truthful and not misleading…as long as a supplement is not marketed as a drug, it is not regulated like a drug.” Second, the FTC’s own published substantiation guidance explicitly states that the “competent and reliable scientific evidence” test, unlike the standard for drug claims, is “flexible…Randomized clinical trials are not required….”  Third, the “competent and reliable scientific evidence” standard in Bayer’s order did not give it adequate notice that the only acceptable substantiation for its probiotic claims was an RCT. The FTC, the court found, “presented no evidence of any law, regulation or guidance that would have provided notice to Bayer that…RCTs are required for the…claims at issue.”      

Reaching a different conclusion, the Eleventh Circuit in September affirmed a lower court decision in FTC v. National Urological Group holding Hi-Tech Pharmaceuticals and other defendants in contempt for violating a prior order which prohibited them from making health claims without “competent and reliable scientific evidence,” and upheld the $40 million judgment against them.  Unlike in Bayer, where the court found that the company had not been given fair warning that “competent and reliable scientific evidence” meant an RCT, the Eleventh Circuit accepted this stringent interpretation because the defendants had repeated notice for years that it was how the FTC and the district court construed the standard. It also noted that defendants had not raised objections to the clarity of the standard when the prior order was being proposed to the court.

Beginning with its defeat in Bayer, the FTC now expressly defines “competent and reliable scientific evidence” to mean an RCT in its dietary supplement and other health product orders. Notwithstanding the Bayer court’s findings that neither DSHEA nor the FTC’s official substantiation guidance requires an RCT, and regardless of the adequacy of notice of an RCT requirement to any particular defendant, dietary supplement and other health product marketers should be under no illusion about the FTC’s mission to mandate RCTs for health claims, especially following its win in National Urological Group.  More than ever, supplement marketers should assume that, whatever the courts say (short of a final definitive decision by the Supreme Court), the FTC will expect them to have an RCT to support their claims, and will make them pay dearly if they don’t.  Just ask Hi-Tech Pharmaceuticals and its co-defendants in National Urological Group.

Talking about Direct Response, FTC

Comments are closed.

  • Newsletter Sign Up

    join our mailing list
  • Recent Posts

  • Archives


  • Categories

  • Tags