The commissioners held that an array of POM Wonderful advertisements made deceptive claims that its juice was proven to treat heart disease, prostate cancer and erectile dysfunction. In so doing, the FTC rejected POM Wonderful’s argument that the ALJ’s May 2012 ruling was flawed because the ads were not deceptive and were protected by the First Amendment.
Significantly, the Commission stated that health claims should be supported by two randomized, well-controlled, human clinical trials:
Competent and reliable scientific evidence shall consist of at least two randomized and controlled human clinical trials (RCTs) of the Covered Product that are randomized, well controlled, based on valid end points, and conducted by persons qualified by training and experience to conduct such studies. Such studies shall also yield statistically significant results, and shall be double-blinded unless Respondents can demonstrate that blinding cannot be effectively implemented given the nature of the intervention.
This differed from the AJL’s ruling which stated that, while health claims should always be supported by “competent and reliable scientific evidence,” there is no requirement that substantiation must always require two randomized controlled trials (RCT).
In a concurring statement, hoewver, FTC Commissioner Maureen K. Ohlhausen, disagreed with the Commission’s findings that all ads were misleading. Ohlhausen pointed to several ads for which she said there is no extrinsic evidence to show that consumers would reasonably interpret the claims as disease claims. “We must keep in mind … that if we are too quick to find stronger claims than the ones reasonable consumers actually perceive, then we will inadvertently, but categorically, require an undue level of substantiation for those claims.”
Expect to hear more on this one since POM Wonderful is sure to appeal this ruling to the U.S. Circuit Court of Appeals for the D.C. Circuit.