FTC Prohibits pomegrenate juice disease claims

The Federal Trade Commission issued a final order prohibiting POM Wonderful, maker of POM pomegranate juice products, from claiming that any of its products is effective in diagnosing, treating, or preventing any disease unless such claims are supported by at least two randomized and controlled human clinical trials (RCTs). Earlier, the administrative law judge had found that POM Wonderful made the alleged claims, and that these claims were false or misleading because they were not substantiated with “competent and reliable scientific evidence,” which the ALJ found must include appropriate clinical studies but not necessarily RCTs.

On September 24, 2010, the Commission issued an administrative complaint alleging that Respondents engaged in deceptive acts and practices and disseminated false advertising in violation of Sections 5(a) and 12 of the FTC Act in promoting the Challenged POM Products. The Complaint alleged that Respondents disseminated advertising and promotional materials representing that consumption of certain dosesof Challenged POM Products treats, prevents or reduces the risk of heart disease, prostate cancer, or erectile dysfunction (“ED”), without having a reasonable basis to substantiate these claims. The Complaint also alleged that Respondentsdisseminated advertising and promotional materials representing that clinical studies, research, and/or trials prove that consumption of the Challenged POM Products in certain doses treats, prevents or reduces the risk of heart disease, prostate cancer, or ED, when in fact clinical studies, research, or trials do not so prove.

The Commission agreed with the ALJ’s finding that POM Wonderful’s claims were not backed by competent and reliable scientific evidence, and also held that hecause of POM Wonderful’s “serious disease claims,” RCTs were required for substantiation. The Commission found that some of the ads conveyed claims that POM Wonderful had clinical proof supporting its claims; and the FTC concluded that to satisfy the requirement that an advertiser have a “reasonable basis” supporting objective performance or efficacy claims, RCTs are also required.

The requirement for two RCTs in Part I of the Order applies only to claims for disease prevention, risk reduction, and treatment; future representations relating to efficacy or health benefits of covered products that fall short of disease claims are covered by Part III of the Order. That provision requires substantiation consisting of competent and reliable scientific evidence (as defined in that Part), that must be sufficient in quality and quantity when considered in the light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.

The Commission found that these disease-related claims were conveyed through the use of the word “disease” and reference to specific diseases or symptoms (e.g., “cancer,” “prostate cancer,” “erectile dysfunction,” “coronary heart disease”); medical imagery (e.g., the caduceus symbol of the medical profession, the image of a POM bottle connected to electrocardiogram leads); references to physicians and medical research (as opposed to nutritional or other research); and references to quantifiable results (e.g., “eight ounces of POM a day can reduce plaque in the arteries by up to 30%!”).