The case originated in 2010, when the FTC’s Complaint Counsel brought suit alleging that POM Wonderful violated Sections 5(a) and 12 of the FTC Act by making false or misleading claims in their advertisements for POM products, including POM Wonderful juice and POMx supplements. Specifically, the Complaint alleged that POM Wonderful made unsubstantiated claims that POM products treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction, and that clinical proof established the efficacy of POM products for such purposes. The FTC challenged a total of 43 advertising and promotional materials, such as the ones seen here, here,and here.As previously discussed, an Administrative Law Judge 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. Both POM Wonderful and FTC Complaint Counsel appealed the decision to the Commission.
The Commission agreed with the ALJ’s finding that POM Wonderful’s claims were not backed by competent and reliable scientific evidence, and expanded from 19 to 36 the number of ads it found to be false or misleading. However, the Commission held that in light of POM Wonderful’s “serious disease claims,” RCTs were required for substantiation. First, the Commission found that some of the ads conveyed claims that POM Wonderful had clinical proof supporting its claims. The Commission concluded that such claims require proof sufficient to satisfy the relevant scientific community (i.e., experts in heart disease, prostate cancer, and erectile dysfunction) of the claims’ truth, in the form of RCTs. Second, the Commission concluded that to satisfy the requirement that an advertiser have a “reasonable basis” supporting objective performance or efficacy claims, RCTs are also required.
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%!”). The Commission found that that the juxtaposition of these elements would convey to at least a small minority of reasonable consumers that POM products treat, prevent or reduce the risk of certain diseases and, for many of the ads, that such efficacy was scientifically established.
The Commission found that the ALJ improperly relied on expert testimony regarding the level of substantiation that would support general health benefit claims rather than focusing on the substantiation needed to support POM Wonderful’s specific disease treatment and prevention claims. It further found that the relevant expert testimony established that RCTs -- specifically, randomized, placebo-controlled, double-blind trials yielding statistically significant results -- were necessary to substantiate POM Wonderful’s claims.
While the Commission decided that it did not need to make a finding as to the required number of RCTs necessary to substantiate the claims, the final order contains fencing-in relief that prohibits POM Wonderful from making disease-related claims about any food, drug, or dietary supplement unless the claims are backed by at least two RCTs. The Commission found that this was appropriate for two reasons: (1) it is consistent with FTC precedent, such as Thompson Medical, and with expert testimony about the need for consistent results, and (2) POM Wonderful’s tendency, in the view of the FTC, to misrepresent research outcomes. The Commission did not go so far as to require POM Wonderful to obtain FDA approval before making disease-related claims, a remedy sought by Complaint Counsel, because it found that requiring two RCTs accomplished the benefits of FDA pre-clearance, including establishing a clear and easily enforceable standard.
The Commission explicitly limited its ruling to POM Wonderful’s disease treatment, prevention and risk reduction claims. As the Commission explained “[t]he need for RCTs is driven by the claims Respondents have chosen to make (i.e., establishment claims about a causal link between the Challenged POM Products and the treatment or prevention of serious diseases).” It refrained from deciding the level of substantiation required to support other health claims involving food products, other than to reiterate the “competent and reliable scientific evidence” standard, which it described as “tests, analysis, 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.” However, as the Commission noted, this decision indicates how it is likely to analyze other health claims in the future.
POM Wonderful has indicated that it will appeal the Commission’s decision in federal court. For now, food product advertisers should carefully evaluate whether their advertising conveys disease treatment or prevention claims to avoid the time and expense of meeting the Commission’s substantiation requirements for such claims or responding to an FTC inquiry.