In a recent opinion, the Federal Trade Commission (“FTC”) affirmed in part and reversed in part an Administrative Law Judge’s decision that Pom Wonderful deceptively advertised its products. According to the Commission, Pom Wonderful did not have sufficient substantiation to support claims the FTC deemed implied that POM’s products could treat, prevent, or reduce the risk of heart disease, prostate cancer, stroke, and erectile dysfunction, and that its products were clinically proven to work. POM countered that within context its claims did not imply those connotations and could not be presumed implied without survey evidence corroborating consumer perception to be as FTC described it, were disclaimed to prevent such connotations, and, in any event, were backed by scientific evidence supporting the actual (and even the allegedly implied) claims. One of the FTC Commissioners, Ohlhausen, dissented from the FTC’s decision concerning implied claims, finding many of the claims the majority said were implied not to be implied from the plain language of the ads.
FTC also issued a Final Order barring Pom Wonderful from claiming that a food, drug, or dietary supplement is “effective in the diagnosis, cure, mitigation, treatment, or prevention of any disease,” including heart disease, prostate cancer, and erectile dysfunction, unless the claim is supported by two randomized, well-controlled, human clinical trials (“RCTs”).
FTC’s two RCTs requirement will inevitably result in self-censorship across industry. Although the Final Order was directed at Pom Wonderful, it illustrates FTC’s current thinking on the amount of evidence needed to substantiate claims about diseases and health benefits. Specifically, it suggests that all disease and health benefit claims, including implied and qualified claims, must be substantiated with two RCTs.
Unlike drugs, nutrients are not patentable. Accordingly, there is no incentive for advertisers to conduct expensive RCTs on nutrients. After all, why would a company spend money on one RCT, let alone two, if competitors can share in the benefit of favorable results? Moreover, RCTs are better suited for testing the efficacy of drugs because it is relatively easy to determine if a drug is treating a disease or not. It is much more difficult to determine if a nutrient reduces the risk of getting a disease using RCTs, because, for example, the decades it would take to conduct such a study. Observational, in vitro, and animal studies, which FDA and FTC reject for the most part, are much better suited for substantiating risk reduction claims as are epidemiological studies.
In short, FTC’s decision will dumb down the marketplace as advertisers self-censor health benefit claims that have evidence in support of them because the evidence that falls just short of the 2 RCT gold standard. Unfortunately, consumers are the ones who will pay the price because they will have less information when making decisions about their health.
The FTC’s order also suggests that at least one RCT will be required for advertising claims of health benefit that do not reference disease (express or implied). That requirement will also result in self-censorship and a general diminution in the health information available to the public.
The overall effect of this decision, unless it is reversed on appeal, is that it will make it far more difficult for consumers to obtain access to emerging science associating nutrients with disease and health benefits. The decision will thus redound to the detriment of consumers and sellers alike.