The intersection of health claims and emerging science in advertising is fraught with uncertainty, constitutional concerns, and litigation. As discussed here, here, and here, POM Wonderful (POM) has been standing in the middle of this dangerous intersection for years. POM has been defending its claims that consuming its products could help people fight heart disease, prostate cancer, or erectile dysfunction. As discussed here, the Federal Trade Commission (FTC) held that POM’s claims were not backed by competent and reliable scientific evidence and prohibited POM from making disease-related claims that weren’t supported by at least two randomized and controlled human clinical trials (RCTs). In the latest installment, the D.C. Circuit issued its opinion confirming the Commission’s finding that POM’s ads lacked adequate support, but rejecting the Commission’s two RCT requirement.

The Court was unconvinced by POM’s studies and criticized POM’s selective reliance on studies as proving its claims and downplaying or ignoring negative studies, while at the same time saying that its products were supported by millions of dollars in research. The Court also upheld the Commission’s conclusion that POM’s use of qualifiers such as “preliminary,” “promising,” and “initial” did not sufficiently disclose the limitations of POM’s evidence. 

POM challenged the Commission’s liability determination and its order under the First Amendment.  The Court rejected POM’s liability challenge because it is well-settled that the First Amendment does not protect misleading commercial speech. The Court analyzed POM’s challenge to the order using the framework in Central Hudson Gas & Electric Company v. Public Services Commission, 447 U.S. 557, 566 (1980). The Court found that the order advanced a substantial government interest (preventing misleading speech) in a manner that is not more extensive than necessary to the extent it required a “general RCT-substantiation requirement.” However, the two RCT-substantiation requirement was not a “reasonable fit” with the government interest being advanced.

The FTC failed to provide sufficient justification for the categorical two RCT requirement. There could be situations, for example, where one well-designed RCT, perhaps with other supporting non-RCT evidence, adequately substantiated a claim. In such a situation, barring a claim based on this evidence would deny consumers truthful information about the product. The Court rejected the FTC’s argument that its precedent militated in favor of the two RCT requirement.  That precedent involved a specific type of claim -- comparative efficacy claims for OTC pain relievers. In that context two RCTs was appropriate, but no similar finding was present in the FTC’s POM order. The Court rejected the FTC’s other examples because they also demonstrated that the FTC has imposed a two RCT requirement only in selective circumstances “based on particular concerns.” The FTC’s concerns that POM might cherry-pick studies was addressed by the order’s requirement that POM’s claims be supported by competent and reliable evidence based on the entire body of the evidence.

Because the Court largely upheld the Commission’s findings, advertisers must still make sure that they have solid scientific evidence supporting health related claims. While the Court’s opinion does not preclude the FTC from imposing a two-RCT substantiation requirement as a remedy in an enforcement action, it may cause the FTC to reconsider its position on when it is appropriate. Consistent with the Court’s framework, a two-RCT requirement would need to be justified by the particular facts of each case.

This shift may already be underway, as evidenced by Commissioner Olhausen’s and Commissioner Wright’s concurring statements on the two-RCT requirement in the recent HCG Platinum case.  Since RCTs are quite expensive, particularly given the sample size necessary to substantiate more moderate effects, this may make it a little safer to enter the intersection of health claims and emerging science.