In an opinion addressing the amount and type of scientific evidence required to substantiate disease treatment and prevention claims, the U.S. Court of Appeals for the District of Columbia upheld the Federal Trade Commission’s finding that claims regarding the benefits of pomegranate juice with respect to various medical conditions were false or misleading but reduced (from two to one) the number of randomized, controlled trials demonstrating statistically significant results required to support future disease-related claims. POM Wonderful, LLC, et al. v. Federal Trade Commission, Case No. 13-1060 (D.C. Cir., Jan. 30, 2014) (Srinivasan, J.).

From 2003 to 2010, POM Wonderful’s marketing materials cited medical studies that purported to support the daily consumption of pomegranate juice for the treatment, prevention and/or reduction of risk of heart disease, prostate cancer and/or erectile dysfunction.  A number of these advertisements, however, mischaracterized the evidence underlying such claims by failing to disclose the studies’ limitations (e.g., non-statistically significant findings, small sample size, reliance on post-hoc analyses) and/or the existence of published data suggesting pomegranate juice is not associated with the described benefits.  An administrative law judge concluded the company lacked sufficient evidence to substantiate several health benefit claims and ordered the company to cease and desist from making such claims about any food, drug or dietary supplement unless the claims are non-misleading and supported by competent and reliable scientific evidence.  On appeal, the full Federal Trade Commission (FTC or the Commission) upheld the administrative law judge’s decision to impose liability and broadened the scope of the injunctive order to specify that, for the purposes of substantiating claims that a product cures, mitigates, treats or prevents a disease, the company must have two double-blind, randomized controlled trials yielding statistically significant results.

The company appealed the Commission’s order on several grounds (e.g., alleging violations of the FTC Act, Administrative Procedure Act, and the First Amendment).  The D.C. Circuit affirmed the Commission’s finding of liability, noting it had no basis to set aside the conclusion that the company’s advertisements were false and misleading.  The court agreed with the company, however, that the requirement for two supportive randomized controlled trials before claiming a causal relationship between consumption of pomegranate products and the treatment or prevention of disease was overly burdensome and therefore failed Central Hudson scrutiny.

In applying the Central Hudson standard, the court emphasized that the two-trial threshold would require manufacturers to expend substantial resources to support such trials and that consumers would be denied access to useful, truthful information about products with a demonstrated capacity to treat or prevent serious disease where such claims are supported by the results of a single trial, regardless of that trial’s quality.  The court acknowledged that there is precedent for the FTC’s imposition of a two-trial requirement, but noted that the previous application of that standard had been confined to narrow circumstances based on concerns specific to a particular class of products (i.e., comparative claims regarding the efficacy of over-the-counter analgesics).  As such, the D.C. Circuit upheld the Commission’s order, but only insofar as it required disease-related claims to be supported by a single randomized controlled trial.

Practice Note:  The court explicitly stated that the decision to reduce the required number of randomized controlled trials to one was based on the FTC’s failure to offer adequate justification for the two-trial standard in this specific case, and should not be construed as a blanket prohibition on the imposition of a two-trial requirement.