Late last month, the D.C. Circuit Court issued its long-awaited opinion in the POM Wonderful case. The court’s opinion affirmed the FTC’s January 2013 decision that POM Wonderful had deceptively advertised that their products could treat, prevent, or reduce the risk of certain serious diseases without having performed the necessary clinical trials to substantiate those claims. In a press release, FTC Chairwoman Edith Ramirez touted the decision as a “victory for consumers,” which was keeping within the “established law that advertisers who market products for serious health conditions must have rigorous science to back up those claims.”
While the decision is a victory for consumers in as much as it upheld the FTC’s action against POM Wonderful, the greater significance of the decision was the court’s rejection of the FTC’s categorical position that all disease-related claims had to be supported by at least two randomized clinical trials (RCTs). The court held that while two RCTs would be better and more reliable than one, the FTC had failed to justify the imposition of a two RCT requirement for all disease-related claims. Even still, the court was unwilling to completely foreclose the possibility of imposing a two-RCT requirement going forward. Instead, the D.C. Circuit Court carefully left open the possibility that a narrowly crafted two-RCT requirement could survive First Amendment scrutiny if the FTC could offer an appropriate justification.
Thus, while the FTC’s action was upheld, the D.C. Circuit Court recognized the burden of the RCT process, and rejected a categorical rule regarding all disease-related claims. It will be interesting to see how, if at all, this impacts how the FTC crafts its orders in disease-related claim cases going forward.