On May 2, 2016, the Supreme Court declined to review the D.C. Circuit’s January 2015 ruling upholding a 2013 FTC decision finding that POM Wonderful, LLC (“POM”) misled consumers in advertising that its 100% Pomegranate Juice and POMx supplements could prevent, treat or reduce the risk of prostate cancer, heart disease and erectile dysfunction.
The FTC’s decision required POM to have two randomized, well-controlled human clinical trials before making disease prevention, risk reduction or treatment claims for any food, drug or dietary supplement sold by POM. POM appealed the decision to the D.C. Circuit, which affirmed the FTC’s finding of liability but reduced from two to one the number of clinical trials necessary before POM can make disease prevention or treatment claims in the future.
POM then sought to appeal to the Supreme Court, which this week denied the company’s petition for a writ of certiorari. In a statement regarding the Supreme Court’s decision not to grant review, FTC Chairwoman Edith Ramirez said, “I am pleased that the POM Wonderful case has been brought to a successful conclusion. The outcome of this case makes clear that companies like POM making serious health claims about food and nutritional supplement products must have rigorous scientific evidence to back them up. Consumers deserve no less.”
The D.C. Circuit’s decision still leaves some uncertainty in the area of advertising – namely, what level of “competent and reliable scientific evidence” will be required in cases where advertisers’ health claims are found to have violated the FTC’s standards. Going forward, advertisers, marketers and the FTC may still need to grapple with the propriety of requiring randomized, well-controlled human clinical trials, and if so, how many, when making disease prevention or treatment claims.