The U.S. Court of Appeals for the District of Columbia Circuit recently affirmed a Federal Trade Commission (“FTC”) decision that POM Wonderful, LLC  (“POM”) deceptively advertised its products’ ability to prevent, treat, or reduce the risk of certain diseases.  The FTC had initially ruled that POM’s advertisements for POM Wonderful 100% Pomegranate Juice, and two dietary supplements containing a concentrated form of pomegranate extract, POMₓ Pills and POMₓ Liquid, which claimed to be clinically proven to have the aforementioned benefits, did not meet the standards for substantiation regarding either disease-related, or health-based claims.

The D.C. Circuit’s ruling has been hailed by FTC Chairwoman Edith Ramirez as a victory for consumers due to the Court’s requirement that POM have at least one randomized, well-controlled human clinical study as support for future disease/health benefit claims.  Notably, however, the D.C. Circuit stopped short of affirming the FTC’s order requiring POM to have two such clinical trials.  Nevertheless, the Court did note that in certain other circumstances, two such studies may be warranted.

Use Caution When Making Health and Disease-Related Claims

The ruling is a clear indication that businesses must be vigilant in gathering verifiable, scientific evidence to substantiate claims concerning the health benefits of their products.  While the D.C. Circuit’s decision was limited by particularized representations made by POM, and the evidence gathered by POM in support of its health and disease-related claims, the opinion nevertheless provides guidance on the types of substantiation required before businesses can safely make disease-related claims regarding their products.   Despite the Court’s rejection of the FTC’s two-study requirement in this instance, it would be unwise to assume that one randomized, well-controlled human clinical trial will always be sufficient in the eyes of the FTC and the courts.

As we have previously reported, the FTC has become increasingly aggressive in pursuing marketers that tout the health benefits of their products.  As such, it is imperative that businesses ensure that all of their health and disease-related claims are supported by credible and reliable clinical studies.