The U.S. Court of Appeals for the D.C. Circuit issued an opinion on Friday, January 30, upholding the Federal Trade Commission’s findings that POM Wonderful’s advertising, in which it claimed that consuming POM Wonderful pomegranate juice could prevent or reduce the risk of heart disease, prostate cancer, and erectile dysfunction, was deceptive. Although the D.C. Circuit acknowledged the importance of clinical trial evidence in supporting disease risk reduction claims, the Court disagreed with the Commission’s application of the two randomized clinical trial (RCT) standard, finding it unjustified under the First Amendment.

The D.C. Circuit Held that POM’s Advertising was Deceptive

The Court’s opinion discusses the research that POM Wonderful conducted regarding heart disease, prostate cancer, and erectile dysfunction and how the studies were used to support the advertising.  In this analysis, the Court was critical of POM’s selective use of favorable small-scale studies in advertising while disregarding other, larger, unfavorable or inconclusive studies.  The Court also noted certain inconsistencies in POM’s arguments regarding the inability to conduct RCTs on certain food products, such as the hurdles of blinding and expense, both of which POM overcame to perform its own research.  The Court gave appropriate deference to the agency as an expert in determining whether an advertisement is deceptive and substantively upheld the Commission’s conclusion that POM’s advertising was deceptive.

Continue Reading D.C. Circuit Upholds FTC on POM’s Advertising, Strikes Two-Study Standard

On May 2, 2014, POM Wonderful LLC (“POM”) argued before the U.S. Court of Appeals for the D.C. Circuit, urging it to overturn a Federal Trade Commission (“FTC”) decision prohibiting POM from making disease-related claims without first having at least two randomized and controlled human clinical trials (“RCTs”) to back them up.  POM argued that it will be impossible to perform two RCTs in accordance with the Commission’s standard, noting that this standard has never been applied to food products in an FTC order.  POM accused the FTC of holding POM, a beverage company, to the same standard as pharmaceutical companies.

In certain advertisements, POM touted a number of studies and questionnaires to support its claim that pomegranate juice and dietary supplements provide health benefits.  According to the FTC, however, POM systematically distorted the results of these studies to imply greater health benefits than the results supported.  Because of POM’s history and alleged demonstrated propensity to suppress and distort scientific results, the FTC imposed the two-RCT requirement to curb misleading advertising and prevent recidivism.  However, POM argued that “suppressing and distorting scientific evidence” did not form the basis of liability in the FTC’s decision. According to POM, the FTC found the company liable for making unqualified disease claims i.e., not having a particular level of substantiation.  POM argued that the two-RCT requirement does not address POM’s alleged lack of substantiation.  Rather, that remedy addresses POM’s alleged suppression and distortion of evidence, which was not a part of the FTC’s liability finding.

Continue Reading POM Wonderful LLC Raises the Stakes at the D.C. Circuit