By Riëtte van Laack –
On September 27, 2010, less than two week after POM Wonderful LLC (“POM”) filed a complaint against the Federal Trade Commission (“FTC”) (see our previous post here), the Agency filed a Complaint against POM, its sister corporation Roll International Corp. and several of its officers for violation of the FTC Act. Specifically, the FTC charges POM with false and misleading advertising because POM’s claims that POM’s products (POM Wonderful 100% pomegranate juice, POMx Pills, and POMx Liquid) prevent, reduce the risk of, or treat heart disease, high blood pressure, prostate cancer, and erectile dysfunction are not supported by competent and reliable evidence. The Complaint includes 25 pages of exhibits evidencing POM’s advertising, which includes POM’s statements that its claims are supported by extensive clinical studies. Although POM in fact appears to have invested in numerous clinical studies, the FTC alleges that the results of these studies do not support POM’s claims for the health benefits of POM products.
It is noteworthy that the Complaint and the Proposed Order do not include the two clinical study standard which led to POM’s lawsuit charging that the FTC had illegally changed its standard for substantiation. Throughout the Complaint, the FTC refers to its standard as requiring “competent and reliable scientific evidence” and nowhere does the FTC suggest that POM’s advertising is false and misleading because the claims are not supported by two adequate and well-controlled clinical studies. In addition, the Complaint does not allege that POM’s advertising claims are false and misleading because they have not been approved by FDA. The Proposed Order does include a provision requiring FDA pre-approval of future claims for POM products. The FTC’s press release suggests that FTC proposes to include this requirement in order to “provide clearer guidance for the company, facilitate [POM’s] compliance with the proposed order, and make it easier to enforce.”
The FTC has scheduled a hearing on May 24, 2011, at which POM must show cause why a cease and desist order should not be entered. The FTC's Complaint's statement that "it may be necessary and appropriate for the [FTC] to seek relief to redress injury to consumers . . . in the form of restitution . . . and such other types of relief" suggests that the FTC is almost certain to seek money from POM.
- POM’s statement in response to the FTC’s complaint is available here.