There are some spectacles we geeks in the food and drug bar follow as avidly as any mini-series. The epic, two-year battle between POM Wonderful (producer of pomegranate products) and the Federal Trade Commission (FTC) is almost as addictive as HBO’s “Game of Thrones” – only without all the beheadings.
Though POM Wonderful extols the health benefits of pomegranates and their juice, the FTC insists that the company’s product claims are not substantiated by competent and reliable scientific evidence, in violation of the FTC Act. Last week, the FTC won a round when U.S. District Court Judge Richard Roberts dismissed POM Wonderful’s complaint against the FTC. POM Wonderful LLC v. The Federal Trade Commission, Civil Action No. 10-1539 (RWR) (Sept. 30, 2012).
Battle lines were drawn in 2010 when the FTC entered into orders with Iovate Health Sciences and Nestle HealthCare Nutrition. The FTC required both of those companies to possess two adequate and well-controlled human clinical studies to support their product health claims; FDA also had to pre-approve any disease claims for Nestle products.
In September 2010, POM Wonderful launched the first salvo when it sued the FTC, alleging that the agency imposed these new substantiation requirements unlawfully. POM Wonderful was prescient, because two weeks later the FTC counter-attacked. It filed an administrative complaint, challenging the company’s health claims for its pomegranate products. This administrative complaint was eventually followed by a 345-page decision by the FTC’s Administrative Law Judge (ALJ).
The ALJ decision was a draw for Pom Wonderful and FTC staff. The ALJ found some of POM Wonderful’s claims to be false and misleading, but also rejected the FTC’s demands that POM Wonderful obtain FDA pre-approval and conduct two clinical studies. Appeals followed, with oral argument before the FTC Commissioners in August. A decision is expected by December 2012.
With the Commission decision pending, the combatants turned to the federal district and, this time, POM Wonderful lost. Judge Roberts found that POM Wonderful’s preemptive filing two weeks before the FTC’s administrative suit left “the disfavored appearance that POM hastily filed the instant case, in part, to secure tactical leverage from proceedings in this forum.” In light of the advanced administrative proceeding, allowing the case to proceed in federal court would not help resolve the matter and so Judge Roberts dismissed Pom Wonderful’s complaint.
The adversaries withdraw for now and await the full Commission’s ruling. However, POM Wonderful can return to federal court by appealing any final FTC judgment against it. The battle may be over, but the war promises to continue.