The suit, which contends that the FTC is attempting to encroach on the Food and Drug Administration's authority and create a new, unconstitutional standard by requiring that the FTC pre-approve some health benefits and disease-related product claims made by advertisers, was filed on Sept. 13 in the U.S. District Court for the District of Columbia.
The National Law Journal reported the filing on Sept. 15. However, the suit had received relatively little national attention/coverage until yesterday's announcement by the FTC that it had issued a complaint charging the makers of POM Wonderful 100% Pomegranate Juice and POMx supplements with making false and unsubstantiated health claims.
POM was among 17 food makers that received warning letters in February from the FDA which contended that they were in violation of federal laws as a result of specific claims made about disease prevention/treatment benefits.
In settlements reached in July, Nestlé Healthcare Nutrition Inc. and Iovate Health Sciences USA Inc. agreed to the FTC's requirement of preapproval of future food, beverage or supplements product claims relating to disease, according to The National Law Journal. But POM's suit contends that the requirement would constitute unlawful prior restraint, as it would apply regardless of whether or not advertising claims are truthful or "supported by competent, reliable scientific evidence."
POM's suit also maintains that the FTC's additional requirement that two clinical studies back non-disease health claims constitutes a significant and unauthorized change in the level of substantiation required for such claims by the FTC, the Journal reported.
In its Sept. 27 statement, POM accused the FTC of "acting beyond its jurisdiction, exceeding its authority, and creating a new regulatory scheme that attempts to treat our juice as a drug, which it is not," and maintained that POM Wonderful does not make claims that its food products act as drugs.
"For more than a decade, we have provided over $34 million to support scientific research on pomegranates, working with top researchers, including a Nobel Laureate, at leading universities around the globe," the company stated. "To date, more than 55 studies on POM products, including 19 clinical trials, have been published in peer-reviewed journals. The results have been encouraging and many additional studies are in progress."
The company said that it stands behind "the vast body of scientific research documenting the healthy properties of Wonderful variety pomegranates" and its right to inform consumers about this research, and accused the FTC of "wasting taxpayer resources to persecute the pomegranate."