Pomegranate product makers POM Wonderful are embroiled in a fight with the U.S. Federal Trade Commission (FTC) over their use of health claims-based marketing for their products. The action is the latest example of efforts by FTC and the U.S. Food and Drug Administration (FDA) to more heavily scrutinize and regulate health claims from product manufacturers.
FTC filed an official administrative complaint against the company, whose products include 100 Percent Pomegranate Juice and POMx supplements, citing "false and unsubstantiated claims" that their products can "prevent or treat heart disease, prostate cancer, and erectile dysfunction." Also named in the complaint are sister company Roll International and principal executives from POM Wonderful.
The move comes after similar FTC action against other companies, including settlements with Nestle Healthcare Nutrition and Iovate Health Sciences. POM Wonderful filed a preemptive lawsuit against FTC in September over these settlements, which the company alleges set new standards and precedents that could injure its business. POM Wonderful’s suit states that FTC’s regulation targets “POM's goodwill and brand identification with consumers as the juice company that focuses on science and good health.”
The impact of the recent regulatory crackdown is that FTC is deeming research studies based on animal studies or isolated ingredients as an insufficient basis for health claims. The agency is instead attempting to enforce a requirement of two human clinical trials before claims based marketing will be allowed. FTC is also focusing on the enforcement of existing FDA pre-market approval conditions that must be met before these health claims can be used. The agency says POM Wonderful circumvents these approval conditions in its national advertising campaigns.
FTC had previously challenged other health claims by the company back in February, including claims that pomegranate can improve atherosclerosis and lower blood pressure. The company has invested $35 million in clinical research backing its health claims. Critics claim the science behind the research is not up to par,citing flaws like small sample sizes and lack of control groups. The company has stood by its research and the health claims it uses in its advertising, calling the challenges by FTC “unwarranted.”
The outcome of this and similar cases could be very important for the future of claims-based marketing for the entire nutrition industry, analysts say. It may become increasingly expensive and difficult to make health claims if regulation continues to be ramped up by FTC and FDA.
Published in WholeFoods Magazine, December 2010 (online 10/27/2010)