FTC Blasts POM for Disease Claims, Highlighting Substantation Issues

The FTC blasted POM Wonderful for making deceptive and unsupported advertising claims regarding their pomegranate products.

These included claims that the products could:

• treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction, and
• were clinically proven to work.

The FTC Press Release states:

… The Federal Trade Commission upheld an Administrative Law Judge’s decision that the marketers of POM Wonderful 100% Pomegranate Juice and POMx supplements deceptively advertised their products and did not have adequate support for claims that the products could

The Commission issued an Opinion upholding Chief Administrative Law Judge D. Michael Chappell’s May 2012 Initial Decision that the POM marketers made false or deceptive advertising claims.

The Commission Opinion found that the POM marketers made deceptive claims in 36 advertisements and promotional materials challenged at trial after issuing a September 2010 administrative complaint – going beyond Judge Chappell’s ruling, which found false or deceptive claims in only 19 of the challenged items.

The Commission issued a Final Order that bars the POM marketers from making any claim that a food, drug, or dietary supplement is “effective in the diagnosis, cure, mitigation, treatment, or prevention of any disease,” including heart disease, prostate cancer, and erectile dysfunction, unless the claim is supported by two randomized, well-controlled, human clinical trials. The Order also prohibits misrepresentations regarding any test, study, or research, and requires competent and reliable scientific evidence to support claims about the “health benefits, performance, or efficacy” of any food, drug, or dietary supplement.

In upholding Judge Chappell’s Initial Decision and issuing its Opinion and Final Order, the Commission denied the appeal filed by POM Wonderful, LLC, Roll Global LLC, Stewart Resnick, Lynda Resnick, and Matthew Tupper. The Commission also granted in part and denied in part the appeal filed by the FTC staff.

The Commission rejected the POM respondents’ arguments that the Commission’s actions would violate their First Amendment rights, or their Fifth Amendment right to due process.

The challenged ads appeared in national publications such as Parade, Fitness, The New York Times, and Prevention magazines; on Internet sites such as pomegranatetruth.com, pomwonderful.com, and pompills.com; on bus stops and billboards; in newsletters to customers; and on tags attached to the product.

The Commission vote approving the Opinion and Final Order was 5-0. In addition to writing the Commission’s opinion, Commissioner Maureen K. Ohlhausen explained in a concurring statement that she would require extrinsic evidence to conclude that some of the exhibits conveyed the challenged disease-related claims rather than general health benefit claims and that she would have required only one randomized clinical trial regarding disease-related claims as fencing-in relief in the final order. Commissioner J. Thomas Rosch also filed a concurring statement.

The Respondents may file a petition for review of the Commission Opinion and Final Order with the U.S. Circuit Court of Appeals within 60 days after service of the Final Order.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.

Whenever marketing a food, dietary supplement, beverage, medical device, or cosmetic, be aware that the FDA and FTC have overlapping jurisdiction. The FTC can bring an enforcement action if the product’s advertising is false, deceptive, or misleading. Contact our Los Angeles based FDA and FTC healthcare attorneys for legal and regulatory advice to bring your product to market. Our California legal team at the Cohen Healthcare Law Group can advise you on FDA and FTC legal and regulatory compliance.