FTC Commissioners recently ruled against POM Wonderful on a variety of claims made in advertisements and on the company’s web site that the company’s pomegranate juice products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction.
Rejecting claims that the products had been proven to work in clinical data, the FTC on Jan. 16 further ruled that future assertions made by Pom Wonderful regarding its products would need to be proven in two randomized, controlled clinical trials before the company can make claims of their effectiveness with regard to the three diseases.
The trade commission will also require that other health-benefit claims be substantiated by “competent and reliable scientific evidence.”
Additionally, the commissioners added another 17 claims to the original 19 ads and promotional materials from a previous ruling by an administrative law judge.
According to POM, the claims had been protected by the First Amendment, and that the company had not been granted due process during the commissioners’ review process — an argument that had been turned down by the administrative law judge last May.
At that time, the FTC had requested the right to review all potential disease claims from POM in the future; the judge denied that request.
Here is the full text of the FTC ruling. Pom has 60 days to file an appeal.
Release is below:
FTC Commissioners Uphold Trial Judge Decision that POM Wonderful, LLC; Stewart and Lynda Resnick; Others Deceptively Advertised Pomegranate Products by Making Unsupported Health Claims
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 treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction, and that they were clinically proven to work.
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.
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