As part of its ongoing efforts to uncover over-hyped health claims in food advertising, the Federal Trade Commission has issued an administrative complaint charging the makers of POM Wonderful 100% Pomegranate Juice and POMx supplements with making false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction.

The FTC complaint charges that POM Wonderful LLC, sister corporation Roll International Corp., and principals Stewart Resnick, Lynda Resnick, and Matthew Tupper violated federal law by making deceptive disease prevention and treatment claims. The ads in question appeared in national publications such as Parade, Fitness, The New York Times, and Prevention magazines; on Internet sites such as pomtruth.com, pomwonderful.com, and pompills.com; on bus stops and billboards; in newsletters to customers; and on tags attached to the product. POM Wonderful Pomegranate Juice is widely available at grocery stores nationwide, and a 16 oz. bottle retails for approximately $3.99. POMx pills and liquid extract are sold via direct mail, with a one-month supply costing approximately $30.

“Any consumer who sees POM Wonderful products as a silver bullet against disease has been misled,” said David Vladeck, Director of the FTC’s Bureau of Consumer Protection. “When a company touts scientific research in its advertising, the research must squarely support the claims made. Contrary to POM Wonderful’s advertising, the available scientific information does not prove that POM Juice or POMx effectively treats or prevents these illnesses.”

The advertisements touted POM Juice and POMx supplements with statements such as:

“SUPER HEALTH POWERS! … 100% PURE POMEGRANATE JUICE. … Backed by $25 million in medical research. Proven to fight for cardiovascular, prostate and erectile health.”

“NEW RESEARCH OFFERS FURTHER PROOF OF THE HEART-HEALTHY BENEFITS OF POM WONDERFUL JUICE. 30% DECREASE IN ARTERIAL PLAQUE … 17% IMPROVED BLOOD FLOW … PROMOTES HEALTHY BLOOD VESSELS … ”

“ Prostate health. Prostate cancer is the most commonly diagnosed cancer among men in the United States and the second-leading cause of cancer death in men after lung cancer.

Time pill. Stable levels of prostate-specific antigens (or PSA levels) are critical for men with prostate cancer. Patients with quick PSA doubling times are more likely to die from their cancer. According to a UCLA study of 46 men age 65 to 70 with advanced prostate cancer, drinking an 8 oz glass of POM Wonderful 100% Pomegranate Juice every day slowed their PSA doubling time by nearly 350%. … 83% of those who participated in the study showed a significant decrease in their cancer regrowth rate.”

Prostate cancer is the most commonly diagnosed cancer among men in the United States and the second-leading cause of cancer death in men after lung cancer. Stable levels of prostate-specific antigens (or PSA levels) are critical for men with prostate cancer. Patients with quick PSA doubling times are more likely to die from their cancer. According to a UCLA study of 46 men age 65 to 70 with advanced prostate cancer, drinking an 8 oz glass of POM Wonderful 100% Pomegranate Juice every day slowed their PSA doubling time by nearly 350%. … 83% of those who participated in the study showed a significant decrease in their cancer regrowth rate.” “You have to be on pomegranate juice. You have a 50 percent chance of getting [prostate cancer]. Listen to me. It is the one thing that will keep your PSA normal. You have to drink pomegranate juice. There is nothing else we know of that will keep your PSA in check. … It’s also 40 percent as effective as Viagra.” The FTC’s administrative complaint against POM Wonderful alleges that these claims are false and unsubstantiated:

Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat heart disease, including by decreasing arterial plaque, lowering blood pressure, and improving blood flow to the heart;

Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat prostate cancer, including by prolonging prostate-specific antigen doubling time;

Clinical studies prove that POM Juice prevents, reduces the risk of, and treats, erectile dysfunction.

The FTC complaint alleges that POM Wonderful’s heart disease claims are false and unsubstantiated because many of the scientific studies conducted by POM Wonderful did not show heart disease benefit from use of its products. It alleges that the prostate cancer claims are false and unsubstantiated because, among other reasons, the study POM Wonderful relied on was neither “blinded” nor controlled. Finally, it alleges that the erectile dysfunction claims are false and unsubstantiated because the study on which the company relied did not show that POM Juice was any more effective than a placebo.

The complaint sets forth a proposed order that would prevent future law violations by POM Wonderful. In part, the proposed order would require that future claims that any pomegranate-based product cures, prevents, treats, or reduces the risk of any disease not be misleading and comply with Food and Drug Administration regulations for the claim. Although FDA approval of health claims generally is not required for compliance with the FTC Act, the proposed order would require FDA pre-approval before POM Wonderful makes future claims that certain products prevent or treat serious diseases, in order to provide clearer guidance for the company, facilitate POM Wonderful’s compliance with the proposed order, and make it easier to enforce. The complaint also proposes to prohibit the respondents from making any other health claim about any food, drug, or dietary supplement without competent and reliable scientific evidence.

In a related case, Mark Dreher, POM Wonderful’s former head of scientific and regulatory affairs and expert endorser, has agreed to a settlement that bars him from making any disease treatment or prevention claims in advertising for a POM Wonderful product unless the claim is not misleading and comports with FDA requirements for the claim. The settlement also prohibits Dreher from making other health claims for a food, drug, or dietary supplement for human use without competent and reliable scientific evidence to support the claim. The settlement contains a cooperation clause and reporting provisions to assist the FTC in monitoring compliance with the order.

The FTC votes to approve the two administrative complaints, the notice order against the proposed respondents, and the proposed consent agreement with Dreher were 5-0.

Copies of the POM Wonderful complaint and notice order, and of the Dreher complaint and consent agreement, are available from the FTC’s website at http://www.ftc.gov and the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The Dreher consent agreement will be subject to public comment for 30 days, until October 27, 2010, after which the Commission will decide whether to make it final. Written comment should be sent to: FTC, Office of the Secretary, 600 Pennsylvania Ave., N.W., Washington, DC 20580. To file a public comment electronically, please click on the following hyperlink: https://ftcpublic.commentworks.com/ftc/markdreher.

NOTE: The Commission issues an administrative complaint when it has reason to believe that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the respondents have actually violated the law. A hearing will be held before the administrative law judge in eight months. The consent agreement is for settlement purposes only and does not constitute an admission by respondents of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000.

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 1,800 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.

(FTC File No. 0823122)

(POM NR)