Competing "POM" FTC Lawsuits Filed

The Federal Trade Commission and the marketer of POM Wonderful are waging competing legal actions against each other regarding the POM's ability to make certain health claims without obtaining prior FDA approval and possessing certain levels of substantiation. Both actions follow the FTC's recent enforcement actions against Iovate and Nestle relating to those companies health claims.

FTC Administrative Action

On September 27, 2010, the FTC filed an administrative complaint against POM Wonderful, LLC which markets POM Wonderful 100% Pomegranate Juice and POMx supplements, and the company's owners, Lynda and Stewart Resnick of Los Angeles, with making false and unsubstantiated claims that their products will treat or prevent heart disease, prostate cancer, and erectile dysfunction. The FTC also sued Matthew Tupper, the president and chief operating officer of POM as well a as Roll International, a POM-related company.

The FTC complaint alleges that POM Wonderful's heart disease claims are false and unsubstantiated because the company's scientific studies failed to support heart disease benefit from use of its products. The FTC also alleges that the prostate cancer claims are false and unsubstantiated because, among other reasons, POM's study was neither "blinded" nor controlled. Finally, it alleges that the erectile dysfunction claims are false and unsubstantiated because the study on which the company relies upon did not show that POM Juice was any more effective than a placebo.

Among the challenged claims, were the following:

  • "SUPER HEALTH POWERS! ... 100% PURE POMEGRANATE JUICE. ... Backed by $25 million in medical research. Proven to fight for cardiovascular, prostate and erectile health."
  • "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."
  • "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 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; and
  • Clinical studies prove that POM Juice prevents, reduces the risk of, and treats, erectile dysfunction.

The FTC seeks an injunction that would prohibit claims that a pomegranate-based product cures, prevents, treats, or reduces the risk of any disease unless truthful and in compliance with FDA regulations. The proposed order would require FDA pre-approval before POM Wonderful makes future claims that certain products prevent or treat serious diseases. 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.

Pre-emptive Suit

Earlier in September, the company sued the FTC in federal district court in the District of Columbia for declaratory relief, charging that the FTC had had exceeded its statutory authority in asserting a "new" substantiation standard that the agency set forth in the Nestle and Iovate settlements. In addition, the company alleged that the FTC, in adopting its new requirements, violates POM's constitutional free speech rights.

FTC Settles with POM's Former VP of science and Regulatory Affairs

The commission also settled on Monday a related false advertising case against Dr. Mark Dreher, POM Wonderful's former vice president of science and regulatory affairs, who also appeared in various media as an expert endorser of POM Wonderful's products. Without admitting or denying the charges, Dr. Dreher agreed to an injunction along the lines sought by the FTC in its administrative action.

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