Tuesday, May 22, 2012

POM Wonderful’s Disease Treatment, Prevention Claims Held Deceptive

This posting was written by Jeffrey May, Editor of CCH Trade Regultion Reporter.

POM Wonderful LLC, its principals, and an affiliate violated the FTC Act by making deceptive claims in some advertisements that their POM Wonderful 100% Pomegranate Juice and POMx supplements (POM products) would treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction, an FTC administrative law judge (ALJ) has decided.

The ALJ explained in a 345-page initial decision that not all of the advertisements challenged by the FTC could reasonably be interpreted by consumers as making claims that the products could treat, prevent, or reduce the risk of certain diseases.

According to the initial decision, the evidence demonstrated that reasonable consumers would interpret the POM respondents’ advertisements as claiming that drinking eight ounces of POM Juice daily, taking one POMx pill daily, and/or taking one teaspoon of POMx Liquid daily treats, prevents, or reduces the risk of heart disease, prostate cancer, and/or erectile dysfunction, and/or is clinically proven to do so.

Expert testimony demonstrated that there was insufficient competent and reliable scientific evidence to support claims that POM products treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction, or are clinically proven to do so.

Under an order issued with the initial decision, the POM respondents would be barred from making any representation about the “health benefits, performance, or efficacy” of POM products or any other food, drug, or dietary supplement unless the representation is not misleading and the POM respondents possess “competent and reliable scientific evidence . . . to substantiate that the representation is true.” They would also be barred from making unsubstantiated representations that any such product “is effective in the diagnosis, cure, mitigation, treatment, or prevention of any disease.”

The order also would bar the POM respondents from misrepresenting “the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research.”

The ALJ rejected a proposed remedy that would have prohibited the POM respondents from making any disease claims unless the claim had received prior approval from the Food and Drug Administration (FDA). In addition, the ALJ ruled that the POM respondents were not required to conduct double-blind, randomized, placebo-controlled clinical trials to substantiate implied claims for their products.

POM Wonderful Response

The FTC failed in its efforts to “create a new, stricter industry standard, similar to that required for pharmaceuticals, for marketing the health benefits inherent in safe food and natural food-based products,” said Craig Cooper, Chief Legal Officer for POM Wonderful LLC, in response to the decision.

“While we are still analyzing the ruling, it is clear that we will be able to continue to promote the health benefits of our safe, food products without having our advertisements, marketing or public relations efforts preapproved by the FDA and without having to rely on double-blind, randomized, placebo-controlled studies, the standard required for pharmaceuticals,” he added. “We consider this not only to be a huge win for us, but for the natural food products industry.”

The initial decision is In the Matter of POM Wonderful, LLC, dated May 17 and released May 21. Text of the decision is available here on the FTC website.

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