29 September 2010

F.T.C. Challenges Pom Juice’s Health Claims

NY Times


Pom Wonderful, the pricey and popular pomegranate juice sold in the distinctly curvaceous bottle, is advertised as helping to reduce the risk of heart disease, prostate cancer and impotence. But according to the Federal Trade Commission, the evidence does not back up those claims.

On Monday, the F.T.C. charged Pom Wonderful, which markets the juice, and the company’s owners, the billionaire philanthropists Lynda and Stewart Resnick of Los Angeles, with making false and unsubstantiated claims about the power of their pomegranate elixir.

In a complaint that seeks to prevent the company from making any further medical claims unless they are substantiated by the Food and Drug Administration, the commission said the company ignored evidence that contradicted its claims that the juice could help prevent or treat heart disease, reduce the risk of prostate cancer and overcome erectile dysfunction.

The Resnicks said Monday that they planned to contest the charges. Their company has sued the commission in federal district court, claiming that the commission had exceeded its authority and was trampling Pom’s First Amendment rights.

“We stand behind the vast body of scientific research documenting the healthy properties of Wonderful variety pomegranate,” the company said Monday in a statement. “Our research is unprecedented among food and beverage companies, and we take pride in having initiated a program of modern scientific research to investigate the health benefits of this ancient and revered fruit.”

That ancient, revered status as a folk medicine led the Resnicks in 1998 to begin financing research into whether pomegranates and their antioxidants had health benefits, according to a 2008 profile in The New Yorker magazine.

The F.T.C. complaint comes at an awkward time for the Resnicks, whose other business ventures include Teleflora, the flower-delivery service; Fiji Water; Suterra, a maker of environmentally sensitive pest-control products; and Neptune Pacific Line, an Australian shipper. The couple also formerly owned the Franklin Mint, the marketer of commemorative coins, plates and dolls.

Last weekend, the Los Angeles County Museum of Art opened the Resnick Pavilion, a freestanding exhibition space that was financed in part by the couple’s $45 million gift to the museum, where Mrs. Resnick is vice chairman of the board and oversees the acquisitions committee.

Pom Wonderful claims to have spent $34 million on pomegranate research, including 19 clinical trials and multiple studies published in peer-reviewed journals.

In addition to the Resnicks and the company, the commission also charged Matthew Tupper, the president and chief operating officer of Pom Wonderful, and Roll International, which provides administrative services to POM and which, like POM, is owned by a Resnick trust. The charges will be heard by an administrative law judge in Washington next May.

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 not to engage in similar acts and to cooperate with further investigations.

The commission does not have statutory authority to assess fines for violations of its regulations, although it can being a lawsuit against someone who violates a consent order. Instead, the commission can order businesses to stop illegal marketing activities and can halt anticompetitive practices.

While not disputing that the company’s medical studies exist, the commission says that the company’s advertising claims overstate the results and ignore that the pomegranate products often showed no more efficacy than a placebo. In addition to the juice, Pom Wonderful sells POMx pill and liquid supplements.

The commission cited examples of Pom advertising that said the products produced “improved heart and prostate health and better erectile function.” Among the results of various studies were a reduction in plaque buildup in the carotid artery and in blood pressure, and slower progression of an indicator for prostate cancer.

Those results ignored the fact, the commission contended, that as early as May 2007 the company knew that a large study financed by the company showed no significant difference in arterial plaque buildup after 18 months between patients who drank Pom and those who drank a placebo.

The commission also stated that the company’s prostate-related claims relied on a study that itself notes uncertainty as to whether the outcomes cited by the company were relevant as an indication of clinical benefit. It also said the company’s studies on erectile function produced no statistically significant results. Pom strongly disputed the commission’s assertions. “We do not make claims that our products act as drugs,” the company said. “What we do, rather, is communicate, through advertising, the promising science relating to pomegranates. Consumers and their health providers have a right to know about this research and its results.”

The commission proposed an order that would require the company to get F.D.A. approval before it makes any future claims that its products prevent or treat serious diseases.

In its federal lawsuit, Pom Wonderful accused the commission of applying a new standard for deceptive advertising to the food and dietary supplement industry that overturns 20 years of commission policy. That policy was laid out earlier this year by the commission in separate deceptive advertising actions against Nestlé HealthCare Nutrition and Iovate Health Sciences.

Pom also said that the commission was, in seeking to require F.D.A. oversight over the company’s claims, treating pomegranate juice as a drug although the products “do not carry the risks associated with pharmaceutical drugs.”

“It’s a shame that the government is unable to understand this fundamental distinction,” the company said, “and instead is wasting taxpayer resources to persecute the pomegranate.”

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