May 25th, 2011

POM Wonderful Claims Lack Scientific Support

Business Week

POM Wonderful LLC doesn’t have the scientific backing to make advertising claims that its pomegranate juice and supplements prevent or treat prostate cancer, erectile dysfunction and heart disease, a U.S. Federal Trade Commission lawyer said.

Studies the company cites often lack comparisons to control groups, don’t show statistically significant changes in medical conditions and are measuring the wrong indicators of improvement, FTC attorney Heather Hippsley said today.

Company documents show that executives of Los Angeles-based POM were aware of the studies’ shortcomings, she said during the first day of an FTC hearing on the claims. “They repeatedly ignored warning signs that the marketing didn’t match the science,” Hippsley said.

The case is a test of the FTC’s campaign to force food companies to support their advertising with more scientific findings. Last year, the FTC pressured Nestle NA and the Dannon Co. Inc., a U.S. unit of Danone SA, to change ads for their probiotic products. Probiotics are bacteria found in the gut that may aid digestion.

The FTC is “aggressively seeking to obtain new legal ground against advertisers” and “apply a pharmaceutical ‘drug’ standard to food products,” according to a brief filed by POM Wonderful and Roll Global, an associated company that is also a defendant.

In its complaint, the FTC highlighted one ad that shows a POM juice bottle blasting off like a rocket and proclaiming, “I’m off to save prostates!”

Prostate Health

The FTC said Lynda Resnick, vice chairman of Roll Global, advised an interviewer for a publication who says his father had prostate cancer, “You have to be on pomegranate juice.” She compared the juice to a popular drug for impotence.

“It’s also 40 percent as effective as Viagra,” she said. “Not that you need it, but couldn’t hurt.”

At the hearing today, Resnick referred to the “8,000-year history” of the pomegranate.

In addition to scientific studies, the fruit has been consumed “by millions of people over thousands of years,” she said.

In its legal brief, POM Wonderful said its ads are backed up by $35 million in research. The company has “sponsored or participated in more than 90 scientific investigations with over 65 studies on POM products, including 17 clinical trials,” according to the brief.

Scientific Evidence

Until recently, the FTC just wanted companies to base their ads on “competent and reliable scientific evidence,” the brief said.

Now the agency requires two well-controlled clinical trials in support of claims, according to the brief.

The requirement is a “radical change” in the FTC’s approach, raising its standard to one the Food and Drug Administration would use, said Jonathan Emord, an attorney who specializes in food and drug cases.

“It’s a bureaucratic power grab,” he said in an interview. “The FTC is doing the FDA’s bidding in a very unfortunate way.”

The FTC case also violates First Amendment rights, POM Wonderful said.

Scientists say companies’ claims for food’s health benefits should be held to the same standards as pharmaceuticals.

Product Labels

The Food and Drug Administration, which oversees information on product labels, doesn’t police food makers’ claims as rigorously as those for drug companies, according to a report last year by the Institute of Medicine, an arm of the National Academies in Washington.

“It’s so unregulated,” said Marion Nestle, a professor of nutrition, food studies and public health at New York University, in an interview. “The standards have gotten lower and lower and lower. You can’t sell food without a health claim nowadays. Nobody will buy it.”

More food makers are making claims that go beyond scientific studies, said Mary Engle, the FTC’s associate director for advertising practices.

“Companies should be on notice,” she told Bloomberg Television. “The FTC is taking a closer look at the claims that have been made for foods, and we’re scrutinizing them more to make sure they can really back up those claims.”

An FTC defeat in the POM Wonderful case would be felt throughout the food industry, Nestle said. It would be “open season on health claims, and companies can say anything they want,” she said.

Engle said the FTC was unsuccessful in its attempts to reach a settlement before the trial.

The trial is expected to continue over at least the next four months.

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