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FDA says Pom Wonderful antioxidant claims not so wonderful

By Shane Starling , 03-Mar-2010

The Food and Drug Administration has issued pomegranate juice market leader, Pom Wonderful, with a warning letter over antioxidant claims it says are unauthorized drug claims.

The warning relates to cancer and other claims being made on the Pom Wonderful website and comes as part of an FDA crackdown that has seen it issue letters to 17 companies for making unauthorized health claims about 22 food products.

Pom Wonderful was unavailable for comment at the time of publication.

The Center for Science in the Public Interest (CSPI) hosted a webcast on the FDA actions at 14:00 eastern standard time and issued a statement.

“For far too long, manufacturers have exaggerated the healthfulness of their products, or even implied that their products contain special ‘functional’ ingredients that provide drug-like protection against various diseases,” the CSPI's legal affairs director, Bruce Silverglade.

“The previous administration tolerated such shenanigans, but I hope that the party is now over. The warning letters sent by FDA today are a welcome step. But unless the FDA uses its authority to issue new, industry-wide regulations to prevent such abuses, the agency will forever be playing a game of Whac-A-Mole with companies that use deceptive labeling."

The warning letter to California-based Pom Wonderful president, Matt Tupper, states claims being made at www.pomwonderful.com and www.pompills.com violate the Federal Food, Drug, and Cosmetic Act because they promote the products’ use in the cure, mitigation, treatment, or prevention of disease.

Pom Wonderful claims included being able to reduce atherosclerosis; reduce blood flow/pressure; slow the onset of prostate cancer; improve erectile function; improve circulation; reduce cholesterol; fight free radicals and benefit diabetes.

The FDA warned Pom Wonderful about citing scientific publications because they could be construed as evidence, “of the product’s intended use”.

Pom Wonderful has 15 days to respond to the February 22 letter that can be found here.

Wonderful opportunity

FDA commissioner, Margaret A Hamburg, MD issued a statement about the crackdown where she emphasized the “wonderful opportunity” the agency had to provide “clear and consistent guidance”.

“I have made improving the scientific accuracy and usefulness of food labeling one of my priorities as Commissioner of Food and Drugs,” she said, noting new guidance on front-of-pack calorie and nutrient labeling was forthcoming.

“I am confident that our past cooperative efforts on nutrition information and claims in food labeling will continue as we jointly develop a practical, science-based front-of-pack regime that we can all use to help consumers choose healthier foods and healthier diets,” she concluded.

She added that,These examples and others that are cited in our warning letters are not indicative of the labeling practices of the food industry as a whole.”

Other companies to receive warning letters included Sunsweet Growers (dried fruit mix antioxidant claims); PBM Products (calcium and other nutrient content claims for baby foods); Pompeian (olive oil-based cancer and other claims).

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