FDA changes restrictions on health claims

WASHINGTON, Dec. 18 (UPI) -- The Food and Drug Administration will begin requiring health claims on food products and dietary supplements be backed by scientific evidence, officials said Wednesday.

Consumer groups said the plan merely eases restrictions on placing health claims on food labeling and paves the way for food manufacturers to include the same type of misleading claims found on dietary supplements. The food and diet supplement industries lauded the FDA plan.

The new initiative is "focused on providing better health information for consumers," FDA Commissioner Mark McClellan told United Press International. "There's a lot of interest among consumers about getting good and up-to-date information about food and nutritional supplements (and this new plan) will allow the best and latest science to be reflected on labeling," he said.

The initiative will require that any health claims on food and supplements "be pre-approved by the FDA and meet the 'weight of the scientific evidence' standard, including support by a credible body of scientific evidence," the agency said in a written statement.

The consumer advocacy group Center for Science in the Public Interest denounced the plan.

"Today's action lowers the standard for health claims for foods to that which has been followed for dietary supplements," CSPI's legal affairs director Bruce Silverglade said in a written statement. "The supplement claims standard has led to a marketplace free-for-all of misleading claims that we fear will now spread to the much larger food industry."

The initiative will be spearheaded by a Consumer Health Information for Better Nutrition task force. Part of its mission will include cracking down on supplement manufacturers who make false or misleading claims on their products, McClellan said.

"We are going to be tough on diet supplement manufacturers that make claims about diseases that are not backed by scientific evidence," he said.

As an example, the FDA said U.S. marshals on Monday seized approximately 3,000 bottles of a dietary supplement called EverCLR that contains the herb echinacea. The marshals seized the product, valued at more than $100,000, because the manufacturer, Halo Supply Co. of San Diego, Calif., made unsubstantiated claims on labeling, including that it could treat herpes infections and protect against the cold and flu.

"We're going to be doing more of that," McClellan said.

Silverglade said the agency does not have the money to increase enforcement efforts.

"While FDA has promised to step up enforcement actions, the agency, as a practical matter, has little resources to do so and no significant new funding appears to be forthcoming from Congress," he said.

Gene Grabowski, spokesman for the Grocery Manufacturers of America, a trade group that represents food manufacturers, told UPI, "We welcome (the FDA's plan), we think this is a victory for consumers."

This makes it easier for food manufacturers to get health claims on product labels, which probably will become more common in the next couple of years as manufacturers submit applications to FDA and get approval, he said.

The claims likely will fall in the category of indicating the food can help ward off cancer, heart disease or aging, Grabowski said.

A standard format may be, "When used as part of your regular diet, this product may help mitigate or reduce symptoms of aging or disease," Grabowski said.

Diet supplement manufacturers welcomed the FDA's plan to eliminate bogus claims on supplements.

"We think this is a good thing," Annette Dickinson, vice president for scientific and regulatory affairs at the industry's Council for Responsible Nutrition, told UPI. "(FDA) has probably not done as much enforcement in that area as they need to."

Supplement makers "don't like to see people making false claims out there because it misleads consumers, and besides that, it's an unfair business practice for the rest of the companies" that are not making misleading claims, Dickinson said.