FDA Easing Rules for Food Health Claims

The Food and Drug Administration, saying it wants to help consumers make more healthful choices, announced Wednesday that it will allow food makers to list health claims on product labels before they have been scientifically proven.

FDA Commissioner Mark McClellan also said his agency will crack down on false health claims made by manufacturers of dietary supplements.

The two-pronged initiative, the first major policy action by the new FDA commissioner, moves the agency clearly in a direction favored by McClellan -- providing more information to consumers while regulating industry less.

“We are committed to improving opportunities for consumers to get scientifically accurate information about the health consequences of the foods they consume, and to enhancing our enforcement efforts against those who would make false or misleading claims for their products,” McClellan said.

The FDA has required “significant scientific agreement” before it has allowed industry to make health and nutrition claims for food. By changing the standard to “the weight of scientific evidence,” the government will make it easier for industry to give consumers more information, and that will promote improved public health, administration officials said.

But a consumer health advocacy group questioned the FDA’s authority to change the standard for health claims and said the action could result in more confusion for consumers.

“Today’s action lowers the standards for health claims for foods to the standards for dietary supplements that has led to a marketplace free-for-all of false and misleading claims,” said Bruce Silverglade, legal director of the Center for Science in the Public Interest.

The full impact of the policy is unlikely to be known before the FDA clarifies exactly how it will determine whether a claim has met a scientific “weight of the evidence” standard.

In documents released Wednesday, the FDA said simply that its specific guidance on the matter would “also make clear FDA’s conviction that consumers are partners in their own health care, and that the perspective FDA adopts in considering whether food claims are misleading is the ‘reasonable consumer’ standard.”

The National Food Processors Assn., the voice of the $500-billion food processing industry, praised what it called “a very positive move by the FDA,” saying it would allow food makers to put more information about health benefits on labels.

“This is something that is in the best interest of everyone -- particularly consumers,” said Rhona Applebaum, executive vice president of the group.

But some consumer advocates questioned whether the FDA would be able to handle the added work of evaluating the truthfulness of more health claims on food labels -- particularly as it also promised to crack down on fraudulent claims by makers of dietary supplements.

“The FDA has just made its job harder,” Silverglade said. “It doesn’t have the resources to conduct systematic enforcement.”

Federal law exempts the $17-billion-a-year dietary supplement industry from most federal regulations. Unlike prescription drugs, supplements do not have to pass FDA tests for safety and effectiveness before going on the market.

The FDA’s authority over the supplements is largely limited to ensuring the truthfulness of their labels and advertising claims. In rare cases, when it has proved that a supplement has caused numerous injuries or deaths, the FDA can take action to force a product off the market.

But the process can take years. It was 1994, for example, when the FDA began receiving complaints of health problems related to the use of ephedrine, the herbal stimulant used in the weight loss product Metabolife 356, made by San Diego-based Metabolife International.

The agency has since collected reports of more than 100 deaths among ephedrine users, and in August the Justice Department opened a criminal investigation into claims that the manufacturer lied when it told the FDA it had received no reports of adverse health affects caused by Metabolife 356.

Yet the product, with annual sales topping $1 billion in 1999, remains on the market.

The FDA said that on Monday, U.S. marshals seized $100,000 worth of EverCLR, a supplement advertised as a treatment for the herpes virus, at Halo Supply Co. in San Diego.

The agency had been trying for two years to get the company to stop marketing EverCLR as a disease treatment.