FDA Seeks to Draw Line on Claims Made by Makers of Dietary Products

The Food and Drug Administration on Friday spelled out what dietary supplement manufacturers can and cannot say about their products--disallowing such health claims as “cures cancer” but permitting factually accurate statements about a supplement’s effect on the bodily functions of healthy people, such as “promotes regularity.”

The agency’s proposals attempt to define what claims can be made by the controversial $6-billion-a-year nutritional supplement industry under the 1994 Dietary Supplement and Education Act. That law preserved consumers’ access to these products--pills, capsules and teas--but it allowed the FDA some authority in regulating the health claims used to sell them.

The industry, which has lobbied vigorously in recent years to operate as freely as possible from government regulation, launched an intense grass-roots campaign that provoked widespread support from Congress, resulting in the legislation.

The new proposals, which are subject to a 120-day public comment period and further FDA review before becoming final, do not affect consumers’ ability to buy dietary supplements, nor do they protect consumers from supplements that may be unsafe. The 1994 law does not require dietary supplements to be cleared for safety before being sold, as is required for drugs. The FDA only can act after there is evidence that consumers actually have been hurt by a product.

Under the new proposals, a supplement maker cannot promote a product for treating or curing a specific illness. If it wishes to do that, then the product would be regarded by the FDA as a drug--not a dietary supplement--and it would be required to undergo the standard FDA drug approval process. This means a manufacturer must sponsor clinical trials showing that the drug is safe and effective, and submit the data to the agency for review before it could be licensed.

If a manufacturer, however, wants to say that a supplement can “protect” against developing a specific disease, it must submit existing scientific evidence of this to the FDA in advance, and the agency must agree to allow the claim.

The only claims that will be permitted without advance FDA approval involve more general statements about a product’s impact on healthy body systems or structures.

For example, it would be allowable for a product to say it “helps promote urinary tract health,” or “helps maintain cardiovascular function.” But it could not claim to “lower cholesterol,” or mention a specific disease or easily recognizable symptoms, such as “reduces the pain and stiffness associated with arthritis.”

The proposals do not specifically address weight-loss claims, but FDA officials said that obesity is now regarded as a disease, so much will depend on the wording of potential claims. For example, “promotes weight loss” probably would be prohibited, whereas “helps curb the appetite” might be allowed, they said.

FDA officials acknowledged there almost certainly will be murky areas subject to debate concerning product claims. An agency statement said: “It might be difficult to distinguish between allowable structure/function claims and prohibited disease claims.”

The Center for Science in the Public Interest, which opposed the 1994 law and favors the FDA’s having tough regulatory power over dietary supplements, attacked the proposals, predicting that they will not help protect consumers against misleading claims or potentially harmful products.

“The FDA proposal is merely bureaucratic hair-splitting,” said Bruce Silverglade, director of legal affairs. “Some of these examples are meaningless--even silly. You can’t say a product ‘lowers cholesterol,’ but you can say ‘helps maintain healthy cholesterol levels.’ . . .

“This is not the FDA’s fault. Congress has tied the agency’s hands.”

But Annette Dickinson, director of scientific and regulatory affairs for the Council for Responsible Nutrition, a trade group that represents the industry, said her organization generally supports the FDA approach.

“We agree with the examples of permissible claims, that they are helpful and consistent with claims already being made, and we agree with many of the examples of non-appropriate claims,” she said. “But we’re sure that there will be some gray areas, where we must give more careful thought, like the cholesterol claims. That may be one of the close calls under debate.”

She added: “The one bright line is between mentioning and not mentioning a specific disease--that is not a bad line to draw.”