By John Schwartz
Washington Post Staff Writer
Saturday, April 25, 1998; Page A01

The Food and Drug Administration yesterday took long-awaited action aimed at protecting consumers from misleading health claims by the booming herbal remedy industry.

The new rules would bar makers of vitamins and herbal remedies such as St. John's Wort and pennyroyal from claiming to cure, prevent or alleviate cancer, AIDS or other specific diseases. Instead, the products would be limited to making more general claims about enhancing the immune system, memory or other bodily processes.

The new rules are a significant new attempt to rein in the $6 billion supplement industry, whose products have gained widespread acceptance but also have raised concerns about dangerous side effects, such as heart and other problems caused by stimulants containing ephedra.

"Consumers want access to dietary supplements, but also need reliable information about the products they are consuming," said William Schultz, the FDA's deputy commissioner for policy. "By clarifying for manufacturers what types of claims can and cannot be made on a dietary supplement label, this new proposal helps consumers make more informed and wiser choices."

Whether the new rules will actually help consumers make sense of the welter of products available on health food store and supermarket shelves, however, is another question. Under the proposal, a manufacturer can't claim that a product "lowers cholesterol," but could say that it "maintains healthy cholesterol levels."

"The FDA proposal is a futile exercise in bureaucratic hair-splitting that will do little to protect consumers from misleading claims," said Bruce Silverglade of the Center for Science in the Public Interest, a consumer health group.

The FDA acknowledged that "because most disease treatments can be described in terms of their effects on a structure or function of the body, it is sometimes difficult to distinguish between allowable structure/function claims and prohibited disease claims."

But Schultz said that the proposal faithfully reflects a law passed by Congress in 1994 limiting the agency's authority over supplements. "We're trying to be true to the statute," Schultz said.

Unlike prescription and over-the-counter drugs, no government agency evaluates supplement safety before the products come to market, or fully evaluates the scientific validity of claims.

The FDA's authority over these products was restricted after the industry launched an intensive campaign to fight agency attempts to require manufacturers to substantiate any health claims they make with scientific evidence.

The 1994 Dietary Supplement Health and Education Act distinguished health and disease claims from "structure/function" claims. If a company wanted to claim that a product would affect the structure or function of the body, it didn't have to prove it to the FDA. A company would only be required to inform the agency beforehand that it was going to do so and then keep the evidence supporting the claim in its files. The act also required product labels to note that the claim was not approved by the FDA. The act left the agency with no systematic way to review the evidence of health claims.

Schultz said the FDA has sent about 100 letters to companies warning them that a claim falls outside of the law, but noted that the only way for the agency to demand to see the scientific evidence would be to file a lawsuit -- something it rarely does. "It's got to be company by company, case by case. The resources of litigation have to compete with everything else that we're doing," Schultz said.

Yesterday's action, which will go through a 120-day comment period and then be reviewed by the agency before being implemented, essentially follows the recommendations made by a presidential commission.

"It's a very difficult subject and they've done some good things," said Margaret Gilhooley, a Seton Hall law professor who served on the presidential commission. Gilhooley applauded the agency's decision to ban names of products that imply it works like a drug, such as calling a supplement "herbal Prozac."

She expressed concerns, however, that the agency would allow claims of functions that seem too close to defining certain diseases, such as "supports immune function" or "improves absent-mindedness."

But Annette Dickinson, director of scientific and regulatory affairs for the Council for Responsible Nutrition, an industry group, said consumers would benefit from the new rules. "Consumers don't have to know all the ins and outs of the legalities to know what an antacid is and what a calcium supplement is," Dickinson said. Both might be made from calcium carbonate, but the first is called an over-the-counter drug while the other is a dietary supplement. "What they need to know is what it is and what it's for."

Back to the top