Critics want supplement risks reported to FDA

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Congress should change the 10-year-old law that governs sales of vitamins and other dietary supplements to require makers to report potential safety risks to regulators, senators and other critics said Tuesday.

An industry group, the American Herbal Products Association, agreed mandatory reporting of serious health problems in patients taking supplements would help the government better police unsafe products.

The Food and Drug Administration, however, believes it has sufficient power to act against risky supplements and is not seeking any changes to the law, said Robert Brackett, director of the agency’s Center for Food Safety and Applied Nutrition.

The agency is trying to make the most of its current powers under the 1994 law “before we ask for any new authority,” Brackett said at a hearing before a Senate Governmental Affairs subcommittee.

“That approach is so timid even the industry is against it,” replied Sen. Richard Durbin, an Illinois Democrat.

“How can you protect American consumers from risk .... if you are not receiving notice from these companies?” Durbin asked.

The American Medical Association also called for mandatory reporting of serious health problems as well as pre-market testing requirements for supplements.

Millions of Americans take vitamins, herbs and other supplements widely available in drug, grocery and health-food stores. The industry’s annual sales are estimated at $18 billion.

Under the 1994 law, companies can sell supplements without putting them through the extensive safety and effectiveness testing required for pharmaceuticals. The FDA has the burden of proving a supplement is risky.

Earlier this year the FDA for the first time banned a supplement, the herbal weight-loss pill ephedra, after it was linked to heart attacks, strokes and deaths.

Durbin said the years it took for the FDA to ban ephedra showed the law was not strong enough to keep dangerous products from the public. “If the object of this law is to protect American consumers, (the law) fails on its face,” Durbin said.

The FDA also came under criticism for failing to set manufacturing standards for supplement makers as the law required. “It’s unacceptable,” said Ohio Republican Sen. George Voinovich, the subcommittee chairman.

The agency proposed the manufacturing standards last year and has been reviewing more than 1,600 pages of comments from the public, Brackett said. The rules are designed to ensure supplements contain the ingredients listed on the label and are free from contamination. 

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