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FDA Draws Fire Over Dietary Aids

Senators urge tougher enforcement against supplements known to be health risks.

October 29, 2003|Shweta Govindarajan | Times Staff Writer

WASHINGTON — Amid growing public concern over the safety of dietary supplements, legislators criticized the Food and Drug Administration on Tuesday for failing to take a harder regulatory stance against some products and urged the agency to step up enforcement efforts against those that are known to pose serious health risks.

"There is no excuse for a supplement manufacturer to market products that are unsafe or inaccurately labeled or that make outlandish claims," said Sen. Orrin G. Hatch (R-Utah) at a hearing held by the Senate Committee on Commerce, Science and Transportation. "Unfortunately, a small number of irresponsible supplement companies are taking advantage of consumers."

Hatch, a longtime supporter of the supplements industry, noted that some products "do raise serious concerns" -- particularly citing ephedra, an ingredient in weight-loss supplements that has been linked to seizures, heart attacks and death, according to the American Medical Assn.

The FDA classifies dietary supplements as food and does not require them to meet the same approval standards as prescription drugs, which have to undergo rigorous premarket testing. Many supplements, such as vitamin tablets and calcium pills offer known health benefits.

Under the 1994 Dietary Supplements Health and Education Act, which Hatch co-sponsored, supplements can enter the market without FDA approval, and manufacturers are not required to inform the watchdog agency of any adverse effects that are associated with the product.

The FDA is in the process of determining whether dietary supplements should carry labels that clearly state their ingredients and their amounts, said John M. Taylor, associate commissioner for regulatory affairs. He did not say how long it might take to make a decision.

The agency also is working with the Federal Trade Commission, which has prosecuted supplement manufacturers that engage in false advertising.

Although congressional leaders approved of the agencies' progress, action should have come sooner, they said.

"We're always playing catch-up. We're playing catch-up rather than assessment. Why did it take nine years?" asked Sen. John McCain (R-Ariz.), referring to the 1994 law that also gives the FDA authority to push dietary supplement companies to follow more stringent manufacturing practices.

Hatch and Sen. Tom Harkin (D-Iowa) have co-sponsored legislation to give the FDA additional funding and resources to more aggressively pursue manufacturers of the products that cause concern. "The FDA simply does not have the staff to do its job. I say Congress should remedy that," Hatch said.

Consumers often do not realize that dietary supplements do not come under the same scrutiny as prescription drugs, said Sen. Richard Durbin (D-Ill.). He has introduced a bill that would require supplement manufacturers to report any adverse health effects to the FDA.

A similar bill has been introduced in the House by Reps. Susan A. Davis (D-San Diego), Henry A. Waxman (D-Los Angeles) and John D. Dingell (D-Mich.).

"Did anyone imagine we would be selling these witches' brews of chemicals that no one has tested?" Durbin asked. "These products are being tested on unsuspecting Americans every day."

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