updated 6/9/2004 12:30:25 PM ET 2004-06-09T16:30:25

A decade-old federal law on dietary supplement safety and the FDA’s enforcement are not up to the job of protecting Americans’ health, two senators told an FDA official Tuesday.

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Sen. Richard Durbin of Illinois, ranking Democrat on the Governmental Affairs Committee’s oversight subcommittee, criticized the law as a failure. Subcommittee Chairman George Voinovich of Ohio, singling out one aspect, said it was unacceptable that Food and Drug Administration has not set regulations for good manufacturing processes in the 10 years since the law was passed.

The Dietary Supplement Health and Education Act requires the FDA to prove that a dietary supplement is harmful, rather than having the manufacturer prove it is safe as is required with drugs. The law also does not require supplement manufacturers to report adverse reactions, as drug companies must.

“If the object of this law is to protect American consumers, it fails,” Durbin told the director of the FDA’s Center for Food Safety and Applied Nutrition, Robert Brackett, who is responsible for enforcing the law. “How can you meet that responsibility when the law is so weak?”

Durbin, who requested the subcommittee hearing, is sponsoring a bill that would make manufacturers report serious adverse reactions such as hospitalizations, permanent injuries or deaths involving users of supplements. The bill also would let the government require manufacturers to prove a product is safe if FDA had received information that suggested adverse reactions from a supplement.

Before the agency would ask for any more power, it wants “to maximize our activities under the current (law),” Brackett responded. “The administration at this time has no plans to make any changes.”

He said the FDA is working with the National Institutes of Health and with academic researchers to identify ingredients and has set up a system to track adverse reactions reported by consumers, health workers or manufacturers.

'As soon as possible'
The law requires require the FDA to set standards for good manufacturing processes so products do not contain contaminants such as bacteria and lead but do contain labeled ingredients in the proper amounts. The agency published a proposed rule in March 2003 and is reviewing responses to it.

That’s not good enough, Voinovich told Brackett. “I just cannot believe that it has taken that long after this law is passed,” the senator said. “It’s unacceptable that it takes 10 years to get something done.”

The regulations will be “done as soon as possible, that is our goal,” Brackett said.

The law allows the FDA to ban ingredients that are proved unsafe, and the agency announced in April that its ban on the diet aid ephedra had taken effect. The substance had been linked to 155 deaths, including that of Baltimore Orioles pitcher Steve Bechler in 2003.

“Consumers are endangered by the FDA’s inability to act on particular supplements,” and ephedra is a case in point, Durbin said. “It took years — literally years — for the FDA to ban this substance under this law, DSHEA.”

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