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United States senators target dietary supplement law.
2004 JUL 1 - (NewsRx.com & NewsRx.net) -- 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.
Senator 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 (FDA) 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 ...
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