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FDA Can Pull Supplements without Proof

Posted - Apr. 2, 2004 at 2:20 p.m.



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Apr. 2--WASHINGTON -- Federal regulators can yank dietary supplements from shelves on the assumption, rather than hard evidence, that their ingredients may pose an unreasonable risk to human health, according to a new federal study released Thursday.

The Institute of Medicine of the National Academies of Science is suggesting minor changes to the federal law that Utah Sen. Orrin Hatch sponsored in 1994 that allowed vitamins and supplements to be regulated as food rather than drugs. The system assumes supplements are safe to consume and can be sold without any federal pre-authorization or advance clinical testing to prove effectiveness or safety.

Critics say the law -- the Dietary Supplement Health and Education Act (DSHEA) -- permits unsafe or ineffective supplements to be sold to the public.

The Food and Drug Administration commissioned the three-year study to determine if there was a better way of warning consumers of potential dangers without having a body of evidence. The study lays out a new science-based framework for assessing the possible risk of supplement ingredients by using available data from recognized sources such as studies on animals or information on similar substances.

"A key point is that the FDA does not have to find direct evidence of actual harm to people from use of a supplement ingredient to determine an ingredient poses an unreasonable risk to consumers' health," said University of California Davis Nutrition Professor Barbara Schneeman, who chaired the committee that wrote the report.

Because (DSHEA) permits the assumption, rather than hard evidence, that a product is safe, determining whether an ingredient carries "an unreasonable risk " can also be based on assumption, Schneeman said at a briefing to release the report.

Schneeman said researchers believe the FDA should adopt the new framework for assessing risk of supplements to enhance its ability to protect the public from the "occasional problem product" among the 29,000 products now on the market, many of which, she said "are probably safe." Hatch praised the committee's findings as validation that DSHEA can work if properly enforced by the FDA.

"The report clearly shows that the vast majority of dietary supplements on the market are safe, and the law is adequate to protect Americans from any dangerous products," he said Thursday. "This new scientific framework could go a long way in helping the FDA act quickly when problems do arise."

Hatch said the FDA has been slow to act on controversial supplements such as ephedra and androstendione, although he praised the recent "aggressive stance" of FDA to use regulatory powers he believes are still untapped in DSHEA to protect consumers from potentially harmful products.

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(c) 2004, The Salt Lake Tribune. Distributed by Knight Ridder/Tribune Business News.

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