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Friday, April 02, 2004 - Page updated at 12:05 A.M.
Closer scrutiny sought for dietary supplements
By Julie Bell
WASHINGTON Congress should require makers and distributors of dietary supplements to report incidents in which their products harm consumers, an expert panel convened to advise the government said yesterday.
The report also said the Food and Drug Administration should require supplement makers and distributors to turn over all information they have on a new product's safety favorable or not before marketing it.
The panel argued that the agency did not need direct evidence of human harm to ban a supplement. The recommendation will add new fuel to a long-running debate over the regulation of dietary supplements the minerals, herbs, vitamins and other naturally occurring substances that people take to supplement their diets, lose weight or enhance athletic performance.
The increased popularity of supplements has brought concerns about possible injury and even death. In a high-profile case a year ago, Orioles pitcher Steve Bechler collapsed at spring training and died after taking the weight-loss supplement ephedra.
Yesterday's report by the Institute of Medicine details how the FDA can use animal studies, laboratory tests and other scientific sources to evaluate a supplement's safety. Unlike drugmakers, supplement providers aren't required to demonstrate a product's safety through human testing.
"This is a report we hope will help the FDA to enhance its ability to protect the health and well-being of the American public," said committee chairwoman Barbara Schneeman, a University of California-Davis nutrition professor who introduced the study at a Washington news conference.
Although many supplements are believed to be safe, she added, "To identify and take action on the occasional problem product, the FDA must rely on available information to evaluate whether the supplement represents unreasonable risk."
Consumer advocates and some industry representatives said they would welcome a law requiring manufacturers and distributors to tell the FDA when their products appear to harm a consumer. Drugmakers are required to do so.
But there was little agreement on many other points.
Under the 1994 Dietary Supplement Health and Education Act, supplement makers do not have to provide safety information or report adverse reactions.
The FDA has tried to use its limited authority to review the safety of supplements before they go on the market. Manufacturers and distributors must inform the FDA at least 75 days before introducing a new dietary supplement ingredient, and provide information showing it "can reasonably be expected to be safe."
There are about 29,000 such products on the market, with an average of 1,000 new ones every year, according to a study cited in the report. Sales were an estimated $18.7 billion in 2002.
The FDA has become more aggressive with supplements in recent months. But the threshold for removing a product from the market is high under the 1994 law, which requires the government to demonstrate "an unreasonable risk of illness or injury."
Until February, when the FDA banned ephedra after a lengthy review, the agency had been reluctant to take such action for fear it might be overturned in court. One manufacturer has since sued, trying to do just that.
Information from The Washington Post is included in this report.
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