FDA Expected to Ban Herbal Weight-Loss Treatment Ephedra
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Posted by Dow Jones Business News on December 30, 2003 at 11:02:30:
WASHINGTON -- After years of debate, federal health officials are expected today to announce they will act to remove the herbal weight-loss treatment Ephedra from the marketplace, the first time the Food and Drug Administration (News - Websites) has moved to ban a dietary supplement, Tuesday's Wall Street Journal reported.
The action will set a precedent for how the FDA deals with the alleged risks posed by supplements and could draw litigation from manufacturers who dispute the agency's assertion that Ephedra is a proven health risk. Ephedra, once widely taken to enhance athletic performance and as a weight- loss aid, has been linked to heart problems and strokes and was fingered in the death earlier this year of 23-year-old Baltimore Orioles pitcher Steve Bechler. Dietary supplements are regulated under a 1994 law that sets a high bar for restrictions. Unlike drugs, herbal supplements don't have to be approved by the FDA before going on the market, and the agency must prove that they pose a " significant or unreasonable risk" before blocking their sale. Ephedra accounts for about 7% of dietary-supplement sales, or about $1.4 billion last year, according to the Nutrition Business Journal. Amid decisions by companies to stop selling Ephedra supplements and the crush of negative publicity, the trade journal predicted that figure could fall to $300 million or $500 million this year. Ephedra, also known as ma huang, for years has been suspected of causing heart problems and strokes. Sales of the substance already have been restricted in some states, and a number of manufacturers and retailers have stepped away from it because of growing consumer concerns about its safety and the risk of lawsuits. Wall Street Journal Staff Reporters Sarah Lueck, Anna Wilde Mathews and Stefan Fatsis contributed to this article.
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