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Unreasonable risk

It's official. The Food and Drug Administration's own study concludes that supplements containing the powerful stimulant ephedra "may be associated with important health risks." The threat from ephedra is so great that Tommy Thompson, Health and Human Services secretary, said: "I would not take this, I would not give it to my family and I don't know why anyone would take these products."

So why is the FDA, an agency under Thompson's control, only proposing a warning label for ephedra-laced supplements? If ephedra is as dangerous as the FDA and others say, it should be banned.

The FDA has known about the ephedra risk for years, but the highly publicized death of Baltimore Orioles pitcher Steve Bechler finally forced it to act. Bechler was using a diet product containing ephedra when he died of heat stroke. The NFL, NCAA and International Olympic Committee have already banned the substance. Major League Baseball's players union recently warned its members to "be extremely reluctant to use any products containing ephedra," and commissioner Bud Selig is trying to determine what, if anything, to do about the problem.

Last week, the FDA announced a study of 16,000 reports of adverse reactions to ephedra. It showed that two people died, four had heart attacks, nine had strokes, one suffered a seizure and five people were left with psychiatric problems. The FDA also noted a medical study that showed an increased risk of hemorrhagic (bleeding) strokes when ephedra products are used at even a third the recommended dose.

According to Public Citizen, a consumer-advocacy group, the FDA is actually aware of more than 100 deaths related to ephedra. In fact, Public Citizen has documented a wide range of ailments linked to ephedra, using the FDA's own documents, and concludes that many more cases go unreported.

After a 30-day comment period, the FDA says it intends to require a warning label on ephedra products. The agency should go further.

Under the law, the FDA can ban ephedra if it believes there is an "unreasonable risk" of harm from its use. That risk has clearly been established.

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