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February 2004

FDA publishes final ephedra rule

The Food and Drug Administration (FDA) has published its final rule banning the sale of dietary supplements containing ephedrine alkaloids (ephedra). The rule becomes effective in 60 days. Supplements with ephedra have been promoted to aid weight loss, enhance sports performance, and increase energy. But FDA determined that ephedra presents an unreasonable risk of illness or injury. It has been linked to serious adverse health effects, including heart attack and stroke. FDA continues to advise consumers not to use ephedra-containing products.

Under the Dietary Supplement Health and Education ACT (DSHEA) of 1994, the FDA may remove a dietary supplement from the market if it presents a significant or unreasonable risk of illness or injury, when used according to its labeling.

More information about the rule is available on the FDA Web site, www.fda.gov.

Source: Food and Drug Administration, www.fda.gov

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