FDA to Prohibit Sales of Ephedra Products

The U.S. Food and Drug Administration (FDA, Washington, DC, USA) has determined that dietary supplements containing ephedra present an unreasonable risk of illness or injury and should not be consumed.

The agency has notified firms that manufacture and market products containing ephedra that it intends to issue a final rule prohibiting their sale, which will become effective 60 days afterward. This action is the result of voluminous evidence about ephedra's pharmacology, gathered and reviewed by the FDA. Overall, the data show little evidence of effectiveness except for short-term weight loss, while confirming that ephedra raises blood pressure and otherwise stresses the circulatory system. These reactions have been conclusively linked to adverse outcomes, including heart ailments and strokes.

Ephedra, also called Ma Huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In contrast to regulated supplements that contain natural ephedra, the safety and effectiveness of the synthesized ephedrine has to be proven by the manufacturer.

"Consumers should stop buying and using ephedra products right away, and the FDA will make sure consumers are protected by removing these products from the market as soon as the rule becomes effective,” said Mark B. McClellan, M.D., Ph.D., commissioner of the FDA.





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