RESEARCH AND MARKET EXPRESS

FDA announces plan to ban ephedra products

Peter Ou, Ph.D.
FDA advises consumers to stop buying and using ephedra products immediately.

HHS Secretary Tommy G. Thompson today announced that FDA has issued a consumer alert on the safety of dietary supplements containing ephedra and has notified manufacturers of its intent to publish a final rule on dietary supplements containing ephedrine alkaloids.

The rule will state that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the sale of dietary supplements containing ephedrine alkaloids when it becomes effective, 60 days following publication.

Ephedra, also called ma huang, is a naturally occurring substance derived from plants. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted to aid weight loss, enhance sports performance, and increase energy. Products containing ephedrine are not affected by FDA’s action.

In 1997, FDA first proposed a rule on dietary supplements containing ephedra including requiring a warning statement on these products. FDA modified this proposed rule in 2000, and last February the agency announced a series of comprehensive actions designed to protect Americans from the potentially serious risks of dietary supplements containing ephedra. FDA also reviewed a comprehensive RAND Corporation report on the data on ephedra.




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