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April 12, 2004

FDA Notice Prohibiting Sales of Supplements Containing Ephedrine Alkaloids (Ephedra)

Sales of Supplements Containing
Ephedrine Alkaloids (Ephedra) Prohibited

Dietary supplements that contain ephedra have been banned in the United States since April 2004. FDA banned the products after it determined that ephedra posed an unreasonable risk to those who used it.

Ephedra, also called Ma huang, is a plant or herb that contains ephedrine, a substance that is regulated by FDA as a drug when created chemically in the lab. As such, it is subject to strict federal standards for safety and effectiveness. However, ephedra has generally been marketed as an ingredient in dietary supplements, which are not bound by the same strict standards as drugs. Nevertheless, under a 1994 law, FDA can remove a dietary supplement from the market if it creates an unreasonable risk of illness or injury.

FDA has long regarded ephedra-based dietary supplements as potential health hazards. Substantial evidence of harm emerged in 2003, when a major study reported more than 16,000 adverse events associated with the use of ephedra-containing dietary supplements, including heart palpitations, tremors and insomnia. The study also found little evidence that ephedra is effective in boosting physical activities and weight loss -- as claimed by its promoters. FDA subsequently determined that ephedra presents an unreasonable risk of illness or injury. On April 12, 2004, the agency's final rule prohibiting the sale of dietary supplements containing ephedra went into effect.

Click here to visit this article's page on the FDA website for related articles and links.


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