April 19, 2004 - Ephedra
On April 12, 2004, the FDA published a final rule that bans the sale of dietary supplements containing ephedrine alkaloids.
After a careful review of the available evidence about the risks and benefits of ephedra in supplements, the FDA found that these supplements present an unreasonable risk of illness or injury to consumers. The data showed that the substance raises blood pressure and stresses the heart. The increased risk of heart problems and strokes negates any benefits of weight loss that were shown. Because there is strong evidence that ephedra is associated with an increased risk of side effects, possibly even fatal ones and there is little evidence of any benefits except for short-term weight loss, the FDA recommends that consumers immediately stop using dietary supplements containing ephedra or ephedrine alkaloids.
The final rule covers essentially all currently marketed dietary supplements that contain ephedra, ma huang, Sida cordifolia, and pinellia. The rule does not pertain to traditional Chinese herbal remedies or to most conventional foods such as herbal teas. In addition, drugs used for the short-term treatment of asthma, bronchitis, and allergic reactions that contain chemically synthesized ephedrine are not covered by this rule. While respecting the traditional uses of herbal medicines, their long history of use, and their potential health benefits, ephedra poses unique public health risks that warrant the FDA's actions to prohibit the sale of ephedra-containing dietary supplements.