The Food and Drug Administration proposed new rules Monday aimed at reducing the risks posed by a popular herbal stimulant that has been linked to seizures and deaths.
Products derived from herb ephedra are sold as an aid to weight loss and for a treatment of allergies, and they are popular among young people as pep pills. The stimulants are also called Ma huang, Chinese Ephedra and Epitonin, and are sold under such product names as Herbal Ecstasy and ULTIMATE Xphoria.
Ephedra contains ephedrine, which is a stimulant.
Since 1994, the FDA has received more than 800 reports of side effects from products made from ephedra, including irregular heartbeat, sleeplessness, anxiety, tremors and headaches. Extreme reactions have included seizures, heart attacks, strokes and two deaths.
Under the proposed rules, manufacturers of products containing ephedrine alkaloids would have to limit the amount used to less than 8 milligrams per dose. Products would also be required to carry labels instructing consumers not to use more than 24 milligrams of the stimulant in any one day or to use the product for more than seven days.
Companies that want to market the products for their stimulant effects would be required to add a warning: “Taking more than the recommended serving may result in heart attack, stroke, seizure or death.”
The proposed rules will appear in the Federal Register on Wednesday.
The agency will receive written comments on the proposal until Aug. 18 and will issue a final regulation after reviewing the comments.
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