| Home | FDA proposes regulation of ephedrine in herbal supplementsposted 6-13-97 Citing evidence that ephedrine can cause heart attack, stroke, and death, the Food and Drug Administration has proposed strict regulations to require government warning labels on herbal supplements containing the drug. According to FDA officials, there have been more than 20 deaths and 800 adverse reactions linked to the drug since 1993. Potent amphetamine-like compounds that stimulate the heart and nervous system, ephedrine alkaloids have become one of the most widely used herbal ingredients in the dietary supplement industry. The trend is declining, however, in light of recent reports. Also dubbed Ma huang, Chinese ephedra, and epitonin, the drug shows up in products marketed for body building, weight loss, and extra energy and as legal alternatives to the street drug "Ecstasy." If confirmed following a public comment period that extends through mid-August, the new regulations would also ban supplements containing more than 8 mg of ephedrine or related alkaloids per serving and limit the maximum daily dose to 24 mg. Currently, some supplements offer as much as 109 mg of ephedrine per dose, FDA officials reported. The regulations would require labels instructing consumers not to take the drug form for more than seven consecutive days. Some product labels would caution that ingesting more than the recommended serving could result in illness or death. The new rules would also prohibit manufacturers from adding caffeine or similar stimulants to products containing ephedrine. Pregnant or nursing women and people with diabetes or high blood pressure should completely avoid ephedrine, officials reported. According to a statement from Global World Media Corp., which manufactures Herbal Ecstasy, the government has no business cracking down on "natural herbal supplements" while approving "toxic drugs such as Prozac [fluoxetine]" and bovine growth hormones. The company questions the validity of the FDA’s reports, stating, "There is no evidence that specifically links ephedra and caffeine to any adverse reactions or deaths." Michael Friedman, deputy commissioner of the FDA, said ephedrine is potentially harmful and urged people who want to try it to talk to their physicians first. "Consumers should be aware that just because a product is labeled ‘natural’ or from an herbal source, it is not guaranteed to be safe." Related Site
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