FDA Proposes More Regulation of Ephedrine

LEGAL DRUGS July 1997

On June 4, the Food and Drug Administration (FDA) proposed new regulations of "dietary supplements" containing the stimulant ephedrine (often derived from or sold as ephedra) to limit the legal dosage of the drug, and mandate a warning label on packages of "dietary supplements" containing ephedrine (Food and Drug Administration, "Dietary Supplements Containing Ephedrine Alkaloids; Proposed Rule," Federal Register, June 4, 1997, vol. 62, no. 107, pp. 30677-30724; John Schwartz, "FDA Proposes Rules to Curb Risks From Herbal Stimulant," Washington Post, June 3, 1997, p. A2; Marian Burros, "F.D.A. Plans to Control Herbal Stimulant Tied to Deaths," New York Times, June 3, 1997, p. A14).

Ephedrine is a drug used in many products sold for weight loss and as treatments for allergies. It is also popular as a stimulant, and is marketed as a supposed herb under brand names such as Herbal Ecstasy® and Ultimate Xphoria®. According to the FDA, the stimulant can produce many serious side effects, including anxiety, irregular heartbeat, seizure, heart attack, and stroke. Since 1994, the FDA has received over 800 reports of such effects. In addition, the FDA is looking at reports that ephedrine has caused several deaths.

Under the FDA proposals, products must not contain more than 8 mg of ephedrine alkaloids (the stimulant contained in ephedra) per "serving." Ephedrine products must be labeled with a warning against using more than 24 mg of the drug in a single day, or for more than seven consecutive days. In addition, the FDA proposes that products containing ephedrine must include a warning label on their packages that reads: "Taking more than the recommended serving may result in heart attack, stroke, seizure or death."

Ephedra is not currently regulated by the FDA because it is a dietary supplement protected under the Dietary Supplement Health and Education Act of 1994. Under the act, the FDA cannot regulate the supplement unless it has been proven unsafe. Consumer advocate Bruce Silverglade of the Center for Science in the Public Interest said this law "forces the FDA to wait `til there's blood on the tracks'" before it can regulate such supplements. Florida and New York banned ephedrine supplements last year after a 20-year-old college student died from taking excessive doses of Ultimate Xphoria®, a herbal stimulant containing ephedrine (Associated Press, "Tougher Rules Coming on Drug," Newsday, June 3, 1997, p. A19).

The proposed regulations are available for review in the Federal Register, and the FDA will accept comments until August 18.

See also: "FDA Prepares to Regulate Dietary Supplements Containing Ephedrine," NewsBriefs, October 1996; "FDA Issues Warning on Herbal `Ecstasy' Drug," NewsBriefs, May 1996.

The Federal Register is available on-line at: http://wais.access.gpo.gov.