FDA Prepares to Regulate Dietary Supplements Containing Ephedrine
An advisory panel recommended that the FDA should tighten controls on the sale of dietary supplements that contain the drug ephedrine (Paul Recer, "FDA gears up to curb ephedrine concoctions," Philadelphia Inquirer, August 28, 1996, p. A3; Robert Cooke, "U.S. Moves To Control Ephedrine," Newsday, August 28, 1996, p. A1; Paul Recer, "Split panel urges FDA to tighten controls on diet aid ephedrine," Star Ledger (Newark, NJ), August 29, 1996, p. 30; Paul Recer, "FDA panel recommends restrictions on ephedrine," Philadelphia Inquirer, August 29, 1996, p. A2 ).
FDA officials organized the advisory committee to gather advice on how to respond to the growing number of deaths and illnesses related to ephedrine. The committee members responded in general agreement on August 28 that the FDA should tighten controls on products containing the drug, but the members were split on how to regulate the drug. "The committee is divided between those who believe there is no safe level for ephedrine in dietary supplements and those who believe a low dose would be OK," said E. Wayne Askew, acting chairman of the committee.
According to the FDA, at least 17 people have died and 800 have been treated for disorders related to the drug. An FDA study found that people sickened by ephedrine products suffered from heart attack, stroke, angina, and heart arrhythmia. The products also caused seizures, psychiatric disorders, dizziness, personality changes, memory loss, rashes, vomiting, diarrhea and fatigue.
The one frequently cited case is that of Peter Schlendorf, 20, who on March 7 took eight pills (twice the recommended maximum dose) of a herbal stimulant during spring break in Panama City, Florida. He was found dead of a heart attack later that night. An autopsy showed that Schlendorf had no other drugs or alcohol in his body and the coroner ruled that the death was caused by a double dose of the stimulant. (For more information, see NewsBriefs, May 1996.) On May 23, Governor George Pataki of New York banned sales of non-medicinal stimulants that contain ephedrine in the wake of Schlendorf's death. Florida already has a similar ban (Associated Press, "Mother of dead man fights herbal stimulants," Buffalo News, May 22, 1996, p. A1; Rick Hampson, "Pataki bans herbal stimulants containing ephedrine," Buffalo News, May 24, 1996, p. A11).
Ephedrine can be extracted naturally from the ma huang herb (imported from Asia) or synthesized in laboratories. It is the active ingredient in many so-called herbal stimulants, including brands like "Ultimate Xphoria®" and "Herbal Ecstasy®." Ultimate Xphoria® is marketed as "completely safe" and "100 percent natural." Herbal Ecstasy® promises its users "a floaty, mind-expanding euphoria," "increased sexual sensations," and "mood elevations." Industry officials say production of herbal stimulants is approaching one billion pills a year. The stimulants are marketed through the Internet, at drug-paraphernalia stores and music festivals, and in ads in magazines such as High Times (Gina Kolata, "The Unwholesome Tale of the Herb Market," New York Times, April 21, 1996, p. E6).
Many supplements with ephedrine are designed for weight loss, "boosting energy" and building muscles. Other prescription and non-prescription drugs containing ephedrine are produced for relief of allergies, colds and asthma, such as Primatene® and Sudafed®. Companies that produce these cold and allergy relief medications point out that their products often have lower doses of ephedrine than the "herbal" stimulants and provide more extensive label information.
On August 27, Judith Foulke, a representative of the FDA, said the FDA sent warning letters recently to six companies that sell ephedrine-based stimulants. The six were advised that "because your firm has continued to manufacture and/or distribute these products despite FDA's warnings, we request that you now advise us of your intentions." The firms were given five days to respond.
FDA Director David Kessler, M.D., said the FDA will take action, ranging from banning products with ephedrine to setting low-dose limits on the drug, by the end of the year. He added that "all of the dose levels claimed as safe (by some committee members) were much lower than what is available today." Michael McGuffin, president of the Herbal Products Association, said his group invites stricter regulation of dietary supplements with ephedrine. "For a lot of products, the dose range was just too high," said McGuffin. "I'd like to see the products placed on the market with warning labels and at a particular dose."