The American Heart Association urged the federal government yesterday to ban sales of the herbal supplement ephedra, saying the dangers of using it far outweigh any possible benefits it could have as a weight loss aid or workout enhancer.
"Ephedra has been associated with a remarkable risk profile," the association said in a formal statement submitted to the Food and Drug Administration. It cited "growing literature" linking use of ephedra -- a powerful natural stimulant -- to a variety of serious side effects, including hypertension, irregular heartbeat, seizure, heart attack, stroke and death.
"The potential health hazards associated with ephedrine are too serious to permit them to be sold on the open market," the statement said. The association "urges the FDA to strongly consider removing dietary supplements that contain ephedra from the open market."
Responding to what he called the association's "disappointing" action, Wes Siegner, counsel to the dietary supplements industry's Ephedra Education Council, said the allegations of ephedra's harmful effects had not been proven scientifically: "Any call for the removal of ephedra products from the market would be irresponsible."
The Heart Association, a nonprofit organization of 4 million volunteers and health professionals, is the latest in a growing chorus of critics of ephedra following the death from heat stroke of Baltimore Orioles baseball pitcher Steve Bechler after a spring training workout. Bechler had an ephedra supplement in his locker.
Association President Robert O. Bonow, chief of cardiology for Northwestern University Hospital, said the organization has long opposed open sales of herbal ephedra and had submitted its statement as a "comment" in response to a new FDA initiative to seek regulation of the supplement.
"We had a prior statement five years ago and said pretty much the same thing we're saying now," he said in an interview. "We had a chance to review everything to see if we wanted to change it, but I think the evidence is stronger today."
Ephedra, an ancient Chinese herbal remedy known as ma huang, is sold in thousands of dietary supplements as a diet pill or workout enhancer. It has been linked in studies by the FDA and other organizations to hundreds of adverse events.
Under the Dietary Supplement Health and Education Act of 1994, ephedra and other herbal supplements, unlike drugs, are not subject to pre-market testing, nor are manufacturers obligated to report the incidence of harmful side effects.
A previous FDA effort to regulate ephedra foundered in 1997, but recent research, coupled with Bechler's death, prompted Health and Human Services Secretary Tommy G. Thompson to reopen debate on regulating ephedra dosage and perhaps banning the supplement.