Updated 11:55 AM ET December 30, 2003
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Tuesday it will ban the weight-loss aid ephedra, saying it is unsafe and can cause heart attacks and stroke.
It is the first time the FDA has banned a supplement but the agency said studies had clearly shown ephedra can kill. The ban will become effective 60 days after the new rule is published but the FDA gave no immediate date for publication.
"Consumers should stop buying and using ephedra products right away and FDA will make sure consumers are protected by removing these products from the market as soon as the rule becomes effective," FDA Commissioner Dr. Mark McClellan said in a statement.
Manufacturers of the supplement insist their product is safe when taken as directed. But FDA and Health and Human Services Department officials have been saying for months that they would like to ban ephedra and were building their case so there could be little dissent.
Some high-profile deaths have been linked with ephedra, which is also known as ma huang. Baltimore Orioles pitching prospect Steve Bechler died of heatstroke in Florida in February and the coroner said his use of an ephedra supplement contributed to his death.
The FDA has reports of 155 deaths of people who took ephedra and more than 16,500 complaints.
Last year researchers in San Francisco found that ephedra is responsible for 64 percent of all adverse reactions reported from herb use, although ephedra products account for less than 1 percent of such supplements sold.
In January, the Mayo Clinic Proceedings published a study that reviewed reports of so-called adverse reactions linked to ephedra. Even at recommended doses, it found 11 sudden deaths, 16 strokes and 10 heart attacks in patients who took products containing ephedrine.
Some retailers like NBTY Inc., CVS Corp. and General Nutrition Centers have halted sales of ephedra-based diet products this year.
Earlier this year Metabolife, a privately held company based in San Diego that was a leading maker of supplements containing ephedra, said it was removing ephedra from its most popular diet pill.
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Tuesday it will ban the weight-loss aid ephedra, saying it is unsafe and can cause heart attacks and stroke.
It is the first time the FDA has banned a supplement but the agency said studies had clearly shown ephedra can kill. The ban will become effective 60 days after the new rule is published but the FDA gave no immediate date for publication.
"Consumers should stop buying and using ephedra products right away and FDA will make sure consumers are protected by removing these products from the market as soon as the rule becomes effective," FDA Commissioner Dr. Mark McClellan said in a statement.
Manufacturers of the supplement insist their product is safe when taken as directed. But FDA and Health and Human Services Department officials have been saying for months that they would like to ban ephedra and were building their case so there could be little dissent.
Some high-profile deaths have been linked with ephedra, which is also known as ma huang. Baltimore Orioles pitching prospect Steve Bechler died of heatstroke in Florida in February and the coroner said his use of an ephedra supplement contributed to his death.
The FDA has reports of 155 deaths of people who took ephedra and more than 16,500 complaints.
Last year researchers in San Francisco found that ephedra is responsible for 64 percent of all adverse reactions reported from herb use, although ephedra products account for less than 1 percent of such supplements sold.
In January, the Mayo Clinic Proceedings published a study that reviewed reports of so-called adverse reactions linked to ephedra. Even at recommended doses, it found 11 sudden deaths, 16 strokes and 10 heart attacks in patients who took products containing ephedrine.
Some retailers like NBTY Inc., CVS Corp. and General Nutrition Centers have halted sales of ephedra-based diet products this year.
Earlier this year Metabolife, a privately held company based in San Diego that was a leading maker of supplements containing ephedra, said it was removing ephedra from its most popular diet pill.