FDA Set to Finalize Ephedra BanFeb 6, 2004 | AP The Bush administration is putting the final touches on its planned ban of ephedra, moving to get the herbal stimulant off stores shelves by April.
It will mark the government's first-ever ban on a dietary supplement. Ephedra has been linked to 155 deaths and dozens of heart attacks and strokes.
In December, the Food and Drug Administration warned consumers to stop using ephedra immediately, saying it was working to ban sales by early this year.
A regulation formally setting that ban in motion will be published "very soon," possibly by Friday, Associate Commissioner Peter Pitts said Thursday.
Sixty days after that publication, all sales must cease.
Ephedra once was hugely popular for weight loss and body building. But it can cause life-threatening side effects even in seemingly healthy people who take the recommended doses, because the amphetamine-like stimulant speeds heart rate and constricts blood vessels. It is particularly risky for anyone with heart disease or high blood pressure or people engaging in strenuous exercise.
Sales already have plummeted because of publicity about the herb's dangers, and three states New York, Illinois and California have passed their own bans. But after FDA's December announcement, sales spiked briefly as some ephedra believers stocked up.
Unlike pharmaceuticals, federal law allows dietary supplements to sell without first providing proof of safety. That law requires the FDA to prove harm before it can force a supplement off the market, a hurdle the agency says is very steep.
The FDA isn't waiting for the formal ban to stop sales of some products that contain ephedra.
On Thursday, the FDA seized supplements from a Massachusetts-based Internet seller, Musclemaster.com, saying the Web site illegally claimed that the products enhanced athletic performance. The products seized included more than 800 bottles of Betatrim, Thermbuterol and Stacker 2.