WASHINGTON – The federal government announced on Tuesday a ban on the sale of ephedra, an herbal supplement used for weight control that has been linked to a number of deaths and harmful side effects.
Health and Human Services Secretary Tommy Thompson said that “based on the best possible scientific evidence” his agency would issue a consumer alert about the dangers of ephedra and will send notices to manufacturers to stop selling the herbs.
“The time to stop taking this product is now,” he said.
“They are just too risky to use,” said the secretary.
Thompson said the decision was “well grounded” and based on extensive scientific study. The ban would take effect in 60 days.
“I don’t want people turning to ephedra thinking they could lose weight,” Thompson told a news conference.
Mark McClellan, head of the Food and Drug Administration, said his agency is notifying consumers and manufacturers that it will publish a rule making it illegal to sell and use ephedra.
He said the agency was concerned about young people and athletes looking to ephedra to boost their performance. Use of the supplement has led to serious health effects, he said.
“We’re sending a strong and clear signal” that such products should come off the market, McClellan said.
McClellan said the FDA reviewed major studies of ephedra and publicly issued findings about the herb. He said the publication received thousands of comment and expressions of support for taking the product off the market.
The rule will go into effect in 60 days “and have the practical effect” of banning ephedra, he said.
“Ephedra raises your blood pressure and stresses your system,” McClellan said. “There are far better, safer ways, to get in shape.”
Critics called the federal crackdown too late. Sales nationwide already have plummeted because of publicity about roughly 155 deaths blamed on the amphetamine-like stimulant, including Baltimore Orioles baseball player Steve Bechler earlier this year. Ephedra is linked to heart attacks and strokes, even when used by outwardly healthy people at recommended doses, because it speeds heart rate and constricts blood vessels.
Ernie Bechler, Steve’s father in Medford, Ore., said he was awakened by a phone call around 6 a.m. local time with word of the decision.
“It’s the only thing that could make my wife and I be happy,” he said. “Nothing else could have done what this is doing. I mean to get this off the market and to save other peoples’ lives is just amazing to us.”
Ernie Bechler testified in Congress, urging a ban. “That’s the last thing I said: ‘Please don’t let my son die in vain.’ “
At the news conference, McClellan said FDA has spent months “scouring all of the adverse effects reports.” The decision was not based on adverse effects alone, he said, but also on clinical studies and expert opinion and review.
“It is the totality of the evidence” that was used to make the decision, McClellan said.
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