FDA bans ephedra, urges consumers to quit using herb now

? The Bush administration is banning the sale of ephedra early next year and urged consumers Tuesday to immediately stop using the herbal stimulant that has been linked to 155 deaths and dozens of heart attacks and strokes.

It was the government’s first-ever ban on a dietary supplement, one that comes eight years after the Food and Drug Administration first began receiving reports that ephedra could be dangerous.

“The time to stop taking these products is now,” Health and Human Services Secretary Tommy Thompson said. “They are simply too risky to be used.”

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 use 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.

The ban isn’t immediate because federal rules require certain paperwork steps that mean the earliest it could take effect would be March. But the FDA wrote 62 current and former manufacturers on Tuesday that, “we intend to shut you down,” Commissioner Mark McClellan said.

“There are companies out there who’ve profited by misleading Americans about the benefits of ephedra, even as they put Americans’ health at risk,” McClellan said. “Any responsible manufacturer and retailer should stop selling these products as soon as possible.”

Thompson said he was announcing the ban now so that people making New Year’s resolutions to lose weight wouldn’t be tempted to try ephedra.

Sales already have plummeted because of publicity about the herb’s dangers, which peaked after the ephedra-related death of Baltimore Orioles pitcher Steve Bechler last February. The Nutrition Business Journal estimates $500 million worth of ephedra was sold this year, down from $1.3 billion in 2002.

Three states — New York, Illinois and California — have passed their own bans. Most retail chains have quit selling ephedra-containing products, and only a handful of major ephedra producers still are in business to supply Internet sellers. Even market leader Metabolife International suspended ephedra sales last month.

“It’s a dead product, and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before,” said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.

Wolfe petitioned the government for a ban in 2001, when the agency had reports of 81 deaths. That number now is 155; also, FDA has reports of more than 16,000 health complaints from ephedra users.