U.S. To Ban Sale Of EphedraDec 30, 2003 | Canadian Press
"The time to stop taking this product is now," Health and Human Services Secretary Tommy Thompson said in announcing the government's first-ever ban on a dietary supplement. "They are just too risky to use." The ban was based on extensive scientific study involving more than 16,000 reports of adverse health effects from products containing ephedra, officials said. It will formally take effect 60 days after a federal rule is formally published in a few weeks.
Thompson said he was announcing the ban now so Americans emerging from the holiday season with New Year's plans to lose weight won't be tempted to use the dietary supplement. "I don't want people turning to ephedra thinking they could lose weight," he said.
Roughly 155 deaths have been blamed on the amphetamine-like stimulant, including the heat stroke of 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.
Canada issued a recall order almost two years ago for ephedra products that make claims of weight loss or increased energy.
However, the January 2002 recall allows ephedra containing products in traditional medicines provided they have no caffeine and contain less then eight milligrams of ephedrine, a chemical derivative of ephedra per dose, to a maximum of 32 milligrams a day.
Much smaller amounts are permitted in a wide range of over-the-counter products such as nasal decongestants and cough medicines.
Mark McClellan, chief of the U.S. Food and Drug Administration, said his agency is notifying consumers and 62 manufacturers that it will publish a rule making it illegal to sell and use ephedra.
But he called on both to stop the sale and use of ephedra immediately.
"By alerting the public right now we're sending a strong and clear signal that dietary supplements containing ephedrine alkaloids should come off the shelves," McLellan said.
"You all know there are companies out there who've profited by misleading Americans about the benefits of ephedra, even as they put Americans' health at risk. Any responsible manufacturer and retailer should stop selling these products as soon as possible," he said.
McClellan said the FDA reviewed major studies of ephedra and publicly issued findings about the herb. He said the publication received thousands of comments and expressions of support for taking the product off the market.
"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. U.S. sales already have plummeted because of publicity about the deaths.
Ernie Bechler, father of the baseball player who died, 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, he said.
McClellan said the FDA was prepared to defend the action in court. "We are laying the strongest possible foundation to not only take the product off the market, but to keep it off," he said.
Three states: New York, Illinois and California have passed their own ephedra bans. Its use has been banned in professional football, college athletics and minor-league baseball, and several retail chains, including supplement giant General Nutrition Centers, recently quit selling it, too.
"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, which petitioned the government for a ban in 2001.
Wolfe urged remaining manufacturers to recall all ephedra-containing products still on store shelves. For any future ephedra-linked injuries, "there's going to be hell to pay in terms of increased liability on the part of the companies that are allowing it to be sold," he said.
The supplement industry's Council for Responsible Nutrition said it didn't oppose a ban, noting that very few companies still make the stimulant, and its members who once did no longer do so.
Remaining ephedra manufacturers didn't immediately comment Tuesday, but have insisted that studies prove their products safe when used properly.
"Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products," Metabolife International chief executive Russell Schreck said over the summer. "We make it quite clear on our label that the ephedra products are not to be sold or used by minors and that customers with certain pre-existing medical conditions should 'consult a physician before product use'."