U.S. to Ban Dietary Supplement Ephedra
U.S. to Ban Dietary Supplement Ephedra
By JOHN SOLOMON, Associated Press Writer
WASHINGTON - The Bush administration has decided to ban the herbal weight-loss supplement ephedra from the marketplace because of concerns about its effects on health, government officials said Tuesday.
Health and Human Services (news - web sites) Secretary Tommy Thompson and Food and Drug Administration (news - web sites) chief Mark McClellan were to announce the ban at a midday news conference, the officials said, speaking only on condition of anonymity.
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.
Three states — New York, Illinois and California — have passed their own ephedra bans; 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 — its members who once did no longer do so.
"We think the reputable players have found so much controversy and difficulty in this marketplace that they've decided to get out of it," said CRN's John Hathcock. "We recognize the controversy is a cloud over our whole industry."
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'."
But several scientists said that it was impossible to prove whether ephedra was safe because studies screen out participants who have health problems — the people most likely to be hurt by the product.
The General Accounting Office (news - web sites), Congress' investigative arm, looked into the issue and found many people who reported problems had followed the label's instructions.
The government ban, one of the first involving a dietary supplement, comes after Thompson this summer urged Congress to rewrite a law that rolled back dietary-supplement regulations and to require manufacturers to acknowledge potential side effects.
Because ephedra is an herb, U.S. law let it sell over-the-counter with little oversight unless the FDA could prove a clear danger to public health. Manufacturers blocked a 1997 FDA attempt to restrict sales of certain dosages and to put warning labels on the herb by arguing the agency lacked enough proof of danger.
In March, FDA again proposed those warnings and said it would re-examine a ban.
JUST GOES TO SHOW YOU THAT THESE PESKY LITTLE ADVOCATES CAN ACCOMPLISH A LOT IF THEY STICK TO IT - NO SCIENCE EVIDENCE NEEDED - AND NOTICE EVERY COLD MEDICINE IS STILL MADE WITH EPHEDRA :rolleyes: MAKES ME WONDER WHY NO ONE HAS BOTHERED TO REALLY GET WITH LEGALIZING OR DECRIMINALIZING (TICKETS, ETC) STEROIDS.
its a hard place to be in
As far as the US gov. banning ephedra (note how horrible some people talk of this drug...i wonder what they think of steroids) it is kinda hard for me to know what they should have done. I understand that they government has responsibility to ensure safety to the citezens, however, there must be a limit to that power for it to be true democracy. There is a fine line when banning drugs that the only danger is to the individual. Im not debating one way or the other on the effects of ephedra, im just saying that if it is bad it is only bad to the individual taking it and shouldnt that be a personal choice....well the government says no. It is a very fine line
