JH
04-13-2004, 12:27 PM
By Lisa Richwine
WASHINGTON (Reuters) - A U.S. ban on the sale of the herbal supplement ephedra took effect on Monday as a federal judge turned down a manufacturer's bid to keep the controversial weight-loss pill on the market.
The nationwide ban is the first for a dietary supplement.
The U.S. government links ephedra to deaths, heart attacks and strokes. Manufacturers say the product is safe when used as directed.
"These products pose unacceptable health risks, and any consumers who are still using them should stop immediately," Health and Human Services Secretary Tommy Thompson said in a statement.
The Food and Drug Administration said it will enforce the ephedra ban while a federal judge in New Jersey considers a request from ephedra seller NVE Inc. to bar the government from outlawing the supplement.
U.S. District Judge Joel Pisano rejected on Monday a bid from NVE to allow ephedra sales to continue at least temporarily.
NVE, a privately held New Jersey-based company, had argued the government failed to prove ephedra posed an "unreasonable risk," as a 1994 supplements law requires.
NVE makes an ephedra product called Stacker 2. The company also sells a version without ephedra. Officials at the company could not immediately be reached for comment.
Another company, the National Institute for Clinical Weight Loss Inc., joined NVE's complaint on Monday.
REPORTS OF DEATHS
Unlike prescription drugs, supplements do not have to be proven safe before they can be sold. The government must show a supplement is too risky to force it off the market.
Health officials describe ephedra as a dangerous stimulant that raises blood pressure and stresses the circulatory system. As of last Thursday, the FDA had received 164 reports of deaths of ephedra users, an agency spokeswoman said.
Ephedra was promoted for shedding pounds, boosting energy and enhancing athletic performance.
Sales fell after risks were publicized and major retailers stopped selling it. The controversy intensified after the February 2003 death of Baltimore Orioles pitching prospect Steve Bechler. A Florida medical examiner said Bechler's use of an ephedra supplement contributed to his death.
Ephedra sales were about $500 million in 2003, a 60 percent drop from $1.25 billion in 2002, according to the Nutrition Business Journal, a trade publication.
FDA officials said they were stepping up surveillance of Internet sites selling ephedra. Violators of the ban could face product seizures or other actions, said Dr. Jeffrey Shuren, the FDA's assistant commissioner for policy.
Sources Reuters & Y!
WASHINGTON (Reuters) - A U.S. ban on the sale of the herbal supplement ephedra took effect on Monday as a federal judge turned down a manufacturer's bid to keep the controversial weight-loss pill on the market.
The nationwide ban is the first for a dietary supplement.
The U.S. government links ephedra to deaths, heart attacks and strokes. Manufacturers say the product is safe when used as directed.
"These products pose unacceptable health risks, and any consumers who are still using them should stop immediately," Health and Human Services Secretary Tommy Thompson said in a statement.
The Food and Drug Administration said it will enforce the ephedra ban while a federal judge in New Jersey considers a request from ephedra seller NVE Inc. to bar the government from outlawing the supplement.
U.S. District Judge Joel Pisano rejected on Monday a bid from NVE to allow ephedra sales to continue at least temporarily.
NVE, a privately held New Jersey-based company, had argued the government failed to prove ephedra posed an "unreasonable risk," as a 1994 supplements law requires.
NVE makes an ephedra product called Stacker 2. The company also sells a version without ephedra. Officials at the company could not immediately be reached for comment.
Another company, the National Institute for Clinical Weight Loss Inc., joined NVE's complaint on Monday.
REPORTS OF DEATHS
Unlike prescription drugs, supplements do not have to be proven safe before they can be sold. The government must show a supplement is too risky to force it off the market.
Health officials describe ephedra as a dangerous stimulant that raises blood pressure and stresses the circulatory system. As of last Thursday, the FDA had received 164 reports of deaths of ephedra users, an agency spokeswoman said.
Ephedra was promoted for shedding pounds, boosting energy and enhancing athletic performance.
Sales fell after risks were publicized and major retailers stopped selling it. The controversy intensified after the February 2003 death of Baltimore Orioles pitching prospect Steve Bechler. A Florida medical examiner said Bechler's use of an ephedra supplement contributed to his death.
Ephedra sales were about $500 million in 2003, a 60 percent drop from $1.25 billion in 2002, according to the Nutrition Business Journal, a trade publication.
FDA officials said they were stepping up surveillance of Internet sites selling ephedra. Violators of the ban could face product seizures or other actions, said Dr. Jeffrey Shuren, the FDA's assistant commissioner for policy.
Sources Reuters & Y!