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U.S. Bans Ephedra

Says diet supplement poses 'unreasonable risk'

TUESDAY, Dec. 30, 2003 (HealthDayNews) -- The federal government announced Tuesday a much-anticipated ban on sales of ephedra, the herbal weight-loss supplement that has been linked to at least 155 deaths.

"We are about to ban dietary supplements containing ephedra," Health and Human Services Secretary Tommy G. Thompson told a press conference in Washington, D.C.

Citing "unreasonable risk," Food and Drug Administration Commissioner Dr. Mark McClellan said at the same press conference that "consumers should stop buying and using ephedra products right away."

Thompson announced a "consumer alert" on the safety of products containing ephedra and said the agency had notified manufacturers of its intent to publish a final rule banning the sale of supplements containing the compound. The ban comes after the government reviewed more than 16,000 reports of adverse events, Thompson said.

The FDA "will publish a final rule as soon as possible that will formalize its conclusions that dietary supplements containing ephedrine alkaloids present unreasonable risks to those who take them for any reason," Thompson said in a prepared statement. "Today's action puts companies on notice of our intentions, and it tells consumers that the time to stop using ephedra products is now."

The FDA said it has sent 62 letters to firms marketing dietary supplements containing ephedra and ephedrine alkaloids to alert them of the ban.

Ephedrine, the active ingredient, increases metabolic rate, heat production, and the risk of heatstroke. A group of San Francisco researchers recently claimed that ephedra is the most dangerous herbal product on the market, based on data collected from poison control centers. Because ephedra is an herb, it is not subject to regulations governing pharmaceutical drugs and can be sold over the counter.

More than 155 deaths have been linked to ephedra, according to Public Citizen's Health Research Group in Washington, D.C., including this year's death of 23-year-old Baltimore Orioles pitcher Steve Bechler. Bechler's death resulted in a slew of negative publicity that, in turn, contributed to declining sales of ephedra products. New York, Illinois, and California have already banned ephedra-containing products, as have various sports associations.

Critics called the government's latest move too little, too late.

"We filed a petition more than two years ago. At the time, the FDA had reports of 81 deaths using ephedra," Dr. Sidney Wolfe, the director of Public Citizen's Health Research, said. "The scientific evidence and legal authority to ban it was clearly there, but the FDA has hunkered behind industry and let the product almost go out of existence before banning it."

"The last manufacturer just took it out," Wolfe added. "The reason is because it is so dangerous and has killed or injured so many people that companies are uninsurable from a product liability standpoint."

Wolfe was referring to Metabolife International Inc., which, according to Public Citizen, was the last major manufacturer of ephedra products to announce it would no longer sell the products.

In a statement, Metabolife said it "respectfully disagrees" with the FDA's decision. "Metabolife strongly believes in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed. Millions of consumers throughout the United States have used ephedra dietary supplements as a safe, inexpensive, and effective means by which to support weight loss."

The company said it would review its legal options once the ban takes effect. According to Metabolife, the FDA "lacks data and information that would enable it to meet the burden of proving that ephedra products -- when taken in accordance with their label directions for use -- present a significant or unreasonable risk of illness or injury."

Wolfe said he expected "some token and symbolic resistance to the ban."

"It's inexcusable," he added. "The blood of the people who died since the FDA could have, and should have, banned ephedra is on the hands of Commissioner Mark McClellan."

Other groups joined in the criticism.

"Why has it taken so long for the FDA to do the right thing?" Diana Zuckerman, president of the National Center for Policy Research for Women and Families, said in a prepared statement. "The law is currently weak because Metabolife and other makers of dietary supplements have more political clout than the teenagers and adults that have been harmed by ephedra."

She added, "That political clout has interfered with the FDA's ability to do its job to protect consumers. It's great that Secretary Thompson has reversed this trend by announcing the ban on ephedra. I only wish it was immediate."

Industry executives reacted cautiously.

"We recognize the controversy created a lot of uncertainty about our industry and urged the FDA in writing that they take decisive action," said John Hathcock, vice president for nutritional and regulatory science at the Council for Responsible Nutrition, a trade group based in Washington, D.C.

Hathcock hedged, however, when asked if he supported a ban.

"We believe that decisive action has to be based on good science, properly interpreted and commensurate with the law," he said. "Having said that, we hope that they will go as far as the evidence allows. They have to rationalize that they're acting in the public interest."

Hathcock added that he did not have enough information at this point to fully assess the FDA's decision.

The American Heart Association, however, applauded the move, calling it "a victory" for the health of Americans.

"It sends a clear message to consumers either using or considering the use of these products, who may be unaware of the potential risks," AHA president Dr. Augustus O. Grant said in a prepared statement. "While they may believe they are doing something good for their health, in truth they could be putting themselves at serious risk."

More information

The FDA has a consumer alert on ephedra. Here is the letter sent to companies that sell ephedra-containing products. For the industry's take, try the Ephedra Education Council, which staunchly opposes a ban.

SOURCES: Sidney Wolfe, M.D., director, Public Citizen's Health Research Group, Washington, D.C.; John Hathcock, Ph.D., vice president for nutritional and regulatory science, Council for Responsible Nutrition, Washington, D.C.; Food and Drug Administration, American Heart Association, National Center for Policy Research for Women and Families, Metabolife International Inc. press releases
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