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Well-Known Member
By William Branigin
Washington Post Staff Writer
Tuesday, December 30, 2003; 1:00 PM
The federal government today issued a warning against the manufacture, sale and consumption of dietary products containing ephedra, saying it intends to formally ban the herbal weight-loss supplement as soon as a new regulation takes effect early next year.
In a news conference, Health and Human Services Secretary Tommy G. Thompson announced a "consumer alert" against ephedra, which has been blamed for strokes and heart failures resulting in scores of deaths.
Although they are sold over the counter in stores and marketed freely on the Internet, dietary supplements containing ephedra "are simply too risky to be used, whether by people who want to lose weight or elite athletes seeking to enhance performance," Thompson said. He said it was important to get the word of the intended ban out now, before New Year's Day, to alert people who have "put on some extra weight" over the holidays and will be making resolutions to shed excess pounds in 2004.
Thompson and Mark B. McClellan, commissioner of the Food and Drug Administration, said the government plans to publish a "final rule" banning ephedra in the coming weeks. Once it officially takes effect 60 days after publication, "the rule will have the practical effect of banning dietary supplements containing any significant amount of ephedra," McClellan said.
Meanwhile, McClellan said, manufacturers and retailers "should stop selling these products as soon as possible." He served notice to them that "as soon as the rule becomes effective, we intend to shut you down."
Addressing consumers in the televised news conference, McClellan added, "There are many ways to take off pounds, but it's important to remember there are no quick fixes. If you resolve to get in better shape in 2004, ephedra is not the answer."
Anticipating legal challenges to the rule from manufacturers, McClellan said the government would do its best to defend the ban in court. But if the ban does not prevail, he said, "it may be time to reexamine" a 10-year-old law that makes it difficult for the government to regulate herbal supplements. The law requires the government to prove such products are harmful, rather than requiring manufacturers to prove they are safe, as is currently the case with drugs.
Ephedra, which is sometimes marketed to athletes as a performance enhancer and energy booster, has been blamed for more than 100 deaths, including that of a Baltimore Orioles pitching prospect who died in February of a heat stroke during spring training. The widow of the pitcher, Steve Bechler, has filed a $600 million lawsuit against the manufacturer and distributor of the ephedra-based supplement, Xenadrine RFA-1, which was found by a coroner to have been a "significant factor" in his death. The product was taken off the market following the death of Bechler, who had been urged by team officials to lose weight.
In announcing the consumer alert, Thompson said the FDA had gathered more than 16,000 "adverse incident reports" about ephedra. Accordingly, he said, the government was sending letters to 62 manufacturers to urge them to stop making and selling products containing the supplement.
McClellan said the decision to ban ephedra was not based on the adverse incident reports alone, but also on evidence about how the supplement affects the body, on clinical studies and on reviews by experts.
The FDA proposed warning labels and dosage limits for ephedra-based products in 1997, but backed off in the face of complaints from manufacturers and their supporters in Congress. Nevertheless, three states have announced their own bans on ephedra. New York did so last month following the lead of Illinois. A similar prohibition by California is scheduled to take effect in January.
Ephedra has also been banned by the NFL, the NCAA and the International Olympic Committee.
http://www.washingtonpost.com/wp-dyn/articles/A41197-2003Dec30.html
Washington Post Staff Writer
Tuesday, December 30, 2003; 1:00 PM
The federal government today issued a warning against the manufacture, sale and consumption of dietary products containing ephedra, saying it intends to formally ban the herbal weight-loss supplement as soon as a new regulation takes effect early next year.
In a news conference, Health and Human Services Secretary Tommy G. Thompson announced a "consumer alert" against ephedra, which has been blamed for strokes and heart failures resulting in scores of deaths.
Although they are sold over the counter in stores and marketed freely on the Internet, dietary supplements containing ephedra "are simply too risky to be used, whether by people who want to lose weight or elite athletes seeking to enhance performance," Thompson said. He said it was important to get the word of the intended ban out now, before New Year's Day, to alert people who have "put on some extra weight" over the holidays and will be making resolutions to shed excess pounds in 2004.
Thompson and Mark B. McClellan, commissioner of the Food and Drug Administration, said the government plans to publish a "final rule" banning ephedra in the coming weeks. Once it officially takes effect 60 days after publication, "the rule will have the practical effect of banning dietary supplements containing any significant amount of ephedra," McClellan said.
Meanwhile, McClellan said, manufacturers and retailers "should stop selling these products as soon as possible." He served notice to them that "as soon as the rule becomes effective, we intend to shut you down."
Addressing consumers in the televised news conference, McClellan added, "There are many ways to take off pounds, but it's important to remember there are no quick fixes. If you resolve to get in better shape in 2004, ephedra is not the answer."
Anticipating legal challenges to the rule from manufacturers, McClellan said the government would do its best to defend the ban in court. But if the ban does not prevail, he said, "it may be time to reexamine" a 10-year-old law that makes it difficult for the government to regulate herbal supplements. The law requires the government to prove such products are harmful, rather than requiring manufacturers to prove they are safe, as is currently the case with drugs.
Ephedra, which is sometimes marketed to athletes as a performance enhancer and energy booster, has been blamed for more than 100 deaths, including that of a Baltimore Orioles pitching prospect who died in February of a heat stroke during spring training. The widow of the pitcher, Steve Bechler, has filed a $600 million lawsuit against the manufacturer and distributor of the ephedra-based supplement, Xenadrine RFA-1, which was found by a coroner to have been a "significant factor" in his death. The product was taken off the market following the death of Bechler, who had been urged by team officials to lose weight.
In announcing the consumer alert, Thompson said the FDA had gathered more than 16,000 "adverse incident reports" about ephedra. Accordingly, he said, the government was sending letters to 62 manufacturers to urge them to stop making and selling products containing the supplement.
McClellan said the decision to ban ephedra was not based on the adverse incident reports alone, but also on evidence about how the supplement affects the body, on clinical studies and on reviews by experts.
The FDA proposed warning labels and dosage limits for ephedra-based products in 1997, but backed off in the face of complaints from manufacturers and their supporters in Congress. Nevertheless, three states have announced their own bans on ephedra. New York did so last month following the lead of Illinois. A similar prohibition by California is scheduled to take effect in January.
Ephedra has also been banned by the NFL, the NCAA and the International Olympic Committee.
http://www.washingtonpost.com/wp-dyn/articles/A41197-2003Dec30.html