FDA Poised to Ban Ephedra
By JOHN SOLOMON, AP
NEW YORK (Dec. 30) -- 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.
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Health and Human Services Secretary Tommy Thompson and Food and Drug Administration chief Mark McClellan were to announce the ban at a midday news conference, the officials said, speaking only on condition of anonymity.
The ban is likely to be met with litigation from manufacturers who dispute the agency's assertion that ephedra, which was blamed in the death of a professional baseball player earlier this year, is a health risk.
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.
Ephedra has been linked to as many as 100 deaths, officials have said. And Congress gathered testimony from families of people who are believed to have died from its side effects. Among those who testified were the parents of Baltimore Orioles pitcher Steve Bechler, who died during spring training last February while trying to lose weight. Toxicology tests showed ephedra in his system.
Executives of several companies that make ephedra-based products have said that studies have proven that they are 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,'' said Russell Schreck, chief executive officer of San Diego-based nutritional supplement-maker Metabolife International. ''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, Congress' investigative arm, looked into the issue and found many people who reported problems had followed the label's instructions.
The FDA had proposed warning labels and dosage limits for dietary supplements with ephedra back in 1997, but then withdrew the proposal after complaints from the industry and members of Congress.
In 2001, the National Football League banned its players from using ephedra as a dietary supplement.
12-30-03 0958EST
Copyright 2003 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL.
By JOHN SOLOMON, AP
NEW YORK (Dec. 30) -- 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.
Talk About It
Chat | Post Messages
Health and Human Services Secretary Tommy Thompson and Food and Drug Administration chief Mark McClellan were to announce the ban at a midday news conference, the officials said, speaking only on condition of anonymity.
The ban is likely to be met with litigation from manufacturers who dispute the agency's assertion that ephedra, which was blamed in the death of a professional baseball player earlier this year, is a health risk.
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.
Ephedra has been linked to as many as 100 deaths, officials have said. And Congress gathered testimony from families of people who are believed to have died from its side effects. Among those who testified were the parents of Baltimore Orioles pitcher Steve Bechler, who died during spring training last February while trying to lose weight. Toxicology tests showed ephedra in his system.
Executives of several companies that make ephedra-based products have said that studies have proven that they are 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,'' said Russell Schreck, chief executive officer of San Diego-based nutritional supplement-maker Metabolife International. ''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, Congress' investigative arm, looked into the issue and found many people who reported problems had followed the label's instructions.
The FDA had proposed warning labels and dosage limits for dietary supplements with ephedra back in 1997, but then withdrew the proposal after complaints from the industry and members of Congress.
In 2001, the National Football League banned its players from using ephedra as a dietary supplement.
12-30-03 0958EST
Copyright 2003 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL.
