U.S. to Ban Dietary Supplement Ephedra
U.S. to Ban Dietary Supplement Ephedra
Dec 30, 10:20 AM (ET)
By JOHN SOLOMON
WASHINGTON (AP) - 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 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.
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