USA bans ephedra today; just FYI

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U.S. to Ban Dietary Supplement Ephedra

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Dec 30, 10:43 AM (ET)

By JOHN SOLOMON

(AP) Health and Human Services Secretary Tommy meets reporters in

Washington on Feb. 28 to...

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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 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.

Critics called the federal crackdown too late. Sales nationwide already have

plummeted because of publicity about roughly 155 deaths blamed on the

amphetamine-like stimulant, including Baltimore Orioles baseball player Steve

Bechler

earlier this year. Ephedra is linked to heart attacks and strokes, even when

used by outwardly healthy people at recommended doses, because it speeds heart

rate and constricts blood vessels.

Three states - New York, Illinois and California - have passed their own

ephedra bans; use has been banned in professional football, college athletics

and

minor-league baseball, and several retail chains, including supplement giant

General Nutrition Centers, recently quit selling it, too.

" It's a dead product and unfortunately it has become a dead product over the

backs of a lot of dead people when the FDA could have acted before, " said Dr.

Sidney Wolfe of the consumer advocacy group Public Citizen, which petitioned

the government for a ban in 2001.

Wolfe urged remaining manufacturers to recall all ephedra-containing products

still on store shelves. For any future ephedra-linked injuries, " there's

going to be hell to pay in terms of increased liability on the part of the

companies that are allowing it to be sold, " he said.

The supplement industry's Council for Responsible Nutrition said it didn't

oppose a ban, noting that very few companies still make the stimulant - its

members who once did no longer do so.

" We think the reputable players have found so much controversy and difficulty

in this marketplace that they've decided to get out of it, " said CRN's

Hathcock. " We recognize the controversy is a cloud over our whole industry. "

Remaining ephedra manufacturers didn't immediately comment Tuesday, but have

insisted that studies prove their products 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, " Metabolife International

chief executive Schreck said over the summer. " 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 government ban, one of the first involving a dietary supplement, comes

after this summer urged Congress to rewrite a law that rolled back

dietary-supplement regulations and to require manufacturers to acknowledge

potential side effects.

Because ephedra is an herb, U.S. law let it sell over-the-counter with little

oversight unless the FDA could prove a clear danger to public health.

Manufacturers blocked a 1997 FDA attempt to restrict sales of certain dosages

and to

put warning labels on the herb by arguing the agency lacked enough proof of

danger.

In March, FDA again proposed those warnings and said it would re-examine a

ban.