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FDA Considers Banning Ephedra

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Breaking news that may be of interest to some ...

 

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Chris (list mom)

 

 

http://www.alittleolfactory.com

 

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http://start.earthlink.net/newsarticle?cat=0

<http://start.earthlink.net/newsarticle?cat=0 & aid=724120631_breakingnews

_story> & aid=724120631_breakingnews_story

 

July 24, 2003 02:20 PM EDT

 

WASHINGTON - The government is considering banning ephedra, an herbal

stimulant used in dietary supplements that has been linked to scores of

deaths and myriad health problems, the head of the Food and Drug

Administration said Thursday.

 

Commissioner Mark McClellan's testimony before House subcommittees

marked a departure for his agency, which had said it had been prevented

from banning such products by a 1994 law that left dietary supplements

largely unregulated.

 

" A ban on ephedra use is in the range of options we are considering, " he

told the lawmakers.

 

McClellan said the agency needs to make sure the evidence it is

reviewing, such as studies on the herb and health complaints submitted

to companies that use it in their products, could support a ban under

the law. The 1994 statute requires the FDA to prove that a dietary

supplement is harmful rather than having the manufacturer prove that it

is safe, as with drugs.

 

Ephedra, which can be used to lose weight and boost athletic

performance, has been linked to as many as 100 deaths. Health problems

can include strokes, heart attacks and seizures.

 

On Wednesday, Health and Human Services Secretary Tommy Thompson said

makers of dietary supplements should have to tell the FDA about

potential side effects, just as drug-makers do. He urged Congress to

revise the 1994 law.

 

During two days of hearings, the House panel heard from scientists,

health officials, the parents of two people who died after taking

ephedra and representatives of pro sports leagues and players, as well

as officials from companies that make products with ephedra.

 

The head of the major league baseball players' union told lawmakers

Thursday that the sport should not ban dietary supplements containing

ephedra unless the government does.

 

" The position of the players' association has long been that players

should not be prohibited from using any substances that the United

States government has effectively determined are not unsafe for

consumption by other American consumers, " said Eugene Orza, associate

general counsel of the Major League Baseball Players Association.

 

The issue is particularly relevant to baseball because of the death in

February of Baltimore Orioles pitcher Steve Bechler, who was taking a

supplement with ephedra. Following the death, Baseball Commissioner Bud

Selig banned players with minor league contracts from taking ephedra but

did not prohibit major leaguers from using the stimulant.

 

Robert Manfred Jr., an executive vice president of major league

baseball, explained Selig's decision, saying the players' union would

not agree to ban any substance that could be purchased over the counter.

 

 

Other sports leagues do ban ephedra and test players to make sure they

are not using the product. They include the National Football League and

Major League Soccer, both of which sent representatives to Thursday's

hearing before the House panel.

 

Orza said that a ban on ephedra would violate players' privacy rights,

since they would be subject to random drug testing.

 

But several lawmakers criticized the union's stance.

 

" It's going to take a long time to legislate this. It always does, " said

Rep. Cliff Stearns, R-Fla., chairman of the commerce subcommittee. " You

in the private sector have the opportunity to act much, much more

quickly than that. I don't know why you're not rushing to get rid of

it. "

 

Manufacturers of ephedra insisted their products were safe.

 

" Ephedra supplements have been used by tens of millions of people in

recent years, " said Robert Chinery Jr., president of Nutraquest Inc.,

formerly Cytodyne Technologies Inc.

 

At Wednesday's hearing, three past or present Metabolife International

officials took the Fifth Amendment and declined to testify. The San

Diego-based company makes supplements that include ephedra.

 

The Justice Department is investigating whether the company lied about

ephedra's safety. The president of the company in 1998 told the FDA that

the firm had never received any consumer complaints of serious side

effects, but later turned over more than 14,000 records of calls from

ephedra consumers with concerns about health-related issues.

 

http://start.earthlink.net/newsarticle?cat=0

<http://start.earthlink.net/newsarticle?cat=0 & aid=724120631_breakingnews

_story> & aid=724120631_breakingnews_story

 

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On the Net:

 

House Energy and Commerce Committee: http://energycommerce.house.gov

 

Ephedra Education Council: http://www.ephedrafacts.com

 

 

 

 

 

 

 

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