Avian Gamers Network

Dec. 30, 2003 -- Ephedra will be the first dietary supplement ever to be banned by the FDA, Secretary of Health and Human Services Tommy G. Thompson announced today.

Ephedra -- also known as ma huang -- is widely used to help with weight loss and improve athletic performance. There's some evidence it may have a small beneficial effect. But the FDA soon will rule that there's a lot more evidence ephedra is harmful.

"The time to stop using these products is now," Thompson said in a news conference. "The FDA will issue a regulation saying the use of these products is an unreasonable risk to the public. ... I am pleased we are able to take this strong action. For too long, dietary supplements containing ephedra alkaloids have been promoted by manufacturers. They are simply too risky to be used, whether for weight loss or by elite athletes seeking to improve their performance -- or by young people emulating these athletes."

Dramatic illustration of the possible extent of this risk came earlier this year when Baltimore Orioles pitcher Steve Bechler died after taking an ephedra-containing product.

The FDA admits there is no definitive proof that ephedra caused Bechler's death or any other serious injury. But lots of circumstantial evidence links the herb to death and injury. And there's no proof that it has any meaningful health benefits. In the end, said FDA Commissioner Mark B. McClellan, MD, PhD, the FDA found that the "risk/benefit calculation" for ephedra tilts decidedly toward unreasonable risk.


Consumers Alerted, Companies Warned

The FDA's official ban on ephedra won't be published for a few weeks. Even then, companies will have 60 days to comply. But the FDA today issued a consumer alert warning people to stop using ephedra-containing products.

At the same time, the FDA is sending letters to 62 companies that manufacture ephedra products. The letter warns that the FDA will begin "enforcing the rule" banning ephedra as soon as it becomes effective.

"My hope is that the responsible companies will take their products off the shelf now and not wait," McClellan said at the news conference.


Products Containing Ephedra

Here's a short list of some products that contain ephedra. Not all ephedra-containing products are on this list:

Metabolife
Ripped Fuel
Diet Fuel
Stacker 3
NaturalTRIM
Hydroxycut
Xenadrine RFA-1
Metab-O-Lite
Metabolift
Up Your Gas
Truckers Luv It
Yellow Jackets


Products that contain ephedra may list it on their label. Products with any of the following ingredients contain ephedra:

Ephedra
Ephedrine
Ma huang
Ephedra sinica
Sida cordifolia
Pinellia

The FDA is not taking action on over-the-counter cold remedies that contain ephedrine-like drugs. That's because these products are properly labeled and are for short-term use only.


A Bad Law, or a Good Law Not Enforced?

Drugmakers have to prove their product is safe and effective. They must submit all the evidence they have to the FDA, including later injury reports that might be drug related. But a 1994 law specifically exempts the makers of dietary supplements from having to do this.

Instead, it's up to the FDA to prove -- in court if necessary -- that a dietary supplement is harmful. Thompson and McClellan say they are ready to do this to ensure that the ephedra ban takes effect.

If they succeed, they say, it will create a "framework" that can be used to go after other dietary supplements deemed harmful.

The drug supplement industry is very happy with the 1994 law. It already gives the FDA the power it needs to regulate harmful herbs like ephedra, Annette Dickinson, PhD, told WebMD in a previous interview. Dickinson is president of the Council for Responsible Nutrition, a trade association of dietary supplement manufacturers and the acting industry representative on the FDA's food advisory subcommittee.

"We are glad to see the FDA taking action against unsubstantiated claims, and we are glad to see Commissioner McClellan grapple with the ephedra issue," Dickinson told WebMD. "If the FDA can deal with that, it goes a long way to show that even in the most controversial situation the law gives the FDA authority to act."

Thompson today said that he'd like to see the law amended to force manufacturers to hand over to the FDA any reports of adverse events linked to their products. But he says that the ban on ephedra is in full compliance with the law as it now exists.