FDA to Ban Ephedra

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.