- The Washington Times - Tuesday, December 30, 2003

The Bush administration announced yesterday that it will outlaw the sale of ephedra, an herbal stimulant used for weight loss that has been linked to 155 deaths and harmful side effects, such as heart attacks and strokes.

“The time to stop taking this product is now,” Health and Human Services Secretary Tommy G. Thompson told reporters in announcing the ban on ephedra and on products that contain it. “They are just too risky to use.”

Dr. Mark McClellan, the head of the Food and Drug Administration, said his agency will publish the final rule, which will state that dietary supplements containing ephedrine alkaloids “present an unreasonable risk of illness or injury.”

This marks the first time that the federal government has banned a dietary supplement. Manufacturers of products containing ephedra are expected to sue, because they deny that ephedra is unsafe, provided it is used properly.

The ban will take effect two months after the new rule is published. FDA spokeswoman Laura Alvey could not provide a firm date for the rule’s publication.

“It will be in the coming weeks,” she said.

Dr. McClellan said despite the legally necessary delays, “consumers should stop buying and using ephedra products right away, and the FDA will make sure consumers are protected by removing these products from market as soon as the rule becomes effective.”

Mr. Thompson said despite the lawsuits, which he expected, the decision to ban ephedra was “based on the best possible scientific evidence.”

A General Accounting Office report found that many people who said they had problems with ephedra had followed the label’s instructions.

The government zeroed in on ephedra days after it was blamed in the death of a professional baseball player. Baltimore Orioles pitcher Steve Bechler died of heatstroke in February during spring training in Florida while trying to lose weight.

Post-mortem toxicology tests showed ephedra was in the 23-year-old pitcher’s system. Medical examiners in Broward County who performed the autopsy identified dietary supplements containing ephedra as a key factor in Mr. Bechler’s death.

His father, Ernie Bechler of Medford, Ore., yesterday told Reuters news agency that the ban is “the only thing that could make my wife and I be happy.”

Mr. Thompson and Dr. McClellan used their joint news conference yesterday to issue a consumer alert about the dangers of ephedra and to announce that they have sent letters to 62 companies that market dietary supplements containing ephedra and ephedrine alkaloids, telling them to stop selling them.

In a statement yesterday, the FDA said ephedra is “an adrenaline-like stimulant that can have potentially dangerous effects on the heart.”

The statement went on to cite “recent studies that have confirmed that ephedra use raises blood pressure and, otherwise, stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes.”

As for athletes and others who take ephedra for bodybuilding and improved performance, the FDA pointed to “many studies reviewed by the Rand Corp., which found little evidence for effectiveness, other than for short-term weight loss.”

Metabolife, a San Diego firm that makes nutritional supplements and has removed ephedra from its diet pills, said yesterday it “respectfully disagrees” with the FDA’s decision to ban ephedra.

“Millions of consumers throughout the United States have used ephedra dietary supplements as a safe, inexpensive and effective means by which to lose weight,” the company said.

Metabolife said it will “carefully consider” its legal options once the FDA publishes its rule. In the meantime, it said it will continue to sell “products that do not contain ephedra.”

The decision to ban ephedra comes as sales have plunged as a result of consumer concerns and because of decisions by retailers, such as General Nutrition Centers, CVS Corp., and NBTV Inc., to remove ephedra products from their shelves.

“GNC discontinued sales of ephedra products in June 2003, in response to consumer demand. Customers wanted ephedra-free alternatives,” said Jamie Young, spokeswoman for the chain of health-food stores.

Also in June, a California judge rendered a $12.5 million false-advertising judgment against Nutraquest, the maker of the diet pill implicated in the Bechler death. The judge also found that the firm had pressured its researchers to make their findings on the herb’s safety more favorable.

In October, Nutraquest filed for Chapter 11 bankruptcy, which stayed all the legal action against it, including a $600 million wrongful-death lawsuit filed by Mr. Bechler’s wife, Kiley.

On July 1, two major ephedra producers in Arizona and Florida agreed to repay customers $370,000 to settle deceptive-advertising charges.

The FDA long has had concerns about ephedra. In 1997, it proposed warning labels and dosage limits for dietary supplements containing the herb. But the agency withdrew the proposal after complaints from the industry and from members of Congress.

If the FDA still has safety concerns about ephedra, it should address them with “strict science-based labeling requirements,” not an outright ban, Metabolife said yesterday.

The National Football League, the International Olympic Committee and the National Collegiate Athletic Association have banned their athletes from using ephedra.

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