FDA to ban use of ephedra

Diet supplement linked to 155 deaths, including that of Orioles pitcher

Time to stop taking it `is now'

Some marketers decry action, saying warning labels are the solution

December 31, 2003|By Julie Bell and Bill Atkinson | Julie Bell and Bill Atkinson,SUN STAFF

The Food and Drug Administration is moving to ban the weight-loss supplement ephedra, saying a comprehensive review has shown it's too dangerous to remain on the market.

The action, announced yesterday, came 10 months after the ephedra-related death of Baltimore Orioles pitcher Steve Bechler and six years after the FDA first proposed regulating the natural stimulant, which constricts the blood vessels, speeds up the heart and can raise body temperature.

It will mark the first time the agency has banned a dietary supplement under authority given to it in a decade-old law.

Mike Flanagan, the Orioles' vice president of baseball operations, was among those who welcomed the move, although Public Citizen's Health Research Group criticized it as too late for 155 ephedra users who have died over the years.

But some supplement marketers decried the ban, arguing that the products have been linked with health problems largely when they're improperly used - a problem that can be addressed through warning labels.

"You can get too much of anything, including water. It's called drowning," said Raymond Hinish, a pharmacist and co-owner of Your Prescription for Health Holistic Pharmacy in Owings Mills.

Hinish said he doesn't sell ephedra products because he doesn't think they have been proven effective. But he and others are still worried that this is a precedent for FDA regulation of other supplements.

"My concern is, it is not going to stop at ephedra," added Jeff McCarrell, president and co-owner of Nutrex Research Inc., a firm based in Winter Park, Fla., that sells muscle-building and performance-enhancing products. "What's next?'

FDA Commissioner Mark McClellan said the agency is prepared to defend its action in court, it necessary. If that doesn't work, he told a news conference, the law might have to be revised to give the FDA the authority it needs.

"The time to stop taking the supplement is now," added Tommy G. Thompson, the secretary of Health and Human Services. Noting that many people resolve to lose weight at the start of a new year, he said, "I want people to eat properly and to exercise ... but I do not want them turning to ephedra products like this."

The ban will take effect 60 days after the FDA's new rule is published, which will be in the next several weeks, officials said. The agency sent letters announcing the ban yesterday to 62 companies that make the supplements. It also advised Americans to stop buying and using ephedra immediately.

Known alternatively as Ma huang, ephedra is derived from the ephedra sinica plant. Its active ingredient is ephedrine, which the FDA regulates as a drug when it is synthetically made.

The drug ephedrine was once commonly prescribed for asthma but has been largely supplanted by new medicines perceived to be safer. Americans, however, continue to buy ephedra supplements, responding to marketing claims that they aid in weight loss, enhance athletic performance and increase energy.

The Orioles' Bechler was among them. At 23, he collapsed on a practice field Feb. 16 and died of heat stroke the next morning. The Broward County, Fla., medical examiner's autopsy pointed to Bechler's use of Xenadrine RFA-1, an over-the-counter supplement that contains ephedra, as one of the causes of his death.

Bechler's widow, Kiley Bechler, referred questions yesterday about the FDA's action to her attorney, David Meiselman, who said he was pleased the supplement would be banned. In July, Kiley Bechler sued Cytodyne Industries, the maker of Xenadrine RFA-1. The company filed for Chapter 11 bankruptcy protection in October and changed its name to Nutraquest.

The Orioles' Flanagan also expressed approval. "We've worked hard on banning the sale of ephedra products, and I think this is a great step in the right direction, so we couldn't be more pleased the way this is playing out," he said.

Unlike chemically synthesized drugs, natural supplements aren't required to pass muster with the FDA before they are put on the market. To restrict a supplement, the government must prove that it presents "an unreasonable risk of illness or injury."

Consumer advocates and some physicians have long criticized the result of that policy: a situation in which ephedra is considered a drug if it is chemically synthesized but is largely unregulated if it is derived naturally.

"I'm not a lawyer: I only know in the world of medicine, I have no comprehension why one is considered different than the other, when they are in fact the same," said Dr. William Goldiner, the Orioles' team internist. "I am absolutely delighted that they've finally seen the light."

Illinois, New York and California have banned ephedra supplements, and the FDA has been concerned about them for years. The number of reported ephedra-related health problems now stands at more than 16,000, the agency said.

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