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Ephedra Ban Puts Market On Notice

Health and Human Services Secretary Tommy Thompson, meets with reporters during a news conference at the Health and Human Services Department in WashingtonTuesday, Dec. 30, 2003 to announced a ban on the sale of ephedra, an herbal supplement used for weight control that has been linked to a number of deaths and harmful side effects.
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The pending ban on the herb ephedra sends a signal to a large and loosely regulated industry that the government is willing to crack down on risky dietary supplements.

But unless current law is changed, such bans may not occur very often.

Federal law makes it very difficult for health officials to curb sales of dietary supplements that seem dangerous, far harder than it is to curb risky drugs, says Health and Human Services Secretary Tommy Thompson, who wants Congress to change that.

"We have a tremendous burden of proof in order to take supplements off of the market," Thompson said Tuesday in announcing the ban on a supplement that has been linked to 155 deaths and dozens of heart attacks and strokes. But he stressed that "we crossed the t's and dotted the i's" so that the ephedra ban should stand up in court if challenged.

The ban, which could take effect by March, comes eight years after the Food and Drug Administration first began receiving reports that the herb used for weight loss and bodybuilding could be dangerous.

While federal paperwork requirements will leave the amphetamine-like stimulant on the market for a few more months, Thompson and the FDA urged consumers to stop taking ephedra-containing supplements immediately.

"Ephedra raises your blood pressure and stresses your system," leading to heart attacks, strokes and death, FDA Commissioner Mark McClellan said. "There are far better, safer ways to get in shape."

Even seemingly healthy people who use the recommended doses are at risk, although ephedra is particularly dangerous for anyone with heart disease or high blood pressure or who engages in strenuous exercise, he said.

While the ban isn't immediate, the FDA on Tuesday informed 62 companies that make or sell ephedra that "we intend to shut you down," McClellan said. "Any responsible manufacturer and retailer should stop selling these products as soon as possible."

Ephedra makers insisted their products were safe when used correctly, but didn't say whether they would sue to block the ban.

"Millions of consumers throughout the United States have used ephedra dietary supplements as a safe, inexpensive and effective means by which to support weight loss," San Diego-based Metabolife International, a major ephedra marketer, said.

"Cold medicine kills more people a year than ephedra does," asserted Robert MacKenzie, owner of MaxOutBody.com, an Internet supplement seller that has sold $300,000 worth of ephedra since July. MacKenzie said he was looking for ephedra-free alternatives to sell once the ban begins.

Ephedra, also called ma huang, has divided the supplement industry, and an industry trade association, the Washington-based Council for Responsible Nutrition, said it had no plans to oppose the ephedra ban.

The final regulation outlining the ban will be released formally in a few weeks, and take effect 60 days later.

Critics called the ban long overdue.

Ephedra sales already have plummeted because of publicity about the herb's dangers, which peaked after the ephedra-related death of Baltimore Orioles pitcher Steve Bechler in February. The Nutrition Business Journal estimates $500 million worth of ephedra was sold this year, down from $1.3 billion in 2002.

Overall, the dietary supplement industry is a $19 billion-a-year business with more than 1,000 companies producing products ranging from mainstream vitamins to herbs to controversial hormones and stimulants

This is the first time the FDA has gone through the difficult steps required to ban a dietary supplement. A law sought by the industry and passed in the 1994 left dietary supplements largely unregulated. The law requires the FDA to prove a supplement harmful rather than requiring a manufacturer to prove the product is safe, which is the standard for prescription drugs.

The FDA first proposed warning labels and a dosage curb for ephedra in 1997, but the powerful supplement industry blocked the move.

But the mood in Congress toward ephedra changed noticeably after the widely publicized Feb. 17 death of Bechler, 23, who collapsed with heatstroke at the Orioles' spring training camp in Florida. Two weeks later, when the FDA ordered that warning labels be placed on products containing the herb, the action was supported by some lawmakers who had voted for the 1994 law, including Sen. Orin Hatch, R-Utah, one of the authors of the law.

Meantime, the death this fall of a semiprofessional football player has been blamed on ephedra. Christopher Mills, 26, of Binghamton, N.Y., who collapsed and died at a September football game in Towanda, Pa., had a "toxic level" of ephedra in his system, according to the Bradford County Coroner's Office.

Three states — New York, Illinois and California — have passed their own bans. Most retail chains have quit selling ephedra-containing products, and only a handful of major ephedra producers still are in business to supply Internet sellers. Even market leader Metabolife suspended ephedra sales last month, citing ambiguities in state laws.

"It's a dead product, and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before," said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.

Others welcomed the FDA crackdown.

"It won't bring Steve back, but it will help and protect other people," said Pat Bechler, the baseball player's mother. Her husband Ernie recently urged Congress to pass a ban, saying, "Please don't let my son die in vain."

CBS Legal Analyst Andrew Cohen says it might be believed the ban would surely help potential plaintiffs make the case that the product is unsafe however it happens to be used, which is why you would think the ban would push companies who manufacture Ephedra to stop making it and distributing it.

Ultimately, it is going to be the science that drives these lawsuits and not necessarily when the government decided to ban Ephedra. Either judges and juries are going to believe that the product was dangerous, even when used as directed, or not. And that judgment will dictate the legal story here.