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Tuesday, December 30
Updated: December 31, 9:50 AM ET
 
Ban of supplement will take effect in 60 days

Associated Press

WASHINGTON -- The Bush administration is banning the sale of ephedra early next year and urged consumers Tuesday to immediately stop using the herbal stimulant linked to the death of Baltimore Orioles pitcher Steve Bechler.

Major events related to ephedra
1994: Law passed allowing dietary supplements to be sold over-the-counter with little oversight unless the FDA could prove a clear danger to public health.

1997: Manufacturers blocked an attempt by the FDA to restrict sales of certain dosages of ephedra and to put warning labels on the herb by arguing the agency lacked enough proof of danger.

Sept. 2001: The National Football League became the first major U.S. professional sports league to ban the stimulant. The drug is also banned by the NCAA and the International Olympic Committee. The Major League Baseball Players Association later banned ephedra for players with minor league contracts.

August 2002: The Justice Department began conducting a criminal investigation into whether Metabolife International lied about the safety of ephedra.

Feb. 17, 2003: Steve Bechler, a 23-year-old pitcher for the Baltimore Orioles, died of heat stroke one day after collapsing during spring training in Fort Lauderdale, Fla. The medical examiner said ephedra contributed to Bechler's heatstroke.

Feb. 28: The FDA ordered labels to be put on products with ephedra warning of the possibility of heart attacks, strokes or death. The agency said it would re-examine a ban.

May 2: Nutritional supplement retailer General Nutrition Centers announced it would stop selling products containing the weight-loss supplement.

May 26: Illinois became the first state to ban ephedra. California followed in October, along with New York in November.

June: The federal government began building a case that could lead to the supplement's ban.

July 1: The Federal Trade Commission announced two companies that promoted ephedra dietary supplements to repay customers $370,000 to resolve federal charges of deceptive advertising.

July 17: The widow of Baltimore Orioles pitcher Steve Bechler sued the manufacturer and the distributor of a dietary supplement containing ephedra for $600 million. The lawsuit also sought a ban on the sale of ephedra-based products.

July: FDA Commissioner Mark McClellan told House members the agency is considering a ban on the drug. Health and Human Services Secretary Tommy Thompson urged Congress to rewrite a law that rolled back dietary-supplement regulations and to require manufacturers to tell the FDA about potential side effects.

Dec. 30: The Bush administration announced it would ban the herbal weight-loss supplement ephedra from the marketplace because of concerns about its effects on health. The ban would take effect in 60 days.

Ephedra has been blamed for 155 deaths and dozens of heart attacks and strokes, and the NFL, NCAA and International Olympic Committee banned its use. Major league Baseball did not.

The government's first ban on a dietary supplement comes eight years after the Food and Drug Administration began receiving reports that ephedra could be dangerous.

"The time to stop taking these products is now," Health and Human Services Secretary Tommy Thompson said. "They are simply too risky to be used."

Ephedra once was hugely popular for weight loss and body building. But it can cause life-threatening side effects even in seemingly healthy people who use the recommended doses, because the amphetamine-like stimulant speeds heart rate and constricts blood vessels. It is particularly risky for anyone with heart disease or high blood pressure or people engaging in strenuous exercise.

The ban isn't immediate because federal rules require certain paperwork steps that mean the earliest it could take effect would be March. But the FDA wrote 62 current and former manufacturers on Tuesday that, "we intend to shut you down," said Commissioner Mark McClellan.

"There are companies out there who've profited by misleading Americans about the benefits of ephedra, even as they put Americans' health at risk," McClellan said. "Any responsible manufacturer and retailer should stop selling these products as soon as possible."

Thompson said he was announcing the upcoming ban now so that people making New Year's resolutions to lose weight won't be tempted to try ephedra.

"Ephedra raises your blood pressure and stresses your system," McClellan added. "There are far better, safer ways to get in shape."

Critics called the ban long overdue.

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

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 International 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.

Wolfe petitioned the government for a ban in 2001, when the agency had reports of 81 deaths. That number now is 155; also, FDA has reports of more than 16,000 health complaints from ephedra users.

"It was unfortunately only with the tragic death of a high-profile athlete that this started to get the attention that was due," added Dr. Mark Estes of the New England Medical Center in Boston, who called FDA unresponsive to years of physician complaints.

Others welcomed the FDA's 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."

The FDA said it couldn't act any sooner because of a federal law that lets dietary supplements sell over the counter without any requirements that they prove to be safe. To curb supplement sales, the FDA must prove a clear danger to public health -- something Thompson called "a tremendous burden of proof" that Congress should rethink.

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

Coronor Gordon Farr said that Mills was found with 10 to 15 times the therapeutic level of ephedra in his system, which led to his heart giving out. The toxicology results were completed early in December.

Ephedra makers insisted their products are safe if used correctly, but so far aren't saying if they'll 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 said.




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