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The government said Tuesday it would ban the sale of the diet supplement ephedra, which has been linked to 155 deaths and 16,000 adverse reactions.
The Food and Drug Administration urged consumers to stop using the supplement immediately, even though ephedra will still be legal until the ban goes into effect. The earliest the ban could be enacted is in March, due to the amount of legal paperwork involved.
Health and Human Services Secretary Tommy Thompson announced the ban after a months-long study of the risks of ephedra, which has been shown to result in short-term weight loss. Bodybuilders and other athletes credit the compound with enhancing their performance.
"The time to stop taking this product is now," Thompson said in announcing the government's first ban on a dietary supplement. "They are just too risky to use."
Use of the supplement, derived from a plant that grows in China, has already been banned by the International Olympic Committee, professional football and college athletics.
Doctors and pharmacologists hailed the government's action as a badly needed, if perhaps tardy, response to a dangerously unregulated stimulant. Some wondered if the ephedra ban might be the first of many to curb the huge herbal and supplements market, which has grown by billions of dollars since Congress in 1994 placed the burden of proving supplements unsafe on the FDA.
"I certainly think the FDA has made a wise decision to ban this," said Dr. Laurence Sperling, chief of preventive cardiology at Emory University Medical School. "The associated evidence is strong. It's nice to see the FDA make a stance like this for consumers."
Ephedra, also call Ma huang, has been used for millennia in China to treat bronchial problems, including asthma. Its stimulant properties enable it to dilate the lung's tiny bronchial tubes.
Those very properties, however, are what make ephedra dangerous and unpredictable, particularly in people with undiagnosed heart ailments.
"It basically does the same thing as adrenaline," said Randy Hatton, co-director of the Drug Information and Pharmacy Resource Center at the University of Florida. After a person takes ephedra, heart rate increases and blood pressure can rise.
Adverse reactions have occurred in people without underlying medical problems, such as Baltimore Orioles pitching prospect Steve Bechler. The 23-year-old baseball player died from heat stroke earlier this year after taking ephedra.
While the herb causes the heart to race and body temperature to rise soon after it is taken, doctors say the effects are not lasting. People who took the supplement six months ago need not fear permanent damage.
In the short term, however, ephedra can cause heart attack and stroke, doctors say. The chemical causes the heart to beat faster, which can cause it to stray from its regular pattern and send more blood to the ventricles, the lower chambers of the heart. That in turn can cause a shortage of blood to other major organs, and even cardiac arrest.
Fans and sellers of ephedra, including an Atlanta manufacturer, said the risks had been exaggerated.
"I am absolutely spitting nails," said Bob Rutledge, president of Elation Therapy. Rutledge said he started using ephedra to lose weight more than 15 years ago and began selling it in 1994. The herb has accounted for 98 percent of his company's sales in recent years.
Sales Tuesday broke records, he said, after customers heard of the ban and began stockpiling.
"The bottom line is this: If ephedra kills, I reasonably would have killed 1,000 people," Rutledge said. "In the vast majority of these cases, the caffeine that people are mixing it with is the problem. They'll wash it down with a double latte and then wonder why their heart races."
Rutledge and some others who sell ephedra said they sensed a conspiracy behind the ban that would result in it being sold by pharmaceutical companies rather than wholesalers.
"It's all about the money," said Rutledge. "When the FDA gets finished with us, you won't be able to buy a vitamin over the counter."
Jeff Allen, co-owner of Pumpin' Iron Pro Shop in Roswell, agreed.
"The lobby is so powerful for tobacco and alcohol that they don't ban those," Allen said. "But we're small players."
Staff researcher Richard Hallman contributed to this report.
Copyright 2003 The Atlanta Journal-Constitution
