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Aug. 22, 2006 -- It appears that ephedra will soon disappear from store shelves -- again.
A federal appeals court last week upheld an FDA ban of the embattled herbal supplement, overturning a 2005 ruling by a lower court that allowed the sale of products containing ephedra in low doses.
The FDA had banned the sale of all dietary supplements with ephedra in 2004, after concluding that the products were too dangerous for sale to the public.
Ephedrine alkaloids, the active ingredient in ephedra supplements, had been linked to some 16,000 adverse events prior to the ban, including heart attacks, strokes, and numerous deaths.
No Safe Ephedra
In overturning the federal ban, a federal judge in Utah last year ruled that the FDA had failed to prove that ephedra was dangerous at low doses of 10 milligrams or less.
The lower court ruling came in response to a lawsuit filed by the Utah-based dietary supplement maker Nutraceutical Corp., which marketed a low-dose ephedra product.
But the higher court agreed with the FDA's contention that there is no safe dosage of ephedra.
"The court found that the 133,000-page administrative record compiled by the FDA supports the agency's finding that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness and injury to users, especially those suffering from heart diseaseheart disease and high blood pressurehigh blood pressure," a statement released Monday by the FDA read.
"No dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the United States is illegal and subject to enforcement action."
Troubled Past
Once hugely popular for weight lossweight loss and for use by athletes hoping to enhance their sports performance, sales of ephedra products dropped sharply in the years prior to the FDA ban.
The sudden death of 23-year-old Baltimore Orioles rookie pitcher Steve Bechler early in 2003 focused the media spotlight on ephedra. Bechler's death was blamed on the supplement, which he reportedly took in high doses before collapsing during a spring training workout. He died the next day.
Neurosurgeon Julian Bailes, MD, was among the first researchers to link ephedra to heatstroke deaths in athletes. When the lower court ruled he expressed concern that allowing the sale of low-dose ephedra products would lead to widespread abuse.
But he tells WebMD that this doesn't appear to have happened.
"Ephedra does have its following, but I think most people now realize that the risks aren't worth it," he says.
Bailes, who is chairman of neurosurgery at West Virginia University School of Medicine, says ephedra was responsible for more than 80 deaths before the FDA ban, although estimates vary greatly.
The number of adverse events associated with the supplement has been more thoroughly investigated. Ephedra-containing supplements accounted for 64% of the adverse reactions to herbs reported in the U.S. in 2001, even though the products made up less than 1% of herbal sales.
Continuing the Fight
Last week's ruling will not end the ephedra fight, the attorney for Nutraceutical Corp. tells WebMD.
Washington-based lawyer Jonathan Emord says he plans to file a petition within 45 days asking for a rehearing before all 19 judges who sit on the Denver-based 10th Circuit Court of Appeals. If this is not granted, he says he will petition the U.S. Supreme Court to hear the case.
"We are not giving up," he says. "We're in it for the long haul."
Emord argues that the ruling essentially clears the way for the FDA to remove any supplement from the market if it can show that the supplement causes harm at high doses.
"If the FDA can show evidence of harm at a certain dose level, it can now ban the product outright," he says. "That is a very dangerous precedent, because just about everything can be harmful if you take too much."
Nutraceutical Corp. no longer sells its 10-milligram ephedra supplement, but many other herbal supplement companies did market low-dose ephedra products prior to last week's ruling.
SOURCES: FDA news release on 10th Circuit ruling, Aug. 21, 2006. FDA report, "Ephedra Ban: No Shortage of Reasons," FDA Consumer Magazine, March-April, 2004. Jonathan Emord, attorney for Nutraceutical Corp. Julian Bailes, MD, neurosurgeon, West Virginia University School of Medicine WebMD Medical News:"Federal Court Weakens FDA Ephedra Ban." "The Relative Safety of Ephedra Compared with Other Herbal Products," Annals of Internal Medicine, March 18, 2003; vol 138: pp 468.