Ephedra Banned Again -- Even Low Dose
Federal Appeals Court Upholds FDA Ban on Herbal Supplement
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."
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.