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Date Posted: 17:07:27 08/19/06 Sat
Aug 18, 2006 8:52 am US/Mountain Time
Appeals Court Upholds FDA Ephedra Ban
A federal appeals court has upheld the FDA ban on products containing the weight-loss supplement ephedra, reversing a Utah judge's ruling that prohibited enforcement of the prohibition against Park City-based Nutraceutical Corp.
A three-judge panel of the 10th U.S. Circuit Court of Appeals in Denver ruled Thursday that the U.S. Food and Drug Administration correctly followed a mandate from Congress to conduct a risk-benefit analysis to determine if a product presents an "unreasonable risk of illness or injury," The Salt Lake Tribune reported.
Ephedra, which was linked to dozens of deaths and thousands of reports of health problems such as heart attack or increased blood pressure, was banned by in 2004 by the FDA, which held that no dosage of the substance was safe.
However, U.S. District Judge Tena Campbell in Salt Lake City said last year that the FDA had not proved that ephedra was unsafe even at low doses and she ruled that the ban could not be enforced against supplements containing doses of ephedra up to 10 milligrams.
Jonathan Emord, attorney for Nutraceutical Corp., said Thursday the Utah company will seek a rehearing in front of the entire 10th Circuit.
The natural supplement industry fears the ruling could give the FDA broader power to yank products where it believes risks outweigh benefits, said Loren Israelsen, executive director of the Utah Natural Products Alliance.
"The worry is that the FDA can say to anyone, 'We don't like you, you're out of here,' " he said.
Elisa Odabashian, senior policy analyst at Consumers Union, publisher of Consumer Reports magazine, said the ban will save lives.
"This is just great news because the evidence is everywhere - ephedra is a killer," she said. "It revs you up, you feel great, you have no appetite. ... But with some people it causes heart palpitations, heart attacks and strokes."
The ban stemmed from studies which showed an increased risk of heart attacks, stroke and death, especially in users who have high blood pressure, heart disease or engage in strenuous exercise.
Since 1997, the amphetamine-like herb has been linked to 19,000 "adverse events" and dozens of deaths, including that of 23-year-old Baltimore Orioles pitcher Steve Bechler, who collapsed during a spring training workout.
In challenging the ban, Nutraceutical and its subsidiary Solaray Inc., argued that dried whole-herb ephedra sinica had been safely used for thousands of years.
Campbell held that in banning ephedra, even at low doses, the FDA was improperly shifted the burden of proving product safety from the government to supplement manufacturers.
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