|
|
[Definitie:] "An ergogenic aid is any substance or phenomenon that enhances performance."
(Wilmore and Costill) 
|
|
|
||
|
||
|
2 9 - 0 8 - 2 0 0 6 Ruling upholds ban on ephedra
Appeals court ratifies FDA report that the supplement is unsafe
By Lesley Mitchell and Pamela Manson
A federal appeals court on Thursday upheld a ban on products containing the weight loss supplement ephedra, reversing a Utah judge who stopped 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 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 FDA said no dosage of ephedra is safe to sell to consumers. The natural supplement industry voiced concern Thursday that the ruling could give the FDA broader power to more easily yank products in cases where it believes the risks outweigh the benefits, said Loren Israelsen, executive director of the Utah Natural Products Alliance. Some supplement makers undoubtedly will even fear a crackdown by the FDA, he said. "The worry is that the FDA can say to anyone, 'We don't like you, you're out of here,' " he said. But Elisa Odabashian, senior policy analyst at Consumers Union, was ecstatic and said the ban will save lives. Her organization, the nonprofit publisher of Consumer Reports magazine, has called for years for a ban on ephedra. "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." Attorney Jonathan Emord, who represents Nutraceutical Corp., said Thursday the Utah company will seek a rehearing in front of the entire 10th Circuit. In recent years, many consumers have switched to ephedra-free weight loss supplements because of safety concerns and the difficulty of finding ephedrine products. Yet Devin Anderson sells a popular ephedra-based weight loss and performance enhancing supplement at his Sugar House store, Herbs for Health. On Thursday, Anderson said he would reluctantly comply with the ban. Anderson has taken ephedra supplements for years and says the substance is "completely safe." He said Thursday's ruling is "crazy" because he believes problems occur only when people take high doses and combine ephedra with caffeine. Ephedrine alkaloids - also called ma-huang - are a class of structurally-related chemical stimulants that occur naturally in some botanicals. In addition to aiding in weight loss, they quell fatigue and are popular among athletes looking for an energy boost. The ban stems from studies which show 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. After studying reports of problems, the FDA decided there is no acceptable dosage level of ephedrine-alkaloid dietary supplements. As of April 12, 2004, the FDA banned them. The ban was challenged in a lawsuit filed in May 2004 by Nutraceutical and its subsidiary Solaray Inc., which said dried whole-herb ephedra sinica - the type of supplement in their products - had been safely used for thousands of years. In April 2005, U.S. District Judge Tena Campbell in Salt Lake City blocked any enforcement action against Nutraceutical for selling supplements containing 10 milligrams or less of ephedra per daily dose. The judge said the FDA's process in banning ephedra improperly shifted the burden of proving product safety from the government to supplement manufacturers. Unlike drug manufacturers, supplement makers do not have to prove their products are safe before marketing them. |
|
|
