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Ephedra Ban Lifted
On 04/14/05 a federal judge struck down the FDA ban on ephedra, the once-popular weight-loss aid that was yanked from the market after it was linked to dozens of deaths.
The judge ruled in favor of a Utah company that challenged the Food and Drug Administration's ban. Utah-based Nutraceutical claimed in its lawsuit that ephedra "has been safely consumed" for hundreds of years.
Supplements that included ephedra have been widely used for weight loss and bodybuilding, but have linked to 155 deaths, including that of Baltimore Orioles pitching prospect Steve Bechler. The FDA ordered the substance off the market in April 2004.
Judge Tena Campbell's ruling sends the matter back to the FDA "for further rulemaking consistent with the court's opinion" and keeps the agency from enforcement action against the companies.
FDA officials did not immediately return a call seeking comment.
Company President Bruce Hough said the decision is about "protecting the public's access to safe and effective dietary supplements."
Though a federal judge struck down some portions of an FDA law that banned the sale or use of ephedra, the laws still remain somewhat intact. Instead, the judge ruled that the FDA did not prove that ephedra was not unsafe in small doses. Thus, large doses of ephedra are still illegal, even under the relaxed regulations.
In fact, many experts say that the ban has only been removed in Utah, where the judge made the ruling, not nationally. However, some states have moved to ban the substance on their own and the federal ruling has no effect on those states' decisions. Additionally, the FDA is expected to appeal the ruling.
What's amazing about all of this, of course, is that ephedra remains illegal even though it's safe, while prescription drugs remain legal (and backed by the FDA) even though they are right now killing nearly 100,000 Americans each year. To learn more on this topic, be sure to also read the related article, As the FDA Banned Ephedra, Over-The-Counter Sudafed Fueled Widespread Harm By Providing Raw Materials for Illegal Methamphetamine Labs.
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