SALT LAKE CITY - A federal judge Thursday 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."
Now all they gotta do is get Tryptophan back on the market.
Makers and users of food supplements were jubilant yesterday when the advocate general at the European court of justice advised that EU restrictions due to take effect this summer were "seriously deficient".
Leendert Geelhoed's recommendation that the court should rule the EU's new list of approved supplements invalid is likely to be adopted by the judges, although they are not obliged to do so.
Campaigners had said that more than 5,000 products containing vitamins and minerals would be banned on scant scientific evidence.
Mr Geelhoed said the rules broke basic principles of EU law. The directive was not clear on the procedures needed to add new products.
Campaigners hope the EU will now be compelled to devise new procedures before ingredients can be banned.
Seriously, FDA is a worthless organisation. Gotta love the amerikan way of doing things. Absolutely no intellegence or research done before going ahead and making this or that illegal or for that matter electing a president.