When the FDA issued a nationwide ban on ephedrine-based products in 2004, many of the nation's largest sellers of dietary supplements were less than pleased. One company, Park City, Utah-based Nutraceutical Corp. decided to fight the ban, claiming the FDA overstepped its authority and failed to follow proper procedures for conducting a risk-benefit analysis when it found the supplement unsafe. A Utah district judge agreed and ruled the company could continue selling its ephedrine products.
Bruce Hough, president of Nutraceutical, stated in an April 2005 press release that the ruling was "about protecting the public's access to safe and effective dietary supplements and clarifying the meaning of the 1994 Dietary Supplement Health and Education Act (DSHEA). The Court's ruling clarifies the steps FDA must take to comply with the law in its regulation of dietary supplements."
That victory was short-lived, however. On Aug. 17, the U.S. Court of Appeals for the 10th Circuit in Denver reversed the lower court's ruling, finding that the FDA followed Congress' mandates in accurately determining the drug unsafe.
According to the FDA, the dietary supplement has been linked to more than 150 deaths.
