On August 17th, the U.S. Court of Appeals for the 10th Circuit in Denver upheld FDA’s final rule declaring all dietary supplements containing ephedrine alkaloids adulterated, and therefore illegal for marketing in the U.S., reversing a decision by the District Court of Utah. The 10th Circuit Court of Appeals’ ruling demonstrates the soundness of FDA’s decision to ban dietary supplements containing ephedrine alkaloids, consistent with the Dietary Supplement Health and Education Act (DSHEA) of 1994. The 10th Circuit Court of Appeals also found that Congress clearly required FDA to conduct a risk-benefit analysis under DSHEA. FDA conducted an exhaustive and highly resource-intensive evaluation of the relevant scientific data evidence on ephedrine alkaloids before issuing its final rule, which became effective in 2004. The court found that the 133,000-page administrative record compiled by FDA supports the agency’s findings that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure. Under this ruling, this means no dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the U.S. is illegal and subject to FDA enforcement action. According to an article in the Salt Lake Tribune, the battle over ephedra is not over. In fact, Nutraceutical Corp. (Park City, UT) attorney Jonathan Emord, who sued FDA in 2005 asking it to repeal the nationwide ban or provide compensation for financial losses, has suggested that Nutraceutical Corp. will appeal this decision to the full 10th Circuit Court of Appeals.