FDA issues statement on ephedrine supplements
On Aug. 17, the U.S. Court of Appeals for the Tenth Circuit in Denver upheld the FDA 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. Commenting on the Denver court's ruling, the FDA said, "The Tenth 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.
FDA issues statement on ephedrine supplements
On Aug. 17, the U.S. Court of Appeals for the Tenth Circuit in Denver upheld the FDA 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. Commenting on the Denver court's ruling, the FDA said, "The Tenth 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 Tenth Circuit Court of Appeals also found that Congress clearly required FDA to conduct a risk-benefit analysis under DSHEA.
To see more Hot off the Press news articles, click here http://www.drugtopics.com/Hot+off+the+Press.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
