United States Tenth Circuit

Summary judgment for plaintiffs, manufacturers and sellers of Ephedra, in a suit challenging an FDA regulation banning ephedrine alkaloid dietary supplements (EDS) in the U.S. market is reversed where: 1) the FDA correctly interpreted the relevant statute to require a risk-benefit analysis in determining if a dietary supplement presents an "unreasonable risk of illness or injury"; and 2) the FDA satisfied its burden of proving that dietary supplements containing EDS present an unreasonable risk of illness or injury when doses of 10 mg or less per day are suggested or recommended in labeling.

Appellate Information

• Decided 08/18/2006
• Published 08/18/2006

Judges

• EAGAN, District Judge., Before KELLY, TYMKOVICH, Circuit Judges and EAGAN, District Judge.

Court

• United States Tenth Circuit

Counsel

• For Appellees:
  
• Christine N. Kohl, Attorney (Peter D. Keisler, Assistant Attorney General, Paul M. Warner, United States Attorney, Jeffrey Bucholtz, Deputy Assistant Attorney General, and Douglas N. Letter, Attorney, Department of Justice, Washington, D.C., and Paula M. Stannard, Acting General Counsel, Sheldon T. Bradshaw, Associate General Counsel, Eric M. Blumberg, Deputy Chief Counsel, and Claudia J. Zuckerman, Associate Chief Counsel, Office of General Counsel, U.S. Department of Health & Human Services, Food and Drug Division, Rockville, MD, with her on the briefs), for Defendants-Appellants., Jonathan W. Emord (Andrea G. Ferrenz with him on the brief), Emord & Associates, P.C., Reston, VA, for Plaintiffs-Appellees.