United States DC Circuit

The FDA properly applied the Federal Food, Drug and Cosmetic Act in determining that plaintiffs could not market "saw palmetto" under their proposed label without first securing approval as a drug. The label indicates an intent to "treat" a disease.

Appellate Information

• Argued 11/10/2003
• Decided 01/09/2004
• Published 01/09/2004

Judges

• Before:  RANDOLPH and ROBERTS, Circuit Judges, and WILLIAMS, Senior Circuit Judge.

Court

• United States DC Circuit

Counsel

• For Appellant:
  
• Jonathan W. Emord argued the cause and filed the briefs for appellants., Anthony L. Young was on the brief for amicus curiae American Herbal Products Association in support of appellants.


• For Appellees:
  
• Howard S. Scher, Attorney, U.S. Department of Justice, argued the cause for appellees.   With him on the brief were Roscoe C. Howard, Jr., U.S. Attorney, Scott R. McIntosh, Attorney, U.S. Department of Justice, Alex M. Azar II, General Counsel, U.S. Department of Health & Human Services, and Daniel E. Troy, Chief Counsel.