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WHITAKER v. THOMPSON

No. 03-5020.

353 F.3d 947 (2004)

Julian M. WHITAKER, et al., Appellants, v. Tommy G. THOMPSON, Secretary, U.S. Department of Health and Human Services, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided January 9, 2004.

Attorney(s) appearing for the Case

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.

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.

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

Opinion for the Court filed by Senior Circuit Judge WILLIAMS.

STEPHEN F. WILLIAMS, Senior Circuit Judge:

When substances aimed at the treatment or prevention of disease are marketed, their regulation by the Food and Drug Administration ("FDA") commonly turns on the nature of the claims made about the substance. Items to be sold with "drug claims," including foods and dietary supplements, are subject to extensive testing; foods or dietary supplements that merely...

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