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PHARMANEX v. SHALALA

No. 99-4087.

221 F.3d 1151 (2000)

PHARMANEX, a Delaware corporation authorized to do business in the State of Utah, Plaintiff-Appellee, v. Donna SHALALA, in her official capacity as Secretary of the United States Department of Health and Human Services; Michael Friedman, in his official capacity as First Deputy Commissioner of the Food and Drug Administration, Defendants-Appellants. National Organization of Rare Disorders; Merck & Co., Inc.; National Nutritional Foods Association, Amicus Curiae.

United States Court of Appeals, Tenth Circuit.

July 21, 2000.

Attorney(s) appearing for the Case

Richard M. Cooper (and Helen I. Dooley, Williams & Connolly, Washington, D.C., and Alan L. Sullivan, Snell & Wilmer, Salt Lake City, Utah, and Stuart M. Pape and Daniel A. Kracov, Patton Boggs, Washington, D.C., with him on the brief), for Plaintiff-Appellee.

Irene M. Solet (and Scott R. McIntosh, Attorneys, Appellate Staff, Civil Division, and David W. Ogden, Acting Assistant Attorney General, Department of Justice, Washington, D.C.; David J. Schwendiman, United States Attorney, Salt Lake City, Utah; Margaret Jane Porter, Chief Counsel, and Neal Parker, Associate Chief Counsel, Food and Drug Administration, Rockville, Maryland, with her on the briefs), for Defendant-Appellant.

Kenneth C. Bass, III, David G. Adams, Nathan A. Beaver, Venable, Baetjer, Howard & Civiletti, Washington, D.C., for Amicus Curiae National Organization of Rare Disorders and Merck & Co., Inc.

Alan Charles Raul, Sidley & Austin, Washington, D.C., for Amicus Curiae National Nutritional Foods Association.

Before KELLY, PORFILIO, Circuit Judges, and ALLEY, Senior District Judge.

PAUL KELLY, JR., Circuit Judge.

This case requires that we address the scope of 21 U.S.C. § 321(ff)(3)(B) as it relates to the FDA's power to regulate dietary supplements. Appellants (hereinafter, "FDA") appeal from the federal district court's order setting aside the FDA's Administrative Decision of May 20, 1998. Our jurisdiction arises under 28 U.S.C. § 1291, and we reverse and remand for resolution of record based arguments not reached below.

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