Pharmanex v. Shalala

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.

Background,

Plaintiff-Appellee, Pharmanex, markets a product, Cholestin, that is intended to promote healthy cholesterol levels. Cho-lestin is made from…