Dietary Supplemental Coalition, Inc. The Health Haus, Inc. v. Louis W. Sullivan, M.D. David A. Kessler, Commissioner of Food and Drug Administration

We consider whether the Food and Drug Administration’s classification of dietary supplement Co-enzyme Q10 (“CoQlO”) is an issue ripe for judicial review. The district court dismissed plaintiff’s action for declaratory judgment on the grounds that 1) the issue raised was not purely legal; 2) the challenged action was not final; and 3) the plaintiffs had not exhausted their administrative remedies, 796 F.Supp. 441 . Plaintiffs timely appeal. We affirm.

I

Plaintiffs-appellants are a coalition of dietary supplement manufacturers, known as the Dietary Supplement Coalition, and an Oregon dietary supplement distributor called the Health Haus, Inc. (referred to collectively as “DSC”).

In 1989, the Food and Drug Administration (“FDA”) initiated two proceedings to seize bottles of CoQlO from Natural Organics, Inc., and Bio-Energy Nutrient, Inc., both member companies of DSC. The FDA stated that under the provisions of the Food and Drug Act, 21 U.S.C. § 321 (sj (1988), CoQlO was an unsafe food additive because no FDA regulation prescribed the conditions under which it could be safely used. The FDA also issued regulatory letters concerning CoQlO informing recipients that CoQlO was an…