United States v. Nutri-Cology, Inc., D/B/A Allergy Research Group Biocurrents, Inc. Stephen A. Levine Susan D. Levine

The government appeals the district court’s denial of its motion for a preliminary injunction and its motion for reconsideration. The government sought to enjoin appellees Nutri-cology, Inc., also doing business as Allergy Research Group, Bio-currents, Inc., Stephen A. Levine, and Susan D. Levine (collectively “Nutri-cology”) from distributing certain products, which the government contends are unapproved “drugs” or “new drugs” within the meaning of the Food, Drug and Cosmetic Act (the “FDCA”), 21 U.S.C. §§ 301-394 . The district court found that the government had made a colorable showing that the products were unapproved “new drugs” and were being distributed in violation of 21 U.S.C. § 331 (d). Nonetheless, the dis trict court found that the government failed to demonstrate irreparable harm and refused to issue a preliminary injunction. We have jurisdiction under 28 U.S.C. § 1292 (a)(1), and we affirm.

I. BACKGROUND

Nutri-cology distributes and promotes a number of products labelled as nutritional or dietary supplements. These products are allegedly promoted as useful to prevent and treat numerous diseases and conditions.

The Food and Drug Administration (the “FDA”) began…