United States v. An Article of Drug, Etc., and Palmer Chemical & Equipment Company, Inc., Claimant-Appellant

Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., an animal drug may not be marketed in interstate commerce unless (1) the FDA has approved a new drug application pursuant to 21 U.S.C. § 360b, or (2) the drug is not a “new animal drug” because it is “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 321 (w)(l). If neither of these conditions is met, the drug is deemed an “adulterated” new animal drug, 21 U.S.C. § 351 (a)(5), and, if found in interstate commerce, may be seized and condemned, 21 U.S.C. § 334 . Shipment of such drugs may be enjoined. 21 U.S.C. §§ 331 , 332(a).

Complaints for forfeiture were filed against the animal drugs Cap-Chur-Sol and U-Tha-Sol. Warrants were issued and quantities of both drugs were seized. Palmer Chemical & Equipment Co. intervened as claimant to defend the drugs against forfeiture. Palmer Chemical conceded no new drug application was on file. The sole issue for trial, therefore, was whether the drugs were…