United States v. 1,048,000

GODBOLD, Circuit Judge:

This case was instituted under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., for seizure and condemnation of a quantity of drug called “Afrodex” marketed by Bentex Pharmaceutical Company, claimant below. The libel alleges that Afrodex is misbranded under 21 U.S.C. § 352(f)(1), and thus subject to seizure and condemnation pursuant to 21 U.S.C. § 334, in that the article is, within the meaning of 21 U.S.C. § 321 (p), a “new drug” whose labeling is not specified in an approved New Drug Application (NDA). The parties stipulate that if Afrodex is a “new…