United States v. Article of Drug … Ova II

414 F. Supp. 660 (1975)

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United States v. Article of Drug … Ova II

United States District Court for the District of New Jersey
414 F. Supp. 660 (1975)

Facts

The Food and Drug Administration (FDA) (plaintiff) brought an action for forfeiture and condemnation of several thousand at-home pregnancy test kits against the manufacturer of the kits, Faraday Laboratories, Inc. (Faraday) (defendant). The government alleged that the test kits were drugs within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA) and were new drugs that required the filing of a new-drug application with the FDA for its determination whether they were safe and effective before they could be marketed in interstate commerce. Faraday moved for summary judgment and argued that the test kits were not drugs within any of the three definitions of a drug in the FDCA and therefore were not subject to the new-drug application requirements. The FDA argued that because of the presence of sodium hydroxide and hydrochloric acid, which were both listed in the United States Pharmacopeia (a compendium of standards for medicines, food ingredients, and dietary supplements), the test kits were, by definition, drugs under the FDCA.

Rule of Law

Issue

Holding and Reasoning (Biunno, J.)

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