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NCJ Number
American Criminal Law Review Volume: 30 Issue: 3 Dated: (Spring 1993) Pages: 717-734
E A Poyck; M A Smith; A Toledo
Date Published
18 pages
After reviewing elements of offenses under the Federal Food and Drug Act, this article discusses defenses to charges under the act, enforcement, and prosecution.
In 1938, pursuant to its constitutional authority to regulate interstate commerce, the U.S. Congress enacted the Federal Food, Drug and Cosmetic Act (FDCA). An extension of earlier, less comprehensive legislation, the FDCA continues to regulate the food, drug, and cosmetic industries. The primary goal of the legislation is to protect the health and safety of the public by preventing deleterious, adulterated, or misbranded articles from entering interstate commerce and sanctioning those who violate its provisions through criminal penalties, injunctions, and seizure of adulterated or misbranded goods. The U.S. Supreme Court has established a standard of strict liability for violations of the FDCA's criminal provisions and held that intent to commit a violation is not required to obtain a conviction. The discussion of defenses focuses on constitutional defenses and affirmative defenses. The examination of enforcement addresses inspections and sanctions. A review of heightened attention to prosecution notes that in early 1991, the Food and Drug Administration embarked on a highly publicized policy of enhanced enforcement of the FDCA in an effort to restore "the credibility and the integrity" of the Federal Drug Administration. 136 footnotes