Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the Federal FDCA, even if there is no affirmation of wrongdoing on the part of the manager individually.

In the Dotterweich case, the jury found Dotterweich, the president and general manager of a drug repackaging company, guilty on two counts for shipping misbranded drugs in interstate commerce, and on a third count for shipping an adulterated drug. One dissenting judge of the Circuit Court of Appeals reversed the decision on the grounds that only the corporation was the “person” subject to prosecution, thus protecting the president personally. But the Supreme Court reversed the decision, thus holding Dotterweich individually responsible, not just the manufacturer. Justice Felix Frankfurter delivered the opinion of the Court: “... under § 301, a corporation may commit an offense and all persons who aid and abet its commission are equally guilty….”

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