The Food Industry And No Fault Crimes - Criminal Liability For The Conduct of Others

According to the Food and Drug Administration (FDA), the no fault criminal provisions under the Food Drug and Cosmetic Act (FDCA) apply to "anyone who has a responsible share in the furtherance of the transaction."

The FDA has powerful and persuasive leverage before a matter gets anywhere near a courtroom to influence the behavior of regulated industry, and it is increasingly wielding that power by preemptively threatening criminal enforcement for failing to establish and follow manufacturing procedures. In a series of Warning Letters issued by the FDA in 2013 to manufacturers throughout the United States, the FDA has signaled that it will rely on the Park Doctrine for routine violations by referencing the following:

United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has "a responsible share in the furtherance of the transaction which the statute outlaws"); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that "agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act" can be held accountable for violations of the Act).

The FDA has put regulated industry on notice that it will apply the Park Doctrine, threatening criminal prosecution for marketing adulterated and misbranded products based upon routine violations such as the following:

Contract Manufacturing: "Although your firm may contract out certain ... manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the [Product] it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with ... CGMP requirements."

Current Good Manufacturing Practices (CGMP) Violations: "The Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce [a Product] that is adulterated for failure to comply with ... CGMP requirements."

New Dietary Ingredients: For using ingredients where "to the best of FDA's knowledge, [the substance] itself is not commonly used as a food or drink by humans."

Generally Recognized as Safe (GRAS): For foods the FDA deems "additives" where the FDA declares a substance is not GRAS by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food...