FDA Issues "Non-Binding" Park Doctrine Criteria for Potential Referral of "Responsible Corporate Officials" for Prosecution for Alleged Violations of the Food, Drug, and Cosmetic Act


The U.S. Food and Drug Administration ("FDA") recently set forth, in its Regulatory Procedures Manual for FDA personnel, criteria for when it would refer a matter for potential prosecution under the Park doctrine. In essence, the Park doctrine provides for criminal liability (first-time misdemeanor and possible subsequent felony) under the federal Food, Drug and Cosmetic Act ("FDCA") without proof that a corporate official acted with intent or even negligence.

Prosecution under the Park doctrine is possible even if the responsible corporate official lacked knowledge or did not participate in the specific offense. The FDA stated it would consider...

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Published In: Administrative Agency Updates, Business Organization Updates, Criminal Law Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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