Credible deterrence: FDA and the Park Doctrine in the 21st century

Food Drug Law J. 2013;68(2):137-88, i.


One of FDA's most powerful enforcement tools is strict liability criminal prosecution of corporate officers under the Park Doctrine. Recent comments by high-ranking FDA officials about using this power more aggressively and recent cases apparently making good on this promise have spurred commentators to call for the doctrine's demise. Critics argue that strict liability for corporate officers violates fundamental notions of fairness and the appropriate relationship between guilt and liability in criminal law. As a response to these critics, this article argues that the Park Doctrine continues to serve a valuable purpose in deterring conduct that endangers the public health and that structural, political, and practical limitations on FDA's use of Park prosecutions have been, and will continue to be, effective protections against the abuses critics fear. This article proposes a model for understanding why and how FDA uses its prosecutorial powers and assesses a sample of recent high-profile prosecutions under this model to argue that the modern "escalation" of Park prosecutions is in fact a continuation of FDA's historical policy.

Publication types

  • Legal Case

MeSH terms

  • Consumer Product Safety / legislation & jurisprudence
  • Criminal Law / legislation & jurisprudence*
  • Drug Industry / legislation & jurisprudence*
  • Food Industry / legislation & jurisprudence*
  • Humans
  • Liability, Legal*
  • United States
  • United States Food and Drug Administration