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February 18, 2021 23 mins

In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government Enforcement Practice and a former federal prosecutor, about the Responsible Corporate Officer (RCO) doctrine, also known as the Park doctrine, and how it impacts the FBA industry. Justin addresses how under the federal Food, Drug and Cosmetic Act (FDCA), the RCO doctrine can result in strict criminal liability for an individual who stands in a position of responsibility with respect to lower-level employees as a result of the conduct of those employees, even without knowledge of that conduct. Although strict liability for a criminal offense – without knowing participation in the conduct – is rare, the U.S. Supreme Court has recognized this exceptional approach in the public welfare context, since public health and safety is paramount in the FBA industry. Jonathan and Justin discuss the practical applications of the doctrine, how the U.S. Food and Drug Administration (FDA) partners with the Department of Justice (DOJ) on enforcement of the RCO doctrine, how federal prosecutors tend to look for evidence, and how companies can implement rigorous policies, procedures and training programs to help maintain compliance.

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