The Food, Drug, and Cosmetic Act (FDCA) has historically allowed prosecutors to charge corporate employees with misdemeanors without having to prove personal participation or wrongful intent. But, as the use
Recent Developments in the Responsible Corporate Office Doctrine
Until recently, the typical FDCA case has involved an executive who pleaded guilty to one or more misdemeanors in the face of DOJ allegations of felony misconduct. But until the Supreme Court clarifies the bounds of the FDCA, district courts will struggle with identifying the necessary elements of individual criminal liability.

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