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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 of the statute has become more frequent and penalties have gotten more severe, the constitutionality of such an application of the FDCA has come under heightened scrutiny. Until recently, the typical FDCA case has involved an executive who pleaded guilty to one or more misdemeanors in the face of Department of Justice (DOJ) allegations of felony misconduct. These negotiated resolutions did not raise the same due process concerns posed by cases today, where defendants are facing these charges at trial and challenging the constitutionality of their sentences. 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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Common Pitfalls In Personal Device Collection
By Marjorie Peerce and Marguerite O’Brien
Both the DOJ and the SEC have made it clear that they will look at company BYOD policies when assessing how to resolve matters under their purview. To avoid pitfalls — and sanctions — counsel must take proactive steps to ensure proper preservation and collection of personal mobile data and verify that clients comply.
FCPA Compliance Guidance for Global Businesses
By Cole Callihan
The Biden administration and its Justice Department have established countering corruption as a core U.S. national security interest. Companies with any international operations should ensure they have a robust written policy and compliance program focused on anti-bribery and corruption.
Regulators Want AI Companies to Respect Antitrust and Consumer Protection Laws
By Karen Hoffman-Lent and Kenneth Schwartz
The new era of AI technology has ushered in competition concerns alongside consumer-protection fears. Accordingly, regulators and lawmakers are taking note of the AI craze and are keen on ensuring that companies involved in AI are respecting both antitrust and consumer protection laws.
Will the Corporate Transparency Act Smother the Cannabis Industry?
By Steve Schain
The CTA requires business entities to file information on their “beneficial owners” with FinCEN, which, in turn, may disclose it to domestic and foreign law enforcement agencies, prosecutors, judges and financial institutions.
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