In Law360, McGuireWoods Trio Analyzes Executive Order on FDCA Enforcement

An executive order could reshape federal criminal prosecutions under the Federal Food, Drug and Cosmetic Act (FDCA), McGuireWoods partners Clint Narver, Eric Olshan and Mindy Sauter wrote in a July 9, 2025, Law360 article.

Executive Order No. 14294, signed May 9, 2025, directs federal agencies to reduce overcriminalization by prioritizing intent-based enforcement and limiting criminal penalties for individuals who unknowingly violate complex regulations.

Narver, Olshan and Sauter said the order could result in the U.S. Department of Justice pursuing felony charges in FDCA cases more frequently and in situations where it previously would have considered a negotiated misdemeanor resolution as an appropriate middle ground. The order could also result in disparate treatment of corporate and individual defendants in FDCA criminal prosecutions, the authors wrote in the article, titled “Federal Regs Order May Spell Harsher FDCA Enforcement.”

While the order does not eliminate strict liability, it “signals a potential shift in the government’s enforcement approach in the short term and promises a reevaluation of criminal strict liability in the long term,” concluded the authors, members of McGuireWoods’ nationally recognized Government Investigations & White Collar Litigation Practice Group.