Strict Liability in the Crosshairs: Executive Order Reshapes Criminal Enforcement of the U.S. Federal Food, Drug, and Cosmetic Act

On May 9, 2025, President Donald Trump issued a new executive order (EO), entitled “Fighting Overcriminalization in Federal Regulations,” aimed at discouraging the use of strict liability offenses and promoting greater transparency in regulatory enforcement. This action revives and expands on the policy direction set by Executive Order 13980, issued in the final days of the first Trump administration and subsequently revoked by President Biden in May 2021.

The May 9, 2025 order includes the following provisions:

• Disfavoring Strict Liability Offenses: The EO explicitly states that strict liability regulatory offenses — that is, those that do not require proof of intent (mens rea) — are “generally disfavored.” Agencies are directed to consider civil or administrative enforcement, rather than criminal prosecution, for such offenses.
• Mens Rea Requirements: Agencies are instructed to review and, where possible, adopt a default mens rea standard for criminal regulatory offenses. Any deviation from this standard must be justified and documented.
• Transparency and Public Notice: Within 365 days of the order, each agency must publicly post a list of all criminal regulatory offenses enforceable by the agency or the Department of Justice (DOJ), including the applicable mens rea standard and potential range of penalties. Criminal enforcement of offenses not included in these public reports is “strongly discouraged.”
• Guidance on Criminal Referrals: Within 45 days of the order, agencies are required to publish guidance outlining the factors considered when referring regulatory violations to the DOJ for criminal enforcement. The EO states that agencies should consider factors such as the harm caused, the defendant’s gain, and whether the defendant had specialized knowledge or awareness of unlawfulness.

Implications for the FDCA and Strict Liability Misdemeanors

The new EO marks a significant policy shift in federal regulatory enforcement, with particular implications for statutes such as the Food, Drug, and Cosmetic Act (FDCA) that have historically relied on strict liability misdemeanors. Under 21 U.S.C. § 333(a)(1), individuals and companies can be held liable for strict liability misdemeanors based on certain violations of the FDCA — even absent proof of intent or knowledge of wrongdoing.

While the EO does not change the underlying law, it signals a clear intent to prioritize prosecutions based on knowledge and intent and a more restrained approach to criminal enforcement of regulatory offenses. This policy shift will likely be strengthened by the recent announcement that the DOJ will disband its Consumer Protection Branch (CPB), which has historically investigated and pursued many FDCA misdemeanor cases. As a result, the Food and Drug Administration (FDA) may face higher hurdles when referring criminal FDCA cases to the DOJ for investigation.

What’s Next: Practical Considerations for FDCA-Regulated Entities

Life sciences companies should remain vigilant as agencies implement these changes and proactively assess how the evolving enforcement landscape may affect their compliance and risk management strategies.

• Engage with DOJ on Existing Matters: To the extent that companies are already subject to ongoing or potential criminal matters related to alleged violations of the FDCA, companies should consider whether those matters fall within the scope of the EO. As appropriate, companies should consider advocating before DOJ that charges be abandoned or modified in light of the EO.
• Review and Maintain Compliance Programs: Companies subject to the FDCA should ensure that their compliance and quality programs are sufficiently robust — a key component of demonstrating good-faith efforts to comply with regulatory requirements. Willful blindness, corner-cutting, and data integrity/falsification issues, for example, may provide evidence of intent and tip the balance on investigation and enforcement decisions.
• Address Whistleblower Risks: While the risk of criminal enforcement of the FDCA and other statutes may be lower in some circumstances under the current administration, enforcement of the False Claims Act — long a key driver of enforcement risk for life sciences companies — remains a top priority. And as companies restructure and downsize, we have seen a rise in direct whistleblower reports to the FDA and DOJ alleging intentional misconduct. Compliance programs need to robustly investigate all allegations of wrongdoing, including those related to product quality and manufacturing, and ensure appropriate remediation.
• Monitor Agency Guidance: Companies should closely monitor FDA’s public reports identifying criminal regulatory offenses and the associated mens rea standards, as these will provide guidance on areas of heightened enforcement risk. Companies should also stay alert for FDA’s forthcoming guidance on criminal referrals and any changes to the agency’s enforcement posture in light of the EO.
• Engage with Agencies on Scope of Criminal Enforcement: The EO’s emphasis on transparency may provide opportunities for industry stakeholders to engage with the FDA and advocate for reforms that limit the use of strict liability in criminal enforcement.

Sidley is closely monitoring the implementation of this EO and its evolving impact on regulatory enforcement. Our team is available to provide tailored guidance as you navigate the changing enforcement landscape and assess strategies for effective engagement with agencies as developments continue to unfold.