Is This the Death Knell of Strict Liability Crimes?

At a Glance

• The executive order disfavors strict liability criminal charges for regulatory offenses.
• The executive order imposes requirements and deadlines on agencies such as the FDA to reduce company and individual exposure to criminal prosecution for regulatory violations.
• The executive order may present opportunities for companies in high-risk industries or presently under investigation for regulatory violations to make new arguments regarding potential outcomes.

Although President Trump’s recent executive order signed May 9, 2025, did not garner much press attention, it is a must-read for executives in highly regulated industries like those regulated by the Food and Drug Administration (FDA) because it directly impacts federal agencies’ ability to seek criminal charges for regulatory violations.¹ Titled “Fighting Overciminalization In Federal Regulations,” this executive order (EO) was designed to reduce excessive and unnecessary regulation by executive branch agencies and to increase agency transparency, particularly concerning regulations that subject violators to criminal penalties, which the EO asserts contribute to the “overcriminalization” of minor regulatory infractions. Notably, the EO does not apply to immigration law enforcement or national security functions; however, that is the only limitation to the reach of this EO.

While it covers all regulations that can trigger criminal charges, the EO focuses on strict liability crimes that can be charged for inadvertent regulatory violations. Unlike most crimes, which require proof of criminal intent — the mens rea element — “strict liability” crimes can subject an individual or a company to criminal exposure regardless of intent. Consequently, even a mistake or inadvertent act that violates a regulation can result in criminal prosecution, a circumstance that is top-of-mind to many executives of food, pharmaceutical and medical device companies. This EO effectively challenges agencies to justify their regulations that allow for criminal charges in the event of a violation.

While the EO does not abolish all strict liability crimes flowing from a regulatory violation, it explicitly states that strict liability crimes are “disfavored” and provides new hurdles (described below) to the promulgation and enforcement of regulations, the violation of which carry potential criminal penalties without an intent requirement. The EO also directs agencies to consider civil and administrative enforcement instead of criminal enforcement and specifies that, in future, the executive branch will prioritize criminal enforcement against those targets who knowingly and intentionally violate regulations, not those who violate them unintentionally, and favor prosecutions where the violations have caused significant harm. The EO also requires all agencies² to provide increased transparency regarding which regulations carry risks of criminal prosecution as well as the circumstances under which such prosecutions will be considered.

The EO establishes specific deadlines to ensure compliance. It directs agencies within 45 days to publish guidance on referring violations for criminal enforcement, considering factors such as harm caused, the defendant’s gain, and awareness of unlawfulness. By May 9, 2026, all agencies must publish a report detailing each regulatory offense that carries a criminal penalty and specify the mens rea required to prove that offense. Thereafter, agency heads, "in consultation with the Attorney General, shall provide to the Director of the Office of Management and Budget (OMB) a report" assessing the appropriateness of existing mens rea standards. 

Further, the EO declares that regulations that trigger strict liability criminal jeopardy constitute “significant regulatory actions” under Executive Order 12866, and therefore require review by the OMB’s Office of Information and Regulatory Affairs (OIRA). This review requirement applies to all current and future regulations that carry strict liability criminal penalties. This declaration may provide a new impediment to current or contemplated strict liability prosecutions for violations of regulations that have not been subjected to the process set forth in EO 12866 insofar as a defendant could argue that the regulation violated was not properly enacted and as such cannot form the basis of a criminal prosecution.

By creating these additional measures for agencies, the current administration appears to be incentivizing those agencies to reduce both the number of regulations that can trigger strict criminal liability as well as the severity of penalties that can potentially be imposed for regulatory violations overall. The EO’s stated rationale for these new requirements is to reduce “overcriminalization” and protect individuals and businesses, particularly small businesses, from unduly harsh penalties for unintentional regulatory violations.

Impact on the FDA and Enforcement of the FDCA

The EO will require considerable action by the FDA. The FDA is primarily responsible for enforcing the Food Drug and Cosmetic Act (FDCA), which imposes criminal penalties for misbranding or adulteration of food, drugs or medical devices, often on a strict liability basis. Notably, FDA has issued many regulations the violation of which render the product or item in question “misbranded” or “adulterated,” which in turn triggers the FDCA’s strict criminal liability provisions.

Although most such FDCA crimes are chargeable as misdemeanors (which carry a maximum prison sentence of one year and a maximum fine of $100,000), some violations may be charged as felonies, and as such may subject an individual defendant to lengthier incarceration. Indeed, under the FDCA’s two-strikes rule, the second violation of a strict liability offense may automatically be charged as a felony without proof of the defendant’s actual intent.³

Historically, the FDCA’s criminal provisions have been used in the business context to hold companies accountable by imposing criminal fines in cases where they sold adulterated or misbranded products where the violations were unintentional or inadvertent. Individuals, including business executives and owners, have also been held accountable criminally for regulatory violations within their organizations, even absent personal knowledge (e.g., United States v. Dotterweich, 320 U.S. 277 (1943)). Company executives and/or owners have found themselves charged with strict liability crimes merely based on their role in the business and the conclusion that they should have known that the company was violating the law, not on any act that they personally committed. (See United States v. Park, 421 U.S. 658 (1975)). This latter concept is sometimes referred to as the Park doctrine or the responsible corporate officer (RCO) doctrine.

The EO’s directive to disfavor strict liability and prioritize civil or administrative enforcement could lead the FDA to reevaluate its approach to referring FDCA violations to the U.S. Department of Justice (DOJ) for prosecution. The FDA may need to justify any continued use of strict liability theories or shift toward requiring proof of intent in all instances of a regulatory violation, potentially reducing the risk of criminal liability for unintentional violations. This EO also may impact use of the Park doctrine, although it remains to be seen how the administration will approach its application in light of this new EO.

On top of the EO’s likely effect of dampening the FDA’s enthusiasm for making criminal referrals, the Consumer Protection Branch (CPB), the DOJ component that historically was responsible for investigating and prosecuting violations of the FDCA, is being disbanded and its prosecutors reassigned to other units within DOJ.⁴ A source at the DOJ has communicated that the branch will be disbanded by the end of DOJ’s fiscal year, on September 30, 2025.⁵

Additional Hurdles to Imposing Strict Liability for Regulatory Violations

The EO not only explicitly disfavors prosecutions on a strict liability basis and imposes the additional bureaucratic steps described above, it also announces that regulations that trigger potential strict criminal liability constitute “significant regulatory action.” This announcement is significant insofar as it subjects agency regulations that carry criminal consequences for violations on a strict liability basis to the requirements of another, earlier executive order (EO 12866 of Sept. 30, 1993).

The 1993 Executive Order 12866, titled “Regulatory Planning and Review,” requires pre-enactment review of significant regulatory actions by OMB’s OIRA. The May 9, 2025, EO specifies that all such regulations — both existing and proposed regulations — that impose criminal penalties without requiring proof of intent shall be submitted to OIRA for the review required by EO 12866.⁶

Presumably, a defendant charged with a strict liability offense based on a regulatory violation that has not undergone this review may appeal within DOJ that the prosecution should be dismissed on the grounds that the agency in question did not first satisfy the requirements of EO 12866. If that route is unsuccessful, they may also have grounds to challenge the prosecution in court on that same basis.⁷ However, it is uncertain how courts would view such a challenge.

Practical Implications and Next Steps

Businesses and executives in FDA-regulated industries should monitor the FDA’s forthcoming guidance and reports to understand how the agency will adjust its enforcement priorities. The emphasis on mens rea and transparency may provide opportunities to advocate for clearer regulations and reduce criminal exposure. However, until the FDA issues its guidance and reports, strict liability provisions under the FDCA remain in effect (albeit with new potential defensive arguments based on EO 12866), and compliance with existing regulations is critical. Companies should review their compliance programs to ensure they address both intentional and unintentional violations, while staying alert for further developments as agencies implement the EO’s requirements. Legal counsel can assist in navigating these changes and engaging with the FDA during this regulatory shift.