On May 9, 2025, President Trump issued an executive order titled “Fighting Overcriminalization in Federal Regulations” (the Order), aimed at reducing criminal enforcement of federal regulatory offenses in general and strict liability offenses, in particular.https://www.whitehouse.gov/presidential-actions/2025/05/fighting-overcriminalization-in-federal-regulations/. The Order also includes several requirements for agencies to increase transparency around the criminal offenses they enforce. The action renews President Trump’s efforts from his first administration, which issued a similar executive order, and which was subsequently revoked by the Biden administration.https://www.federalregister.gov/documents/2021/01/22/2021-01645/protecting-americans-from-overcriminalization-through-regulatory-reform and https://www.federalregister.gov/documents/2021/05/19/2021-10691/revocation-of-certain-presidential-actions-and-technical-amendment
At a high level, the Order reflects a shift in federal enforcement policy regarding criminal regulatory offenses, disfavoring criminal enforcement in favor of civil or administrative enforcement. It takes specific aim at “strict liability offenses,” which do not contain an intent requirement and criminalize the conduct alone. The Order expressly directs that enforcement of these offenses is “disfavored” and that criminal enforcement should instead prioritize instances where defendants knew that their conduct was unlawful.
The Order also seeks to increase transparency around criminal regulatory offenses in general, and strict liability offenses in particular. Accordingly, the Order directs agencies, in consultation with the Attorney General, to create a report listing the criminal regulatory offenses they enforce and the state-of-mind requirements and penalties for those offenses. Agencies must post that list on their webpages and update it annually. Criminal enforcement of any provision not on an agency’s list is “strongly disfavored,” and inclusion will be considered in decisions related to referral for prosecution and the initiation of proceedings.
In addition, the Order also requires agencies to publish guidance outlining their approach to criminal regulatory offenses within 45 days following publication of the Order. That guidance must clarify that in considering referral to the Department of Justice for criminal prosecution, the agency should consider certain factors, such as “(a) the harm or risk of harm . . . caused by the alleged offense . . . (b) the potential gain to the putative defendant that could result from the offense . . . (c) whether the putative defendant held specialized knowledge, expertise, or was licensed in an industry related to the rule or regulation at issue . . . [and] (d) evidence, if any is available, of the putative defendant’s general awareness of the unlawfulness of his conduct as well as his knowledge or lack thereof of the regulation at issue.”
Finally, the Order directs agencies to take several steps aimed at decreasing the overall number of strict liability offenses. For example, the Order instructs agencies to investigate whether they have statutory authority to adopt background state-of-mind requirements that would apply to provisions that otherwise do not specify state-of-mind requirements. If authority exists, the agencies are also instructed to develop a plan to adopt the background state-of-mind requirements. Additionally, agencies must work with the Attorney General to address whether the state-of-mind requirements for the offenses they enforce are appropriate.
These efforts to decrease the number of strict liability regulatory offenses also apply to the rulemaking process. Moving forward, all new proposed and final rules must expressly state if the rule results in a criminal regulatory offense, identify the authorizing statute, and specify the state-of-mind requirement for each element of the offense. Proposed or final rules which include strict liability offenses will be classified as “significant regulatory actions” and subjected to additional review.
The Order clarifies that it does not apply to enforcement of laws or regulations relating to immigration, national security, or defense.
One area where the Order will impact enforcement is under the Federal Food, Drug, and Cosmetic Act (FDCA).21 U.S.C. § 301 et seq. Section 333(a)(1) of the FDCA sets forth misdemeanor liability for a violation of Section 331 of the FDCA (which, among other things, prohibits the introduction of any adulterated or misbranded food, drug, device, tobacco product, or cosmetic into interstate commerce). Under this provision and the caselaw interpreting it, United States v. Park, 421 U.S. 658 (1975) and United States v. Dotterweich, 320 U.S. 277 (1943), corporations or individuals can be held criminally liable for violations of the FDCA, including the regulatory provisions enforcing it, even absent a showing of intent to engage in wrongdoing.
This Order reduces the likelihood of criminal misdemeanor enforcement under the FDCA. For one, the Order explicitly disfavors criminal enforcement of any provision lacking a mens rea requirement. In addition to that general policy, the Order also requires the agency to consider whether the putative defendant had knowledge of the unlawfulness of their conduct when making a referral for prosecution. In practice, this may mean that misdemeanor plea agreements under the FDCA, which are currently used to settle criminal investigations, may be less prevalent. Moving forward, the US Food and Drug Administration will also be required to examine whether it has statutory authority to provide for alternate state-of-mind provisions and, if so, to provide justification for deviation from that standard. Notably, enforcement of the felony provision of the FDCA will be unaffected by the Order, since that provision already requires an intent to defraud or mislead.21 U.S.C. § 333(a)(2).
While the Order has a broad scope and contemplates sweeping changes, effects in practice beyond the FDCA may be limited. That is because statutory offenses that contemplate criminal liability premised on regulatory violations largely contain mens rea requirements. For instance, the US Fish and Wildlife Service (Service) has established regulations under the Lacey Act,16 U.S.C. §§ 3371-3378.
Yet another example is the Controlled Substances Act (CSA)21 U.S.C. § 801 et seq. and its implementing regulations. For instance, the Drug Enforcement Administration (DEA) enacted a regulation that requires entities registered with the DEA to distribute, manufacture, and dispense controlled substances to “notify” the DEA “in writing” if it “discovers the theft or significant loss of any controlled substances.”21 C.F.R. § 1301.76(b). Yet, the CSA’s regulations do not impose criminal penalties for noncompliance with this regulation. Instead, the CSA separately imposes criminal liability only if the government can prove the CSA registrant knowingly or intentionally failed to file the record with the DEA.21 U.S.C. § 842(a)(5); id. § 842(c)(2)(A). Accordingly, federal regulations themselves often may not be independently criminal offenses — criminal penalties may attach only if the defendant violates the text of the statute with the applicable mens rea.
Following this Order and the Administration’s policy shift, individuals and businesses can anticipate a reduction in criminal enforcement for regulatory violations, with a rise in civil and administrative actions instead. However, the Order’s overall impact may be limited, as most regulatory violations that could lead to criminal liability typically involve mens rea requirements.