On May 9, 2025, President Trump signed an Executive Order titled “Fighting Overcriminalization in Federal Regulations.” The Order seeks to reduce the regulatory burden on Americans and prevent individuals from being criminally penalized for unknowingly violating complex regulations. In pursuit of these goals, the Order sets forth a policy “generally disfavor[ing]” strict liability crimes. Agencies are directed to consider “civil rather than criminal enforcement of strict liability regulatory offenses,” with criminal prosecution reserved for cases involving “persons who know or can be presumed to know what is prohibited or required by the regulation and willingly choose not to comply, thereby causing or risking substantial public harm.” The Order further directs agencies to complete several longer-term tasks, including preparing a report for the Office of Management and Budget containing a list of criminal offenses they or the U.S. Department of Justice (DOJ) enforce, and identifying whether the offenses have a mens rea requirement.
One of the statutes implicated by the Order is the Federal Food, Drug, and Cosmetic Act (FDCA), which imposes strict criminal liability for certain violations of the statute without regard to the defendant’s mental state. This alert considers the impact that a policy disfavoring strict liability prosecutions could have on FDCA criminal prosecutions of individuals and corporations.
Criminal Liability Under the Federal Food, Drug and Cosmetic Act
The FDCA imposes two levels of liability for most criminal violations of the statute. First, the FDCA authorizes misdemeanor liability for persons (defined to include corporations) who commit or cause the commission of a prohibited act, such as the introduction of misbranded or adulterated drugs into interstate commerce. 21 U.S.C. § 333(a)(1). No showing of intent is required for misdemeanor liability under the FDCA, “thus creating a form of strict criminal liability” under the statute. United States v. Watkins, 278 F.3d 961, 964 (9th Cir. 2002). FDCA misdemeanor liability includes the Park Doctrine (also referred to as the Responsible Corporate Officer Doctrine), which imposes strict criminal liability on a responsible corporate officer even where the officer was not personally involved in or aware of the underlying violation. See United States v. DeCoster, 828 F.3d 626, 632 (8th Cir. 2016).
Second, the FDCA authorizes felony liability for persons who commit certain prohibited acts “with the intent to defraud or mislead.” 21 U.S.C. § 333(a)(2). The FDCA’s felony intent element includes both the intent to defraud or mislead consumers and the intent to defraud or mislead the Food and Drug Administration (FDA) (by, for example, committing a prohibited act with the goal of interfering with or obstructing the FDA). While both misdemeanor and felony convictions can result in significant penalties for defendants, felony convictions carry greater penalties and can more readily give rise to serious collateral consequences, such as exclusion by the U.S. Department of Health and Human Services, FDA debarment, and FDA disqualification.
Strict Criminal Liability in Practice
DOJ is responsible for prosecuting criminal violations of the FDCA and litigating these cases in federal court. When making charging decisions in FDCA cases, prosecutors typically consult with the FDA and other relevant agencies, follow current DOJ policy, and exercise prosecutorial discretion—that is, prosecutors tailor their charging decisions to reflect case-specific facts and circumstances and do not mechanically adhere to the FDCA or other statutes.
While DOJ has brought many FDCA misdemeanor cases over the years, it has not typically pursued “pure” strict liability misdemeanors against defendants who genuinely lack criminal intent. Rather, DOJ has brought misdemeanor charges where there is at least some evidence of felony intent and against “persons who know or can be presumed to know what is prohibited or required by the regulation and willingly choose not to comply.” DOJ has frequently used the misdemeanor charging option to reach negotiated resolutions with culpable defendants. In these situations, the government may have significant evidence of felony intent, but the defendant is able to raise countervailing considerations based on any number of mitigating factors, ranging from evidentiary issues and litigation risk to policy considerations and alignment with prior charging decisions. A misdemeanor resolution in such a case provides a benefit to both the prosecutor and the defendant, as it offers a middle ground that facilitates a mutually acceptable and tailored resolution to the case at hand.
Implications for FDCA Criminal Prosecutions
Fewer resolutions and more felony indictments. DOJ’s Criminal Division recently identified FDCA violations and healthcare fraud as priorities under the current administration, raising the possibility of aggressive criminal enforcement in this space. Because DOJ prosecutors typically establish considerable evidence of felony intent in any FDCA case they seek to pursue, absent a misdemeanor option prosecutors could pursue more felony indictments than they have historically. That is, in the absence of any “middle ground,” DOJ could end up pursuing felony charges more frequently and in situations where it previously would have considered a negotiated misdemeanor resolution as an appropriate middle ground. As a result, the effect of the Order under the FDCA may be to swap rare instances of unknowing misdemeanor prosecutions for an increase in harsher, felony cases.
Disparate treatment for corporate and individual defendants. The lack of an FDCA misdemeanor option could impact corporate and individual defendants differently. For example, corporate defendants may seek the benefit of the DOJ Criminal Division’s recently revised Corporate Enforcement and Voluntary Self-Disclosure policy (CEP)—which offers a declination (meaning that the Criminal Division would not pursue criminal charges or a criminal resolution) to companies that self-disclose wrongdoing and cooperate in the government’s investigation.[1] Companies that do not self-disclose could find a more limited range of potential outcomes absent a misdemeanor charging option, though many companies may still be able to obtain deferred prosecution agreements (DPAs)[2] in appropriate scenarios. Because a DPA is not a criminal conviction, it provides a mechanism to resolve an investigation with far less exposure to certain collateral consequences (such as FDA debarment and HHS exclusion).
Individual defendants, on the other hand, have not customarily been candidates for DPAs in FDCA cases. Implementation of the Order, therefore, would place individuals in a situation where—absent a misdemeanor option—they might not have a middle ground by which to resolve a threatened FDCA charge. While individuals can self-disclose and cooperate with DOJ in an effort to avoid being charged, the framework governing individual self-disclosure is more piecemeal and less uniform than the corresponding policy for corporations. Given these considerations, individuals should cautiously navigate FDCA criminal investigations and carefully evaluate whether to seek a resolution or aggressively contest the government’s case.
Best Practices
While the Order does not put an end to strict liability under the FDCA, 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.
Companies, executives, and other individuals embroiled in FDCA investigations should consider the following principles in light of the developing regulatory landscape.
- Consider voluntary self-disclosure. Through its revised CEP, the Criminal Division has recalibrated its incentivizes for corporations to voluntarily self-disclose potential criminal wrongdoing in order to receive a declination. Companies that identify significant violations of the FDCA within their organizations should promptly consider the potential benefits and risks of self-reporting. Companies should specifically consider the possibility that, in the event of a DOJ investigation that arises without the company self-reporting, DOJ may not be willing to resolve the case with a misdemeanor charge. Individuals should similarly evaluate the pros and cons of self-disclosure and cooperation with DOJ in this context.
- Define and implement your defense strategy. For individuals and companies that find themselves involved in FDCA criminal investigations, it is important to evaluate your potential criminal exposure and define your defense strategy at an early stage. If the only foreseeable outcome is a felony charge, then a strategic decision should be made about whether and how to engage with the government in the absence of a misdemeanor charging option.
- Leverage all possible defenses. FDCA criminal prosecutions raise challenging and complex issues. These cases often present nuanced legal questions, involve substantial scientific and medical evidence, raise significant policy implications, and involve many government and third-party stakeholders. It is critical for subjects and targets of FDCA investigations to look beyond the four corners of the statute and aggressively consider all potential avenues for defense, particularly if DOJ offers fewer options for resolving criminal liability.
McGuireWoods is nationally recognized for its healthcare and life sciences, litigation and enforcement capabilities. The team is comprised of former high-level federal prosecutors that are experienced at managing every stage of complex DOJ investigations and litigation, both criminal and civil, and helping clients navigate the intricacies of healthcare and FDA-related laws. For assistance on any matter, reach out to the authors of this alert.
[1] It has been reported that the criminal FDCA work historically handled by DOJ’s Consumer Protection Branch is being transitioned to DOJ’s Criminal Division. The CEP (which applies to the Criminal Division) would be applicable to FDCA criminal cases brought by the Criminal Division.
[2] A DPA is an agreement between DOJ and a defendant in which the government charges the defendant but agrees to seek dismissal of the charges so long as the defendant abides by certain terms and conditions (typically including payment of substantial financial penalties) for a specified period of time.