Client Alert: DOJ Fraud Section Establishes New Health and Safety Unit
KEY TAKEAWAYS
- The U.S. Department of Justice (DOJ), Criminal Division’s Fraud Section has established a new Health and Safety Unit (HSU) to investigate and prosecute criminal violations of federal public health and safety laws.
- The creation of the HSU signals heightened criminal scrutiny and enforcement risk for companies and individuals operating in health, safety, and consumer product related industries.
BACKGROUND
On December 2, 2025, DOJ announced the formation of the HSU within the Fraud Section. According to the Fraud Section, the HSU will pursue criminal cases involving failures to maintain sanitary conditions, the distribution of adulterated or misbranded food and drugs, concealment of safety-related information from the Food and Drug Administration (FDA), and material misrepresentations affecting public health and safety.
The HSU was created following the dissolution of the Civil Division’s Consumer Protection Branch (CPB) earlier this year. Former CPB attorneys were reassigned to the Fraud Section to help create the HSU, which now serves as DOJ’s central hub for criminal enforcement of federal health and safety laws. The HSU will coordinate with U.S. Attorneys’ Offices and federal regulators on complex, multi-district investigations and will work in parallel with the Civil Division’s Enforcement and Affirmative Litigation Branch, which now leads civil enforcement of statutes administered by the FDA, Consumer Product Safety Commission (CPSC), Department of Transportation (DOT), and the National Highway Traffic Safety Administration (NHTSA).
HEALTH AND SAFETY UNIT: SCOPE AND PRIORITIES
As the Fraud Section’s fourth specialized unit, the HSU can bring criminal charges under Title 18 (including fraud, false statements, obstruction, and conspiracy) and Title 21 (including misbranding offenses). It will work closely with the FDA, DOT, and NHTSA to enforce statutes such as the Consumer Product Safety Act (CPSC) and the Federal Hazardous Substances Act.
HSU’s priorities include:
- Food safety: contamination, adulteration, and sanitation failures.
- Pharmaceuticals and medical devices: counterfeit products, falsified data, and quality system violations.
- Consumer products: dangerous or defective products regulated by the CPSC or FHSA.
- Transportation safety: concealment of vehicle defects and failures to report safety hazards, in coordination with DOT and NHTSA.
- Tobacco and dietary supplements: misbranding, unlawful distribution, and regulatory concealment.
IMPLICATIONS FOR COMPANIES AND INDIVIDUALS
Companies and individuals involved in healthcare, life sciences, manufacturing, transportation, and consumer products should anticipate increased criminal exposure for safety failures, regulatory concealment, and misleading submissions to regulators. DOJ is expected to closely scrutinize quality, safety, and compliance systems, with continued emphasis on cooperation and voluntary self-disclosure under its Corporate Enforcement Policy. Companies should reassess whether safety risk management is fully integrated into enterprise compliance programs and subject to appropriate board-level oversight.
CONCLUSION
The establishment of the HSU reflects DOJ’s expanded use of criminal investigations and prosecutions to address public health and safety violations. Conduct traditionally viewed as regulatory noncompliance may now be pursued as criminal misconduct. Companies operating in these industries should reevaluate their compliance programs, policies, and procedures to align with DOJ’s heightened expectations for safety, transparency, and accountability. Sher Tremonte LLP will continue to monitor developments related to DOJ’s priorities. If you have any questions, please contact us. Written by Brian Kidd and Taylor Fontan.