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On December 2, 2025, the Department of Justice ("DOJ") published a website for a dedicated Health & Safety Unit ("HSU") within the Criminal Division's Fraud Section. According to DOJ's description, the new unit is designed to centralize and elevate the Department's criminal enforcement efforts where corporate misconduct risks serious harm to patients, consumers, or workers. The establishment of HSU follows the disbanding of the Civil Division's Consumer Protection Branch (as we discussed in our September 2025 Legal Update) and the transfer of multiple experienced former Consumer Protection Branch prosecutors to the Criminal Division's Fraud Section. By institutionalizing this capability within the Fraud Section, DOJ has signaled that health- and safety-related misconduct—particularly where it intersects with fraud, obstruction, and false statements—remains a DOJ priority and will continue to receive nationwide attention, backed by the full resources of the Criminal Division.
Role and Purpose
The HSU will investigate and prosecute criminal schemes that jeopardize health and safety, including criminal offenses under the Food, Drug, and Cosmetic Act ("FDCA") involving "food, prescription medications and other drugs, counterfeit pills, medical devices, dietary supplements, and tobacco." The unit's scope, as described by DOJ, spans misconduct involving product quality and safety, integrity of safety data and certifications, and failures in systems, controls, or disclosures that conceal or perpetuate safety risks. The unit also "brings criminal enforcement actions under the Consumer Product Safety Act, the Federal Hazardous Substances Act, and related statutes" and works with the Department of Transportation ("DOT") and DOT's National Highway Traffic Safety Administration ("NHTSA") to bring criminal actions. The unit is likely to serve as a hub for complex, multidistrict matters and to coordinate closely with US Attorneys' Offices and investigative partners in cases where safety harms are intertwined with fraud, concealment, or obstruction—as well as with the recently established Enforcement & Affirmative Litigation Branch of the Civil Division (also staffed by former Consumer Protection Branch trial attorneys), which now leads civil affirmative enforcement efforts related to statutes administered by the Food and Drug Administration ("FDA"), the Consumer Product Safety Commission ("CPSC"), and NHTSA.
Authority and Enforcement Approach
Housed within the Fraud Section, the HSU will draw on the Criminal Division's nationwide jurisdiction and its established tools for corporate enforcement. That includes charging authorities under Title 18 with the use of conspiracies, fraud, false statements, obstruction, and related offenses, as well as the full range of corporate resolution mechanisms—deferred and non‑prosecution agreements, monitorships where warranted, compliance undertakings, and the Department's Corporate Enforcement and Voluntary Self-Disclosure policies. DOJ's announcement underscores that the unit will leverage cross-agency expertise and pursue individual accountability. The unit is also likely to partner with other federal agencies, including the FDA, the CPSC, and NHTSA.
Practical Takeaways for Companies
The creation of this unit signals that criminal risk remains for companies operating in safety‑critical environments, including health care, life sciences, manufacturing, transportation, energy, consumer products, and any business with workplace or product safety obligations—notwithstanding the recent elimination of DOJ's Consumer Protection Branch. Companies should promptly assess whether safety risks are fully integrated into enterprise fraud and compliance frameworks, with particular attention to safety data integrity, quality systems, incident reporting and escalation, third‑party oversight, and board‑level governance of health and safety. The Fraud Section's involvement also reinforces the importance of timely, well‑documented internal investigations, calibrated remediation, and careful consideration of voluntary self‑disclosure in the event of potential criminal exposure related to safety harms or concealment.
Mayer Brown's multidisciplinary team is well-positioned to provide strategic legal counsel on the complex legal and compliance issues presented by actions brought by the newly-established Health & Safety Unit.
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