Contributors

Related

The U.S. Department of Justice (DOJ) has escalated its criminal enforcement efforts with the formation of the new Health & Safety Unit (HSU) within its Criminal Division’s Fraud Section, effective December 2, 2025. This critical development, following the consolidation of civil enforcement capabilities, signals an unmistakable intent: companies operating in health, safety, and consumer product sectors face unprecedented scrutiny and significantly heightened criminal risk.

The HSU is tasked with investigating and prosecuting violations of federal laws designed to safeguard public health and consumer safety. This launch is likely the result of establishing the Enforcement & Affirmative Litigation Branch and consolidating the Consumer Protection Branch from the Civil Division into the Fraud Section (see more details in our previous client alert on October 8, 2025), signaling DOJ’s intent to centralize and strengthen criminal enforcement of health and safety laws.

The HSU’s Sharpened Focus on Safety, Pricing, and Consumers

The HSU is charged with criminal enforcement of the Food, Drug, and Cosmetic Act (FDCA), including Misbranding Offenses under 21 U.S.C. § 331. It prosecutes a broad range of offenses involving food, prescription medications, counterfeit pills, medical devices, dietary supplements, and tobacco products. These efforts form a critical part of the infrastructure protecting the nation’s food and drug supply chain and will affect a broad spectrum of industries.

HSU works closely with the Food and Drug Administration (FDA) and other federal partners to pursue criminal actions against companies and individuals who engage in conduct such as:

  • Fail to maintain sanitary facilities
  • Distribute adulterated or misbranded food or drug products
  • Conceal safety-related information from FDA
  • Make significant misrepresentations to the public

These actions are no longer just regulatory hurdles; they are potential criminal liabilities.

The HSU will also investigate violations of the Consumer Product Safety Act (CPSA), the Federal Hazardous Substances Act (FHSA), and related statutes. The focus will be on companies and individuals who deliberately fail to report defects or hazards that pose an unreasonable risk of serious injury or death. This extends to critical collaborations with the Department of Transportation (DOT) and NHTSA, targeting those who conceal dangerous vehicle defects that endanger lives on our roads.

Further underscoring this shift, President Trump’s December 6, 2025, Executive Order, “Addressing Security Risks from Price Fixing and Anti‑Competitive Behavior in the Food Supply Chain,” directs DOJ and FTC to establish task forces to combat anti-competitive conduct. While focused on competition, this initiative reinforces the Administration’s overarching commitment to the integrity and safety of the U.S. food supply. Companies in the food and agriculture sectors must now anticipate a dual threat: heightened scrutiny of pricing alongside intensified health and safety enforcement.

Takeaways

  • Heightened Criminal Risk: DOJ’s new Health & Safety Unit signals increased criminal scrutiny for companies in sectors such as pharmaceuticals, medical devices, consumer products, automotive, and food and agriculture.
  • Civil Enforcement Realignment: The Enforcement & Affirmative Litigation Branch now leads civil affirmative enforcement under statutes administered by the FDA, FTC, CPSC, DEA, and NHTSA, while the Federal Programs Branch will no longer support NHTSA defect enforcement cases.
  • Strengthen Compliance Programs: Companies should review and enhance safety reporting protocols, product quality controls, and escalation procedures to ensure timely disclosure of risks. Familiarity with DOJ’s voluntary self-disclosure programs should be reviewed and considered (see our previous client alert on August 28, 2025).
  • Anticipate Congressional Investigations on Key Issues: Companies that receive congressional inquiries, investigative subpoenas, or any other form of compulsory process from federal or state authorities should treat the matter with the highest level of seriousness. It is critical to promptly assess the scope and legal basis of the request and to manage the response in a deliberate, coordinated, and well-documented manner. Doing so helps safeguard the organization’s interests while minimizing legal, reputational, and operational risks.
  • Cross-Agency Collaboration: Expect increased coordination between DOJ components and agencies such as FDA, CPSC, DOT/NHTSA, and FTC, amplifying enforcement reach and complexity.

Womble Bond Dickinson (US) LLP’s White Collar Defense and Criminal Investigations Team navigates domestic and international clients in all manner of white collar, regulatory, corporate and congressional investigations. Our team includes a distinguished roster of veteran defense attorneys, former federal prosecutors and U.S. Attorneys who served at the highest levels of the Department of Justice and at leading United States Attorneys’ Offices. Our team includes Chambers Ranked (Band 1) lawyers and alumni of the U.S. Department of Justice, the SEC’s Enforcement Division, the U.S. Senate, House of Representatives, and in-house compliance specialists of publicly traded companies.

 

Recommended