What the Dissolution of DOJ’s Consumer Protection Branch Means for Future Life Sciences and Consumer Protection Enforcement

The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and criminal enforcement of consumer protection laws, most notably the Food, Drug, and Cosmetic Act (“FDCA”), CPB’s rushed dismantling raises significant questions about how future DOJ enforcement actions will be prioritized, coordinated, and executed.

This development represents a sea change in the federal enforcement landscape. While DOJ insists that enforcement will continue under other divisions, the loss of its centralized, expert-led component will likely produce a fragmented and uneven enforcement approach that heightens legal risk and uncertainty for industry. What was once a predictable, focused enforcement unit with well-established institutional knowledge may now give way to a patchwork of local and regional prosecutions marked by variability in quality, strategy, and civil and/or criminal theories of liability.

Unwinding a Half-Century of Enforcement Expertise

For over 50 years, CPB has occupied a unique space in the Department of Justice, bridging criminal and civil enforcement and coordinating closely with the Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Federal Trade Commission (“FTC”), the Consumer Product Safety Commission (“CPSC”), and other regulatory bodies. It has played a lead role in the DOJ’s most high-profile cases involving prescription opioids, adulterated and misbranded drugs and medical devices, dietary supplements, tainted food products, and dangerous consumer products. It has also often acted as an investigatory partner in cases involving violations of the False Claims Act tied to FDA-regulated products.

CPB attorneys are especially proficient in navigating the complexities of the FDCA, the FTC Act and regulations, and the Consumer Product Safety Act. And its work is not limited to after-the-fact enforcement; CPB attorneys also help obtain industry-altering consent decrees that often shape compliance programs across the nation.

Importantly, CPB also helps assure centralized, coordinated enforcement strategies across districts. It enables DOJ to respond swiftly and coherently to emerging threats, such as opioid abuse, adulterated or unapproved drugs, and dangerous and deceptive marketing practices. When outbreaks occur or enforcement priorities shift in response to threats to public health and safety, CPB can quickly deploy resources and expertise without needing to rely on disparate regional offices.

One example is CPB’s growing focus in combatting the escalating threat of counterfeit pharmaceuticals. These include fentanyl-laced fake pills disguised as legitimate medications, illicit amphetamines, and counterfeit versions of high-demand drugs like Ozempic. CPB’s involvement in these cases ensured sophisticated legal strategies that integrated FDCA violations, criminal fraud statutes, other criminal and civil statutes, and international coordination to dismantle international supply chains. With CPB’s closure, DOJ’s seamless coordination with DEA, FDA, FTC, and other regulatory agencies will be slowed or lost altogether.

The Increased Risks of Decentralized Enforcement

With CPB’s dissolution, its responsibilities will be dispersed among DOJ divisions, components, and individual U.S. Attorneys’ Offices. This includes, in part, the mass reassignment of CPB’s 200-plus attorneys and staff. For instance, the Branch’s criminal portfolios — and presumably some of the CPB trial attorneys who handle them — will be moved to the DOJ Criminal Division’s Fraud Section. The decision to disperse criminal consumer protection cases across the larger Fraud Section, rather than create a dedicated unit (as the Criminal Division plans to do with a new Tax Section), risks diluting the expertise and focus devoted to these matters.

Another sizable portion of CPB’s staff will likely stay within the DOJ’s Civil Division, getting reassigned to other civil litigation branches. Notably, CPB lawyers who primarily handled defensive litigation for FDA (e.g., defending the agency in Administrative Procedures Act challenges) will likely be transferred to the Federal Programs Branch where they will likely have to split their time with other defensive litigation facing the Trump administration. Other civil enforcement work of CPB (such as civil FDCA cases and civil penalties cases under the FTC Act) might be absorbed by existing Civil Division components or possibly by U.S. Attorney’s Offices’ civil divisions. This dispersion of civil enforcement actions could make coordination more challenging. Previously, CPB served as a central hub for consumer-facing actions against corporations and individuals.

Whatever the final reallocation and reduction in resources, the result will likely include:

• Decentralized enforcement with various Main Justice components and U.S. Attorney’s Offices having greater latitude to initiate consumer protection actions without the aid of established subject-matter expertise.
• Inconsistent enforcement priorities that depend heavily on local prosecutorial discretion and political will.
• Uneven expertise following the loss of CPB’s institutional knowledge and specialized training along with an influx of newer or reassigned prosecutors bringing cases without fully grasping the technical nuances of drug and device regulation.

This presents dual-sided risk. On one hand, companies may find themselves facing more enforcement actions overall, as a wider array of prosecutors begin to target consumer protection issues. On the other hand, these actions may lack the coordination, consistency, and legal focus that CPB once provided. Cases that would have once been screened, developed, or managed by CPB will now proceed from local offices without the same rigor — possibly leading to investigative overreach, duplicative proceedings, or misapplication of regulatory standards. For national companies with complex product portfolios, this fragmentation increases both legal exposure and operational uncertainty.

This also creates the risk of more aggressive investigations initiated by prosecutors with limited understanding of FDA’s risk-based enforcement priorities or regulatory frameworks. The result could be a proliferation of “overcharged” cases, unnecessary parallel proceedings, and a heavier reliance on negotiated settlements simply to avoid the reputational and financial cost of enduring a disjointed process.

Preparing for the New Enforcement Environment

Companies should act now to adjust to this new, less predictable enforcement landscape. A few concrete steps can mitigate the risk:

• Reevaluate compliance programs to ensure they reflect current applicable guidance, address known enforcement hotspots (e.g., supply chain security, third-party distribution, labeling practices), and are designed to hold up under prosecutorial scrutiny. This includes documentation of decision-making processes, internal audits, and corrective actions — all of which can serve as critical evidence in avoiding or resolving enforcement.
• Map risk across regions. With Main Justice components and U.S. Attorney’s Offices likely to act more independently, firms should assess where their manufacturing, marketing, or distribution activities intersect with higher-risk jurisdictions and be ready for inquiries that emerge from unfamiliar quarters.
• Prepare for politicized enforcement. Companies manufacturing politically sensitive products must be prepared not only with sound science, but with transparent, defensible communications strategies and documentation showing good-faith regulatory compliance. This includes robust training of field staff, clear internal policies, and a crisis communication plan that anticipates media or Congressional attention.
• Engage the right counsel. Selecting experienced outside counsel has never been more critical. Companies navigating this new enforcement regime should look for firms or individuals with:
  • Combined criminal and civil defense capabilities: Many consumer protection statutes (like the FDCA) can trigger either type of case — or both. Counsel must understand how civil regulatory issues can escalate into criminal charges.
  • Deep knowledge of applicable regulations: Prosecutors without CPB’s backing may misinterpret or overreach in applying specialized regulations (such as those from FDA or CPSC). Counsel must know the science, the law, and the enforcement history to push back effectively.
  • Main Justice and United States Attorney’s Office connections: With more cases likely to originate from diverse Main Justice components and U.S. Attorney’s Offices, counsel should have relationships with both Main Justice and regional prosecutors. This enables strategic escalation or resolution depending on the venue.

Final Thoughts

The disbanding of CPB is more than a bureaucratic reshuffling. It’s a bellwether of a less centralized, more fragmented enforcement model that will shape how the life sciences and consumer products industries interact with the federal government for years to come.

Companies must take this moment seriously. With decentralized decision-making, more politically charged investigations, and less consistent application of law, the stakes are higher and the margin for error smaller. Thoughtful preparation, a strengthened compliance posture, and the right legal team are essential to staying ahead of what could be a volatile new enforcement era.