Core False Claims Act Violations Lead DOJ Criminal Enforcement Priorities

In a significant development for companies operating in highly regulated sectors, the Department of Justice’s Criminal Division has outlined ten “high-impact” areas that will serve as focal points for criminal enforcement actions through 2025 and beyond. The May 12 memo from the head of the Criminal Division signals an intensified approach to white-collar crime, with particular emphasis on areas that have traditionally fallen under False Claims Act (FCA) civil investigations.

Three priority targets stand out as particularly relevant for businesses already navigating FCA compliance. Topping the list is “waste, fraud, and abuse, including health care fraud and federal program and procurement fraud that harm the public fisc.” This category has historically represented a cornerstone of FCA enforcement, consistently generating hundreds of millions in annual civil recoveries for the federal government.

The second priority—”trade and customs fraud, including tariff evasion”—represents a newer focus area for DOJ’s FCA enforcement efforts. Earlier this year, the Justice Department publicly committed to allocating substantial resources toward using the FCA to police violations of customs laws, signaling an expansion of traditional enforcement boundaries into international commerce.

Also featured prominently is a focus on “violations of the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act (FDCA), including the unlawful manufacture and distribution of chemicals and equipment used to create counterfeit pills laced with fentanyl, and unlawful distribution of opioids.” This priority continues the Department’s established pattern of targeting the opioid distribution chain but potentially signals an expanded focus to include equipment manufacturers in the enforcement crosshairs.

Legal experts note that these priorities indicate DOJ’s evolving strategy of pursuing parallel tracks of civil FCA liability and criminal prosecution in high-priority areas. For healthcare providers, government contractors, pharmaceutical companies, and businesses subject to U.S. customs regulations, this approach means facing potential simultaneous civil and criminal investigations for the same underlying conduct.

The enforcement landscape has become increasingly complex with recent changes to DOJ’s policies regarding self-disclosure, cooperation, and remediation. Companies now face a critical decision matrix when potential violations are discovered internally—with significantly different outcomes possible depending on how they respond to government scrutiny.

“We’re seeing a deliberate alignment of civil and criminal enforcement priorities,” noted one former DOJ official who requested anonymity to discuss the Department’s strategy. “This creates a more comprehensive enforcement approach but raises the stakes dramatically for regulated entities.”

For pharmaceutical distributors and manufacturers, the memo’s language suggests particular scrutiny of equipment that could be used in illicit fentanyl production. This represents a potential upstream expansion of liability that could affect companies previously considered peripheral to opioid enforcement actions.

Healthcare providers should take special note of the prioritization, as healthcare fraud has consistently represented the largest category of FCA recoveries. In fiscal year 2024 alone, the government recovered over $1.8 billion from healthcare fraud cases, accounting for approximately 60% of all FCA settlements and judgments.

The customs and tariff fraud prioritization comes amid heightened trade tensions and increased scrutiny of global supply chains. Companies importing goods into the United States face enhanced compliance risks as the DOJ appears poised to leverage the FCA’s powerful treble damages provisions against importers allegedly evading proper duties and tariffs.

Industry compliance officers across affected sectors are reviewing their existing protocols in response to the memo. The enhanced focus on criminal enforcement underscores the need for robust compliance systems, careful legal interpretations, and proactive risk assessment in highly regulated industries.

For companies operating in these priority enforcement areas, the memo serves as a clear warning: a compliance misstep now carries potentially heavier consequences than ever before, with the full weight of both civil and criminal enforcement mechanisms poised to respond to alleged violations.