Key Takeaways

• The DOJ has revised two sections of the Justice Manual—Section 1-19.000 (Limitations on Issuance and Use of Guidance Documents) and Section 4-4.111 (DOJ Dismissal of a Civil Qui Tam Action)—signaling a renewed emphasis on fair notice and transparent enforcement under the False Claims Act.
• The guidance document revisions place strict limitations on how guidance can be used to establish noncompliance in FCA enforcement actions.
• The qui tam dismissal revisions direct DOJ attorneys to continually reassess whether to seek dismissal of qui tam actions that lack legal or factual merit, even after the government has declined to intervene.

I.                   Overview

On September 18, 2026, the U.S. Department of Justice (“DOJ”) announced revisions to department policy governing False Claims Act lawsuits. The revisions target two areas of the Justice Manual: Section 1-19.000, which governs the issuance and use of agency guidance documents, and Section 4-4.111, which addresses the DOJ’s authority to seek dismissal of qui tam actions filed by private whistleblowers.

Associate Attorney General Stanley E. Woodward Jr. framed the changes as part of a broader effort to ensure enforcement accountability: “The Department of Justice should enforce the law, not make law through enforcement.” The revisions signal both a tightening of the DOJ’s internal enforcement standards and a continued willingness to deploy the FCA as a primary enforcement tool.

II.                Section 1-19.000: New Limits on the Use of Guidance Documents in FCA Enforcement

The revised Section 1-19.000 reinstates and builds upon DOJ policy first established in 2017. Under the new framework, DOJ components are prohibited from issuing guidance documents that create rights or obligations binding on parties outside the Executive Branch, and they may not issue guidance that establishes binding standards from which the DOJ would determine a party’s regulatory or statutory compliance. Critically, the revision provides that DOJ criminal and civil enforcement actions—including FCA actions—cannot be based solely on noncompliance with an agency’s guidance documents.

The revisions, however, do not eliminate guidance documents from the enforcement toolkit entirely. DOJ attorneys may still use a party’s awareness of a guidance document describing a statute or regulation as evidence of that party’s knowledge of the law. Attorneys may also use a guidance document as probative evidence of a party’s compliance with industry or professional standards, or to establish the existence of a duty.

For regulated entities this revision provides a layer of protection against FCA enforcement actions premised primarily on the violation of sub-regulatory guidance. The updated policy makes it harder for the DOJ to use informal agency pronouncements as the primary standard of compliance in FCA litigation. That said, awareness of guidance remains relevant because the DOJ can still use it as evidence of knowledge—a critical element of FCA scienter.

III.             Section 4-4.111: Expanded Framework for Dismissal of Qui Tam Actions

The revised Section 4-4.111 addresses the DOJ’s authority to seek dismissal of qui tam actions  under the FCA. Under the revised policy, DOJ attorneys are now directed to revisit dismissal assessments “as appropriate,” even after the government has initially declined to intervene in a qui tam action. The DOJ stated it will “exercise this authority judiciously . . .  seeking dismissal of qui tam actions that lack legal or factual merit.”

The revisions largely track the prior DOJ policy as of October 2021, including the requirement that the Assistant Attorney General or a U.S. Attorney must provide prior approval before the DOJ seeks dismissal of a qui tam. And the set of factors that can serve as a basis for dismissal remains in place.

Even with the dismissal factors staying in place, this revision is significant. The government’s decision to decline intervention in a qui tam does not end the case, relators can continue to litigate the action independently. The updated policy makes clear that DOJ attorneys should treat the dismissal question as an ongoing one, not merely a threshold determination made at the time of the initial intervention decision.

For defendants in qui tam actions, this creates a potential avenue for relief from meritless cases. If the DOJ determines that a qui tam action lacks legal or factual merit after declining to intervene, it can move to dismiss. For relators and their counsel, the revisions serve as a reminder that the DOJ will actively police the quality of qui tam filings and may seek to dismiss cases it views as lacking in substance or duplicative of existing government efforts.

IV.             Recommended Actions

Organizations subject to FCA exposure should consider the following:

1. Understand the Distinction Between Guidance and Binding Law. The revised Section 1-19.000 reinforces that agency guidance documents do not carry the force of law for FCA purposes. Organizations should ensure their compliance programs are grounded in the requirements of underlying statutes and regulations, while remaining mindful that awareness of guidance can still be used as evidence of knowledge.
2. Monitor Qui Tam Developments. The revised Section 4-4.111 signals that the DOJ will take a more active role in dismissing meritless qui tam actions. Organizations that are defendants in declined qui tam cases should evaluate whether the revised dismissal framework and other case-specific developments may provide grounds for seeking DOJ support in moving to dismiss.

The FCA enforcement landscape continues to evolve rapidly. Organizations should stay informed of further developments in DOJ policy and enforcement priorities. If you have questions about these Justice Manual revisions or their implications for your organization, please contact us.