DOJ Revises Justice Manual To Strengthen False Claims Act Enforcement

On September 18, 2026, the Department of Justice announced two revisions to the Justice Manual aimed at sharpening the standards governing False Claims Act (FCA) enforcement. The changes address two distinct enforcement levers: the Department’s reliance on sub-regulatory guidance to establish liability, and its use of dismissal authority over qui tam actions in which the government has declined to intervene. Both revisions are framed by Department leadership as efforts to promote fair notice, transparent enforcement, and more efficient use of government resources.

What Changed

1. Limits on sub-regulatory guidance: The first revision reinstates and builds on the Department’s 2017 policy providing that sub-regulatory guidance, including agency letters, manuals, bulletins, and similar materials that lack the force and effect of law, cannot itself create binding legal obligations beyond those already established by statute or regulation. The policy had been rescinded in 2023 and is now being restored and revised. Under the revised policy, the Department states it will hold individuals and businesses accountable only for violating binding legal or contractual obligations, not for departing from guidance that does not carry independent legal force. The Department has stated that this also directs its enforcement resources toward violations of binding obligations, rather than technical or interpretive disputes over non-binding guidance. Under the new provisions, the Department may still use sub-regulatory guidance as evidence of scienter, knowledge, or generally accepted standards of practice.
2. Heightened review of qui tam dismissal: The second revision addresses cases brought by private relators (qui tam actions) in which the government declines to intervene. For many years the Justice Manual has included guidance on when the Department might exercise its statutory authority to move to dismiss qui tam actions, and the factors it will consider are largely unchanged. The revised guidance directs the Department to affirmatively consider exercising its statutory dismissal authority not only at the outset, but also to revisit that assessment as the litigation progresses. This formalizes a practice announced by DOJ earlier this year. The Department has indicated it will exercise this authority “judiciously,” with particular emphasis on seeking dismissal of qui tam suits that lack legal or factual merit, in order to concentrate government resources on matters that serve the interests of the United States.

Why This Matters

For companies operating in heavily regulated sectors, including healthcare, financial services, government contracting, and life sciences, these revisions could meaningfully affect both enforcement risk and litigation strategy under the FCA:

• Guidance-based liability theories become harder to sustain. Where the government’s theory of falsity or materiality rests on an agency’s sub-regulatory guidance document rather than a statute or regulation, defendants now have a clearer, Department-endorsed hook to challenge that theory at the outset of a case or in settlement negotiations.
• Non-intervened qui tam defendants have a new avenue to press for dismissal. Because the Department is now directed to revisit its dismissal posture throughout the litigation, not only at the intervention decision, defendants facing weak or stale relator-driven suits have a stronger basis to petition the Department to exercise its dismissal authority even after the case has been pending for some time. Relators are not bound by the Department’s position on when sub-regulatory guidance can be used, but the Government may use its dismissal authority to effectively force that position onto relators.

The practical impact of these revisions, however, will depend on implementation. The Justice Manual revisions announced set out policy, not a change to the FCA’s statutory text. Their effect will play out case-by-case as U.S. Attorney’s Offices and the Civil Division apply the new standards. Companies with pending qui tam exposure should watch closely for how individual line attorneys apply the revised dismissal factors.

Next Steps

Companies currently under investigation, negotiating an FCA settlement, or defending a non-intervened qui tam action should consider reviewing the government’s theory of liability to identify whether it rests on sub-regulatory guidance rather than a binding statute or regulation, and should evaluate whether pending non-intervened cases warrant a renewed request that DOJ exercise its dismissal authority under the revised standard.