U.S. Department of Justice Announces Major Justice Manual Revisions on Sub-Regulatory Guidance and Dismissals of False Claims Act Qui Tams

In a move with substantial implications for federal enforcement generally and the False Claims Act (FCA) in particular, the U.S. Department of Justice (the Department) on September 18, 2026, announced major revisions to two sections of the Justice Manual: (1) Section 1-19.000, which governs the issuance and use of guidance documents, and (2) Section 4-4.111, which governs the Department’s authority to seek dismissal of FCA qui tams. Reverting to the Department’s position in the first Trump administration, the revisions to Section 1-19.000, as the Department explained, “reinstate[] and build[] upon [the Department]’s 2017 policy that sub-regulatory guidance cannot impose legal obligations beyond those established by statute or regulation.” And the revisions to Section 4-4.111 provide that the Department will evaluate every FCA qui tam for potential dismissal by the Department under 31 USC Section 3730(c)(2)(A). The Department framed the changes as strengthening its fight against fraud through clearer standards that promote fair and effective enforcement.

Revisions on Sub-Regulatory Guidance

In a subtle but telling change, the Department retitled Section 1-19.000 on guidance documents from “Principles for Issuance and Use of Guidance Documents” to “Limitations on Issuance and Use of Guidance Documents.” The change signals a more restrictive view of sub-regulatory guidance that aligns with the Department’s announced “commitment to fair notice and the rule of law.”

Limitations on Issuance (§ 1-19.100)

Citing President Bill Clinton’s Executive Order 12,866, the revisions establish a new definition of “guidance document”: “any agency statement of general applicability and future effect that sets forth a policy on a statutory, regulatory, or technical issue or an interpretation of a statute or regulation, other than a substantive action by an agency that promulgates or is expected to promulgate a regulation.” The prior Manual definition was notably simpler: “a statement of general applicability issued by an agency to inform the public of its policies or legal interpretations.” In a footnote, the Justice Manual now carefully excludes from the new definition of “guidance document” (1) documents issued in adjudicatory actions that do not bind anyone beyond the parties; (2) documents informing the public of the agency’s enforcement priorities or factors considered as to prosecutorial discretion; (3) internal directives, memoranda, or training materials on agency personnel’s duties, on positions taken by an agency in litigation, or on legal advice from the Department; and (4) documents shared with state, local, and tribal law enforcement agencies to assist their cooperation with the Department. 

The Justice Manual now deploys a host of requirements for the Department’s issuing guidance documents. Department components must

• identify the documents as guidance and disclaim any force or effect of law
• clearly state that the documents have no legally binding effect on persons or entities outside the Executive Branch and may be rescinded in the Department’s complete discretion
• avoid using the documents to coerce action beyond what statutes or regulations require
• avoid mandatory language such as “shall,” “must,” “required,” or “requirement” unless restating clear mandates from statutes, regulations, or binding judicial precedent with citations
• clearly state that noncompliance with voluntary standards will not, in itself, result in enforcement action

Limitations on Use in Litigation (§§ 1-19.200 – 1-19.260)

The prior version of the Justice Manual stated that guidance documents cannot form the basis for an enforcement action on their own but that Department attorneys could rely on them when appropriate, including when a guidance document might be entitled to deference or carry persuasive weight. The revisions replace that formulation with a more restrictive framework. The new version states plainly that criminal and civil enforcement actions must be based on violations of applicable legal requirements — not mere noncompliance with guidance — and that the Department may not bring actions based solely on allegations of noncompliance with guidance documents. The revisions delete the prior version’s references to Kisor v. Wilkie and the possibility that guidance documents might receive deference. The new Sections 1-19.220 through 1-19.260 provide examples of permissible uses of guidance in litigation: 

• to help show that a party had the requisite scienter, notice, or knowledge of the law or to help establish mens rea
• to help show that a party satisfied or failed to satisfy professional or industry standards relating to applicable statutory or regulatory requirements
• to help establish the existence of a duty, custom, or practice with respect to a government agency
• to support a claim that a certain action, or factual or expert witness’s opinion, is consistent or inconsistent with scientific or technical processes that are generally accepted in a particular field
• to provide helpful context when a party’s compliance, or failure to comply, with the agency guidance is itself relevant to the claims at issue
• to provide relevant legal or factual background context in briefs and other filings

Revisions on the Department’s FCA Dismissal Authority

The changes to Section 4-4.111 represent a significant shift in the Department’s approach to dismissing qui tams. The prior version stated that when evaluating a recommendation to decline intervention, Department attorneys “should also consider whether the government’s interests are served ... by seeking dismissal.” The new version imposes a mandatory case-by-case assessment: Department attorneys “will in each case assess whether the government’s interests are served by seeking dismissal.” And even “[f]or cases in which the Department concludes at the time of declination that dismissal pursuant to § 3730(c)(2)(A) is not warranted, the Department may re-evaluate whether dismissal becomes appropriate as the litigation progresses.” 

The revisions also add that “[d]ismissal will not be warranted in every declined case, because to maximize its resources the government often will investigate a qui tam action only to the point where it concludes a declination is warranted, which may not equate to the conclusion that a qui tam is meritless.” The Department may intend this language to counter defendants’ arguments that declination means that the qui tam is meritless or that the alleged misconduct was immaterial to the government.

The Department made only one change to the Justice Manual’s list of factors “that can serve as a basis for dismissal.” Previously, the Justice Manual provided that in contemplating dismissal, the Department should consider “[c]urbing meritless qui tams that facially lack merit (either because the relator’s legal theory is inherently defective, or the relator’s factual allegations are frivolous).” Now the Justice Manual provides much more broadly that the Department should consider “[c]urbing meritless qui tams.”

Finally, the revisions add a procedural requirement: U.S. Attorneys’ Offices must “provide notice to the assigned Fraud Section attorney at least 10 days prior to filing any motion to dismiss in a delegated matter.” This addition likely reflects increased oversight of U.S. Attorney-level dismissal decisions by the Department’s Civil Division.

The Justice Manual revisions can be found here and here.