DOJ Revises Justice Manual, Addressing Sub-Regulatory Guidance and Qui Tam Dismissal Authority

The U.S. Department of Justice (DOJ or Department) on September 18, 2026, announced revisions to its Justice Manual (JM) designed to prohibit reliance on sub-regulatory guidance in criminal enforcement or civil False Claims Act (FCA) cases.

Along with the announcement, Associate Attorney General Stanley Woodward Jr. stated, "The Department of Justice should enforce the law, not make law through enforcement." He reiterated that the changes "reflect the Department's commitment to fair notice, transparent enforcement, and the rule of law."

Further revisions indicate that DOJ will evaluate qui tam whistleblower cases for dismissal at the point of declination and beyond.

The revisions codify the Department's positions developed over the past year into the JM, limiting the use of guidance documents in enforcement matters and signaling a more disciplined approach to qui tam litigation. These changes are significant for government contractors, healthcare providers and other regulated entities subject to FCA exposure.

Limited Role for Sub-Regulatory Guidance

The JM revisions build on a stated enforcement position by the administration. In February 2025, then U.S. Attorney General (AG) Pam Bondi issued a memorandum reinstating the prohibition on DOJ's use of agency guidance documents. This revived policies previously established during the first Trump Administration through the Sessions Memo (November 2017) and Brand Memo (January 2018), each of which addressed a limited role of sub-regulatory guidance. Both the Sessions Memo and Brand Memo were rescinded by the Biden Administration.

The September 18 JM revisions formalize positions previewed by DOJ Civil Division Commercial Litigation Branch Deputy Assistant AG Brenna Jenny in remarks at the Federal Bar Association's Qui Tam Conference in February 2026. There, Jenny signaled the Department's commitment to not rely on sub-regulatory guidance to drive the Department's FCA enforcement, describing restrictions on its use of sub-regulatory guidance. Jenny also emphasized the Department's renewed willingness to exercise its dismissal authority under 31 U.S.C. Section 3730(c)(2)(A).

According to DOJ's announcement, JM 1-19.000 "reinstates and builds upon the Department's 2017 policy that sub-regulatory guidance cannot impose legal obligations beyond those established by statute or regulation." The revised section recognizes that criminal and civil enforcement actions "must be based on violations of applicable legal requirements, not mere noncompliance with guidance documents issued by federal agencies, because guidance documents cannot by themselves create binding requirements that do not already exist by statute or regulation."

Why This Makes Sense: Sub-regulatory guidance – such as agency manuals, FAQs and advisory opinions – has not undergone notice-and-comment rulemaking. Agencies regularly issue sub-regulatory guidance, often without input from industry, to explain complex regulatory schemes. Though this may be helpful in establishing agency understanding of its own regulations, holding entities liable for failing to comply with nonbinding guidance raises concerns about the adequacy of fair notice, particularly in the wake of a recent U.S. Supreme Court decision that overruled agency deference and fundamentally altered judicial review of agency interpretations of ambiguous statutes.

Practical Significance: The revision does not make agency guidance entirely irrelevant. The JM preserves several permissible uses, for example, by using awareness of a guidance document to establish scienter, notice or knowledge of the law, or as evidence of professional or industry standards. Additionally, the Department may use agency guidance when the guidance is "relevant to the claims at issue." The revisions highlight one FCA-specific circumstance: "when a provider falsely certifies compliance with a guidance document, and the certification is material to an agency's payment decision, the false certification to obtain a payment may be offered to establish the elements of falsity, materiality, and scienter." And though the agency guidance may be used to establish FCA elements, "the deceit of the false certification is probative, not the binding or nonbinding nature of the guidance."

For contractors and healthcare providers accustomed to an enforcement landscape where agency manuals and sub-regulatory pronouncements have functioned as de facto rules that create severe penalties, the JM revision may meaningfully narrow the playing field.

Proactive Evaluation of Qui Tam Suit Dismissals

The second JM revision, JM 4-4.111, makes clear that the Department should consider exercising its dismissal authority under 31 U.S.C. Section 3730(c)(2)(A) when it declines to intervene in a qui tam action and that it should revisit its decision, as appropriate, during the course of litigation. The Department has stated it will "continue to exercise this authority judiciously, with an emphasis on seeking dismissal of qui tam actions that lack legal or factual merit."

The revision codifies and strengthens the framework originally established in the January 2018 Granston Memo, which first directed Department attorneys to evaluate whether dismissal would advance the government's interests. The Granston Memo identified seven factors for Department attorneys to consider, including curbing meritless qui tam actions, preventing parasitic or opportunistic actions and preserving government resources. This is supported by a 2023 Supreme Court decision affirming the government's broad discretion in exercising its dismissal authority.

Jenny previewed this shift at the Federal Bar Association conference, signaling that the Department had significantly increased its exercise of dismissal authority compared to the prior administration. She emphasized that the Department was committed to using its dismissal authority where cases appear to be meritless, inconsistent with current law or where the affected agency does not support the case. Notably, Jenny indicated that DOJ would now evaluate whether dismissal is appropriate at the declination stage of each case, rather than on an ad hoc basis.

Implications for Defendants and Relators: For FCA defendants, this revision is a welcome development. It provides additional grounds to urge the Department to seek dismissal of declined qui tam actions. For relators and their counsel, the revision introduces meaningful new risk to the qui tam calculus, particularly in cases where the government has declined to intervene and the underlying theory of liability rests on uncertain legal footing.

Practical Takeaways

Do Not Abandon Guidance Compliance Entirely: Though guidance documents no longer serve as an independent basis for liability, they remain relevant to scienter and knowledge determinations. Companies should still track and consider agency guidance as part of a comprehensive compliance program but with an understanding that noncompliance with guidance alone is not an independent basis for FCA liability.

Audit Your Compliance Framework Against Binding Legal Obligations: Distinguish between statutory and regulatory requirements on the one hand and sub-regulatory guidance on the other. Ensure that internal compliance programs focus on requirements that carry the force of law.

Engage Proactively with DOJ After Declination: When the government declines to intervene in a qui tam action, defendants should consider affirmatively presenting the case for dismissal under Section 3730(c)(2)(A), particularly where the action lacks factual merit, is inconsistent with current law or is not supported by the affected agency. Defendants with pending declined qui tam cases should evaluate whether the revised dismissal framework provides a basis to seek dismissal or encourage voluntary dismissal by relators' counsel.

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