Déjà Vu as DOJ Resumes Sub-regulatory Guidance Limits and FCA Dismissal Policy

On September 18, 2026, the Department of Justice (DOJ) announced revisions to the Justice Manual aimed at “strengthening” False Claims Act (FCA) enforcement. For FCA defense practitioners, the announcement carries a distinct sense of déjà vu, as the revisions largely reinstate policies from the first Trump administration, most notably the November 2017 “Brand Memo” and the January 2018 “Granston Memo” — both rescinded under the Biden administration.

The revisions to the Justice Manual focus on two principal areas: (1) limiting the use of sub-regulatory guidance; and (2) reiterated qui tam dismissal authority.

Limiting Use of Sub-Regulatory Guidance. The first revision “reinstates and builds upon” the 2017 policy that sub-regulatory guidance cannot impose legal obligations beyond those established by statute or regulation. As Associate Attorney General Stanley Woodward stated, “[t]he Department of Justice should enforce the law, not make law through enforcement.” This directly echoes the Brand Memo’s core principle: defendants cannot be held liable under the FCA for violating guidance documents that lack the force of law. As with DOJ’s 2017 policy, the reinstated policy describes multiple contexts in which sub-regulatory guidance may still be used, including as evidence of scienter or a professional standard, or when a defendant made representations of compliance with the guidance.

Reiterated Qui Tam Dismissal Authority. The second revision clarifies DOJ “should consider exercising its dismissal authority when it declines to intervene in a qui tam action” and should “revisit that assessment as appropriate during litigation.” The emphasis is on dismissing qui tam actions that “lack legal or factual merit” and that “waste taxpayer resources and impose unjustified burdens on businesses.” This, too, is a re-issue of a DOJ pronouncement — including the same seven factors that in 2018 DOJ asserted could prompt the agency to act.

Why This Matters Across Industries

These revisions carry significant implications for any industry that operates within a landscape of extensive sub-regulatory guidance. Agencies across the federal government routinely issue guidance documents, manuals, FAQs, policy statements, and informal letters that, while technically non-binding, have effectively operated as de facto compliance standards for years.

Health Care. Health care providers and life sciences companies face perhaps the most complex guidance environment. Centers for Medicare and Medicaid Service’s (CMS) Medicare Benefit Policy Manual, National and Local Coverage Determinations, Office of Inspector General (OIG) advisory opinions, and Food and Drug Administration (FDA) guidance documents long have been cited in FCA enforcement actions. The revised Justice Manual acknowledges such documents may be used as “relevant evidence” of whether procedures were medically “reasonable and necessary” but critically emphasizes “such usage does not give these documents the force of law.” For health care organizations, this distinction could be the difference between defending a meritless claim and having it dismissed or addressed outside of court.

Government Contractors. Defense contractors and other companies doing business with the federal government operate under the Federal Acquisition Regulation (FAR) and also under layers of agency-specific guidance, contracting officer interpretations, and compliance manuals. FCA cases against government contractors frequently have relied on alleged violations of guidance-level requirements. Under the revised Justice Manual, enforcement must be grounded in binding legal or contractual obligations, not agency guidance alone. Contractors facing FCA exposure should assess whether claims against them rest on actual regulatory violations or merely on guidance.

Customs and International Trade. Importers face FCA exposure when the government alleges fraud in the importation process, including misclassification of goods, undervaluation, or false country-of-origin declarations. DOJ has authority to pursue civil remedies for importation fraud under 19 U.S.C. § 1592, and FCA claims have been asserted based on alleged violations of CBP guidance regarding product classification and origin declarations. The revised Justice Manual’s principle that enforcement must rest on binding legal requirements, not agency guidance, offers importers a potential defense when FCA claims rely on non-binding CBP interpretations rather than violations of statutes or regulations.

Higher Education. Colleges and universities receiving federal funds have faced FCA exposure based on alleged noncompliance with Department of Education guidance on issues ranging from Title IX implementation to financial aid administration. The revised Justice Manual’s distinction between binding legal requirements and agency interpretation offers institutions a stronger defense against claims based solely on guidance violations.

Practical Implications for FCA Defense & What Your Organization Can Do Now

Companies facing FCA exposure — or seeking to reduce future risk — should consider the following:

• Reassess pending FCA matters. If your company is defending against an FCA claim, evaluate whether the allegations rest on violations of binding legal requirements or merely on agency guidance. The revised Justice Manual provides strong grounds for early dismissal where relators or the government rely primarily on guidance documents rather than statutes, regulations, or contracts.
• Seek dismissal of meritless whistleblower suits. The Justice Manual now instructs DOJ attorneys to “assess whether the government’s interests are served by seeking dismissal” whenever DOJ declines to intervene in a qui tam case. If your company is facing a declined qui tam, there may be an opportunity to ask DOJ to dismiss, particularly where the claims lack legal or factual merit or duplicate prior government investigations.
• Audit your compliance posture. Distinguish between compliance with binding legal requirements and voluntary adherence to agency guidance. Understanding this distinction can help your organization allocate compliance resources appropriately and strengthen your position if questions arise.
• Monitor ongoing litigation. The Justice Manual provides that even where DOJ does not initially seek dismissal, it should “revisit that assessment as appropriate during litigation.” For companies in extended FCA disputes, this creates an ongoing opportunity to seek dismissal as weaknesses in relator cases become more apparent.

For businesses operating in guidance-intensive regulatory environments, these revisions represent a return to a framework that recognizes the difference between enforcing the law as written and enforcing agency guidance that was never subject to notice-and-comment rulemaking. If your organization is facing FCA exposure — or wants to understand how these changes affect your compliance posture — Foley can help you navigate this shifting landscape.

Foley is here to help you address the short- and long-term impacts in the wake of change. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Government Enforcement Defense and Investigations Group with any questions.