On September 18, 2026, the U.S. Department of Justice (DOJ) announced updates to the Justice Manual to "clarify the limits on the use of sub-regulatory guidance across Department litigation and when the Department will seek dismissal of qui tam actions that do not serve the interests of the United States." The announcement includes several potentially important discretionary constraints on qui tam actions brought under the federal False Claims Act (FCA), 31 U.S.C. § 3729.  

First, the updates reinstated and expanded upon 2017 DOJ guidance stating that mere violations of "sub-regulatory guidance" cannot be the basis for FCA claims because such guidance has not undergone notice-and-comment rulemaking and thus lacks the force of law. This position is consistent with policies adopted in the first Trump administration by then-Attorney General (AG) Jeff Sessions and then-Associate AG Rachel Brand (as reported previously, officials in the present administration have been strongly critical of former AG Merrick Garland's reversal of those policies). Associate AG Stanley E. Woodward, Jr., explained: "The Department of Justice should enforce the law, not make law through enforcement."

Consistent with the 2017 guidance, the Justice Manual updates say that the DOJ may continue to use a party's awareness of agency guidance as evidence of scienter to satisfy the FCA's knowledge element. However, the Manual includes "three important limiting principles": 

1. A defendant's knowledge of guidance does not give that guidance the force of law
2. "[A] guidance document alone does not establish what the relevant mens rea standard is for a criminal offense"
3. "[T]he Department may not treat awareness of a legal interpretation in a guidance document as an admission that the guidance document is a correct interpretation of the binding legal requirements in a statute or regulation"

Second, the DOJ revised the Manual to state that it should consider exercising its authority to voluntarily dismiss cases brought by qui tam relators when it declines to intervene in a case and, if it does not seek dismissal at that time, should revisit that assessment as appropriate as litigation proceeds. The Manual identifies the following non-exhaustive interests for the DOJ to consider when determining whether to dismiss a case:

1. Curbing meritless qui tams
2. Preventing parasitic or opportunistic qui tam actions that duplicate a pre-existing government investigation and add no useful information to the investigation
3. Preventing interference with an agency's policies or the administration of its programs
4. Controlling litigation brought on behalf of the U.S. in order to protect the DOJ's litigation prerogatives
5. Safeguarding classified information and national security interests
6. Preserving government resources, particularly where the government's costs (including the opportunity costs of expending resources on other matters) are likely to exceed any expected gain
7. Addressing egregious procedural errors that could frustrate the government's efforts to conduct a proper investigation

If applied forcefully, this provision has the potential to meaningfully expand the circumstances in which the DOJ will exercise its discretionary authority to voluntarily dismiss meritless qui tam claims, even against the wishes of the relator who brought the case. Associate Deputy AG Paul Perkins stated: "These revisions will help ensure the Department uses its enforcement authority fairly and effectively — holding fraudsters accountable for violations of binding legal or contractual obligations while seeking dismissal of meritless qui tam actions that waste taxpayer resources and impose unjustified burdens on businesses."

In recent years, the DOJ has repeatedly emphasized its focus on using the FCA as a tool to combat waste, fraud, and abuse, including by expanding to areas outside areas of historic enforcement focus such as trade and customs violations and allegedly unlawful diversity, equity, and inclusion (DEI). However, the announced updates to the Justice Manual underscore that defendants still retain strong defenses to meritless cases brought by qui tam relators. 

For more information, please contact:

Joshua Drew, jdrew@milchev.com, 202-626-5811

Bradley E. Markano, bmarkano@milchev.com, 202-626-6061

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