First Revision: Guidance Documents Have Limited Authority and Cannot Create New Rights or Obligations.

The Department explained the first change “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 reference is to a pair of memoranda issued during the first Trump administration—the first dated November 16, 2017 (“the Sessions Memo”), and the second dated January 25, 2018 (“the Brand Memo”). Collectively, the directives ordered that DOJ “may not issue guidance documents that purport to create rights or obligations binding on persons or entities outside the Executive Branch,” and ordered that guidance documents should “disclaim any force or effect of law,” among other restrictions. The Memos also made clear that the same directive applied to guidance documents from other agencies.

The Sessions and Brand Memos both stressed that noncompliance with guidance documents could not be the basis of civil enforcement.

Rescission — and Rescinding the Rescission

On July 1, 2021, Attorney General Merrick Garland rescinded the 2017 and 2018 memos, declaring them “overly restrictive” and discussing their negative consequences, such as “discourag[ing] the development of valuable guidance.”

At the start of the second Trump Administration, then-Attorney General Pam Bondi rescinded, but did not replace, the Garland memorandum on February 5, 2025.

The Recent Revision Tracks the Memos Implemented During Trump I

The first revision, now reflected in the Justice Manual, tracks the directives from the 2017 and 2018 memos from AG Sessions and AAG Brand, respectively. In sum: “Agency guidance documents may not be used as a substitute for regulation and may not be used to impose new requirements on persons outside the Executive Branch except as expressly authorized by law or contract.” Tracking previous instruction, DOJ guidance documents are to identify themselves as such and “disclaim any force or effect of law.”

The revised Justice Manual also provides “illustrations of appropriate uses of guidance documents,” such as to establish scienter, notice, knowledge, or even mens rea where a party is aware of—and disregards—Department guidance concerning a relevant statute or regulation. Guidance documents can also be used by agency personnel as probative evidence that a party has satisfied, or failed to satisfy, professional or industry standards. The Justice Manual states this “rationale applies more broadly in the healthcare arena,” and provides an example applicable to healthcare entities:

"[I]f a physician writes prescriptions in excess of the CDC Guideline for Prescribing Opioids for Chronic Pain, which contain medical recommendations for primary care physicians, that fact may be offered as evidence that the prescriptions were issued and opioids dispensed without a “legitimate medical purpose” and outside “the usual course of [] professional practice,” 21 C.F.R. § 1306.04(a), in violation of the Controlled Substances Act."

Guidance documents may also be used to reflect accepted scientific or technical processes, or to establish compliance or noncompliance with guidance where relevant to the claims at issue (e.g., if a party falsely claimed compliance with aguidance document).

Second Revision: Department Attorneys Should Consider Seeking Dismissal of Qui Tam Actions Inconsistent with the Interests of the United States.

Similar to the first modification, the second revision tracks guidance issued during Trump I. During the first Trump administration, a leaked internal document, dated January 10, 2018, was titled “Factors for Evaluating Dismissal Pursuant to 31 U.S.C. 3730(c)(2)(A)” and authored by Michael D. Granston, Director of the DOJ’s Civil Fraud Section, Commercial Litigation Branch (“the Granston Memo”). The Granston Memo noted “record increases” in qui tam actions consuming Department resources and instructed DOJ attorneys to “consider whether the government’s interests are served . . . by seeking dismissal” of meritless actions.

The Granston Memo acknowledged the action was done “sparingly,” yet it encouraged DOJ lawyers to consider a list of non-exhaustive factors when making the determination:

• Curbing meritless qui tams;
• Preventing parasitic or opportunistic qui tam actions that duplicate a pre-existing government investigation and add no useful information to the investigation;
• Preventing interference with an agency’s policies or the administration of its programs;
• Controlling litigation brought on behalf of the United States, in order to protect the Department’s litigation prerogatives;
• Safeguarding classified information and national security interests;
• 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; and
• Addressing egregious procedural errors that could frustrate the government’s efforts to conduct a proper investigation.

The 2026 Justice Manual revision closely follows the Granston Memo, including substantially similar non-exhaustive factors for Department personnel to consider when seeking dismissal. It instructs Department attorneys to consider seeking dismissal “in each case” of declination, going even further than the 2018 guidance in that directive. It further instructs that where the Department initially concludes at the time of declination not to seek dismissal, “the Department may re-evaluate whether dismissal becomes appropriate as the litigation progresses.” This directive potentially provides entities and individuals with a foothold to seek not only DOJ declinations, but also DOJ intervention in the form of dismissal.

The Grassley Letter

The second revision follows a letter from Senate Judiciary Chairman Chuck Grassley dated April 2, 2026, where the legislator observed a “substantially higher number” of DOJ dismissals of qui tam actions in 2025. Senator Grassley—who has an established history of utilizing whistleblowers—expressed concern over potentially discouraging FCA relators from exposing fraudulent activities and demanded additional information from the Department.

Conclusion

The first revision underscores that guidance documents do not have the force of law and, as stated in the Department’s announcement, “reflects the Department’s commitment to fair notice and the rule of law.” On the margins, it may deter aggressive DOJ attorneys from arguing that claims are legally false based on agency guidance documents, though the risk of enforcement remains significant for industries and individuals in business with the government.

The second revision recognizes the potential for meritless qui tam suits and relator-led litigation that consumes government resources unnecessarily. The change tracks the consistent increase of qui tam actions filed per year (with new records set in 2024 and again in 2025). Industries and individuals seeking DOJ declination in FCA matters may further advocate for DOJ attorneys to seek dismissal where appropriate under the reinstated guidance.