Introduction

On September 18, 2026, the Department of Justice (DOJ) announced revisions to the Justice Manual limiting the use of agency guidance in affirmative civil enforcement, including under the False Claims Act (FCA).  According to the DOJ press release, the changes are intended to ensure that parties are “held accountable for violations of binding legal obligations, not agency guidance that lacks the force and effect of law.”  The changes are the latest in a line of DOJ policy shifts relating to the use of agency guidance, and they represent a departure from the prior policy issued by Attorney General Merrick Garland.  Parties facing FCA investigations or litigation based on agency guidance should consider whether the changed policy can be harnessed to defend against those claims or used in negotiating a favorable settlement with DOJ.

DOJ Policy on Agency Guidance

Prior DOJ Policies on Agency Guidance

The latest revisions to the Justice Manual represent the third time in the last decade that DOJ has modified its policy on using agency guidance in affirmative civil enforcement.  In 2018, Associate Attorney General Rachel Brand issued a memorandum (Brand Memo) prohibiting DOJ from both treating agency guidance as a binding legal requirement and “us[ing] noncompliance with guidance documents as a basis for proving violations of applicable law.”  The Brand Memo was itself built on an earlier memorandum from Attorney General Jeff Sessions that addressed the DOJ’s own agency guidance (Sessions Memo).  The Brand Memo, however, did not wholly disclaim agency guidance.  For instance, according to the Brand Memo, DOJ could use evidence that a party read agency guidance that explained or paraphrased a legal mandate to “help prove that the party had the requisite knowledge of the legal mandate.”¹

In 2021, Attorney General Garland issued a memorandum (Garland Memo) rescinding the Brand and Sessions Memos.  Attorney General Garland characterized the prior memoranda as “substantially chang[ing] the Department’s traditional approach to guidance documents,” including “by placing additional restrictions and requirements on … relying on agency guidance” in affirmative civil enforcement.  The Garland Memo authorized use of agency guidance documents in enforcement proceedings “in any appropriate and lawful circumstances, including when a guidance document may be entitled to deference or otherwise carry persuasive weight with respect to the meaning of the applicable legal requirements.”  But the Garland Memo also reaffirmed several of the same principles espoused by the Brand Memo, including that guidance documents do not bind the public, do not have the force and effect of law, and cannot form the basis of an enforcement action.

DOJ’s Revised Policy on Agency Guidance

DOJ’s most recent policy states that it is intended to “reinstate[] and build[] upon” the Brand and Sessions memoranda.  As before, enforcement actions must now be based on violations of applicable legal requirements, not noncompliance with guidance documents, and DOJ will not treat a party’s noncompliance with agency guidance as a violation of applicable law.  DOJ may, however, continue to use guidance documents as evidence in FCA enforcement proceedings.  The Justice Manual describes several circumstances where DOJ contends that use of agency guidance is appropriate:

• A party’s “awareness of the guidance document (or its contents)” may serve as evidence that the party had notice of the applicable law or had the requisite mens rea to establish a violation of the law.  An appropriate use of agency guidance under the latter circumstance, according to the Justice Manual, is where a party’s deliberate indifference to a guidance document is probative of deliberate indifference to requirements that are imposed by law.
• DOJ “may use a guidance document as probative evidence that a party has satisfied, or failed to satisfy, professional or industry standards or practices relating to applicable statutory or regulatory requirements.”
• In addition, failure to comply with guidance documents may also help establish the party’s violation of the FCA.  As one example, the Justice Manual provides that a party falsely certifying compliance with a guidance document “may be offered to establish the elements of falsity, materiality, and scienter.”

Practical Implications for Parties

The revised Justice Manual underscores several key points for parties that are currently facing or may face investigations or litigation under the FCA: 

• Parties may benefit from revisiting strategies for challenging enforcement theories that rely on guidance documents.  The revised policy may provide additional support for arguments that alleged violations of nonbinding guidance cannot establish liability under the FCA.
• The revisions may also create new opportunities to engage with DOJ leadership where line attorneys or relators are relying on agency guidance to assert claims under the FCA in a manner that is inconsistent with DOJ’s stated policy.  In declined qui tam cases or investigations involving novel legal theories in particular, parties may find value in emphasizing the distinction between binding legal requirements and agency interpretations expressed in agency documents.
• At the same time, parties should be cautious about viewing the announcement as diminishing the practical importance of agency guidance.  The Justice Manual revisions make clear that guidance documents can play an important role in establishing legal violations under the FCA.  Parties should therefore continue to monitor relevant guidance closely in their respective industries, even where that guidance does not itself carry the force of law.

WilmerHale represents corporate, institutional, governmental, and individual clients in a range of FCA matters.  Our team is available to provide FCA counseling and to defend against FCA investigations and litigation.