Executive Order 13891 (EO 13891): Why It Was Issued and Why It Still Matters

For many years, federal agencies have relied heavily on documents known as “guidance.” These guidance documents include policy statements, manuals, FAQs, and advisories meant to explain how federal agencies understand the law.  The Drug Enforcement Administration (DEA) is one of the many agencies that issues guidance documents.

Consistent with the requirements of the Administrative Procedure Act (APA), guidance documents are, in most cases, non-binding on the public.  This is because guidance documents usually do not go through notice-and-comment rulemaking.

Even though guidance documents are non-binding, for some agencies, the regulated industry has treated guidance documents as effectively binding.  DEA is one such example. In practice, DEA registrants have often not just integrated DEA guidance documents into their regulatory practice; they have considered DEA guidance binding.

When Diversion Investigators came calling, DEA guidance documents were frequently treated as if they were law. Companies were cited for failing to follow them. Licenses were threatened. Enforcement actions were justified by pointing to expectations that appeared nowhere in statutes or formally adopted regulations.

For all federal agencies (not just DEA), this gap between what guidance was supposed to be and how it was applied eventually became a major concern inside and outside government.

It was against this backdrop that Executive Order 13891 was issued.

The Problem EO 13891 Was Meant to Fix

The heart of the problem was process. Under the U.S. Constitution and the APA, only Congress can make laws.  Federal agencies generally can impose binding requirements only through regulations adopted using notice‑and‑comment rulemaking. That process exists to ensure transparency, public participation, and fair notice.

Guidance documents typically bypass that system. For most agencies, they are issued without public input, without judicial oversight, and without clear limits. While guidance documents can be helpful when they simply explain existing law, agencies increasingly used them to fill regulatory gaps, expand obligations, or announce new expectations, all without following the rulemaking process.

Executive Order 13891, which was issued on October 9, 2019, explicitly acknowledged these considerations. It recognized that even when guidance carries disclaimers stating it is non‑binding, it can still operate as law because regulated parties understand that noncompliance may bring enforcement consequences. The Order characterized this as a “Rule of Law” matter, not merely a paperwork issue.

What EO 13891 Required Agencies to Do

In an effort to prevent agencies from issuing guidance documents that would impose – or be viewed by the public as imposing – binding legal requirements, Executive Order 13891 directed the Office of Management and Budget (OMB) to issue a memorandum providing instructions to federal agencies on how to implement the Order.  On October 31, 2019, OMB issued that memorandum.

One of the key elements of the OMB memorandum was mandating that all agencies include the following disclaimer prominently in each guidance document:

“The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.”

To give that principle real meaning, the Executive Order, combined with the OMB memorandum, imposed several concrete requirements, including the following:

First, agencies were required to collect and publicly post all guidance documents in a single, searchable online location. If a document wasn’t posted, the agency could not rely on it for enforcement purposes, except to explain historical facts. This requirement addressed a long‑standing complaint from regulated industries, that guidance was often scattered, outdated, or effectively hidden.

Second, agencies were prohibited from using guidance to create new legal obligations. Guidance could explain existing statutes or regulations, but it could not add requirements, expand duties, or serve as an independent basis for enforcement.

Third, with regard to “significant” guidance documents, agencies were required the provide the public with the opportunity to comment at least 30 days prior to issuing such guidance.  Agencies were further required to provide a public response to the comments received.

Fourth, agencies were required to allow the public to petition for modification or withdrawal of guidance. This was a major shift. For the first time, regulated parties were given a formal mechanism to challenge agency guidance outside of litigation.

Together, these changes were designed to pull agencies back toward formal rulemaking and away from informal regulation-by-guidance.

Why EO 13891 Was Especially Important for DEA

The effects of EO 13891 were particularly significant for the Drug Enforcement Administration (DEA).

DEA regulates highly sensitive areas involving controlled substances, including manufacturers, distributors, pharmacies, hospitals, practitioners, and opioid treatment programs. Over time, DEA developed extensive guidance on topics such as suspicious order monitoring, prescribing practices, recordkeeping, and security. Much of this guidance was not codified in regulation.

Before EO 13891, DEA frequently cited guidance documents during inspections and investigations. Registrants often felt compelled to comply, not because guidance was law, but because enforcement consequences were real.

What Happened at DEA When EO 13891 Was Implemented

When Executive Order 13891 was implemented, it had an immediate and far‑reaching impact within the Drug Enforcement Administration. At that time, while serving as the Section Chief of DEA’s Regulatory Drafting and Policy Support Section, I was tasked with leading a comprehensive agency‑wide review of DEA policy and guidance documents. The scope of the review covered every DEA policy document issued from July 1, 1973, through November 19, 2019.

Over the course of that review, my section examined more than 13,000 policy and guidance documents. The results were striking. Following the review, DEA rescinded all but approximately 50 guidance documents, which were ultimately reposted in DEA’s newly created public guidance document portal.

The substantive findings of the review were equally significant. Many of the rescinded documents imposed restrictions and expectations on registrants that had no basis in statute or regulation, while others directly contradicted one another or reflected interpretations that were not supported by existing DEA regulations. In short, decades of accumulated guidance had created an inconsistent and legally unsupported compliance landscape.

The mass rescission of these policy documents caused immediate and unintended consequences for DEA registrants. Programs that had long operated under informal policy, such as the campus registration program, medical missions, and other similar initiatives, were abruptly halted because they lacked statutory or regulatory support once the guidance was withdrawn. To this day, DEA has not promulgated regulations to formally reestablish many of these programs. These programs were previously listed on the Unified Agenda to be published but were removed when the Trump administration took office.

In at least one instance, the regulatory gap became so significant that Congress was forced to intervene, passing legislation to allow DEA researchers to maintain a single registration covering multiple locations, effectively recreating a campus‑style registration through statute rather than agency policy. This outcome underscores the broader lesson of EO 13891: when agencies rely on guidance instead of regulation, long‑standing practices remain legally fragile and vulnerable to collapse once informal policy is removed.

The Rescission of EO 13891—and Its Reemergence

On January 20, 2021, Executive Order 13891 was revoked by Executive Order 13992 as part of a broader regulatory reset under the Biden administration. The rescission removed the mandatory, government‑wide structure imposed by EO 13891.

Then, exactly four years later, on January 20, 2025, Executive Order 13992 was revoked by Executive Order 14148. What is the net result of these back-and-forth executive orders?  EO 13891 is back in effect.

With or without EO 13891 being in effect, the underlying law remains unchanged. The APA still governs rulemaking. Due process still requires fair notice. And guidance documents still lack independent legal force.

Importantly, even during the four years when EO 13891 was revoked, DOJ and DEA did not abandon the core protections that EO 13891 had emphasized. DOJ continues to state—publicly and repeatedly—that guidance documents do not have the force of law, may not create new obligations, and generally may not be relied upon for enforcement unless supported by statute or regulation. DEA’s guidance portal remains active today.

In practice, EO 13891 formalized principles that agencies have continued to follow.

Why EO 13891 Still Matters Today

EO 13891 remains highly relevant for several reasons.

First, it represents a formal admission by the executive branch that guidance‑based enforcement raises serious rule‑of‑law and due‑process concerns. That acknowledgment carries weight in litigation and regulatory disputes.

Second, many agency practices adopted in response to EO 13891 remain in place, demonstrating that these were not temporary political preferences but practical governance reforms.

Finally, EO 13891 provides a useful analytical framework for courts, experts, and regulated parties when evaluating whether an agency has overstepped by enforcing informal policy rather than law.

In Plain Terms

EO 13891 did not eliminate guidance. Instead, it drew a bright line:

• Law binds.
• Guidance explains.
• Guidance does not enforce itself.

Even today, that distinction remains central to fair regulation, especially in complex, highly regulated fields like controlled substances.

Brinks DEA Consulting Can Help

If you are struggling to understand how agency guidance documents apply to your business, or if you believe guidance is being treated as binding law when it should not be, experienced help matters. Brinks DEA Consulting works with registrants, healthcare organizations, and regulated entities nationwide to analyze, interpret, and respond to DEA and DOJ guidance issues. If you need assistance evaluating guidance documents, preparing for inspections or enforcement actions, or ensuring your compliance approach is grounded in actual law rather than informal policy, you can contact Brinks DEA Consulting at https://sbrinksconsulting.com.

Disclaimer: Brinks DEA Consulting is not a law firm, and the information provided in this blog is not legal advice. The views expressed are the opinions of Brinks DEA Consulting and are based on our extensive experience and expertise in DEA regulatory compliance and diversion control. While we strive to provide accurate and practical insights, readers should consult with a qualified attorney for legal advice specific to their circumstances. For legal guidance, we recommend reaching out directly to a licensed law firm.