Recent news that President Donald Trump signed an executive order directing the Attorney General to “expedite” the rescheduling of cannabis to Schedule III has generated predictable excitement — and predictable confusion. Framed as decisive executive action, the order suggests momentum toward a long-awaited federal shift. But when placed in its full legal and regulatory context, the announcement looks less like a turning point and more like a familiar episode in a process that has already demonstrated how slow, fragile and litigation-prone rescheduling truly is.
The effort to reschedule cannabis did not begin with Trump. It began under President Biden in October 2022, when the administration directed the Department of Health and Human Services (HHS) to conduct a scientific and medical review of cannabis under the Controlled Substances Act. That review took roughly a year and culminated in HHS recommending Schedule III placement. This generated a great deal of excitement, but, since then, the matter has been before the Drug Enforcement Administration (DEA), which is responsible for implementing any scheduling change through formal rulemaking.
Nearly three years later, cannabis remains in Schedule I. More significantly, the rescheduling process is now indefinitely stalled. In early 2025, a federal judge canceled and suspended the DEA’s rescheduling hearing pending the outcome of a lawsuit alleging DEA bias against rescheduling and conflicts of interest. That history alone should temper expectations. If a Democratic administration that initiated the process in 2022 could not carry it to completion, there is little reason to believe that a directive to “expedite” will suddenly overcome the same legal constraints.
Administrative Procedure Act
The constraints are structural and flow primarily from the Administrative Procedure Act (APA).
Rescheduling a controlled substance involves rulemaking. It alters legal rights and obligations nationwide, affecting criminal liability, prescribing authority, research protocols, manufacturing standards and registration requirements. Under the APA, such actions must proceed through notice-and-comment rulemaking unless Congress has explicitly created an exemption. The Controlled Substances Act does not.
Before the DEA can propose a scheduling change, it must first obtain from the Department of Health and Human Services a scientific and medical evaluation of the substance and a scheduling recommendation. That step was completed in 2023 under the Biden administration, when HHS recommended marijuana be transferred to Schedule III. The recommendation is binding on scientific and medical matters. While the DEA retains discretion on policy and enforcement considerations, it may not contradict HHS’s scientific findings. This phase of the process, which took roughly a year, occurs entirely within the executive branch and does not satisfy the APA’s public participation requirements.
Following receipt of HHS’s recommendation, the DEA initiated formal rulemaking by publishing a Notice of Proposed Rulemaking (NPRM) in the Federal Register in May 2024. The NPRM sets forth the agency’s legal authority, describes the factual and scientific basis for the proposed rescheduling and addresses the Controlled Substances Act’s eight statutory scheduling factors. Courts require that an NPRM disclose sufficient information to permit meaningful public comment. A conclusory or underdeveloped proposal exposes the rulemaking to significant legal risk.
After publication of the NPRM, the APA requires a meaningful opportunity for public comment. Given the stakes, the cannabis record has been extensive and adversarial, drawing submissions from industry participants, scientists, state governments, advocacy organizations, competitors and other federal agencies. The DEA is required to consider and respond to significant comments in any final rule. Disregarding material arguments or evidence is not permissible.
An executive order directing the Attorney General to “take all necessary steps to complete the rulemaking process” does not alter these requirements. At most, it signals executive branch prioritization of a process that is already underway and constrained by statute, regulation and ongoing litigation. The remaining steps — evaluation of the comment record, resolution of procedural challenges, issuance of a final rule and defense of that rule on judicial review — remain governed by the APA and the Controlled Substances Act (CSA), not by executive instruction.
The CSA further complicates matters by allowing interested parties to request administrative hearings, including testimony and cross-examination before an administrative law judge. These hearings do not replace notice-and-comment; they add another procedural layer. In the current rescheduling effort, allegations of bias and conflicts of interest were sufficient to prompt the chief administrative law judge of the DEA to cancel and suspend the hearings entirely, demonstrating just how exposed the process is once it becomes contested.
If DEA eventually issues a final rule, it must include a reasoned explanation responding to significant comments and justifying any departure from prior policy. Given the federal government’s decades-long position that cannabis lacked accepted medical use, that explanation must be particularly careful. Political preferences and executive pressure are not valid substitutes for analysis.
Loper Bright Enterprises v. Raimondo
Layered on top of these procedural requirements is a critical shift in administrative law. In Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), the U.S. Supreme Court made clear that courts will no longer reflexively defer to agency interpretations of ambiguous statutes. The decision effectively dismantled the Chevron framework that had long allowed agencies to resolve statutory ambiguity with minimal judicial interference.
For cannabis rescheduling, this matters enormously. DEA cannot rely on generalized claims of expertise or broad discretion to paper over weaknesses in the administrative record. Courts will independently assess whether the agency’s interpretation of the CSA is correct and whether its reasoning is sound. If anything, Loper Bright raises the bar on rulemakings by inviting courts to probe more deeply and relentlessly into agency decisions.
That reality makes “expediting” not only difficult, but risky as well. Visible political pressure strengthens arguments that the agency prejudged the outcome or acted to satisfy executive preferences rather than statutory criteria. In a post–Loper Bright world, courts are more likely — not less — to scrutinize that conduct.
Legal Consequences to Rescheduling
Even if rescheduling eventually occurs, the legal consequences of Schedule III have received far less attention than the political symbolism. Schedule III classification formally recognizes accepted medical use and pulls cannabis squarely into the ambit of the Food, Drug, and Cosmetic Act (FDCA). That shift has profound implications.
For decades, adult-use cannabis has existed in a peculiar federal vacuum. Illegal under the CSA, but largely untouched by FDA, which has historically treated Schedule I substances as outside its core drug-approval framework. Schedule III changes that dynamic. Once cannabis is recognized as having medical use, FDA jurisdiction is no longer theoretical.
FDA would have authority over manufacturing standards, labeling, routes of administration, misbranding and approval pathways. Many products that dominate state adult-use markets, such as smokable flower, high-dose edibles and concentrates, do not fit comfortably within FDA’s regulatory architecture and, in some cases, would never be approved as drugs.
The agency would not need to shut down dispensaries nationwide to destabilize the industry. Selective enforcement, guidance or warning letters could be enough to inject regulatory uncertainty into capital markets, stall transactions and reshape risk assessments. The CBD market offers a recent and instructive example.
Schedule III also realigns private incentives. Pharmaceutical companies willing to invest billions in clinical trials and FDA approvals are unlikely to tolerate a parallel market selling the same active compounds to anyone over 21 in forms that bypass federal safety standards. The legal tools to challenge that market already exist, including FDA citizen petitions, administrative litigation and unfair competition theories. None of which require new legislation.
Rescheduling is a Slow, Adversarial Process
The experience of the past three years offers a clear lesson: Cannabis rescheduling is not a switch that can be flipped by executive order. It is a slow, adversarial process governed by the APA, complicated by the CSA, and now subject to heightened judicial scrutiny after Loper Bright. The Biden administration’s inability to complete the process despite initiating it in 2022 underscores that reality.
Moving cannabis to Schedule III without addressing the structural mismatch between federal drug law and state adult-use markets risks trading one form of uncertainty for another, one that is more centralized, more enforceable and less forgiving. Headlines may come and go, but the APA, the courts and the FDA will ultimately decide what rescheduling means in practice.
In the meantime, for licensees, the immediate effect is measured mostly in phone calls asking what this actually changes.
Harris Beach Murtha’s cannabis attorneys continue to follow developments throughout the industry. Our Cannabis Industry Team is on top of all regulatory developments and other pertinent industry news. For more information, please contact attorney Jason W. Klimek at (585) 419-8646 and jklimek@harrisbeachmurtha.com, or the Harris Beach Murtha attorney with whom you most frequently work.
This alert is not a substitute for advice of counsel on specific legal issues.
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