Federal Drug Policy, April 2026: The Operative Architecture of Cannabis Rescheduling, the Psychedelic Therapeutic Acceleration Directive, and the Road to June 29
RN Collins | https://www.linkedin.com/in/rn-collins/
Abstract
The week of April 18 through April 23, 2026 produced two distinct and legally consequential federal actions on controlled substances. On April 18, President Trump signed Executive Order 14401, directing the federal government to accelerate access to psychedelic therapies for serious mental illness and mandating expedited rescheduling review for Schedule I substances that have completed Phase 3 clinical trials. On April 23, the U.S. Department of Justice issued AG Order No. 6754-2026, transferring FDA-approved marijuana products and marijuana subject to qualifying state medical marijuana licenses from Schedule I to Schedule III of the Controlled Substances Act. Both actions operate through federal statutory authority under the Controlled Substances Act, both invoke the treaty-compliance scheduling framework, and both share a parallel structural logic: medical access through controlled regulatory pathways rather than broad decriminalization.
This article gives each order full legal analysis. Part II analyzes EO 14370 as the December 2025 presidential cannabis directive. Part III provides complete legal analysis of EO 14401 — its statutory provisions, its qualifying criteria, the Right to Try access mechanism, and its rescheduling mandate. Part IV examines AG Order No. 6754-2026 as the operative cannabis legal event. Part V analyzes the two-authority framework under 21 U.S.C. §§ 811(a) and 811(d)(1) as it applies to both cannabis and psychedelics. Part VI addresses the EO 14401 implementation sequence — the parallel psychedelic rescheduling pathway from Phase 3 completion through FDA approval to a potential § 811(d)(1) rescheduling action. Part VII sets out the cannabis compliance architecture. Part VIII addresses § 280E tax consequences. Part IX covers the cannabis hearing reset. Part X surveys state developments. Part XI identifies the open questions and litigation risks heading into June 29, 2026 and the EO 14401 timeline. Part XII concludes.
I. Introduction
Federal controlled-substance law shifted on two fronts in one week in April 2026. On April 18, EO 14401 directed the Attorney General to initiate and complete rescheduling review for Schedule I substances that have completed Phase 3 clinical trials for serious mental health disorders, and created a Right to Try federal access pathway for qualifying patients. On April 23, AG Order No. 6754-2026 moved qualifying medical marijuana from Schedule I to Schedule III using the treaty-compliance authority under 21 U.S.C. § 811(d)(1), while DOJ simultaneously terminated the existing administrative hearing track for broader cannabis rescheduling and opened a new hearing set to begin June 29, 2026.
These two actions are connected expressions of a unified 2026 federal policy posture, not coincidental events that happen to share a calendar week: the Trump administration’s willingness to use existing statutory scheduling authorities to bring federal drug law into closer alignment with accumulated clinical evidence, operating through medically bounded pathways rather than broad liberalization. EO 14370, signed December 18, 2025, established the cannabis-specific presidential mandate; EO 14401 extended the same framework to psychedelics; AG Order No. 6754-2026 is the first operative legal result. A second operative result — a rescheduling action for psilocybin — is foreseeable on the EO 14401 timeline if Compass Pathways submits a New Drug Application to FDA in 2026 and FDA acts under Priority Review.
This article treats both orders as subjects of full legal analysis. EO 14401 is an independent legal instrument with its own statutory provisions, qualifying criteria, access mechanism, and rescheduling mandate. It is the governing instrument for the next wave of federal controlled-substance action on psychedelics. Practitioners advising clients in cannabis law, psychedelic therapy, clinical research, pharmaceutical development, or behavioral health need to understand both.
II. The Presidential Cannabis Directive: Executive Order 14370
Executive Order 14370, ‘Increasing Medical Marijuana and Cannabidiol Research,’ was signed by President Trump on December 18, 2025, and published in the Federal Register on December 23, 2025, at 90 Fed. Reg. 60,541.¹ Its operative function is direction: the order instructs the Attorney General to complete Schedule III rulemaking for marijuana ‘in the most expeditious manner’ under 21 U.S.C. § 811. Presidential executive orders do not themselves reschedule controlled substances; that authority is statutory and requires agency action. EO 14370 is the policy mandate that the April 23 agency action implemented.
The order’s substantive grounding draws on FDA and HHS’s 2023 determination that marijuana has a currently accepted medical use in treatment in the United States — the doctrinal pivot that the April 11, 2024 DOJ Office of Legal Counsel opinion² confirmed cleared the path for Schedule III placement. EO 14370 treated that determination as settled, characterized the scheduling delay as a policy failure, and directed completion of rulemaking.
The order extends beyond scheduling. It directs White House legislative affairs staff to work with Congress on the statutory definition of hemp-derived cannabinoid products and a regulatory framework for full-spectrum CBD, including potential THC-per-serving and per-container thresholds. It also directs HHS, FDA, CMS, and NIH to develop a real-world-evidence research program for cannabis. Those CBD and research mandates operate on a separate legislative and regulatory timeline from the scheduling action but belong in any comprehensive analysis of EO 14370.
The April 23 DOJ press release announcing AG Order No. 6754-2026 expressly states that the order was issued in accordance with EO 14370,³ creating the administrative record linkage that matters in any future APA challenge. In litigation, any challenger attacking DOJ’s decision to use the § 811(d)(1) treaty-compliance pathway rather than the § 811(a) formal rulemaking route will need to account for that express claim of presidential authority.
III. Executive Order 14401: Full Legal Analysis
A. Scope and Target Substances
Executive Order 14401, ‘Accelerating Medical Treatments for Serious Mental Illness,’ was signed April 18, 2026, and published in the Federal Register on April 22, 2026, at 91 Fed. Reg. 21,709.⁴ Its subject is Schedule I substances that have completed Phase 3 clinical trials demonstrating efficacy for serious mental health disorders. The primary qualifying substances as of April 2026 are psilocybin and MDMA (midomafetamine). Ketamine is Schedule III and falls outside the order’s scope. The order does not list specific substances; it establishes a threshold — Phase 3 completion for serious mental health indications — and directs federal agencies to act on substances meeting that threshold.
Psilocybin meets the Phase 3 threshold as of April 2026. Compass Pathways completed two Phase 3 trials under its COMP360 program — COMP005 in June 2025 and COMP006 in February 2026⁵ — generating Phase 3 data on psilocybin’s efficacy for treatment-resistant depression. The FDA granted Breakthrough Therapy designation to psilocybin for treatment-resistant depression,⁶ which accelerates FDA’s review process and signals that the agency views the preliminary clinical evidence as promising. Psilocybin remains Schedule I as of April 2026, making it squarely within EO 14401’s scope.
MDMA’s status under EO 14401 is legally unsettled. MAPS completed two Phase 3 MDMA trials — the MAPP1 and MAPP2 studies — that enrolled adults with severe PTSD. The MAPP1 trial produced statistically significant results published in Nature Medicine in 2021.⁷ FDA nonetheless declined to approve MDMA-assisted therapy (midomafetamine) in August 2024,⁸ issuing a complete response letter citing concerns about trial design, blinding methodology, and aspects of the therapist conduct record. MAPS has indicated a resubmission strategy requiring additional data. EO 14401’s qualifying language refers to substances that have ‘completed’ Phase 3 trials rather than received FDA approval based on those trials, leaving open whether MDMA qualifies despite FDA’s rejection. That question will require DOJ and HHS interpretation and is likely to be contested.
B. Statutory Provisions
EO 14401 invokes multiple statutory authorities. The Right to Try access mechanism is grounded in 21 U.S.C. § 360bbb-0a, the federal Right to Try Act enacted as Title I of Public Law 115-176 in 2018.⁹ That statute allows patients with life-threatening diseases or conditions who have exhausted approved treatments to access investigational drugs that have completed Phase 1 trials; EO 14401 applies the same conceptual mechanism at the Phase 3 threshold for qualifying psychedelic compounds, requiring any necessary Schedule I handling authorizations from DEA under 21 U.S.C. § 823. The order also cites section 505 of the Federal Food, Drug, and Cosmetic Act, governing FDA drug approval, and 21 U.S.C. § 811, the scheduling authority under which the rescheduling review mandate operates.
The Right to Try Act’s eligibility criteria are narrower than casual reference to the statute suggests. An eligible patient must: have a life-threatening disease or condition; have exhausted approved treatment options; be unable to participate in a clinical trial; and have a physician who certifies the patient’s informed consent and that the likely benefits outweigh the risks. The statute defines ‘life-threatening disease or condition’ by reference to the FDA’s established regulatory definition at 21 C.F.R. § 312.81(a): a disease or condition where the likelihood of death is high unless the course of the disease is interrupted. That standard is broader than the ‘immediately life-threatening’ subcategory, which requires a reasonable likelihood of death within a matter of months. Treatment-resistant depression and severe PTSD may qualify, but that assessment is patient-specific and physician-certified — EO 14401 does not create a categorical authorization for all patients with those diagnoses.
C. The Rescheduling Mandate and Its Legal Force
The most consequential legal provision of EO 14401 is its directive that the Attorney General, in consultation with HHS, initiate and complete rescheduling review ‘as quickly as practicable’ under 21 U.S.C. § 811 for qualifying substances. That directive carries the same legal structure as EO 14370’s direction to complete marijuana rescheduling: it is a presidential mandate that places the Attorney General under an obligation to act and provides the policy authorization that DOJ will cite when it does act. The mandate does not itself reschedule any substance; the agency action produces the operative legal result. The April 23 cannabis order demonstrates what acting on such a mandate looks like.
‘As quickly as practicable’ is a standard of diligence, interpreted by the Attorney General in consultation with HHS based on the scientific and medical record, FDA’s review of any related NDA, and the available administrative mechanisms. For psilocybin, the practical meaning of the standard runs through the NDA timeline: the Attorney General cannot practically initiate the § 811(d)(1) rescheduling sequence for psilocybin until FDA has approved a psilocybin product, because FDA approval is the event that creates an ‘FDA-approved Schedule I substance’ — the factual predicate that makes the treaty-compliance rescheduling route available for a psychedelic, as it was for the qualifying medical cannabis category.
D. Funding, Data Sharing, and Research Infrastructure
EO 14401 directs at least $50 million in existing HHS funds toward federal-state collaboration on therapeutic research for the qualifying substances, including data-sharing arrangements with veterans’ organizations and private research institutions. That funding direction is meaningful for research institutions — Johns Hopkins’ Center for Psychedelic and Consciousness Research, the Usona Institute, the Heffter Research Institute, and similar organizations — that have operated primarily on private foundation funding. The $50 million is not a new appropriation; it is a direction to reprogram existing HHS funds, which means its implementation is subject to HHS’s programmatic priorities and the availability of funds within the mandated pool.
The veterans’ data-sharing provision reflects the evidence base for psychedelic therapies in combat-related PTSD and the specific political authorization that veterans’ advocacy has generated for psychedelic research access. The MAPS Phase 3 MDMA trial enrolled adults with severe PTSD, with veterans among the participants, producing results⁷ that members of Congress have cited in legislation pushing for VA psychedelic research access. EO 14401 gives that legislative push a presidential policy foundation without changing VA treatment protocols directly.
IV. The Operative Cannabis Legal Event: AG Order No. 6754-2026
A. What the Order Does
AG Order No. 6754-2026, issued April 23, 2026, amends the schedules of controlled substances established under 21 U.S.C. § 812 to transfer two categories of marijuana from Schedule I to Schedule III.¹⁰ The first is FDA-approved products containing marijuana. As of April 2026, no botanical marijuana drug occupies Schedule I with FDA approval — Epidiolex (cannabidiol) received FDA approval in 2018 and was rescheduled to Schedule V at that time,¹¹ placing it outside this provision. The FDA-approved marijuana category is therefore currently prospective, creating the federal compliance framework for any future FDA-approved botanical marijuana product that emerges from the clinical pipeline. The second category is marijuana, marijuana extract, and naturally derived delta-9-tetrahydrocannabinol subject to qualifying state medical marijuana license programs.
The order simultaneously amends 21 C.F.R. § 1312.30 to require DEA import and export permits for the newly covered marijuana categories. It creates an expedited DEA registration process for entities holding qualifying state medical marijuana licenses, in which state licensure constitutes conclusive evidence of state authorization. When a state medical marijuana license is suspended, revoked, or expires, DEA registration automatically suspends — a structural linkage that gives state regulatory actions immediate federal compliance consequences.
B. What the Order Does Not Do
The order does not reschedule marijuana generally. Adult-use cannabis, recreational dispensary operations, bulk marijuana not incorporated into an FDA-approved product, and marijuana sold outside a qualifying state medical license program all remain in Schedule I. The order does not change the criminal prohibition structure for non-qualifying activities. State-legal adult-use marijuana transactions remain federally illegal. The order does not address expungement, retroactive relief, or the status of prior convictions. The federal-state disconnect for the adult-use market is unchanged.
C. The Effective Date and Federal Register Mechanics
As of April 25, 2026, the publicly available DOJ PDF of AG Order No. 6754-2026 still contained a placeholder for the Federal Register publication date. A final published Federal Register citation was not available in the primary materials as of that date. The effective date mechanics — including the precise date from which Schedule III obligations attach for qualifying businesses — depend on the publication date and any delayed effective date specified in the order. Practitioners relying on the order for compliance planning should verify the final Federal Register publication before calculating compliance deadlines.
V. The Two-Authority Framework: §§ 811(d)(1) and 811(a) Across Both Substances
The feature shared by the April 23 cannabis order and the EO 14401 psychedelic pathway that carries the most analytical weight for practitioners is 21 U.S.C. § 811(d)(1), the treaty-compliance scheduling authority. Both the cannabis rescheduling already accomplished and the psychedelic rescheduling EO 14401 sets in motion run through the same statutory provision. Understanding that provision is essential for practitioners tracking either substance class.
Section 811(a) is the ordinary rescheduling pathway. It requires HHS scientific evaluation, an on-the-record administrative hearing if any party objects, the eight-factor analysis, and a final rule subject to APA substantial evidence review. The 2024 NPRM for cannabis proceeded under § 811(a),¹² and the June 29, 2026 hearing is the § 811(a) proceeding for broader marijuana rescheduling. The § 811(a) route is procedurally protective and generates a durable evidentiary record for judicial review.
Section 811(d)(1) is the treaty-compliance route. It allows the Attorney General to control a substance to the extent necessary to meet U.S. obligations under an applicable international treaty, without going through the § 811(a) hearing process. DOJ used § 811(d)(1) for the April 23 cannabis order because the United States is party to the Single Convention on Narcotic Drugs, 1961,¹³ which requires control of substances with abuse potential but permits lower-schedule placement for substances with medical utility under a regulated system. The medical-only scope of the April 23 order fits within the treaty framework in a way that adult-use cannabis does not.
The same statutory pathway applies to psychedelics. If FDA approves a psilocybin product, psilocybin becomes an FDA-approved Schedule I substance with demonstrated medical utility in a serious condition. DOJ could then invoke § 811(d)(1) to move psilocybin to Schedule III using the same treaty-compliance logic applied to qualifying cannabis on April 23, because medical use under a regulated framework is consistent with the Single Convention’s control requirements. The § 811(a) eight-factor evidentiary hearing would not be required for that move. That is the specific legal pathway EO 14401’s ‘as quickly as practicable’ directive sets in motion for psilocybin.
The two-authority framework therefore operates on parallel tracks for both substance classes: § 811(d)(1) for narrow, FDA-approval-predicated medical rescheduling; § 811(a) for broader, evidentiary-record-based rescheduling that extends beyond FDA-approved products. For cannabis, both tracks are currently active simultaneously. For psychedelics, the § 811(d)(1) track opens when FDA approves a qualifying product; the § 811(a) track for broader psychedelic rescheduling is not yet initiated.
VI. EO 14401 Implementation: The Parallel Psychedelic Rescheduling Sequence
A. Psilocybin: The Defined Near-Term Path
Psilocybin is the substance for which the EO 14401 implementation sequence has the most defined near-term path. Compass Pathways completed COMP005 in June 2025 and COMP006 in February 2026⁵ — two Phase 3 trials under its COMP360 program studying psilocybin for treatment-resistant depression. With two Phase 3 datasets, Compass Pathways has the evidentiary foundation required for a New Drug Application submission to FDA. FDA’s Breakthrough Therapy designation for psilocybin in treatment-resistant depression,⁶ if maintained, would apply a collaborative, expedited review process; Priority Review designation would give FDA a six-month review goal rather than the standard ten-month timeline. If Compass submits an NDA in 2026 and FDA applies Priority Review, FDA action could occur in 2027.
FDA approval of a psilocybin product creates an FDA-approved Schedule I substance. That is precisely the factual condition that — combined with the EO 14401 rescheduling mandate — would allow DOJ to invoke § 811(d)(1) to move psilocybin to Schedule III without a § 811(a) evidentiary hearing. The treaty-compliance justification is the same as for cannabis: the Single Convention requires control of substances with abuse potential, but permits lower-schedule placement for substances with established medical utility under a regulated system. An FDA-approved psilocybin drug satisfies that condition. A rescheduling action for psilocybin following FDA approval would parallel what DOJ did for qualifying cannabis on April 23 — narrow, FDA-predicated, treaty-compliance-grounded.
The sequence is foreseeable but not guaranteed. NDA submissions can be delayed. FDA can reject an NDA as it did for MDMA-assisted therapy in August 2024, even after Phase 3 completion. The clinical data from COMP005 and COMP006 must support an NDA with sufficient evidence on safety, efficacy, and proposed labeling. None of those steps are certainties. Practitioners advising clients on psychedelic-adjacent practices should model the psilocybin pathway as a plausible 2027 event, not a certain one.
B. MDMA: The Unresolved Track
MDMA’s path under EO 14401 is more complex. MAPS completed its Phase 3 program — the MAPP1 and MAPP2 studies — and submitted an NDA for midomafetamine capsules for PTSD.⁷ FDA issued a complete response letter in August 2024 declining to approve the application.⁸ FDA’s advisory committee raised concerns about blinding methodology — the difficulty of conducting a placebo-controlled trial for a substance with pronounced subjective effects — and about aspects of the therapist conduct record in the trial sites. MAPS has indicated it is pursuing a resubmission strategy, which requires additional data collection and potentially a new trial design addressing FDA’s concerns.
The legal question EO 14401 creates for MDMA is whether a substance that has ‘completed’ Phase 3 trials but whose NDA was rejected qualifies under the order’s threshold. The order’s text refers to substances that have completed Phase 3 trials for serious mental health disorders, not to substances that have received FDA approval based on those trials. Under a plain-text reading, MDMA’s completed Phase 3 trials satisfy the textual threshold even without FDA approval. Under a purposive reading tied to the FDA-approval predicate for § 811(d)(1) rescheduling, MDMA cannot move through the rescheduling sequence until FDA approves an MDMA product. DOJ and HHS will need to resolve this interpretive question, and their resolution will be subject to challenge under the APA’s arbitrary-and-capricious standard if it excludes MDMA from EO 14401’s reach based on the FDA rejection.
The practical MDMA timeline under the most optimistic scenario involves a resubmission to FDA incorporating additional data — potentially in 2027 or 2028 — followed by FDA review, followed by approval, followed by the § 811(d)(1) rescheduling sequence. That is a multi-year pathway measured from April 2026. In the interim, MDMA remains Schedule I, and access through the EO 14401 Right to Try pathway — even if EO 14401 technically covers MDMA given the completed trials — requires a supply chain and physician willingness to provide the treatment that do not yet exist at scale for MDMA.
C. Litigation Risk in the EO 14401 Sequence
The EO 14401 rescheduling sequence carries litigation risk at two points. First, challengers may contest whether specific substances qualify under the order’s Phase 3 threshold — particularly MDMA given FDA’s rejection. Second, challengers may contest DOJ’s use of § 811(d)(1) treaty-compliance authority for psychedelic rescheduling on the same grounds available against the April 23 cannabis order: that the treaty-compliance justification does not support the scope of the action, or that the APA requires the more procedurally protective § 811(a) route for a change of this magnitude. The government’s best response in both cases mirrors its cannabis position: the treaty permits but does not require Schedule I classification, § 811(d)(1) gives the Attorney General authority to calibrate scheduling to the minimum treaty-compliance level, and the clinical and medical record has been developed through the FDA review process.
VII. Compliance Architecture for Qualifying Cannabis Businesses
A. DEA Registration
Entities handling FDA-approved marijuana products require DEA Schedule III registration under 21 U.S.C. § 823 and 21 C.F.R. Part 1301. State medical marijuana licensees in qualifying programs gain access to an expedited registration track in which state licensure constitutes conclusive evidence of state authorization. DEA registration does not replace state licensing; both are required. The expedited process’s procedural mechanics — application form, review timeline, documentation requirements — were not yet specified in final form as of April 25, 2026.
B. Recordkeeping, Security, and Labeling
Schedule III placement generates substantive federal obligations. Biennial inventory requirements under 21 U.S.C. § 827 apply to Schedule III registrants. Recordkeeping for dispensing, distribution, and manufacturing follows DEA regulations in 21 C.F.R. Part 1304. Security requirements for Schedule III substances are less stringent than Schedule I or II but still require adequate controls against diversion. Labeling and packaging obligations follow 21 C.F.R. Part 1302, which requires accurate content labeling under Schedule III standards.
C. Prescription Controls
For FDA-approved marijuana products, the Schedule III prescription framework applies: prescriptions may be written or oral, may be refillable up to five times within six months, and do not require the triplicate-prescription controls that apply to Schedule II. As of April 2026, this framework is forward-looking — no FDA-approved botanical marijuana product is currently in Schedule I. State medical marijuana programs use physician recommendations rather than DEA-regulated prescriptions; the order does not automatically resolve how the CSA prescription framework interacts with state recommendation systems.
D. The State-License Dependency Structure
The automatic DEA registration suspension that follows state license suspension, revocation, or expiration is operationally consequential. A state enforcement action against a medical marijuana licensee immediately triggers federal compliance consequences. Operators in qualifying state programs should treat state license compliance as a federal compliance matter; it carries immediate DEA consequences. Multi-state operators with both medical and adult-use licenses need entity-level analysis because the two lines of business now carry materially different federal compliance profiles.
VIII. Tax Consequences: Internal Revenue Code § 280E
Internal Revenue Code § 280E disallows deductions and credits for businesses trafficking in Schedule I or Schedule II controlled substances. Cannabis businesses have faced effective federal income tax rates materially higher than comparable non-cannabis businesses as a result, because they cannot deduct wages, rent, and other ordinary operating expenses. Schedule III placement of qualifying medical marijuana removes the § 280E bar for those operations on the statute’s plain text — a qualifying medical cannabis operator is no longer trafficking in a Schedule I or II substance.
Treasury and IRS announced on April 23, 2026 that forthcoming guidance will address the tax consequences of rescheduling,¹⁴ including a transition rule under which the Schedule III treatment generally applies beginning with the taxpayer’s full taxable year including the order’s effective date. That announcement is not itself binding guidance; the formal published guidance governs. Mixed medical-and-adult-use operators need to segregate qualifying and non-qualifying operations because § 280E continues to apply to adult-use activities. State income tax conformity is a separate analysis: states conforming to the federal Internal Revenue Code as of a fixed date may not automatically extend § 280E relief, requiring state-by-state assessment for operators in California, Colorado, and other states with cannabis-specific tax provisions.
The cost-of-goods-sold methodology that cannabis businesses have used to reduce § 280E exposure — established through Tax Court litigation, including Patients Mutual Assistance Collective Corp. v. Commissioner, 151 T.C. No. 11 (2018), affirmed by the Ninth Circuit at 995 F.3d 671 (9th Cir. 2021)¹⁵ — becomes less strategically important for qualifying medical operations once § 280E no longer applies. But operators should not assume the transition is automatic; they should model pre- and post-effective-date tax positions and document the transition-rule application carefully.
IX. The Cannabis Hearing Reset: AG Orders 6752 and 6753
On April 23, 2026, DOJ issued two companion instruments: AG Order No. 6752-2026, withdrawing the August 29, 2024 notice of hearing and terminating prior DEA administrative proceedings,¹⁶ and AG Order No. 6753-2026, issuing a new hearing notice for the still-pending broader marijuana rescheduling question.¹⁷ The new hearing is scheduled to begin June 29, 2026.
The withdrawal resets the procedural clock. The August 29, 2024 notice opened formal on-the-record proceedings under the CSA and APA for moving marijuana generally from Schedule I to Schedule III.¹⁸ Dozens of parties had requested status in those proceedings. By withdrawing that notice and issuing a new one, DOJ resets party status and the evidentiary record. Existing party requests and submitted materials carry over only to the extent the new notice expressly incorporates them. The June 29 hearing now addresses a narrower question than the 2024 proceeding: whether the marijuana remaining in Schedule I after the April 23 order — adult-use cannabis, bulk marijuana, and other non-qualifying categories — should receive Schedule III treatment through the § 811(a) process.
From a litigation posture, parties that opposed the 2024 NPRM should reassess their strategy. The April 23 order changes the position: medical operators now have Schedule III status regardless of the June 29 hearing outcome. Adult-use operators and civil society organizations focused on broader reform retain strong incentives to participate. The June 29 hearing is also where public health research on adult-use cannabis will be tested against the eight-factor analysis — the evidentiary record that results will govern any subsequent judicial review of a final broader-rescheduling rule.
X. State Developments and the Federalism Gap
On April 19, 2026, Massachusetts Governor Maura Healey signed cannabis reform legislation modernizing the Commonwealth’s cannabis laws, strengthening oversight, and streamlining the regulatory agency governing cultivators, processors, and retailers.¹⁹ The Massachusetts action illustrates a consistent feature of current cannabis federalism: state systems continue to develop independently of federal scheduling, and the federal rescheduling does not pause or redirect state legislative activity.
The federalism gap the April 23 order creates is precise. Qualifying state medical marijuana operators have a federal compliance pathway for the first time. The gap between state-legal adult-use systems and federal Schedule I status is unchanged. Practitioners advising multi-state operators must assess each legal entity and activity type separately because the federal tax and compliance consequences now differ by activity type as well as by state.
On the psychedelic side, Oregon and Colorado have implemented state psilocybin access programs — Oregon under Measure 109 and Colorado under Proposition 122²⁰ — that operate independently of federal scheduling. Persons accessing psilocybin under those state programs are still handling a Schedule I substance federally until DOJ acts under EO 14401’s rescheduling mandate following FDA approval.
XI. Open Questions, Litigation Risk, and Parallel Timelines
A. Litigation Vulnerability of the April 23 Cannabis Order
The April 23 cannabis order’s primary litigation target is its use of § 811(d)(1). A challenger could argue that the treaty-compliance justification does not support placing state medical marijuana licensees into Schedule III — that the Single Convention does not require Schedule III and that Schedule I satisfies treaty obligations equally well. DOJ’s position will be that the Convention permits but does not require Schedule I classification and that § 811(d)(1) gives the Attorney General authority to calibrate scheduling to the minimum treaty-compliance level. APA procedural challenges are also available on the ground that the scale of the change requires the § 811(a) process. Fifth Amendment equal protection arguments may emerge from the medical-versus-adult-use stratification. The litigation risk is real and practitioners should monitor federal circuit court activity following any legal challenge filing.
B. The June 29 Cannabis Hearing
Industry trade associations — including the National Cannabis Industry Association, the Cannabis Trade Federation, and various state-level trade groups — will present evidence on the economic effects of Schedule I treatment on adult-use businesses. Public health researchers will contest or support the eight-factor analysis on abuse potential and public health risk. Civil liberties organizations will present evidence on disparate enforcement consequences. The administrative law judge’s recommended decision, following the hearing and briefing, will go to the DEA Administrator, whose final order is subject to APA judicial review. The pipeline from hearing opening to final rule typically takes years; adult-use operators should plan for a multi-year uncertainty period.
C. The EO 14401 Timeline and the Psilocybin Inflection Point
The EO 14401 psychedelic timeline runs parallel to the June 29 cannabis hearing. Its next inflection point is an NDA submission from Compass Pathways to FDA based on the COMP360 Phase 3 data. If Compass submits in 2026, FDA action under Priority Review could occur in 2027, triggering the § 811(d)(1) rescheduling sequence for psilocybin under EO 14401’s mandate. That sequence would produce the first operative federal rescheduling of a psychedelic substance — parallel in structure to what April 23, 2026 produced for qualifying cannabis. Practitioners advising psychedelic therapy programs, pharmaceutical researchers, and related investors should model this timeline and track the NDA submission announcement as the key triggering event.
D. Unresolved Compliance Questions
Several compliance questions remain open across both substance classes. The Federal Register effective date for AG Order No. 6754-2026 was not final as of April 25, 2026. Treasury and IRS § 280E transition guidance has been announced but not published. The DEA expedited registration process for state medical marijuana licensees has not been specified in procedural detail. EO 14401’s Right to Try access pathway requires DEA to issue implementing guidance on Schedule I handling authorizations for qualifying patients. Practitioners should monitor the Federal Register and agency guidance channels closely through June 2026 for all four streams.
XII. Conclusion
The week of April 18 through April 23, 2026 produced the most consequential shift in federal controlled-substance law since the Controlled Substances Act’s enactment in 1970. EO 14401 established a presidential mandate for accelerated psychedelic therapeutic access and rescheduling, with psilocybin the most likely near-term operative result. AG Order No. 6754-2026 accomplished the first operative federal rescheduling of marijuana, moving qualifying medical cannabis from Schedule I to Schedule III through the treaty-compliance authority of § 811(d)(1). Both actions share a parallel structural logic and point toward the same operative next step: a § 811(d)(1) treaty-compliance rescheduling action for psilocybin following FDA approval, using the same legal mechanism DOJ applied to qualifying cannabis on April 23.
For practitioners, the work on both fronts is immediate. Qualifying medical cannabis operators need DEA registration analysis and § 280E planning; multi-state operators with mixed medical and adult-use operations need entity structure review. Practitioners advising psychedelic-adjacent practices need to model the EO 14401 Right to Try access framework and prepare for the psilocybin rescheduling sequence. Tax advisors working with cannabis clients need to run separate federal and state analyses. Every practitioner with a stake in the broader adult-use cannabis market needs to prepare for the June 29 hearing, which will determine whether the two-tier federal cannabis structure established on April 23 becomes permanent or expands to cover the rest of the market.
Notes
¹ Exec. Order No. 14,370, 90 Fed. Reg. 60,541 (Dec. 23, 2025).
² U.S. Dep’t of Just., Off. of Legal Couns., Questions Related to the Potential Rescheduling of Marijuana (Apr. 11, 2024), https://www.justice.gov/olc/opinion/questions-related-potential-rescheduling-marijuana.
³ Press Release, U.S. Dep’t of Just., Justice Department Places FDA-Approved Marijuana Products and Products Containing Marijuana Subject to State Medical Marijuana Licenses on Schedule III (Apr. 23, 2026) [hereinafter DOJ Press Release], https://www.justice.gov/opa/pr/justice-department-places-fda-approved-marijuana-products-and-products-containing-marijuana.
⁴ Exec. Order No. 14,401, 91 Fed. Reg. 21,709 (Apr. 22, 2026).
⁵ Compass Pathways, COMP360 COMP005 Phase 3 Trial Results (June 2025), https://compasspathways.com; Compass Pathways, COMP360 COMP006 Phase 3 Trial Results (Feb. 2026), https://compasspathways.com.
⁶ Compass Pathways, FDA Grants Breakthrough Therapy Designation for Compass Pathways’ Psilocybin Therapy (Oct. 23, 2018), https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy/.
⁷ Jennifer M. Mitchell et al., MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study, 27 Nature Med. 1025 (2021), https://doi.org/10.1038/s41591-021-01336-3.
⁸ U.S. Food & Drug Admin., Complete Response Letter: Midomafetamine Capsules (Aug. 2024) [referenced in MAPS public disclosures and FDA advisory committee proceedings].
⁹ Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, Pub. L. No. 115-176, 132 Stat. 1372 (2018) (codified at 21 U.S.C. § 360bbb-0a).
¹⁰ Drug Enf’t Admin., Schedules of Controlled Substances: Rescheduling of Food and Drug Administration Approved Products Containing Marijuana from Schedule I to Schedule III; Corresponding Change to Permit Requirements, AG Order No. 6754-2026 (Apr. 23, 2026), https://www.justice.gov/opa/media/1437751/dl [hereinafter AG Order No. 6754-2026].
¹¹ Schedules of Controlled Substances: Placement of FDA-Approved Products Containing Cannabidiol in Schedule V of the Controlled Substances Act, 83 Fed. Reg. 48,950 (Sept. 28, 2018).
¹² Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. 44,597 (May 21, 2024) (proposed rule), https://www.federalregister.gov/documents/2024/05/21/2024-11137/schedules-of-controlled-substances-rescheduling-of-marijuana.
¹³ Single Convention on Narcotic Drugs, Mar. 30, 1961, 18 U.S.T. 1407, T.I.A.S. No. 6298, as amended by the 1972 Protocol Amending the Single Convention on Narcotic Drugs.
¹⁴ Press Release, U.S. Dep’t of the Treasury & Internal Revenue Serv., IRS and Treasury Announce Forthcoming Guidance on Tax Treatment of Rescheduled Marijuana (Apr. 23, 2026).
¹⁵ Patients Mut. Assistance Collective Corp. v. Comm’r, 151 T.C. No. 11 (2018), aff’d, 995 F.3d 671 (9th Cir. 2021).
¹⁶ Drug Enf’t Admin., Withdrawal of Notice of Hearing: Schedules of Controlled Substances: Rescheduling of Marijuana, AG Order No. 6752-2026 (Apr. 23, 2026), https://www.justice.gov/opa/media/1437746/dl.
¹⁷ Drug Enf’t Admin., Notice of Hearing on Proposed Rulemaking: Schedules of Controlled Substances: Rescheduling of Marijuana, AG Order No. 6753-2026 (Apr. 23, 2026), https://www.justice.gov/opa/media/1437741/dl.
¹⁸ Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. 70,148 (Aug. 29, 2024) (notice of hearing), https://www.federalregister.gov/documents/2024/08/29/2024-19370/schedules-of-controlled-substances-rescheduling-of-marijuana.
¹⁹ Press Release, Office of the Governor of Mass., Governor Healey Signs Cannabis Reform Legislation (Apr. 19, 2026).
²⁰ Or. Rev. Stat. §§ 475A.210–475A.722 (2021) (Oregon Psilocybin Services Act, enacted as Measure 109 (2020)); Colo. Rev. Stat. §§ 12-170-101 to -903 (2022) (Natural Medicine Health Act, enacted as Proposition 122 (2022)).