RN Collins (Series 2) No.7 of 20: Federal–State Tensions in Psychedelic Regulation: Where Preemption May Emerge | Cannabis Law Report | Where to buy Skittles Moonrock online

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RN Collins has written a series of 20 new articles for cannabis law report on 2026 Psychedelics & Legal Issues.

This is the seventh

Federal–State Tensions in Psychedelic Regulation: Where Preemption May Emerge

Author RN Collins

Contact: https://www.linkedin.com/in/rn-collins/

Cannabis Law Report Policy Reform / Governance / Oversight Series — Article 7

Abstract

Oregon and Colorado have established the first state-licensed psilocybin service programs in the United States, permitting regulated adult access to a substance that remains a Schedule I controlled substance under federal law. As additional states advance similar frameworks and the federal rescheduling process gains momentum, the legal terrain governing federal–state conflict is evolving rapidly. This article analyzes the constitutional and statutory foundations of federal preemption doctrine as applied to state psychedelic programs, identifies the principal vectors through which preemption pressure is most likely to emerge, maps the design choices that increase or reduce states’ preemption exposure, and surveys the current federal posture toward state psilocybin programs. The analysis draws on the Controlled Substances Act’s savings clause, Commerce Clause jurisprudence, anti-commandeering doctrine, and the distinct structural features of Oregon’s and Colorado’s programs. The article concludes that formal preemption litigation is not the primary near-term risk; rather, functional preemption through banking exclusion, DEA registration conditions, and Medicaid/Medicare facility restrictions poses the more immediate structural constraint on state program viability. An emerging and distinct preemption risk arises from the post-rescheduling scenario: if psilocybin receives Schedule II status and FDA pharmaceutical approval, the obstacle preemption doctrine could generate contested terrain for state non-medical service center programs, through a mechanism that differs structurally from the CSA preemption analysis that has governed the cannabis context.

I. Introduction

When Oregon voters approved Ballot Measure 109 in November 2020, and Colorado voters passed Proposition 122 in November 2022, both states created state-supervised psilocybin service programs for adults.¹ Oregon’s program launched commercially in June 2023, making it the first jurisdiction in the United States to permit state-licensed psilocybin services to the general public.² Colorado accepted its first healing center and facilitator license applications on December 31, 2024, with the inaugural state-regulated psilocybin session conducted in Denver on June 6, 2025.³

Both programs operate against the backdrop of unambiguous federal prohibition. Psilocybin remains classified as a Schedule I controlled substance under the Controlled Substances Act of 1970 (CSA), meaning Congress has determined it has “no currently accepted medical use in treatment in the United States” and carries “a high potential for abuse.”⁴ This classification has not changed despite the Food and Drug Administration granting “Breakthrough Therapy” designation to psilocybin-assisted therapy for treatment-resistant depression as early as 2018.⁵

The resulting dual-legality framework — state-permitted, federally prohibited — replicates the structure that has governed state cannabis markets for over two decades, but with important structural differences that alter the preemption calculus. This article examines where and how federal preemption pressure may crystallize, drawing on the statutory text of the CSA, the Supreme Court’s commerce clause and preemption jurisprudence, and the specific regulatory choices that Oregon and Colorado have made to manage their federal exposure.

II. The Preemption Framework: Constitutional and Statutory Architecture

A. The Supremacy Clause and Its Limits

The Supremacy Clause of Article VI of the United States Constitution provides that federal law shall be the “supreme Law of the Land,” and that state laws conflicting with valid federal statutes are void.⁶ Under established doctrine, preemption may be express (where Congress explicitly states its intent to displace state law), field (where Congress occupies a regulatory domain so comprehensively that no room remains for state law), or conflict (where compliance with both state and federal law is impossible, or where state law “stands as an obstacle” to achieving federal objectives).⁷

For the CSA, the express preemption question has long been settled by the statute’s own savings clause. Section 903 of the CSA provides that no provision of the Act “shall be construed as indicating an intent on the part of the Congress to occupy the field” of drug regulation, and that the Act shall only preempt state law where “there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.”⁸ Congress thus expressly foreclosed field preemption and confined preemptive effect to genuine positive conflicts.⁹

Courts applying this standard have generally held that a state drug law is preempted by the CSA only if (1) it is physically impossible to comply with both state and federal law simultaneously, or (2) it stands as an obstacle to the accomplishment of Congress’s objectives under the CSA.¹⁰ A state’s decision to cease punishing conduct that remains federally prohibited does not, standing alone, constitute the kind of positive conflict required by Section 903.¹¹ As Professor Robert Mikos has framed the point, “the states themselves are no longer criminalizing some of these activities. And while that may disappoint federal expectations, and even conflict philosophically with the federal outlook, that circumstance by itself does not give rise to preemption under the Supremacy Clause.”¹²

B. Gonzales v. Raich and the Commerce Clause Foundation

The Supreme Court’s 2005 decision in Gonzales v. Raich remains the controlling authority on Congress’s power to prohibit local cultivation and possession of a Schedule I controlled substance, even where state law authorizes the activity.¹³ In a 6-3 decision authored by Justice Stevens, the Court held that Congress’s authority under the Commerce Clause extended to prohibiting Angel Raich’s home cultivation of marijuana for personal medical use, even though California law permitted that activity under the Compassionate Use Act of 1996. The Court applied the “substantial effects” doctrine, holding that Congress had a rational basis for concluding that excluding locally grown marijuana from federal prohibition would create a significant gap in the CSA’s regulatory scheme.¹⁴

The Raich holding is significant for state psilocybin programs in two respects. First, it confirms that the federal government retains the constitutional authority to enforce the CSA against individual participants in state-licensed psilocybin programs. Second, and critically, the Raich Court was not asked to determine whether California’s state authorization law was preempted — it was asked whether federal enforcement of the CSA in that state was constitutionally permissible. The answer to that question (yes) does not answer the preemption question (does federal law void state authorization).¹⁵

The distinction is consequential. Raich means that the DEA can prosecute Oregon service center operators under federal law even while they hold valid state licenses. It does not mean that the state program itself is unconstitutional or preempted — the state simply stops punishing the conduct while federal authorities retain the option to pursue it independently.

C. Anti-Commandeering Doctrine and State Program Integrity

The Tenth Amendment’s anti-commandeering principle, reinforced by New York v. United States (1992) and Printz v. United States (1997), provides an additional doctrinal layer protecting state drug reform programs from forced displacement.¹⁶ Congress may not compel states to enact federal regulatory programs or direct state law enforcement officers to enforce federal law. This principle means that a state’s refusal to criminalize psilocybin possession or to fund state enforcement of the federal prohibition does not expose the state to a viable preemption challenge on obstacle-preemption grounds — the state is simply exercising its sovereign authority to define the content of state criminal law.

Both Oregon and Colorado explicitly acknowledged this boundary in their state statutes. Oregon Revised Statute § 475A.215(7) provides that nothing in the Oregon Psilocybin Services Act “shall be construed to exempt any person from the application of, or arrest or prosecution under, applicable federal law.” Colorado Proposition 122 contains equivalent language.¹⁷ These savings clauses are both legally accurate and tactically designed — they signal to federal authorities that the state programs do not attempt to nullify or substitute for the federal prohibition, only to establish a parallel state legal framework.

III. Vectors of Preemption Pressure: Where Conflict Is Most Likely to Emerge

A. Federal Funding Conditions and Healthcare Facility Integration

The most significant near-term preemption risk for state psilocybin programs does not arise from direct enforcement of the CSA but from federal funding conditions attached to healthcare institutions. Hospitals and healthcare systems that receive Medicare, Medicaid, or federal research funding face potential jeopardy if they integrate psilocybin services into their operations, because administering a Schedule I substance that has not been approved by the FDA for medical use would place them in violation of conditions of federal program participation.¹⁸

Harvard Law School Professor Mason Marks, who directs the Project on Psychedelics Law and Regulation at the Petrie-Flom Center, has identified this as the principal distinction between Oregon’s and Colorado’s regulatory designs and their respective federal exposure. Oregon’s statute expressly prohibits psilocybin service centers from operating within licensed healthcare facilities, from making medical claims, and from requiring clients to have a medical diagnosis or prescription.¹⁹ These structural firewalls insulate the Oregon program from conflict with conditions governing Medicare- and Medicaid-participating facilities.

Colorado’s Natural Medicine Health Act (NMHA), codified at C.R.S. § 12-170-101 et seq., takes a different approach, explicitly anticipating and permitting the integration of psychedelic services with healthcare settings.²⁰ One Colorado legal commentator observed that “if a hospital wants to offer psilocybin, they might not be able to because they receive federal grants or Medicaid money. That could preclude an established health care facility from integrating this into their everyday practice.”²¹ The DEA’s issuance of a warning letter to Georgia pharmacists, cautioning them against dispensing medical marijuana permitted under Georgia law through a pharmacy-dispensing model, illustrates the agency’s sensitivity to the blending of Schedule I substances with licensed medical infrastructure.²²

B. DEA Registration Requirements and Facilitator Licensing

A distinct preemption vector arises from the CSA’s registration requirements for practitioners who handle controlled substances. Under 21 U.S.C. § 823, practitioners who dispense or possess Schedule I controlled substances for research purposes must obtain DEA registration, and such registration authorizes use only within the bounds of an FDA-approved research protocol.²³

The litigation led by Dr. Sunil Aggarwal and the Advanced Integrative Medical Science Institute (AIMS) illustrates the limits of this framework across two separate proceedings. In Aggarwal v. U.S. Drug Enforcement Administration, No. 22-1718, 2023 WL 7101927 (9th Cir. Oct. 27, 2023), the Ninth Circuit held that the DEA had failed to provide adequate analysis when denying a petition to reschedule psilocybin, directing the DEA to clarify its pathway for denying the petition or to reevaluate it.²⁴ In a subsequent proceeding, Advanced Integrative Medical Science Institute, PLLC v. U.S. Drug Enforcement Administration, No. 22-1568, 128 F.4th 1133 (9th Cir. Feb. 13, 2025), the Ninth Circuit upheld the DEA’s denial of Dr. Aggarwal’s request for a CSA registration waiver to administer psilocybin under state and federal Right to Try laws, holding that the CSA’s registration requirements are not abrogated by the federal Right to Try Act of 2018.²⁵ The court reasoned that while the Right to Try Act exempts eligible investigational drugs from FDA approval requirements, it does not exempt such drugs from the FDA’s Attorney-General-delegated oversight pursuant to the CSA.²⁶

For state-licensed facilitators who are also licensed healthcare professionals holding DEA registrations, the interaction between their state facilitator authorization and their federal practitioner registration creates a zone of legal uncertainty. Oregon’s regulations require facilitators to operate solely in that capacity during psilocybin sessions, and expressly prohibit them from simultaneously practicing under a healthcare license — a structural choice that reduces, though does not eliminate, the DEA-registration conflict.²⁷ Colorado’s emerging regulations for “clinical facilitators,” who must hold a valid state secondary license in psychology, social work, or a related field, create closer proximity to the DEA registration risk that Oregon sought to avoid.²⁸

On August 11, 2025, the DEA transmitted Dr. Aggarwal’s rescheduling petition to the Department of Health and Human Services for scientific and medical evaluation — the most significant step yet toward potential psilocybin rescheduling.²⁹ If HHS issues a scheduling recommendation and DEA initiates formal rulemaking to move psilocybin to Schedule II, the registration landscape for state-licensed facilitators would shift considerably.

C. Banking and Financial Infrastructure

The most pervasive source of functional preemption — the mechanism through which federal law renders state programs practically unworkable without formal legal conflict — is the absence of banking access for psilocybin businesses. Because psilocybin remains a Schedule I controlled substance, federally insured banks and credit unions that extend credit, process payments, or maintain accounts for psilocybin service centers risk potential criminal and civil liability under federal anti-money-laundering statutes, including 18 U.S.C. §§ 1956–1957, as well as potential adverse action by federal bank regulators.³⁰

The cannabis industry has confronted this barrier for over two decades. As of 2025, despite the passage of state-regulated cannabis markets in 38 states and the District of Columbia, no federal safe harbor for cannabis banking has been enacted.³¹ Psilocybin service businesses in Oregon face the same structural challenge. Legal analysis from Harris Sliwoski LLP, which has tracked the Oregon program since its launch, identified “intractable issues caused by federal prohibition, especially around taxation and lack of banking” as among the structural constraints suppressing program growth.³²

The banking issue functions as a form of de facto preemption: federal law does not void the state authorization, but it forecloses the financial infrastructure necessary to operate viable licensed businesses. Unlike direct enforcement or formal preemption litigation, this constraint is difficult to challenge in court because it arises from private actors’ risk-management decisions in response to federal law, rather than from any affirmative government act. The Congressional Research Service has documented the specific legal exposure: financial institution personnel who knowingly facilitate transactions involving proceeds of CSA-prohibited activity face potential prosecution under §§ 1956 and 1957, and institutions can face federal insurance revocation and regulatory enforcement for BSA and AML violations, creating a category of institutional risk that no amount of state licensing can eliminate without federal legislative action.³³

D. Liability Exposure for Federally Regulated Third Parties

A distinct and underanalyzed preemption vector arises from the exposure of federally regulated third parties that interact with state-licensed psilocybin operators — not as enforcement targets themselves, but as regulated actors who face federal compliance obligations arising from those interactions.

A federally chartered bank that extends a line of credit to a psilocybin service center is not distributing a controlled substance, but its credit exposure to a borrower engaged in Schedule I trafficking generates the AML and BSA compliance obligations described above, plus potential asset forfeiture exposure under 18 U.S.C. § 981 if the loan collateral is deemed to derive from or be traceable to proceeds of an unlawful controlled substance transaction.

A pharmacist licensed by a state pharmacy board who holds DEA registration and refers a patient to a state-licensed psilocybin service center faces a distinct question: does that referral constitute aiding and abetting a federal controlled substance offense under 18 U.S.C. § 2, or does it fall outside the CSA’s prohibition because the pharmacist is not dispensing, distributing, or manufacturing? The answer is not obvious: the DEA’s enforcement posture toward healthcare professionals who facilitate access to state-authorized controlled substance programs has been cautious, as the Georgia pharmacist warning letter demonstrates, and no definitive guidance has been issued for psilocybin service referrals by federally registered practitioners.

A Medicare-participating physician whose patient participates in a state-licensed psilocybin session faces potential complications under conditions of participation if the physician either recommends the session as part of a treatment plan or prescribes medications in anticipation of or following the session in ways that could be characterized as facilitating access to a Schedule I substance. This risk is theoretical in the current enforcement environment but becomes more concrete as healthcare-adjacent psilocybin models develop.

These third-party exposure risks are structurally different from the direct preemption questions addressed in Sections II and III above. They are not about whether state programs are preempted; they are about whether federally regulated actors can engage with state-authorized activity without incurring federal liability. Federal law does not need to preempt the state program to limit its practical viability by constraining the participation of banks, pharmacists, and physicians who would otherwise support program access. State designers should treat third-party federal exposure as a distinct design consideration — identifying which third-party relationships are essential to program functionality, mapping the specific federal legal exposure each creates, and designing state law provisions (like statutory referral protections and banking access programs) that reduce, even if they cannot eliminate, that exposure.³⁴

E. Interstate Commerce and Diversion Control

The CSA reflects Congress’s determination that even purely intrastate drug activity can substantially affect interstate commerce — the rationale that sustained the Raich holding. For state psilocybin programs, this principle creates ongoing federal authority to act against intrastate activity involving Schedule I substances. More practically, it creates a structural risk if state programs generate supply chains or distribution networks that federal authorities characterize as affecting interstate markets.

Both Oregon and Colorado have adopted supply-chain traceability requirements designed partly to demonstrate compliance with state law and partly to rebut any claim that state-licensed activity is feeding illicit interstate commerce.³⁵ Oregon’s regulatory framework requires licensed manufacturers, service centers, and testing laboratories to maintain chain-of-custody documentation. Colorado’s Natural Medicine Division similarly licenses the full supply chain from cultivation through healing centers, with transport restricted to licensed employees.³⁶ These compliance measures reduce the likelihood of federal intervention predicated on diversion concerns, but they do not eliminate federal authority to prosecute any participant in the state-licensed supply chain.

IV. Comparative Structural Analysis: Oregon Versus Colorado

The regulatory architectures of Oregon and Colorado reflect meaningfully different approaches to managing federal preemption risk, with Oregon generally adopting a more insulated model and Colorado opting for deeper healthcare integration at the cost of elevated federal exposure.

Oregon Psilocybin Services Act (Or. Rev. Stat. Ch. 475A): Oregon’s framework is deliberately designed to exist in a separate regulatory category from healthcare. Psilocybin service centers may not overlap with licensed healthcare facilities. Facilitators may not diagnose, treat, or make medical claims. No medical prescription or diagnosis is required for access. These structural choices minimize the program’s footprint in federally regulated healthcare space, thereby reducing the risk of conflict with Medicare/Medicaid conditions of participation and limiting the relevance of DEA practitioner-registration requirements.³⁷

Colorado Natural Medicine Health Act (C.R.S. § 12-170-101 et seq.): Colorado’s statute anticipates and enables deeper integration of natural medicine services with healthcare systems. The NMHA establishes a “clinical facilitator” pathway for licensed healthcare professionals and envisions psilocybin services being offered alongside conventional therapeutic services. While this design may improve access and clinical quality, it heightens the risk of conflict with conditions governing federally funded healthcare institutions and raises the stakes of any DEA scrutiny of facilitators who hold both state facilitation licenses and federal practitioner registrations.³⁸

The Colorado Lawyer analysis from the Colorado Bar Association observed directly that “neither the NMHA nor the Oregon PSA comply with the CSA because both decriminalize under state law a schedule I controlled substance — psilocybin — and offer a legal path to access it under state law,” but that “the federal government’s tolerance of state-legal activities that violate federal law is dependent on the law enforcement priorities articulated by the current political administration.”³⁹

V. The Federal Enforcement Posture: From the Cole Memo to the Current Administration

The most direct analogy for the prior federal approach to state psilocybin programs was the Obama-era Cole Memorandum framework for state cannabis programs, issued in August 2013. Under that guidance, the Department of Justice directed federal prosecutors to exercise enforcement discretion and refrain from prioritizing prosecution of state-authorized cannabis activity that did not implicate federal enforcement priorities such as sales to minors, diversion to non-legal states, or involvement with organized crime.⁴⁰ Attorney General Jeff Sessions rescinded the Cole Memo in January 2018, but no systematic federal enforcement campaign against state-licensed cannabis markets followed in practice — illustrating that enforcement discretion, while legally fragile, can provide durable operational stability.

No equivalent formal policy statement has been issued with respect to state psilocybin programs by the Trump administration. The current federal posture toward psilocybin is more complex — and more internally contradictory — than the Cole Memo era presented.

On the pro-access side, several senior administration officials have publicly expressed strong support for psychedelic therapy. HHS Secretary Robert F. Kennedy Jr. told members of Congress in mid-2025 that “this line of therapeutics has tremendous advantage if given in a clinical setting and we are working very hard to make sure that happens within 12 months.”⁴¹ FDA Commissioner Marty Makary declared the evaluation of MDMA and other psychedelics “a top priority,” announced the Commissioner’s National Priority Voucher program that could reduce drug review timelines from months to weeks, and has reportedly told Kennedy directly: “We don’t want to wait two years to get this done.”⁴² HHS hired Matt Zorn, a drug policy lawyer, to work specifically on psychedelics policy issues in May 2025, and the department has hired several other new staffers with ties to the psychedelic movement.⁴³ The DEA’s August 2025 transmission of the Aggarwal rescheduling petition to HHS suggests at least institutional tolerance of accelerating the scheduling review process.⁴⁴

On the cautious side, the administration’s stated openness has not translated into consistent institutional action. In October 2025, Trump administration officials at HHS and the White House vetoed the FDA’s plan to include Compass Pathways’ COMP360 psilocybin treatment for severe depression on the first list of Commissioner’s National Priority Voucher recipients — despite Makary’s public advocacy for expedited psychedelic review. According to reporting by STAT News, the veto occurred hours before the announcement was made, suggesting internal discord between MAHA movement supporters and other administration officials skeptical of corporate psilocybin pharmaceutical development.⁴⁵ No formal DOJ policy statement on state psilocybin program enforcement has been issued, and the DEA’s leadership posture toward state programs remains undefined.

The practical upshot for state psilocybin programs is an enforcement environment that is more tolerant than the absence of formal guidance would suggest, but more uncertain than the current administration’s rhetoric implies. The combination of pro-access statements from senior officials and the veto of the Compass voucher signals that the administration views psychedelics through a veterans-and-mental-health access lens rather than a pharmaceutical-regulatory approval lens — which may mean more tolerance for state-licensed therapeutic access programs than for corporate pharmaceutical fast-tracking, but this inference cannot be stated with the confidence that a formal non-enforcement policy would provide. State programs operate without the legal clarity that even the rescinded Cole Memo provided for cannabis.

VI. Dormant Commerce Clause Considerations

State psilocybin programs raise a distinct constitutional issue from preemption: whether their residency requirements, intrastate production mandates, or other market-structuring provisions violate the dormant Commerce Clause by discriminating against out-of-state interests. Oregon’s initial requirement that majority ownership of psilocybin businesses be held by state residents for at least two years — which sunsetted on December 31, 2024 — illustrates this risk.⁴¹

Harris Sliwoski LLP noted that the residency requirement “was likely unconstitutional from the start” under dormant Commerce Clause doctrine, which prohibits state laws that discriminate against interstate commerce in favor of local economic actors without adequate justification.⁴² No court challenge to the residency requirement was filed before it expired, but the constitutional vulnerability was real. As more states adopt psilocybin programs with residency preferences, local-ownership requirements, or intrastate sourcing mandates — measures that may be politically popular but economically protectionist — dormant Commerce Clause challenges from out-of-state investors or competing businesses are foreseeable.

VII. The Rescheduling Pathway and Its Preemption Implications

If the DEA ultimately moves psilocybin from Schedule I to Schedule II in response to HHS’s scientific recommendation — a process that could require formal rulemaking and public comment — the preemption calculus for existing state programs would shift significantly. A Schedule II classification would mean that psilocybin has a currently accepted medical use with severe restrictions, which would enable FDA-regulated prescription access alongside state service center models.⁴⁷

This dual-track landscape would itself generate new preemption questions. The American Bar Association’s analysis of the Oregon program notes that FDA approval of a psilocybin pharmaceutical product would create “an inherent competing interest” between the FDA-regulated prescription model and the Oregon service center model, and that “the regulated healthcare industry will permit state practitioners holding an appropriate license to prescribe psilocybin to eligible patients” in ways that could compete with and potentially displace the non-medical service center framework.⁴⁸

The most plausible preemption mechanism through which FDA approval of a Schedule II psilocybin pharmaceutical could assert preemptive force over state non-medical service center programs is obstacle preemption under the framework applied in Wyeth v. Levine, 555 U.S. 555 (2009), and its successors — not impossibility preemption under the CSA’s § 903 savings clause. In Wyeth, the Supreme Court articulated the obstacle preemption test as asking whether state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress” as expressed through the FDCA.⁴⁹ The Court in Wyeth ultimately found no preemption on those facts, but the dissent — joined by Chief Justice Roberts and Justice Scalia — argued that “where the FDA determines, in accordance with its statutory mandate, that a drug is on balance ‘safe,’ our conflict preemption cases prohibit any State from countermanding that determination.”⁵⁰

Applied to a hypothetical FDA-approved Schedule II psilocybin pharmaceutical, the obstacle preemption argument would run as follows: FDA approval establishes specific conditions of use — dosage, indication, patient population, prescribing authority, and monitoring requirements — that represent the agency’s expert determination of the conditions under which the substance is safe and effective. A state program permitting administration of psilocybin by non-medical facilitators without a diagnosis, without a prescription, and outside of approved-indication conditions could be characterized as establishing an alternative and competing safety regime that undermines the FDA’s determination of appropriate use conditions. Unlike the Wyeth context — where state tort law supplemented rather than contradicted FDA’s safety regime — a state-authorized non-medical access program could be argued to contradict the FDA’s determination that medically appropriate administration requires clinical infrastructure.

This argument is not certain to prevail. Wyeth‘s majority held that FDA approval establishes a floor, not a ceiling, and emphasized that Congress has historically declined to enact express drug preemption provisions. Under the CSA § 903 savings clause, moreover, the direct positive conflict standard would also need to be satisfied, which is a demanding threshold. But the obstacle preemption argument is legally significant and structurally different from the CSA preemption analysis: it arises from the FDCA rather than the CSA, it is not foreclosed by the CSA’s savings clause, and it would be asserted not because the state authorizes conduct the CSA prohibits but because the state authorizes a different access model than the FDA’s approval conditions contemplate. State program designers should build regulatory architectures capable of defending against this distinct preemption vector — in particular, by maintaining structural separation between state service center models and any FDA-approved pharmaceutical product that may contain psilocybin, and by ensuring that state program conditions of access do not purport to conflict with or substitute for any FDA-approved indication or safety regime.⁵¹

VIII. Legislative Triggers, Intra-State Conflicts, and State Policy Responses

Anticipating the rescheduling scenario, several states have enacted “trigger bill” legislation that automatically modifies state drug classifications upon FDA approval and DEA rescheduling. Colorado House Bill 25-1063, FDA-Approved Crystalline Polymorph Psilocybin Use, was enacted into law, removing psilocybin from Colorado’s controlled substances schedule for FDA-approved synthesized crystalline psilocybin products upon federal approval — a design intended to harmonize state law with any future federal rescheduling rather than maintain a divergent regime.⁵² Similar trigger bills were introduced in Virginia (S.B. 1135), Iowa, and Rhode Island during the 2025 legislative session.⁵³

Colorado’s trigger bill illustrates an intra-state conflict that the federal-preemption literature has not yet addressed: HB 25-1063 creates a pharmaceutical prescription pathway for FDA-approved synthetic psilocybin operating alongside Colorado’s existing natural medicine healing center framework under the NMHA. If FDA approves a synthetic crystalline psilocybin product — the form covered by the trigger bill — and a physician prescribes it to a patient, that patient could access the pharmaceutical product through a traditional healthcare setting without going through a licensed healing center or a certified facilitator. The result would be two parallel state-authorized access pathways: the NMHA healing center model, with its training requirements, session format, and administrative infrastructure; and the pharmaceutical prescription model, with its clinical prescribing and dispensing framework.

These two pathways are not merely distinct — they may be functionally competitive and substantively inconsistent. A patient whose physician prescribes FDA-approved crystalline psilocybin under the trigger bill does not need a facilitator, a healing center, or a preparation-administration-integration session sequence. The trigger bill pathway could thus effectively displace the NMHA pathway for patients who have access to a willing prescriber, without any formal legislative decision to do so. State policymakers who enact trigger bills alongside service center frameworks should include explicit legislative guidance on how the two pathways interact — specifically, whether the trigger bill pathway is intended to supplement the healing center framework, displace it for FDA-approved product forms, or operate in parallel with no coordination mechanism.⁵⁴

These legislative trigger mechanisms represent a governance strategy for managing federal–state tension by programming automatic state-law adaptation to federal regulatory changes, thereby reducing the duration and depth of any preemption conflict. They also reflect a recognition that states operating in the shadow of federal prohibition need mechanisms to realign state law when the federal baseline shifts.

IX. Recommendations for State Program Design

Based on the foregoing analysis, the following design principles can reduce preemption risk in state psychedelic programs:

Structural Firewalls from Federally Funded Healthcare. Service center models should maintain clear separation from Medicare- and Medicaid-participating facilities. Prohibiting service centers from operating within licensed healthcare facilities, as Oregon has done, reduces conflict with conditions of federal program participation. States that pursue healthcare integration, as Colorado has done, should conduct formal legal analysis of each integration point against applicable federal funding conditions.

Savings Clauses and Non-Nullification Language. Explicit statutory provisions acknowledging that the state program does not purport to exempt participants from federal law, and that federal authorities retain full enforcement authority, help demonstrate the absence of a positive conflict under 21 U.S.C. § 903. Both Oregon and Colorado have included such provisions; future states should model this approach.

Third-Party Federal Exposure Mapping. States should identify the third-party relationships essential to program functionality — banking, pharmacist referrals, physician coordination — and adopt state-level structural provisions designed to reduce those parties’ federal exposure. This includes banking access programs using state-chartered institutions, statutory referral protection for healthcare providers who recommend state-licensed services, and coordination with federal agencies to establish guidance on the treatment of state-licensed service participation under Medicare conditions of participation.

Supply Chain Traceability. Robust seed-to-session tracking systems reduce the likelihood of federal characterization of state-licensed activity as feeding illicit interstate commerce, and provide evidence of compliance with state program requirements in any federal enforcement action.

Avoidance of Resident-Preference and Intrastate-Sourcing Requirements. Market-structuring provisions that favor in-state operators or local supply chains create dormant Commerce Clause vulnerabilities. States should pursue equity and access goals through non-discriminatory means such as technical assistance, subsidized training, and sliding-scale fee structures.

Trigger Mechanisms with Intra-State Conflict Resolution. Legislation that automatically aligns state classification with federal rescheduling reduces the risk of sustained dual-regime operation. Where trigger bills create parallel access pathways alongside existing service center frameworks, the enabling statute should include explicit guidance on how the pathways interact to prevent inadvertent displacement of the service center model.

Post-Rescheduling FDCA Preemption Architecture. State programs should maintain structural separation between the non-medical service center model and any FDA-approved pharmaceutical product form of psilocybin, to reduce the surface area for obstacle preemption arguments under the FDCA framework articulated in Wyeth v. Levine and subsequent cases. Specifically, state program rules should not purport to authorize administration of FDA-approved psilocybin pharmaceutical products outside the conditions established by FDA approval, which would generate the strongest form of the obstacle preemption argument.

X. Conclusion: Current Federal Posture — A Synthesis

Federal–state tension in psychedelic regulation is real, legally complex, and evolving faster than at any prior point in the history of state psychedelic programs. The risk of formal preemption litigation invalidating state programs remains lower than public discourse sometimes suggests: the CSA’s savings clause, the anti-commandeering doctrine, and the absence of direct positive conflict between state non-criminalization and federal prohibition provide substantial insulation against formal preemption claims under the CSA framework.

The federal enforcement posture as of early 2026 is best described as tolerant but structurally uncertain. Senior administration officials — including HHS Secretary Kennedy, FDA Commissioner Makary, VA Secretary Collins, and White House adviser Calley Means — have publicly embraced psychedelic therapy in terms that suggest a low priority on enforcement against state-licensed therapeutic access programs. At the same time, the veto of Compass Pathways’ Priority Voucher in October 2025 revealed that the administration’s psychedelic policy is not monolithic: MAHA-aligned officials who support access for veterans and mental health patients may not prevail in every internal policy dispute against officials skeptical of pharmaceutical fast-tracking or broader access expansion. The DEA has transmitted the Aggarwal rescheduling petition to HHS — the furthest the rescheduling process has ever advanced for psilocybin — but has issued no formal enforcement posture statement toward state programs, and the DOJ has maintained silence. No formal Cole Memo equivalent exists. State programs operate on informal tolerance, not legal certainty.

The more significant risks remain structural and functional: banking exclusion under the AML and BSA framework, DEA registration conflicts for dual-licensed practitioners, federal funding conditions for healthcare-adjacent facilities, and third-party federal exposure for banks, pharmacists, and physicians. These functional constraints operate without litigation and are difficult to challenge in court, yet they shape the practical viability and equity profile of state programs in ways that formal preemption doctrine does not.

As the DEA’s transmission of the Aggarwal petition to HHS in August 2025 signals at least the possibility of federal scheduling reform — and as President Trump’s December 2025 executive order directing expedited rescheduling of marijuana to Schedule III signals a broader administration willingness to use executive authority to accelerate drug policy change — state program designers face a new planning imperative: building frameworks capable of adapting to a changed federal baseline, while simultaneously protecting against the distinct FDCA preemption vector that FDA pharmaceutical approval would introduce. The CSA preemption analysis that has governed cannabis federalism for two decades provides a partial but incomplete roadmap for that task. The post-rescheduling preemption landscape will require independent doctrinal analysis — grounded in the FDCA’s obstacle preemption framework rather than the CSA’s savings clause — that the field has not yet fully developed.

Endnotes

¹ Oregon Measure 109, Psilocybin Mushroom Services Program Initiative (2020); Colorado Proposition 122, Decriminalization and Regulated Access Program for Certain Psychedelic Plants and Fungi Initiative (2022). See Ballotpedia, Oregon Measure 109, Psilocybin Mushroom Services Program Initiative (2020), https://ballotpedia.org/Oregon_Measure_109,Psilocybin_Mushroom_Services_Program_Initiative(2020); Ballotpedia, Colorado Proposition 122 (2022), https://ballotpedia.org/Colorado_Proposition_122,Decriminalization_and_Regulated_Access_Program_for_Certain_Psychedelic_Plants_and_Fungi_Initiative(2022).

² Oregon Health Authority, Oregon Psilocybin Services, https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Pages/Oregon-Psilocybin-Services.aspx (OPS began accepting applications January 2, 2023; licensed service centers began operating summer 2023).

³ Snell & Wilmer, Colorado’s Magic Mushroom Industry Has Officially Arrived (Oct. 31, 2025), https://www.swlaw.com/publication/colorados-magic-mushroom-industry-has-officially-arrived/ (reporting June 6, 2025 inaugural session and Dec. 31, 2024 license application opening).

⁴ 21 U.S.C. § 812(b)(1)(A)–(C); Drug Enforcement Administration, Psilocybin Drug Fact Sheet (2024), https://www.dea.gov/sites/default/files/2025-01/Psilocybin-Drug-Fact-Sheet.pdf.

⁵ King & Spalding, Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics (June 2025), https://www.kslaw.com/news-and-insights/administrative-congressional-and-state-interest-signal-a-potential-breakthrough-moment-for-psychedelics (noting FDA Breakthrough Therapy designation granted to psilocybin for treatment-resistant depression in 2018 and major depressive disorder in 2019).

⁶ U.S. Const. art. VI, cl. 2.

⁷ Congressional Research Service, Medical Marijuana: The Supremacy Clause, Federalism, and the Interplay Between State and Federal Laws, R42398 (Nov. 9, 2012), https://www.everycrsreport.com/reports/R42398.html.

⁸ 21 U.S.C. § 903; U.S. House of Representatives Office of Law Revision Counsel, 21 U.S.C. § 903: Application of State Law, https://uscode.house.gov/view.xhtml?req=(title:21+section:903+edition:prelim).

⁹ Robert A. Mikos, Preemption Under the Controlled Substances Act, 16 J. Health Care L. & Pol’y 5, 5 (2013), https://digitalcommons.law.umaryland.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1287&context=jhclp (noting Congress “declined to assert express preemption in the area of controlled substances and directly foreswore field preemption, leaving only conflict preemption”); Congressional Research Service, supra note 7.

¹⁰ American University Journal of Gender, Social Policy & the Law, Whether the Controlled Substances Act Preempts State Laws Legalizing Marijuana (Apr. 2015), https://jgspl.org/blog-post-34-whether-the-controlled-substances-act-preempts-state-laws-legalizing-marijuana/ (surveying court holdings on impossibility and obstacle preemption under 21 U.S.C. § 903).

¹¹ Marijuana Policy Project, State Marijuana Regulation Laws Are Not Preempted By Federal Law, https://www.mpp.org/issues/legalization/state-marijuana-regulation-laws-are-not-preempted-by-federal-law/ (courts have generally held state drug laws preempted by the CSA only when they require someone to violate the CSA or present an obstacle to its enforcement).

¹² Rick Esenberg, Does Federal Law Actually Preempt Relaxed State Marijuana Laws?, Marquette University Law School Faculty Blog (Apr. 2013), https://law.marquette.edu/facultyblog/2013/04/does-federal-law-actually-preempt-relaxed-state-marijuana-laws/ (describing and quoting from Professor Mikos’s preemption analysis in Preemption Under the Controlled Substances Act, 16 J. Health Care L. & Pol’y 5 (2013)).

¹³ Gonzales v. Raich, 545 U.S. 1 (2005), https://supreme.justia.com/cases/federal/us/545/1/.

¹⁴ Id. at 19–22 (applying Wickard v. Filburn, 317 U.S. 111 (1942), and holding Congress had a rational basis for including intrastate, noncommercial marijuana cultivation within the CSA’s regulatory scheme).

¹⁵ Harris Sliwoski LLP, The Commerce Clause and Medical Marijuana: Gonzales v. Raich, 545 U.S. 1 (2005), Canna Law Blog (Oct. 2025), https://harris-sliwoski.com/cannalawblog/gonzales-v-raich-545-u-s-1-2005/.

¹⁶ New York v. United States, 505 U.S. 144 (1992); Printz v. United States, 521 U.S. 898 (1997).

¹⁷ Or. Rev. Stat. § 475A.215(7); Colorado Proposition 122, § 1. See DLA Piper, State Psychedelic Regulation: Oregon and Colorado Taking the Lead (Jan. 2023), https://www.dlapiper.com/en/insights/publications/2023/01/state-psychedelic-regulation-oregon-and-colorado-taking-the-lead.

¹⁸ American Bar Association, Genna Walsh, Rescheduling Psilocybin: The Path to FDA Approval of Magic Mushrooms, Health Law eSource (Dec. 2023), https://www.americanbar.org/groups/health_law/resources/esource/2023-december/rescheduling-psilocybin/ (discussing Medicare and Medicaid conditions of participation as a structural constraint on healthcare integration).

¹⁹ Harvard Gazette, Why Regulators May Toss Cold Water on Buzz Over Psychedelics, interview with Professor Mason Marks (Jan. 2024), https://news.harvard.edu/gazette/story/2024/01/why-regulators-may-toss-cold-water-on-buzz-over-psychedelics/ (noting Oregon’s statutory prohibition on service centers within healthcare facilities and on making medical claims).

²⁰ C.R.S. § 12-170-101 et seq. (Natural Medicine Health Act); Colorado Lawyer, Colorado’s Bold Move to Legalize Psychedelics (July 2024), https://cl.cobar.org/features/colorados-bold-move-to-legalize-psychedelics/.

²¹ Filter Magazine, As First Psilocybin Center Comes to Colorado, How Is the Rollout Going? (Apr. 2025), https://filtermag.org/as-first-psilocybin-center-comes-to-colorado-how-is-the-rollout-going/.

²² Harvard Gazette, supra note 19 (describing DEA warning to Georgia pharmacists about cannabis dispensing through pharmacy channels as evidence that healthcare-adjacent models attract distinct federal scrutiny).

²³ 21 U.S.C. § 823(f); National Law Review, Federal Appeals Court Rules Against Doctor Seeking to Use Mushrooms to Aid Terminal Patients (Mar. 2025), https://natlawreview.com/article/federal-appeals-court-rules-against-doctor-seeking-use-mushrooms-aide-terminal (explaining that the CSA requires Schedule I registration for physicians seeking to dispense psilocybin outside a research protocol).

²⁴ Aggarwal v. U.S. Drug Enforcement Administration, No. 22-1718, 2023 WL 7101927 (9th Cir. Oct. 27, 2023) (unpublished) (holding DEA’s denial of rescheduling petition “failed to provide sufficient analysis” and directing DEA to “either clarify its pathway for denying Aggarwal’s petition or reevaluate Aggarwal’s petition on an open record”); Marijuana Moment, Federal Appeals Court Rules Against DEA in Psilocybin Rescheduling Lawsuit (Oct. 27, 2023), https://www.marijuanamoment.net/federal-appeals-court-rules-against-dea-in-psilocybin-rescheduling-lawsuit-brought-by-doctor-who-wants-to-give-psychedelic-to-cancer-patients/; National Psychedelics Association, DEA Advances Psilocybin Rescheduling (Aug. 2025), https://yournpa.org/dea-petition/.

²⁵ Advanced Integrative Medical Science Institute, PLLC v. U.S. Drug Enforcement Administration, No. 22-1568, 128 F.4th 1133 (9th Cir. Feb. 13, 2025) (denying petition for review; upholding DEA’s denial of CSA registration waiver request; distinct from the rescheduling petition case at No. 22-1718); Harris Sliwoski LLP, Ninth Circuit Issues Disappointing Ruling on Terminally Ill Patients and Psilocybin (Feb. 14, 2025), https://harris-sliwoski.com/psychlawblog/ninth-circuit-issues-disappointing-ruling-on-terminally-ill-patients-and-psilocybin/.

²⁶ Advanced Integrative Medical Science Institute, 128 F.4th at 1133 (holding that the Right to Try Act “does not exempt such drugs from the FDA’s Attorney-General-delegated oversight pursuant to the CSA”); Drug & Device Law Blog, Ninth Circuit Rejects “Right to Try” Hallucinogenic Drugs (Feb. 21, 2025), https://www.druganddevicelawblog.com/2025/02/ninth-circuit-rejects-right-to-try-hallucinogenic-drugs.html.

²⁷ Or. Admin. R. 333-333-1010 through 333-333-8260; Odyssey PBC, How to Apply for a Psilocybin Facilitator License (2025), https://www.odysseypbc.com/blog-posts/how-to-apply-for-a-psilocybin-facilitator-license-2025-guide (noting Oregon facilitators must operate solely as facilitators and may not simultaneously practice under a healthcare license during psilocybin sessions).

²⁸ Colorado Sun, Colorado Prepares Rollout of Psychedelic-Assisted Therapies in 2025 (Nov. 19, 2024), https://coloradosun.com/2024/11/19/colorado-psychedelic-assisted-therapies/ (describing Colorado’s “clinical facilitator” pathway requiring a secondary healthcare license); Colorado Dept. of Regulatory Agencies, Natural Medicine Rules, https://dpo.colorado.gov/NaturalMedicine.

²⁹ National Psychedelics Association, DEA Advances Psilocybin Rescheduling (Aug. 11, 2025), https://yournpa.org/dea-petition/; Marijuana Moment, DEA Advances Psilocybin Rescheduling Petition to Federal Health Officials (Aug. 21, 2025), https://www.marijuanamoment.net/dea-advances-psilocybin-rescheduling-petition-to-federal-health-officials-following-years-long-legal-challenge/ (DEA transmitted petition to HHS on August 11, 2025, for scientific and medical evaluation and scheduling recommendation).

³⁰ 18 U.S.C. §§ 1956–1957 (federal money laundering statutes); Harris Sliwoski LLP, Oregon Psilocybin: Slow Start (Feb. 7, 2025), https://harris-sliwoski.com/psychlawblog/oregon-psilocybin-slow-start/ (identifying banking exclusion as an “intractable issue caused by federal prohibition”).

³¹ SAFE/SAFER Banking Acts & the CLAIM Act, Cover Cannabis (Aug. 2025), https://covercannabis.com/blog/safe-banking-act-cannabis/ (tracking legislative status of cannabis banking safe harbor; no enactment as of 2025).

³² Harris Sliwoski LLP, Oregon Psilocybin: Slow Start, supra note 30.

³³ Congressional Research Service, Financial Services for Marijuana Businesses, IF11373 (2023), https://www.congress.gov/crs-product/IF11373 (documenting AML and BSA compliance obligations; noting that financial institution personnel face potential twenty-year prison sentences under § 1956 for knowingly facilitating transactions involving proceeds of CSA-prohibited activity, and that institutions face insurance revocation and regulatory enforcement for BSA and AML violations); Congressional Research Service, Marijuana Banking: Legal Issues and the SAFE(R) Banking Acts, LSB11076 (2023), https://www.congress.gov/crs-product/LSB11076 (describing scope of legal exposure for financial institutions serving Schedule I businesses).

³⁴ See Harvard Gazette, supra note 19 (describing DEA warning to Georgia pharmacists and its significance as a data point on healthcare-adjacent model scrutiny); Harris Sliwoski LLP, Oregon Psilocybin: Slow Start, supra note 30 (identifying banking as the primary structural constraint; no equivalent federal guidance has been issued for psilocybin banking equivalent to the 2014 FinCEN marijuana guidance).

³⁵ Or. Rev. Stat. Ch. 475A; Or. Admin. R. 333-333-1010 through 8260.

³⁶ Snell & Wilmer, supra note 3 (describing Colorado’s supply chain licensure from cultivation through healing centers, with transport restricted to licensed employees).

³⁷ Oregon Health Authority, Oregon Psilocybin Services, https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Pages/Oregon-Psilocybin-Services.aspx; Harvard Gazette, supra note 19.

³⁸ Colorado Lawyer, supra note 20; Filter Magazine, supra note 21.

³⁹ Colorado Lawyer, supra note 20.

⁴⁰ Memorandum from James M. Cole, Deputy Attorney General, to All United States Attorneys re: Guidance Regarding Marijuana Enforcement (Aug. 29, 2013); Harvard Gazette, supra note 19 (discussing the Cole Memo framework and its relevance to state psychedelic programs).

⁴¹ CNN, RFK Jr. and Other Trump Officials Embrace Psychedelics after FDA Setback (July 16, 2025), https://www.cnn.com/2025/07/16/health/psychedelics-ibogaine-trump-kennedy (quoting HHS Secretary Kennedy’s statement to Congress that “this line of therapeutics has tremendous advantage if given in a clinical setting and we are working very hard to make sure that happens within 12 months”).

⁴² STAT News, Psychedelics Proponents Hope Trump Administration Will Foster a New Era (June 18, 2025), https://www.statnews.com/2025/06/18/fda-approval-psychedelics-rfk-jr-trump-allies-see-opening-mdma-psilocybin-mental-health-treatment/ (FDA Commissioner Makary calling evaluation of MDMA and other psychedelics “a top priority” and announcing Commissioner’s National Priority Voucher program); MAPS, Nine Months into Trump’s Second Term, Psychedelic Reform Hangs in the Balance, https://maps.org/news/bulletin/psychedelic-policy-reform-2025/ (reporting that Makary told Kennedy: “We don’t want to wait two years to get this done”).

⁴³ King & Spalding, supra note 5 (reporting HHS hired Matt Zorn, a drug policy lawyer, to work on psychedelics policy issues in May 2025, and that HHS and FDA hired several staffers with ties to the psychedelic movement).

⁴⁴ Marijuana Moment, DEA Advances Psilocybin Rescheduling Petition, supra note 29.

⁴⁵ STAT News, Trump Administration Officials Blocked FDA Effort to Fast-Track Review of Psychedelic Treatment (Feb. 4, 2026), https://www.statnews.com/2026/02/04/psilocybin-depression-psychedelic-drug-fast-track-blocked/ (reporting that Compass Pathways’ COMP360 psilocybin treatment was vetoed from the Commissioner’s National Priority Voucher list by HHS and White House officials in October 2025, hours before the announcement was made; describing the veto as evidence of internal discord between MAHA supporters and other administration officials); Psychedelic Alpha, Psychedelic Bulletin #219: Trump Admin. Vetoed Compass Priority Voucher (Feb. 2026), https://psychedelicalpha.com/news/p%CE%B1-psychedelic-bulletin-219-trump-admin-vetoed-compass-priority-voucher-ibogaine-in-focus-definium-sued-by-former-vendor-psychedelics-feature-in-epstein-files (characterizing the veto as “further evidence that MAGA and MAHA remain unaligned on some fronts”).

⁴⁶ Harris Sliwoski LLP, Oregon Psilocybin: Preparing for the End of Local Ownership Rules (2024), https://harris-sliwoski.com/psychlawblog/oregon-psilocybin-preparing-for-the-end-of-local-ownership-rules/ (noting residency requirement “was likely unconstitutional from the start”).

⁴⁷ American Bar Association, supra note 18 (discussing implications of rescheduling for state service center models and potential insurance coverage pathways).

⁴⁸ Id.

⁴⁹ Wyeth v. Levine, 555 U.S. 555, 563 (2009) (articulating obstacle preemption standard as asking whether state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)); https://supreme.justia.com/cases/federal/us/555/555/. Wyeth held, 6-3, that FDA approval of a prescription drug label did not preempt a Vermont state tort failure-to-warn claim on the specific facts presented, finding neither impossibility preemption nor obstacle preemption — but the decision left open the possibility of preemption under different facts, particularly where FDA has engaged more comprehensively with a specific safety question. The dissent, joined by Chief Justice Roberts and Justice Scalia, argued that FDA approval sets a regulatory balance that states may not countermand, foreshadowing the stronger preemption argument available in a context where FDA has specifically approved conditions of psilocybin use. See also Manatt, Phelps & Phillips, FDA Preemption: Implications of Dobbs Decision for Uniform Access to FDA-Approved Drugs (2022), https://www.manatt.com/insights/newsletters/health-highlights/fda-preemption-implications-of-dobbs-decision-for (analyzing the FDCA preemption framework applicable to FDA-approved drugs post-Wyeth).

⁵⁰ Wyeth v. Levine, 555 U.S. at 603 (Alito, J., dissenting, joined by Roberts, C.J., and Scalia, J.).

⁵¹ The preemption architecture recommended here would, for example, require that if FDA approves a pharmaceutical psilocybin product with specific indication and dosing requirements, state service centers should not be authorized to administer that specific approved product outside the FDA’s conditions of approval. State programs could maintain authorization for natural psilocybin mushroom products that are not the FDA-approved pharmaceutical — a product-form distinction analogous to the one Colorado’s HB 25-1063 trigger bill employs in the other direction. See Colorado General Assembly, HB25-1063, https://leg.colorado.gov/bills/hb25-1063.

⁵² Colorado General Assembly, HB25-1063 — FDA-Approved Crystalline Polymorph Psilocybin Use (enacted 2025), https://leg.colorado.gov/bills/hb25-1063 (bill enacted into law; removes psilocybin from Colorado’s controlled substances schedule for FDA-approved synthesized crystalline psilocybin products upon federal approval); CPR News, Colorado Bipartisan Trigger Bill on Synthetic Psilocybin Passes First Hearing (Jan. 14, 2025), https://www.cpr.org/2025/01/14/colorado-medical-psilocybin-bill-first-hearing/ (reporting first committee hearing passage 12-1).

⁵³ King & Spalding, supra note 5 (noting Virginia SB 1135 vetoed by governor; describing trigger bills introduced in multiple states during 2025 legislative session); Psychedelic Alpha, 2025’s Psychedelic Policy Surge: A State-by-State, Bill-by-Bill Analysis (Jan. 31, 2025), https://psychedelicalpha.com/news/2025s-psychedelic-policy-surge-a-state-by-state-bill-by-bill-analysis.

⁵⁴ The intra-state conflict identified here — between the pharmaceutical trigger pathway and the existing healing center framework — is structurally analogous to the federal-preemption tension described in Section VII, but operates at the state level and is entirely within the state legislature’s authority to resolve through explicit coordination provisions. The absence of such provisions in Colorado’s HB 25-1063 reflects the limited drafting scope of trigger bills, which are designed to address one discrete issue (rescheduling alignment) rather than comprehensive pathway coordination.