Psilocybin is a naturally occurring chemical compound derived from the fungus species Psilocybe cubensis. Worldwide, there are more than 180 psilocybin-containing mushrooms species that can induce hallucinogenic and psychedelic effects when consumed. When ingested, “psilocybin is converted by the body to psilocin, the actual compound which produces the psychoactive effects.” Psilocybin and psilocin are psychedelic tryptamines with a similar molecular structure to serotonin, which regulates our mood, sleep, and stress. Psilocybin molecules activate the 5-HT2A receptors in the brain associated with reasoning and rational thoughts to mediate different functions like mood, imagination, learning and perception. As psilocin begins to activate these receptors, it temporarily disables and shuts down the default mode network in the brain used as the “information highway.” This disconnection forces the brain to create new pathways to communicate. Thus, when psilocin is consumed, it has the ability to re-wire and reprogram the brain. Depending on the strength and dosage, the user will feel a change in consciousness, mood, perception, and sensory experience. At higher strengths and dosages, users may experience visual and auditory hallucinations.
According to research, psilocybin molecules appear “to mediate their effects through activating [5-HT] 2A serotonin receptors while leaving the brain’s existing supply of serotonin untouched,” preventing the potential for up or down regulation of neurotransmitters because the level of serotonin in the brain remains balanced. Thus, “a user consuming psilocybin one day would have a far diminished effect consuming the same amount the next day. The body’s ability to quickly create a high tolerance for psilocybin means there is a low potential for addiction.”
History of Psilocybin
In the early 1950s and 1960s, psychiatrists in the U.S. began investigating the therapeutic potential of psilocybin. The Controlled Substance Act (CSA) was enacted by Congress in 1970, and in 1971, Title II of the CSA’s Comprehensive Drug Abuse Prevention and Control Act became effective and ultimately halted psychedelic research of psilocybin, a Schedule I drug. In 2000, the Food and Drug Administration (FDA) granted regulatory approval to Johns Hopkins Center for Psychedelic & Consciousness Research to reinitiate research with psychedelics in the U.S.. Johns Hopkins is the leader in psychedelic research worldwide, publishing groundbreaking, peer-reviewed studies within scientific journals. Their general research focuses on how psychedelics affect behavior, mood, cognition, brain function, and biological markers of health. Their publications also include narrower studies focused on the effectiveness of psilocybin as a treatment for depression, anxiety, OCD, PTSD, Alzheimer’s disease, post-treatment Lyme disease, anorexia nervosa, and addiction to opioids, alcohol, and nicotine.
Entheogenic use precedes the emergence of psilocybin in the U.S. Indigenous communities and native cultures throughout Mexico and Central America used psilocybin in healing rituals and religious ceremonies long before scientists in the U.S. began to explore and research the benefits of psychedelic treatment. Entheogenic use refers to the religious sacrament and spiritual aspect derived from psychedelic plant experiences that induce profound changes in perception in the spiritual setting. The word “entheogen” comes from the Ancient Greek language and “refers to a connection with the inner divine,” most commonly used when substances are taken with intent to experience spiritual effects; the decriminalization movement growing throughout a number of cities in the U.S. has coined this term in its aim to amend laws against the possession and use of entheogenic plants and fungi..
Psilocybin is currently classified by federal law as a Schedule I drug under the CSA, the federal drug policy that regulates “the manufacture, distribution, dispensing, importation or exportation of any controlled substance.” The federal classification means that, according to the Drug Enforcement Administration (DEA), psilocybin has “a high potential for abuse, no currently accepted medical use in treatment in the U.S., and there is a lack of accepted safety for use under medical supervision.” To ensure compliance, any persons who engage in the lawful activities of any controlled substances, such as clinical trials, are subject to state licensure and are required to register with the DEA to obtain a Certificate of Registration, granting the practitioner the federal authority to engage in such activities.
Decriminalization and Federal Prohibition
In May 2019, the city of Denver, CO, enacted Ordinance 301, making it the first U.S. city to decriminalize and deprioritize the enforcement of criminal penalties for possession of psilocybin. The ordinance did not legalize psilocybin, rather the purpose of the ordinance was, “to place possession and use of psilocybin mushrooms at the lowest level of law enforcement priority rather than to legalize the substance.” Oregon shortly after followed with the enactment of the Drug Addiction Treatment and Recovery Act, effectively reducing criminal sentencing laws regulating the possession of low-level controlled substances, including psilocybin. Most recently, Colorado voters approved Proposition 122 in the November 2022 general election to become the second state in the U.S. to legalize and provide access to psilocybin within the state regulated Natural Medicine Program.
Possession of psilocybin in the class of entheogenic plants and fungi has been decriminalized in other cities around the U.S., including:
- Oakland, CA (June 2019)
- Santa Cruz, CA (February 2020)
- Washington D.C. (December 2020)
- Ann Arbor, MI (September 2020)
- Somerville, MA (January 2021)
- Cambridge, MA (February 2021)
- Northampton, MA (March 2021)
- Arcata, CA (October 2021)
- Seattle, WA (October 2021)
- Easthampton, MA (October 2021)
- Detroit, MI (November 2021)
- Hazel Park, MI (March 2022)
- Port Townsend, WA (December 2021)
- San Francisco, CA (September 2022)
Although decriminalized in cities across the U.S., entheogenic plants and fungi, including psilocybin, remain unlawful. Today, federal law makes it illegal for “any person knowingly or intentionally to manufacture, distribute, dispense, or possess with intent to manufacture a controlled substance.” Any person who knowingly violates the statute, for instance, by cultivating or manufacturing a controlled substance like psilocybin, may be prosecuted and subject to imprisonment or a fine under federal law.
Oregon Psilocybin Services Act, Ballot Measure 109
In the November 2020 general election, Oregonians voted Ballot Measure 109 (M109), the Oregon Psilocybin Services Act (OPSA), into law, and it is now codified in the Oregon Revised Statutes. M109 directs the Oregon Health Authority (OHA) to license and “regulate the manufacturing, transportation, delivery, sale, and purchase of psilocybin products and the provisions of psilocybin services.” Oregon is the first state in the U.S. to legalize psilocybin services, creating a regulatory framework and two-year program development period from January 1, 2021, to December 31, 2022. During that period, the Oregon Psilocybin Services Section (OPS), an intersection agency within the OHA, will work alongside the state appointed Oregon Psilocybin Advisory Board (OPAB) and the Rules Advisory Committees (RAC) to draft and finalize the administrative rules by December 31, 2022. The OPS began accepting license applications on January 2, 2023. Clients must be age 21 or older to access psilocybin services and Oregon residency is not required.
OPS issues four different licenses, including manufacturer, testing laboratory, service center and facilitator.. Individuals may apply and be approved to hold multiple licenses subject to eligibility requirements per license, however, an individual may not hold more than one manufacturer license or more than five service center operator licenses. M109 allowed voters to opt-out or prohibit the establishments of manufacturers or psilocybin service centers in local cities and counties.
- Manufacturer license: Psilocybin products must be cultivated, produced, and processed by a licensed manufacturer and tracked in the Psilocybin Tracking System (PTS). Manufacturer license applicants will be required to produce a Land Use Compatibility Statement (LUCS) to demonstrate the proposed use of the property is consistent with local zoning. Additionally, applicants must provide proof of the property owner’s informed consent to the production of psilocybin on the property. M109 prohibits an individual from growing psilocybin for personal use.
- Testing laboratory license: Psilocybin products must be tested by a licensed testing laboratory accredited by the Oregon Environmental Accreditation Program (ORELAP). The laboratory must pass an on-site assessment to determine compliance and is required to conduct the testing of psilocybin products under The NELAC Institute (TNI) 2016 Standard. ORELAP will accredit the testing laboratory for potency and concentration, speciation by DNA, residual solvents, and sampling of psilocybin products. If successfully completed, ORELAP will issue a certificate of accreditation that must be renewed annually and is subject to on-site assessments every two years. Psilocybin products must be entered into the PTS for compliance.
- Service center license: Psilocybin products must be sold and transferred from a licensed manufacturer to a licensed service center operator and tracked in the PTS. Service center operator license applicants will be required to produce a LUCS to demonstrate the proposed use of the property is consistent with local zoning. M109 requires a service center to be at least 1,000 feet from a school, with defined boundaries, and is prohibited on public lands.
- Facilitator license: To provide psilocybin services to clients, OPS requires a licensed facilitator to be 21 years of age or older, hold a high school diploma (or equivalent) and be a two-year resident of Oregon (requirement sunsets in 2025). Additionally, licensed facilitators will be required to complete a facilitator training program with curriculum approved by OPS, pass a regulations exam administered by OPS, pass a criminal background check, and pay a license application fee and an annual license fee.
Service Center Model
Under M109, psilocybin is administered to clients through a service center model. M109’s service center model is unique as it does not operate like a retail shop, nor does the participation require physician supervision or prescription for medical use. Under Oregon law, psilocybin services consist of three sessions—preparation, administration, and integration—to be held at a service center location. A client must participate in a preparation session at least twenty-four hours prior to an administration session. The goal of a preparation session is to create an individual treatment plan. At that time, the client will complete intake forms, sign necessary disclosures including informed consent and the Client Bill of Rights, create a transportation plan, create a safety and support plan, and have the opportunity to meet and approve the facilitator. During an administration session, the client is required to “purchase, consume, and experience” psilocybin at the service center under the supervision of a licensed facilitator. Finally, the licensed facilitator must offer the client the opportunity to participate in an integration session and evaluate future treatments. However, the client is not required to participate in any further sessions.
State Administrative Agency Roles
State administrative agencies play a critical role in the development towards licensure, education, compliance, safety, consumer protection and rule-making functions related to the access of psilocybin services under M109.
Oregon Health Authority
The OHA is a state-administered organization whose mission is to “ensure all people and communities can achieve optimum physical, mental, and social well-being through partnerships, prevention, and access to quality, affordable health care.” The OHA is the regulatory state agency responsible for the licensure and regulation of psilocybin products and services. The OHA’s administrative role, to oversee and collaborate with the OPAB and the internal departments below, is required to successfully facilitate psilocybin services throughout Oregon.
Oregon Psilocybin Services Section
The OPS is a new section created under the OHA’s Public Health Division to implement M109. During the two-year program development period, the OPS is working to build the regulatory framework for psilocybin services, including:
- Drafting and adopting administrative rules by December 31, 2022
- Developing a psilocybin services facilitator training program approval system
- License tracking and using a compliance case management system
- Securing a custom product tracking system
- Working online payments for licensees
- GIS mapping for compliance work
- Equity- and justice-centered approach to criminal background checks
- Creating processes and procedures for programs;
- Supporting the OPAB and subcommittees
- Providing access to important industry updates and information
- Building partnerships with diverse communities
- Creating and launching education and training for the regulatory community and the public
Higher Education Coordinating Commission
The OPS receives and approves facilitator training programs and determines that the curriculum meets core model requirements as outlined in the Oregon Administrative Rules (OAR). In addition to OPS approval, facilitator training programs are subject to licensure by the Higher Education Coordinating Commission (HECC). The HECC works to improve success in higher education and postsecondary training for Oregonians by ensuring an accessible, affordable, equitable, and coordinated network of college and career training programs.
Oregon Psilocybin Advisory Board
The purpose of the OPAB is to advise and provide recommendations to the OHA and “to develop long-term strategic planning to ensure psilocybin services remain safe, accessible, and affordable” under the compliance of state regulations. Board members are appointed by the governor to serve four-year terms, and positions will be filled as vacancies become available. The board is composed of 14–16 members who are appointed to serve positions based on their specific expertise and experience. Generally, the meetings of the OPAB are live and available to the public to view. Recorded meetings are archived and available online. Board members are selected from the following positions:
- Public health director
- Designee of the Oregon Health Policy Board
- State employee who has technical expertise in the field of public health
- Local health officer
- Member of a federally recognized Indian tribe
- Member of the OHA Addictions and Mental Health Planning and Advisory Council
- Member of the OHA Health Equity Policy Committee
- Member of the OHA Palliative Care and Quality of Life Interdisciplinary Advisory Council
- Individual who represents individuals who provide public health services
- Licensed psychologist with experience diagnosing or treating mental, emotional, or behavioral condition
- Licensed physician who holds a degree of Doctor of Medicine
- Licensed naturopathic physician
- Expert in the field of public health who has a background in academia
- Person who has professional experience conducting scientific research regarding the use of psychedelic compounds in clinical therapy
- Person who has experience in the field of mycology
- Person who has experience in the field of ethnobotany
- Person who has experience in the field of psychopharmacology
- Person who has experience in the field of psilocybin harm reduction
- Person representing the Oregon Liquor Control Commission who has experience working with the system developed and maintained by the commission for tracking the transfer of marijuana items
- Person representing the Oregon Department of Justice
M109 conferred the power to the OPAB to establish subcommittees as necessary for the operation of the board. In 2021, the OPAB created equity, licensing, products, research, and training subcommittees to provide recommendations to the OHA regarding the requirements, guidelines, and specifications for providing psilocybin services in Oregon.
Scientific Literature Review and Cultural and Anthropological Review
In accordance with psilocybin regulations, the OPAB reviewed available medical, psychological, scientific studies, research, and other information related to the safety and efficacy of psilocybin in treating mental health conditions. The findings report that psilocybin is an effective treatment for addressing mental health issues and problematic alcohol and tobacco use. The OPAB published the scientific literature review in July 2021 and a subsequent cultural and anthropological review in November 2022. The publications are available online and will be updated periodically by the OPS and the OPAB.
Rules Advisory Committee
The OHA is required to adopt administrative rules to implement psilocybin regulations under the OPSA. During the rule-making process, the OPS received recommendations from the OPAB, input from the RACs, and public comments. The OPS created three RACs in September 2022 to discuss and provide recommendations to the proposed administrative rules before they went into effect. The process was designed to include diverse opinions and evaluate the fiscal and racial impact of the draft rules. The three RACs addressed: 1) packaging, labeling, and product transportation; 2) licensing, facilities, and operations; and 3) facilitator conduct, preparation, administration, and integration sessions. The RAC meetings, proposed rules, and public comments are recorded and available online. The OHA adopted the first subset of rules regulating psilocybin products, testing, and training programs in May 2022. The remaining rules regulating the production of psilocybin products and services were adopted December 27, 2022.
Federal Tensions Surrounding Ballot Measure 109
Oregon being the first state in the U.S. to legalize psilocybin services under M109 will experience inherent conflicts with federal law relating to the DEA, informed consent, right to privacy, right-to-try laws, advertising, and real property.
DEA Certificate of Registration
M109 legalizes psilocybin services at the Oregon state level, however, psilocybin still remains federally unlawful, posing a number of inherent conflicts of interest and concerns. Those individuals who hold a DEA Certificate of Registration must also hold a practitioner license pursuant to the State Medical Board, “in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.” A DEA registered practitioner “may only engage in those activities that are authorized under state law for the jurisdiction in which the practice is located.” When federal and state laws conflict, the practitioner is required to follow the more stringent regulations and laws. In the case of psilocybin services, a licensed facilitator who is also a DEA-registered practitioner is required to adhere to federal law as psilocybin is a Schedule I controlled substance. This inherent conflict will limit the pool of qualified licensed practitioners who may apply for a facilitator license under the OPS and OHA because engaging in federally unlawful activities diminishes the protection afforded from the DEA Certificate of Registration. The facilitator licensure and the administration session of psilocybin services presents a direct conflict and risk of liability to clients that the DEA registration seeks to protect. Because facilitators may fear losing the DEA registration or state practitioner license, psilocybin services may be limited to less qualified facilitators to supervise administration sessions.
In the proposed rules, the OHA regulates the requirements for informed consent. Every licensed facilitator must provide the client with the informed consent document during a preparation session to fully inform the client of the known benefits and risks associated with psilocybin services. Additionally, the client must acknowledge the “Client Bill of Rights” and the legal risks involved. Before participating in the administration session, the client must review and acknowledge both documents. At issue here is whether clients will be fully informed of all the associated benefits and risks before providing informed consent. Under Oregon law, informed consent requires a physician to disclose to their patient the description of the treatment the patient will receive, a description of alternative treatments, and a description of any risks involved with the treatment. Psilocybin is currently not approved by the FDA and is regulated as a Schedule I controlled substance, meaning “there is a lack of accepted safety for use under medical supervision.” Under M109, the service center model does not require physician supervision, rather the requirement is facilitator supervision. Although research suggests that psilocybin is generally safe, it is important to note that in providing informed consent to the facilitator and service center operator, the client will be required to agree and acknowledge that all benefits and risks of psilocybin services are not yet fully understood and results may vary. The threshold required to obtain informed consent from a client to a facilitator is inherently a lower bar to meet than a patient to physician. The imposed FDA restrictions on access to psilocybin narrows the cognizable adequacy of a clients informed consent to psilocybin services.
Right to Privacy Post-Dobbs
The right to privacy means a person is granted the substantial right to make choices essential to personal autonomy free from unwarranted governmental intrusion. In Roe v. Wade, the Supreme Court held that a women’s right to terminate her pregnancy before viability is a fundamental and constitutional right. Next, the Supreme Court decision in Planned Parenthood v. Casey upheld that a state abortion regulation placing an undue burden on a woman’s right to an abortion is unconstitutional if its purpose or effect is to place a substantial obstacle in the path of a woman seeking an abortion before the fetus attains viability. In Roe and Casey, the federal government respected a women’s right to privacy and personal autonomy pre viability. Most recently, the decision from the Supreme Court in Dobbs v. Jackson Women’s Health Organization overturned its predecessors, Roe and Casey, with the majority holding that “the Constitution makes no reference to abortion, and no such right is implicitly protected by any constitutional provision.” According to the ruling, the U.S. Constitution does not expressly confer the women’s right to abortion and, furthermore, does not confer the right to personal autonomy. The dissent states that “the majority substituted a rule of the judges for the rule of law.” Textually, the U.S. Constitution does not expressly confer the right to privacy and personal autonomy. The Dobbs decision narrowly interpreted and limited the scope of the right to privacy. Although the majority states that the opinion applies only to abortion case law, the decision is generally alarming because the precedent has been set for privacy. The right to privacy is at risk of being deprived and eliminated over the protection of what the Supreme Court ultimately decides will be the state’s legitimate interest in the future. Oregon’s Constitution does not expressly state the right to privacy. The client’s right to choose psilocybin services is a right and personal choice essential to personal autonomy. The Dobbs ruling opens the door for the federal government’s departure from the right to privacy, personal autonomy, and the right to choose psilocybin services.
In 2015, the Oregon Right to Try (RTT) Act was voted into law permitting doctors to prescribe treatments not yet approved by the FDA to terminally ill patients. However, under federal law, psilocybin remains inaccessible and prohibited to patients due to its Schedule I classification. In 2018, the federal RTT Act was enacted by Congress “to authorize the use of experimental drugs, biological products, and devices by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.” In other words, the federal government created a uniform system for terminally ill patients to seek access to eligible investigational new drugs that have completed the Phase I clinical trial, have not yet been approved by the FDA, and for which an application has been filed for approval. However, RTT laws do not mention allowing access to Schedule I controlled substances under the CSA. Therefore, patients have not been able to access psilocybin under the federal RTT law, as access remains unlawful and subject to criminal prosecution.
Advocacy efforts are legislating to bridge the gap. In 2022, Congress introduced the Right-to-Try Clarification Act, to ensure that “RTT law applies to Schedule I substances for which Phase I clinical trial has been completed” in order to provide access to eligible patients. For now, psilocybin remains heavily regulated by federal and state agencies.
The First Amendment protects commercial speech from unwarranted government regulation. The Supreme Court held in Central Hudson that advertising is protected under commercial speech. However, the Federal Trade Commission (FTC) prohibits the advertising of unlawful activities. The concern is whether the FTC will restrict lawful psilocybin service licensees from advertising their services due to the federal prohibition. In the proposed rules, the OHA narrowly defines advertising regulations for psilocybin services at the state level. The tension arises under the U.S. Constitution and Supremacy Clause, which says federal law takes precedence over any conflicting state laws and state constitutions. Psilocybin service licensees must adhere to the OHA’s narrowly tailored proposed regulations to afford state protections in the furtherance of building intrastate commerce.
While psilocybin remains federally unlawful, psilocybin services will work similar to cannabis operations in terms of securing real property. Acquiring real property will likely require all cash or seller financing due to federal backing of the banking industry. If the licensee does not have the liquid capital to purchase real property, the licensee will look to secure a lease from a landlord, establishing a tenancy. This poses a conflict of interest to the landlord as the landlord must provide informed consent to the licensee securing the property. If the landlord has a mortgage on the commercial-use property, banks and most other lenders for real property will call the loan the moment they are privy to owners or tenants using the premises for federally unlawful business activities. Calling the loan can mean the owner must cure the loan by paying the full balance due immediately or by ceasing the unlawful business activities. Engaging in federally unlawful business activity puts property owners at risk of losing secure financing and, worst case, foreclosure or seizure by the federal government.
Additionally, it is a crime punishable by up to 20 years in prison to make property available to others “for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance.” It is unlawful to: (a)(1) knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any controlled substance; (a)(2) manage or control any place, whether permanently or temporarily, either as an owner, lessee, agent, employee, occupant, or mortgagee, and knowingly and intentionally rent, lease, profit from, or make available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance.”
Future of Psilocybin Services
As Oregon legislation moves forward, the U.S. will watch M109’s development and implementation under a microscope. The framework that is being implemented will pave the way for future states’ drug reform and federal recognition.
Oregon Psilocybin Services Act Implementation
As directed by M109, the OPS began accepting applications for licensure on January 2, 2023. As Oregon is the first state to roll out access to psilocybin services, it is unclear when psilocybin services will be available to clients. Access will depend heavily upon the approval of licensure through the OHA and the OPS state agencies, as well as the timing for psilocybin service licensees to be up and running.
Federal Task Force for Psychedelic-Assisted Therapies
The federal Substance Abuse and Mental Health Services Administration (SAMHSA) responded to letters from congressional lawmakers requesting that SAMHSA consider a federal task force to establish and publish national guidelines and standards of practice for psychedelic-assisted therapies. The letter addressed concerns for “issues associated with the anticipated approval by the FDA of 3,4-methylenedioxymethamphetam (MDMA) for the treatment of PTSD and psilocybin for the treatment of depression” within the next 24 months. SAMHSA agrees that “too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic” and that there is an urgent need to address the ongoing crisis. Establishing federal guidelines and ethical standards of practice would ease the burden on the states by providing a reference to develop and implement their own regulatory framework. Federal guidelines would likely further incentivize due care for psychedelic-assisted therapies by engaging trained, credentialed, and licensed facilitators to the industry.
In conclusion, M109 is trailblazing the U.S.’ psychedelic drug reform and legislation. Oregon is the first state in the U.S. to decriminalize and legalize psilocybin services. Although the voters have approved the new treatment and business for the state, the future of psilocybin services finds itself at a delicate new beginning because of the inherent conflicts passed down from federal law, making psilocybin services a complicated issue.