Discussion About Recent Developments in the Law of Psychedelics and Natural Medicines in the United States

By Ron McNutt, attorney, September 2, 2024

This is a very active time for the law affecting psychedelic substances and many forms of easing restrictions and enthusiasm for wider access to psychedelics have appeared recently. It is a good time to reflect on what we can offer to contribute in this space. As we progress from a prohibitionist past into a more flexible future, we attorneys are in a good position to help promote accountability and redress for misconduct involving the administration of psychedelics in nonmedical ceremonial contexts and in clinical and therapeutic settings. Attorneys have a duty to be informed and to educate the public about important legal issues.

Despite setbacks in the clinical field with MDMA-assisted therapy, with Lykos Therapeutics losing its MDMA application for new drug approval, Usona Institute and Compass Pathways are at Phase 3 with breakthrough therapy status for treatment of depression with psilocybin.

There has been a mixed set of results in the ceremonial settings with the recent failure and closure of the Soul Quest ayahuasca retreat center due to limited protection under the Religious Freedom Restoration Act and repercussions from a large liability verdict against Soul Quest and its owner and the repercussions for ketamine clinics with Matthew Perry’s death after becoming addicted to ketamine. There was also an adverse and restrictive decision in the Iowaska Church of Healing appellate decision. At the same time, some positive results have developed on other religious freedom cases, with a favorable settlement approved with the Church of the Eagle and Condor and a successful court decision upholding the right to redress for the Church of the Celestial Heart. and an Office of General Counsel gave directions to the Drug Enforcement Administration to be more receptive to psilocybin-based ceremonial experience and therapeutic initiatives. The AIMS Right to Try cases and its rescheduling of psilocybin efforts are providing pressure for beneficial changes, and federal authorities are receiving some congressional encouragement to ease restrictions on access to psilocybin.

The momentum has been expanding for adult use and decriminalization programs in Oregon, Colorado, and other states. The Colorado Natural Medicine Health Act rulemaking progress is nearing completion. Important issues will arise in the new regulation programs that may affect prospective and active clients who engage in the adult use programs in Oregon, Colorado, Massachusetts, and elsewhere.

The Colorado and Oregon adult use programs, and the Massachusetts and Washington initiatives and decriminalization efforts provide important opportunities for ordinary people to have access to experience with entheogens, which now appear to be of greater significance because of the hesitant and skittish reception of psychedelics in the medical community, which is unfortunate for the veterans and other people suffering from trauma and anxiety. The present time is an opportunity to channel the momentum in the Psychedelic Re-emergence into the adult use context and re-examine the forgotten culture and subculture in the U.S. that remains after the Controlled Substances Act and culture wars of the 1970s and 1980s.

The chemist and scholar William Leonard Pickard has degrees in public policy and chemistry. He wrote the 2015 paperback book, The Rose of Paracelsus — On Secrets & Sacraments, his tribute to the chemists who manufactured large quantities of LSD. He was incarcerated three times for manufacturing LSD. His most recent term of confinement was for about twenty years in federal prison for manufacturing LSD, beginning in 2000 until his compassionate release in 2020. Dr. Pickard said that he was accused of producing 90 % of the world’s LSD at one of his trials. In addition to his experience living as a monk in a Zen Buddhist monastery in San Francisco, he is a former research associate in neurobiology at Harvard Medical School, Harvard fellow in drug policy at the Harvard Kennedy School of Government with the Interfaculty Initiative on Drugs and Addiction, and Deputy Director of the Drug Policy Analysis Program at UCLA.

In an April 2023 talk at the Harvard Center for the Study of World Religions, Mr. Pickard said that we are in the honeymoon phase of psychedelic experience. He could see possible outcomes with medicalization and permissive religious use being options for increased access to psychedelic experience. He could foresee outcomes like: 1) all is well and things go smoothly, and many new medicines arrive; 2) an untoward event and incidents of behavioral acting out create a pretext for blowback or renewed prohibition; 3) an increase in regulation and backward movement occurs, instead of softening regulation; and 4) formation of new religious groups, creating more opportunity for access to sacramental psychedelic experience.

He sees the future in positive terms, and has a current interest in artificial intelligence and its potential to create new psychedelic compounds. He was working with the pharmaceutical companies Cybin and Gilgamesh. He said that 300 to 500 firms had appeared, with interest in novel applications of psychedelics. He was optimistic about the large-scale interest in the potential of psychedelic compounds. He predicted that tens of thousands of analogues of every conceivable variety could be created.

Clinical and therapeutic topics:

The U.S. Food and Drug Association (FDA) rejected the new drug application from the Lykos/MAPS-led MDMA clinical work for PTSD. The rejection stated that Lykos can submit an FDA-approved phase three trial with data, but this would take years to complete. The rejection has been a major setback for therapists and clinicians who anticipated a major expansion of MDMA-assisted therapy, and for veterans and advocates who are concerned about problems with veteran suicide, anxiety, depression, and posttraumatic stress disorder afflicting people who serve in the military.

Some FDA reviewers expressed opinions that the trials had been low quality or failed to meet standards. Some of the criticism of the Lykos studies concerned the method of combining therapy as part of the treatment protocol. The FDA appears to be concerned with cardiac risks associated with MDMA, a risk of depression, and a risk of misconduct by therapists. There was some concern about the lack of an active control, such as Adderall, for comparison were part of the reason for objections by scientists and the FDA. There was an instance of sexual misconduct during one of the trials. Researcher Jennifer Mitchell at UCSF, who was involved in some of the clinical trials said, “we thought we met the criteria that the FDA requested, and I absolutely stand by our data.”

This setback serves as a rejection of the effort to bring MDMA-assisted psychotherapy into mainstream healthcare within the next few years. This will delay the positive impacts from the MDMA treatments which were expected to help clear other obstacles to more openness on regulating psychedelics. Lykos has laid off 75 % of its workforce, about 100 people, and 14 employees of MAPS, about one-third of its workforce, as a result. It hired a new clinical director, Dr. David Hough, who had helped get Spravato, the nasal esketamine formulary, gain FDA approval. Rick Doblin resigned from Lykos and plans to focus on advocacy for MAPS. After the rejection, it appeared that Lykos had arranged to pursue unannounced patent proceedings for its therapeutic protocol and MDMA formula.

According to the Beckley foundation, 13 million people in the U.S. have symptoms of PTSD, and it calls for programs to address this public health need. Hopefully, there will be some good developments coming after this Lykos rejection. There are several other clinical trials underway, at various stages, that are more promising. The federal government is doing clinical studies with psilocybin and MDMA for active-duty military personnel to help with depression and posttraumatic stress disorder. Another federal agency, the National Center for Complementary and Integrative Health, has created a website to discuss the benefits of psilocybin for therapeutic treatment of depression, anxiety, and existential distress, and is investigating a potential benefit to help ease chronic pain.

State clinical programs have begun in Utah and Arizona, for example. Arizona has passed legislation to fund clinical programs for research with organic psilocybin mushrooms to help treat pain and trauma for people with life-threatening illnesses. Dr. Sue Sisley will serve as the director of this research at Scottsdale Research Institute. Utah enacted legislation that has expanded clinical programs for psilocybin-assisted psychotherapy and MDMA-assisted psychotherapy. In March 2024, it passed a three-year pilot clinical program to take place at the University of Utah and Intermountain Health, a network of providers, to prescribe synthetic psilocybin and MDMA as behavioral health treatments for depression, anxiety, and posttraumatic stress disorder.

House of Representatives Hearing about Veterans Programs with Psilocybin and MDMA Therapies

A Congressional hearing about psychedelic assisted therapies research and treatment for veterans took place on November 14, 2023, before the House Veterans’ Affairs Subcommittee on Health. Two panels including Veterans Administration officials spoke in favor of Congress enacting the Breakthrough Therapies Act, which would streamline the implementation of psilocybin- and MDMA-assisted therapies for veterans to address posttraumatic stress disorder and help prevent veteran suicide. The hearing was titled, “Emerging Therapies: Breakthroughs in the Battle Against Suicide?” It took place after a previous Veterans Administration conference September 2023 State of the Art Conference to consider system-wide clinical implementation for psychedelic compounds for potential future use. The conference presented very encouraging results from outside studies and those conducted through the Veterans Administration.

The first panel consisted of Veterans Administration officials, Carolyn Clancy, M.D., a clinical research specialist with the Department of Veterans’ Affairs, joined by Dr. Ilsa Wiechers and Dr. Rachel Yehuda, who addressed proposals for expanding treatment options to prevent suicide, treatment-resistant depression and posttraumatic stress disorder with therapy using MDMA and psilocybin. Dr. Clancy testified that there have been five Veterans’ Administration clinical studies using psychedelics, including a phase 2 MDMA-assisted therapy program for the military taking place in Loma Linda, California. Dr. Clancy stated that there will be many more studies to be sponsored by the Veterans’ Administration, although there are many steps needed to obtain grants. She expected a large expansion of MDMA-assisted therapy and approval of the Lykos protocol by the Food and Drug Administration as part of rescheduling, which did not occur.

The members of the committee pressed the Veterans’ Administration representatives to be more active in getting studies underway and helping veterans access these programs. Congressional representative Morgan Luttrell, who had undergone psychedelic-assisted therapy to recover from combat trauma, said that he is a strong advocate to expand psychedelic modalities for treatment. He is a Navy veteran who survived a traumatic brain injury from a helicopter crash, and he is part of the Veteran Mental Health Leadership Coalition, a group of over thirty organizations working to persuade lawmakers that psychedelics can bring beneficial therapeutic outcomes. He testified that he had lost hope and that he had tried to take his own life five times before he was healed in a MAPS clinical trial in North Carolina which included therapy. He said that he was able to talk about his demons, resolve his posttraumatic stress disorder and become fully functional, such that he was able to withstand a time consulting in Ukraine and sleep after missile explosions.

Representative Luttrell wanted to know if there were any friction points that could be removed to promote engagement with treatments using psychedelics. He advocated for the Veterans Administration officials to help expanded access to psychedelic therapies, and spoke in favor of Congress enacting the Breakthrough Therapies Act, which would streamline the implementation of psilocybin- and MDMA-assisted therapies for veterans to address posttraumatic stress disorder and help prevent veteran suicide.

Dr. Yehuda stated that MDMA-assisted therapy involves not a pleasant escape, but a means to gain insight and confront traumatic material, explore difficult material that affects behavior, and deal with it in a way to help address the root cause of suffering. The duration of benefit is uncertain, and this will be explored, along with developing safety data and identifying any adverse effects. She stated that the studies will provide data and they will see where it leads.

The second panel included research clinicians and veterans, including retired Army sergeant Jonathan Lubecky and Juliana Mercer, the director of advocacy at Healing Breakthroughs. Ms. Mercer, a 16-year Marine veteran, testified that she had had to go overseas to access healing of posttraumatic stress disorder. She stated that MDMA-assisted therapy has shown an 86 % rate of clinically significant improvement, and a 71 % rate of complete improvement. Brett Waters, an attorney and, with retired Marine Lt. General Martin R. Steele, co-founded Reason for Hope, and the Veteran Mental Health Leadership Coalition, argued that the government should take a leading role in expanding access to psychedelic assisted therapies. He argued for the therapeutic access to be expanded under Right to Try laws, enactment of the Breakthrough Therapies Act, increasing peer support programs, and rescheduling of therapeutic psychedelics to Schedule 2.

Frederick Barrett, the new director of the Johns Hopkins Center for Psychedelic and Consciousness Research discussed results of studies showing that psychedelic therapies have proven effective in a wide range of psychiatric indications. He has been involved with studies over the past ten years with over 400 individuals and over 1000 doses. He testified that psilocybin is relatively safe, that risks can be managed in controlled settings. Studies have shown it to be effective with mood disorders, depression, eating disorders, substance abuse disorders, and obsessive-compulsive disorder.

Dr. Rajeev Ramchaud, a psychologist with Rand Corporation, also spoke about the psychotherapeutic benefits of psychedelics like psilocybin. He described cumbersome and expensive requirements posed by schedule 1 status that create demands and barriers that inhibit research, and urged Congress to remove these by reclassifying them. He testified that all veterans who need the therapy should have access to the benefits of psychedelic therapies through community care network access with a capacity to monitor the quality of care.

State decriminalization and supported adult use programs:

Initiatives to increase opportunities to have experiences with psychedelics face different procedural requirements in different states. The successful results in states and localities are often grassroots efforts, like the results in Oregon and Colorado, primary examples of a movement based on the principle of freedom to have access to a natural substance that grows from the earth.

Dr. Dennis McKenna, a plant pharmacologist and author, and a leading expert on psychedelics and consciousness, wrote a chapter in the textbook, The Handbook of Medical Hallucinogens, p. 41 (C. Grob, J. Grigsby, ed., 2021), titled “Plants for the People.” He reviewed the history of the original psychedelic era and the incongruous laws that resulted in criminalizing these substances. He proposed making natural substances legal internationally for religious use. “Codify into law the principle that plants (and fungi and other biologically active organisms) are not ‘drugs’ in their natural form, and thus should not be regulated. When psychoactive substances are extracted from their natural sources, purified, and concentrated, they are then ‘drugs’ and should be appropriately regulated as such.” He also advised that biomedicine would benefit society by integrating psychedelic healing and restructure therapeutic support protocols using shamanic learning.

This experience, provided in medical or other social contexts, could open a door to more compassionate state of mind and help people experience realizations, adopt healthy attitudes, and begin practices that develop resilience and stimulate feelings of greater gratitude and enthusiasm and willingness to accept greater personal responsibility to promote sustainable and benevolent communities. Thus, state and local initiatives are supported under a due process of law inquiry as having a rational basis. However, there is a potential conflict with federal authority under the supremacy clause with respect to regulation of health and controlled substances.

Provisions adopted in various states and cities that are sometimes described as decriminalization measures are “deprioritizing” measures. These direct law enforcement to stop investigating and prosecuting individuals for using or possessing plants, cacti, and mushrooms that contain DMT, mescaline (not from peyote to respect Indigenous traditions), or psilocybin. Beginning in 2019 Denver decriminalized the use of psilocybin mushrooms by citizen referendum, and one month later, Oakland California’s city council passed a broader plant medicine ordinance to remove law enforcement priority for all natural psychoactive medicines.

In the District of Columbia, a 2020 measure made enforcement of laws prohibiting psilocybin, ayahuasca, and mescaline-containing plants the lowest law enforcement priority. Ann Arbor, Michigan deprioritized enforcement of local laws punishing use and possession of entheogenic plants and compounds in 2020. In 2021, Detroit’s Proposal E made enforcement of laws prohibiting all entheogenic plants the lowest priority of law enforcement. Similar measures passed in 2020 in Santa Cruz, California, and Ann Arbor, Michigan, and in 2021, Somerville, Northampton, and Cambridge, Massachusetts, followed in 2023, by Portland, Maine, and several other municipalities. Most of these measures protect use of psilocybin mushrooms and San Pedro Cactus and ayahuasca and do not include synthetic compounds like LSD, MDMA, 2-CB, synthetic forms of 5-MeO-DMT, and Moxy or 5-MeO-MiPT.

The traditional right to freedom of worship and religious observance involving peyote has been reserved for Indigenous populations such as members of the Native American Church, but the cultivation and use of mescaline-containing San Pedro for personal and ceremonial use by individuals who are not American Indians has typically received protection.

Ayahuasca is a classic hallucinogen from the Amazon, a mixture of Banisteriopsis caapi, a woody vine or liana, also called ayahuasca or by other names, and one of the two common admixtures, known as Chacruna, or Psychotria viridis, and chagropanga, or Diplopterys cabrerana. The leaves of these shrubs contain DMT. Sometimes, other admixtures are included, depending on the traditions. The brew is orally active because of the monoamine oxidase inhibitor in the vine, which prevents metabolizing the DMT. This activation of the tryptamines has a somewhat similar effect to psilocybin which also has tryptamines. It also limits the metabolism of serotonin. There is often a great degree of nausea from the harmine alkaloids. The accompanying visions can be very intense.

Oregon’s supported adult use psilocybin mushroom program is a nonmedical program with supervision by trained facilitators and regulatory supervision for testing, qualifications, and standards of behavior. The Oregon program provides “psilocybin services” regulated by the Oregon Psilocybin Services, a subdivision of the Oregon Health Authority Public Health Division’s Center for Health Protection. Oregon Psilocybin Services began awarding licenses in early 2023. The Oregon psilocybin program does not require a license as a psychotherapist or other professional health credential to be a facilitator. Compliance with regulations can create substantial operating expenses that make participation costly for centers and consumers. Regulation helps ensure safe material for consumption and a setting with an experienced and trained facilitator.

Participants in Oregon’s supported adult use program receive preparation and supervision from trained facilitators who must pass a background check and have a high school diploma. They must also complete a licensed certification program which is approved by the state and meets coursework and practicum hour requirements. Several private training programs for facilitators have been established and many people have received training to be facilitators. There are about 25 healing centers. The first psychedelic treatment centers opened in Oregon in 2023. Over 5000 subjects have been treated, apparently successfully. The state legislature is considering allowing people with disabilities and facing terminal conditions so they can receive psilocybin mushrooms with support in their homes. Licensed service centers have been the exclusive location for consumption, which drew an ADA lawsuit by three trained facilitators and a physician to permit access. The Oregon Health Authority had asserted, in defending against the claims, that legislation would be required to make the changes sought.

Colorado Natural Medicine Health Act:

The Colorado Natural Medicine Health Act was enacted into law after a successful voter referendum in 2022. The Colorado Natural Medicine Health Act has a combined set of provisions including supported adult use, the Regulated Natural Medicine Access Program, and a decriminalization program. The Colorado Natural Medicine Health Act also has personal use and cultivation provisions that do not depend on the regulated program’s requirements for facilitators and locations.

After many meetings of the Natural Medicine Advisory Board and public hearings as part of the rulemaking process, the regulations have been proposed for Colorado’s supported adult use program for consuming psilocybin mushrooms in licensed healing centers and other authorized locations. The regulations will affect access and cost as well as the extent of oversight, accountability, and aspects of medicalization and opportunity for ceremonial uses. The board has set proposed fees for various licensures for operations for the authorized program. The first licenses are expected to be awarded in mid-2025.

The supported adult use program with psilocybin mushrooms will be regulated by a set of regulations under two state agencies. The Division of Natural Medicine, under the Department of Revenue, will oversee healing centers and natural medicine businesses. There are regulations that set standards and address comprehensively aspects of product cultivation, inventory, security, storage, transportation, and product inspection, and set standards for healing centers, testing facilities, manufacturing facilities, and training providers. Small scale ownership is encouraged through limitations on the number of five licenses that can be owned by a single owner. There is flexibility that allows facilitators to receive from a facility and store, and keep in their custody up to 750 milligrams of active psilocybin and be subject to a less demanding standard for storage and documentation. There are provisions that promote community investment and planning for Indigenous benefit sharing.

The Department of Regulatory Agencies or DORA will oversee facilitator licenses and conduct. The regulations set competency as well as ethical standards of practice. The training requirements are a minimum of 150 hours of training, with 40 hours of supervised practice under a trained facilitator. The regulate address matters of documentation, confidentiality, informed consent, permission for touch, prohibition of romantic relations between participants and facilitators and other providers. Training centers for facilitators have been licensed and are training authorized facilitators.

Centers will contract with facilitators, and there are measures to include clinical facilitators who are interested in infrequent participation. There are provisions to allow for multipurpose use of space for practitioners who will facilitate infrequently or on a part-time basis and use space with coexisting purposes. There are fees with dual license arrangements for both roles as facilitators and owners of healing centers. There is a $ 10,000 license fee for training programs during the first year, and a $ 200 to $500 level for facilitators, a $ 7500 fee for licenses for extraction and manufacturing with the organic psilocybin, and $ 300 to $ 6000 for an annual healing center license. Prohibitions on advertising do not appear to prevent sharing information. The regulations that provide for cultivation of psilocybin-containing mushrooms also allow for their processing into “manufactured” products like teabags, capsules, chocolates, tinctures, and soft confections.

The regulations accommodate dual license arrangements for facilitator-owners of healing centers. They provide flexibility that allows facilitators to receive from a facility and store, and keep in their custody up to 750 milligrams of active psilocybin and be subject to a less demanding standard for storage and documentation. Small scale ownership of cultivation facilities, manufacturing facilities, healing centers, and other is encouraged through limitations on the number of five licenses that can be owned by a single owner. There are provisions that promote community investment and planning for Indigenous benefit sharing.

Colorado’s regulations for supported adult use of psilocybin are unique in providing for tiers of facilitators and clinical facilitators. Clinical facilitators are facilitators who are professionals with a secondary license who can offer services to individuals with pre-existing conditions that would not be permitted to participate. Participants undergo a preliminary safety screen before administration sessions, and this is when risk factors are identified. To participate in natural medicine services, people with certain conditions are screened to prevent participation if they have cardiac problems, very high blood pressure, certain mental health challenges, or taking certain medications like antidepressants, would have to gain clearance permission from a therapist or physician, depending on the condition. The clinical facilitators also have the authority as facilitator and the added authority for the clinical screening decisions reserved for qualified medical and behavioral health specialists.

During stakeholder meetings for the supported adult use of psilocybin program, officials stated that the regulators have good working relationships with federal regulatory programs. They expect the federal government to honor state permission for the clinical practitioners and the regulations safe harbor protection for the clinical facilitator licensures.

There is a provision for regulation of group administration sessions. Under § 12–170–205(1)(a)(I)(F), of the Natural Medicine Health Act, the director of the Division of Professions and Occupations has authority to make provisions to regulate group administration of plant medicines and set requirements for the number of facilitators and the number of participants in these group sessions.

Provisions in the law anticipate future discussions to consider adding additional psychedelic medicines and how to implement adult use provisions if other plant-based psychedelic substances are added to the program. The Act anticipates future authorization for supported adult use with other natural psychedelic medicines, including mescaline-containing cactus plants like San Pedro (not including peyote) and DMT-containing tea like ayahuasca upon recommendations by department officials on or after June 1, 2026.

The regulations for the supported adult use psilocybin program will affect access and cost as well as the extent of oversight, accountability, and aspects of medicalization and opportunity for ceremonial uses. The board will decide about which other plant-based psychedelic substances will be added to the program.

Personal use provisions in the Colorado Natural Medicine Health Act:

Personal use, cultivation, and sharing of psilocybin, mescaline-containing cacti other than peyote, and ayahuasca and organic DMT preparations are permitted under the personal use provisions of the Natural Medicine Health Act, which were effective as of July 2023. The law establishes a twelve-by-twelve-foot area allotted for individuals to be able to grow protected plants or fungi. The propagation must take place in compact areas not accessible to minors. There are provisions that prevent counties from prohibiting the personal use provisions or restrict the amount of growing space. Earlier provisions in the Natural Medicine Health Act to include plant material with ibogaine were removed by later amendments to the law.

The Natural Medicine Health Act permits adults aged 21 and over to use, possess, process, and grow natural medicines like psilocybin mushrooms, components of ayahuasca, or San Pedro cactus or huachuma. It allows individuals to cultivate and share natural medicines. It does not allow sale or cultivation or manufacture for sale or commercial purposes. Colorado Revised Statutes § 18–18–434(12)(b)(III)(d). The Act allows consumption, possession, cultivation, and sharing “within the context of counseling, spiritual guidance, beneficial community-based use and healing, supported use, or related services.” Colorado Revised Statutes § 18–18–434.

The provisions for legal sharing do not permit payment for the natural medicines, but they appear to allow for remuneration for support services that may be offered with such sharing. A Apparently, it has become an accepted practice for individuals to receive compensation for harm reduction services or coaching while simultaneously gifting mushrooms. While advertising is prohibited, compensation for services to provide information and education for associated preparation and integration work will apparently be compensable under the Natural Medicine Health Act.

Under Colorado Revised Statutes § 12–170–108(4), practitioners can perform bona fide religious ceremonies if they are not claiming to be licensed, and so long as they are not associated with a for-profit activity. Spiritual use is not prohibited or regulated under the Act so long as facilitators make it clear that they are not certified practitioners under the Natural Medicine Health Act.

The Natural Medicine Health Act, and the ongoing regulatory activity with respect to natural entheogens, appear to be developing into a useful prototype for the decriminalization and supported adult use initiatives that are appearing in California, Massachusetts, and New Jersey. Colorado has adopted a very progressive framework overall, and is attracting attention as an effective model for other states.

The Massachusetts Natural Psychedelic Substances Act:

Massachusetts is considering a decriminalization program that permits Adults 21 and older to legally possess, grow, and share natural psychedelic substances with psilocybin, psilocin, dimethyltryptamine, ibogaine and mescaline (San Pedro, not peyote). Local organizers Massachusetts for Mental Health Options gathered the signatures to secure ballot placement for November. The referendum is expected to succeed in the election.

The measure would create a Natural Psychedelic Substances Commission of five persons, as well as a 20-member advisory board, to regulate the production and use of plant-based psychedelic substances like psilocybin mushrooms for people at least 21 years old to legally consume psychedelics at licensed therapeutic centers. A Natural Psychedelic Substances Advisory Board would “study and make recommendations” to the commission about issues such as public health, regulations, training for facilitators, affordable and equitable access, traditional use of psychedelics and future rules, including possible additions to the list of legal substances.

The measure also would eliminate criminal penalties associated with possessing, consuming, and sharing, without compensation, limited amounts of natural psychedelics and to allow individuals to legally cultivate psychedelics at home. Adults 21 and older could legally possess, grow, and share up to the following amounts of the organic material containing the following weight limits of the active compounds of these specific psychedelics: DMT (one gram), non-peyote mescaline (18 grams), ibogaine (30 grams), psilocybin (one gram) and psilocin (one gram).

Adults could propagate natural psychedelics in a space no larger than a 12 by 12 ft. space. The penalty for possession of amounts of up to double the limit would be a $100 civil fine, with greater penalties for greater amounts.

The effective date of the law would be December 15, 2024. The commission and advisory board would need to be created by March 1, 2025.

The program would be funded with revenues from a 15 percent excise tax on psychedelic substances purchased at licensed facilities. Localities would have the option of imposing an additional two percent tax if they permit the centers to operate in their area. Revenue would be used to fund regulation of the program. Local governments could enact regulations on the time, location, and manner of service centers, but they could not outright ban the centers from operating in their area. There would be civil legal protections related to professional licensure, child custody and public benefits for people who participate in a legalized psychedelic activity.

Massachusetts for Mental Health Options was the leading advocate to support the efforts to secure ballot placement in Massachusetts for November. The referendum has been tarnished by revelations that discredited the principal director of that grassroots organization for impersonating another activist who represented veterans in favor of the measure and fraudulently acting on his behalf. However, it is a very progressive program that permits cultivations of natural psychedelics and has been expected to succeed in the election.

Washington:

The Natural Psychedelics and Supportive Services Act has been approved for a proposed voter referendum in the state of Washington for decriminalization of natural medicines. The ballot title, Initiative Measure №2076, and a summary were issued by the Washington Secretary of State. The proposed voter initiative developed after two bills had failed in the state legislature and after a task force was assembled that merely proposed additional research.

The proposed initiative was prepared by a group of advocates called REACH-WA, for Responsible Entheogen Access and Community Healing. It proposes to fully decriminalize under state law access to certain plants and fungi containing classic serotonergic psychedelics, namely psilocybin, psilocin, mescaline, dimethyltryptamine or DMT, and 5MeO-DMT. The initiative excludes peyote and its derivatives from its protection to respect the prerogative of Indigenous populations and communities. It includes as protected “natural psychedelics” preparations such as “teas, extracts, and mixtures, such as ayahuasca tea and psilocybin chocolates.” It excludes all “versions of any controlled substances that are created by means of chemical synthesis or obtained from animal sources.”

The proposal would allow consumption individually and in community settings. It prohibits the sale of the substances, but allows for the free transfer of natural psychedelics to a person twenty-one years or older for consumption during the provision of bona fide supportive services, which can be provided in exchange for remuneration. Supportive service providers are not licensed under state law. They may receive compensation for bona fide services offered in conjunction with providing natural medicines. Supportive service providers must observe ethical guidelines set forth in the proposal to promote health and safety. Informed consent and advance authorization for supportive touch are required, with disclosure of risks.

The proposal has provisions for Supportive service providers to advertising only for eligible persons who request contact about the supported services for natural psychedelics. Communications must not be misleading of offer clinical or therapeutic services that require licensure, unless the licensing board authorizes such services. Organizations that are organized as nonprofit organizations may offer support services, as can certain cooperative organizations.

The proposal provides for formation of a diverse group of professionals and public servants called the Natural Psychedelics Community Resource Advisory Council. The council will identify and provide best practices and guidelines for services and consider provisions for addressing instances of misconduct. Private experience or personal use provisions provide few restrictions beyond restrictions on public consumption and advertising. The proposal seeks to promote inclusivity to be respectful to other traditions and access to natural psychedelics, from organic sources in spiritual and religious settings.

California:

Following the December 2022 veto of California’s proposal to decriminalize natural psychedelics and establish supported adult use of psilocybin mushrooms, SB 58, by Governor Newsom, there have been other efforts at legislation and a proposed voter initiative. Governor Newsom stated his preference for a clinical and therapeutic program. A voter initiative in California, The Psychedelic Wellness and Healing Initiative of 2026, a proposed regulated adult use program, was drafted following a senate committee amendment that would require that facilitators to have an existing professional health license like those for psychiatrists, social workers, drug and alcohol counselors and nurse practitioners, to administer psychedelics. The initiative will need to have over 500,000 signatures to be certified by the attorney general of California, which would approve its title and summary to the California Secretary of State for placement on the ballot.

Free exercise of religion and protection of ceremonial experience with psychedelics:

The current time is presenting an opportunity for activists, attorneys, and public officials to protect legitimate spiritual experience with natural medicines. Americans are supporting greater access to natural medicines for healing of trauma and for spiritual exploration. There has been pressure to limit their use to a medical context, which appears to be financially prohibitive for most people and restricts access to people presenting themselves as having a mental health pathology. Legal protections are likely to expand and incorporate celebratory and exploratory adult use of psychedelic medicines, as well as a broader category of spiritual exploration that would not depend on insincere presentation or cultural appropriation of another society’s traditions.

North American and European experience faces the problem of an absence of accepted psychedelic spiritual traditions. Authoritarian structures eliminated psychedelic practices in ancient Greece and Europe, and throughout the colonial empires in the Americas and Africa. North American religious institutions have been at the forefront of efforts to suppress and eliminate the longstanding traditions in Central and South America. Traditions in other countries that go back many centuries have survived by withstanding and evading extreme persecution by religious and governmental authorities.

Opposition by mainstream religions and legal authorities, and the social stigma associated with drug culture and psychedelics, have resulted in ordinary people having no legal access to psychedelics. These forces have also inhibited or prevented formation of social groups and organizations that would have developed naturally to provide practices and social reinforcement for safer practices and risk reduction. The United States judicial system is inhibited by initial experience of its society with psychedelics because of missteps, abuses, and inappropriate uses that led to adverse consequences, and because of the insights that led to challenges to mainstream society’s expectations of social conformity.

Some of the challenges to having a more universal, experience-based religion that incorporates psychedelic substances include improper or corrupt motivations by leaders, inadequate preparation or exploitation of vulnerable participants in a hyper-suggestible mental and emotional state, incompetency in administration of the sacraments or in addressing uncomfortable or hazardous reactions, factionalism, divisiveness, envy, and misunderstanding between leaders, an absence of reverence for the medicines, and disrespect of the viewpoints and experience of other participants.

As Americans are moving away from organized religion or becoming more entrenched in religious institutions that are firmly opposed to ceremonial use of entheogens, there is a crosscurrent of influences that could inform a more universal spiritual message consistent with the experience of an unfolding psychedelic journey. Disenchantment with mainstream religious institutions can help reveal beneficial and more holistic theologies from other traditional frameworks, and open worldviews to incorporate new ideas and realizations drawn from individual and community experience.

Careful, deliberate, and confident preparation and oversight can help mitigate risks and provide a safe container for an inward healing process that can afford people with a deepened sense of connection with nature, community, the ground of being, and contact with the numinous. The psychedelic experience can provide a sense of greater aliveness and motivation through restorative insights that bring about gratitude, love, forgiveness, and compassion. It creates the potential to bring about a clarity of awareness about one’s own experience and motivations, and exposing one to truths about one’s past actions and experiences that can enhance insight and motivation for transformation. It can motivate the inner work to transform in more engaging and positive ways.

While programs for adult use in non-clinical settings evolve, Colorado’s program will be a fine example of the guidelines most beneficial to employ in providing a safe container. People will have an opportunity to shed layers of resistance and deepen understanding and compassion for oneself and for others, and other opportunities for personal transformation due to a mysterious neuroplasticity process that can reveal unfamiliar types of awareness. Risk mitigation practices with informed consent for voluntary participation with disclosures of risks, and accountability for best practices, will contribute to reaching the greatest potential for psychedelics.

Recent cases involving the free exercise of religion and psychedelics

The major psychedelics became illegal nationwide by October 1968. In 1970, the Federal Controlled Substances Act, was enacted, and it gave authority to the Food and Drug Administration to create schedules for criminal sanctions for the use and possession of psychoactive drugs and substances. See 21 U.S.C. §§ 841(a)(1), 811–821. After the Controlled Substances Act was enacted, and under its authority, LSD, mescaline, peyote, ayahuasca, and psilocybin mushrooms were placed in the highly restricted Schedule I as having no medical potential and being subject to abuse and presenting grave dangers. The substances listed in Schedule I of the Controlled Substances Act are subject to an outright ban on all importation and use except for strictly regulated research projects. See, 21 U.S.C. §§ 823, 960(a)(1).

Although ayahuasca can be dangerous because of the reaction to other drugs, it is constitutionally protected as a religious practice under a 2006 Supreme Court case. There are many ayahuasca churches, especially in Brazil, and many indigenous or neo-shamanic retreats in Peru, Colombia, Ecuador, and elsewhere. There are retreat centers and underground medicine circles throughout the U.S.A.

The Supreme Court refused to afford First Amendment protection for use of peyote as a sacrament in Employment Division, Department of Human Resources of Oregon v. Smith, 494 U.S. 872 (1990). This represented a departure from the traditional protection of a fundamental right, the right to freedom of worship and religious observance. This removal of constitutional protection received bipartisan criticism and Congress was motivated to pass legislation to undo this unpopular approach. The Congress in 1993 responded by legislatively overturning the diminished constitutional scrutiny adopted in Employment Division v. Smith decision by enacting of the Religious Freedom Restoration Act (RFRA).

The Religious Freedom Restoration Act was enacted to provide a private cause of action for persons whose religious exercise has been substantially burdened, allowing them to “assert that violation as a claim or defense in a judicial proceeding and obtain appropriate relief against a government.” 42 U.S.C. § 2000bb-1 provides, in section (a), “Government shall not substantially burden a person’s exercise of religion even if the burden results from a rule of general applicability, except as provided in subsection (b).” Section (b) states, “Government may substantially burden a person’s exercise of religion only if it demonstrates that application of the burden to the person- (1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.”

42 U.S.C. § 2000bb-1(c) of the Religious Freedom Restoration Act provides a federal cause of action with judicial relief for infringement of religious freedom and religious practices. It has been construed, however, to apply exclusively to federal enforcement activity. Subsection © states as follows:

A person whose religious exercise has been burdened in violation of this section may assert that violation as a claim or defense in a judicial proceeding and obtain appropriate relief against a government. Standing to assert a claim or defense under this section shall be governed by the general rules of standing under article III of the Constitution.

42 U.S.C. § 2000bb–3(a) states that the Religious Freedom Restoration Act “applies to all Federal law, and the implementation of that law, whether statutory or otherwise, and whether adopted before or after November 16, 1993.”

The law provides that a prima facie showing that the federal government activity, applying the Controlled Substances Act to place a substantial burden on a sincere exercise of religion, shifts the burden of persuasion to the federal government to establish that its burdensome actions furthered a compelling interest in the least restrictive manner. Gonzales v. O Centro Espirita Beneficente União do Vegetal, 546 U.S. 418, 437–38(2006).

Many states followed the Religious Freedom Restoration Act, which applies only to federal enforcement, with state laws of similar effect. These laws reinstate the constitutional standards for the protection of religious activity, including the ceremonial use of psychedelics. The standards in effect prior to Employment Division v. Smith were stated in Sherbert v. Verner, 374 U.S. 398 (1963), and Wisconsin v. Yoder, 406 U.S. 205 (1972). These decisions of the Supreme Court applied a balancing test for constitutional protection, weighing a compelling state interest against the extent of the burden it placed on religious activity. The Court in Sherbert v. Verner stressed that cases that sustained statutes despite a burden placed on religion have involved activities that “invariably posed some substantial threat to public safety, peace, or order.” Id., 374 U.S. at 403 (citations omitted). The state has an obligation to present evidence of a compelling interest in regulation and upon such a demonstration, a court will decide whether the state could achieve its goals by less restrictive alternative means. The Court held that if it had found the state had a compelling state interest, it would have required the state to show that “no alternative forms of regulation would combat the abuse without infringing First Amendment Rights.” Id., 374 U.S. at 407.

The Drug Enforcement Administration Diversion Control Division issued a “Guidance Regarding Petitions for Religious Exemption from the Controlled Substances Act,” which invites applicants to invoke its administrative process. The Drug Enforcement Administration (DEA) has only agreed to recognize bona fide ceremonial psychedelic practices (in each case ayahuasca) after court intervention. The Government Accountability Office has admonished the DEA for its pattern of delay and refusal to recognize protection for psilocybin churches. The Government Accountability Office urged the DEA adopt a more hospitable approach to ceremonial experience with psilocybin mushrooms and process several deficiencies in administering religious exemptions from the controlled Substances Act.

Some courts have shifted responsibility for factfinding and legal conclusions entailing the balancing fundamental rights and deferring to the DEA. One example is the adverse D.C. Circuit decision in the Iowaska Church of Healing case. In Soul Quest Church of Mother Earth, et. al. v. Attorney General, United States of America, et. al., the request for a DEA exemption led to findings that led to a very limited opportunity for review, with deference to the agency findings. There was a finding of lack of sincerity or religious purpose. The district court’s deference to agency findings did not allow for this balancing of interests because there was no review of the finding of lack of sincerity. In the Eleventh Circuit, Soul Quest raised a challenge to the DEA process with factfinding authority without adopting rules. Because this was not raised in the district court, it was deemed to be waived.

In Soul Quest, there was an agency determination of a lack of sincerity. The Eleventh Circuit decision interpreted the DEA review as a final administrative decision and found there was an untimely appeal. This interpretation would give the DEA’s determinations a deferential standard of review under an arbitrary and capricious standard. More concerning still is the court’s implicit prerequisite of DEA administrative review prerequisite in future cases. The government separately supported its denial of an exemption by concluding that restrictions on ayahuasca did not place an impermissible burden on religion because ayahuasca posed risks to safety justifying legal restrictions. Facts in Soul Quest that were viewed unfavorably by the agency included its resemblance to a retreat center model, a lack of universal tenets or beliefs, for-profit aspects of its structure, and the existence of a pending wrongful death case.

These precedents could represent a pattern of courts delegating fact finding, including the constitutional balancing of interests under the Free Exercise Clause, to the Drug Enforcement Administration. It is important in litigation to protect the province of the judiciary to make the findings and conclusions to protect rights under the Religious Freedom Restoration Act. It may be appropriate in some states and in the federal government to try to address, through legislation the need to protect the decision-making authority of the courts and safeguard the higher scrutiny, requiring compelling state interests to justify activity that burdens religious liberty.

There has been a great expansion of ayahuasca and psilocybin mushroom spiritual practices in the time since the O Centro Espirita Beneficente União do Vegetal decision. The opposition to legal protection by government authorities, the expense and stress of litigation, and the skepticism of the courts, has led many spiritual communities that employ plant medicines to avoid seeking recognition through judicial proceedings.

Church of the Eagle and the Condor v. Garland:

On April 22, 2024, the plaintiffs in Church of the Eagle and the Condor v. Garland, 2:22-cv-01004, (D. Ariz.), announced a settlement with federal defendants that recognizes their right to religious liberty that encompasses sacramental experience with ayahuasca, which contains dimethyltryptamine (DMT), a controlled substance. The Church of the Eagle and Condor is a church based in Phoenix, Arizona with leadership including Indigenous persons that practices worship with sacramental experience with ayahuasca. The plaintiffs included leaders and board members of the church, Joseph Tafur, M.D., Belinda Eriacho, Kewal Wright, Benjaman Sullivan, and Joseph Bellus. The Church of the Eagle and Condor has been incorporated as a not-for-profit organization and it has bylaws, a code of ethics, and ceremonial guidelines in place to help guide its ceremonies.

Although the Church of the Eagle and Condor has been granted legal authority for its ceremonies, it had to accomplish this result with exemplary facts and several outstanding and conscientious attorneys. It was not required to apply under the application process, the “Guidance Regarding Petitions for Religious Exemption from the Controlled Substances Act Pursuant to the Religious Freedom Restoration Act,” the Drug Enforcement Administration’s internal process for assessment of the validity of religious claims. The settlement recognized “activities of a religious entity” in setting forth the rights and responsibilities of the Church of the Eagle and Condor. As a prevailing party, the Church of the Eagle and Condor is entitled to petition for attorney fees as prevailing plaintiff under the Religious Freedom Restoration Act and 42 U.S.C. § 1988. If the issue is not resolved, it could petition the district court for determination about an award of fees.

The Church of the Eagle and Condor alleged that it accepts a lineage of teachers and maintains a broad set of ethics that promote the wellbeing of participants. The church presented appropriate factors for religious protection. The allegations of the complaint with respect to the sincerity of the church and its membership in their sacramental practices were accepted. No adverse evidence was produced to discredit their sincerity.

The church exhibited sincerity, promoted an understanding of the purpose of worship among its members, and encouraged careful practices that prevent diversion for health and safety. The church would observe measures to prevent diversion for unauthorized purposes that were inconsistent with the shared beliefs. Its leaders were inspired by the Shipibo ayahuasca medicine tradition of Peru that holds ayahuasca ceremony as an essential sacrament to draw together heart and wisdom traditions. Its members adhered to a code of ethics. It has maintained a communal tradition with tenets based upon an ancestral prayer and call of the Spirit of the Americas to bring about a beneficial re-encounter bridging countervailing influences.

The federal defendants, who were officials sued in their official capacities, were Attorney General Merrick Garland as head of the Department of Justice, Secretary Alejandro Mayorkas for the Department of Homeland Security, Administrator Anne Milgram for the Drug Enforcement Agency, and Acting Commissioner Troy Miller representing the U.S. Customs and Border Protection.

The church had continued to participate in its practices under the guidance of a trained ayahuasquero. The settlement agreement allows the Church of the Eagle and Condor plaintiffs to import, receive, manufacture, distribute, transport, securely store, and dispose of ayahuasca solely for the church’s religious purposes. The church is authorized to receive ayahuasca “in concentrated paste or in liquid form” and, when needed, to “combine the ayahuasca paste with water to manufacture ayahuasca tea for sacramental uses” at a designated church facility in Phoenix. The settlement agreement states that it would be receiving kilograms of paste and liquid ayahuasca from Ricardo Amaringo, a Shipibo elder who has helped train Dr. Tafur. Shipments will be subject to sampling and inspection by the DEA or Customs and Border Protection. Ports of entry are Los Angeles, Miami, Houston, and Atlanta.

The settlement allows the DEA to take spot samples of the imports “for the purpose of confirming that the consignment is in fact ayahuasca which contains no controlled substance other than DMT.” The settlement provides for the church to be issued certificates of registration during periods of compliance. The church will receive annual permits for shipments, registering the importer. Applications for shipment are not required to designate quantities of material. The church would be issued a bulk manufacturer registration. It also will register as an importer.

The DEA will not seek to limit the quantity of ayahuasca necessary for the plaintiffs’ religious use. It will not be required to register as a distributor. The persons designated to have responsibility for receiving, handling, preparing, manufacturing, storing, and transporting the ayahuasca are the ayahuasqueros, Joseph Tafur and Benjamin Sullivan.

According to the terms of the settlement, the Church of the Eagle and Condor anticipated holding regular meetings at members’ residences and specified locations. The church will provide the local DEA field office with general information about the locations and dates of their ceremonies. It will not be required to report the names or addresses of individual members or non-member ceremonial participants. The church asserted the privacy interests of its adherents, and their rights to freedom of association, to shield its membership lists from disclosure as part of discovery. The ayahuasca will be delivered and served by designated dispensers at ceremonial locations. The government agreed not to make public the addresses of locations.

The health screening process and first aid processes in place by the church were adopted in the settlement as safety protocols that will continue. The settlement provides for participants to be asked to disclose their medications and health conditions in order to identify contraindications for participation. A person with basic life support training will be present during ceremonies in case of medical or psychological events. The designated person must be present during church ceremonies and may partake of the medicine in keeping with traditions for attendees to participate in consuming ayahuasca.

The church agreed to recordkeeping for the importation, receipt, manufacture, distribution, transportation, storage, and disposition of ayahuasca. The batches and containers will be identified. The ayahuasca will be stored in a secure location locked with a deadbolt with an alarm system, and in a locked refrigerator. The ayahuasqueros are responsible for handling the containers. During an authorized inspection of manufacturing location, church representatives would be present with DEA inspectors and the inspection will not entail physical handling of the containers by agency personnel. The ayahuasqueros are responsible transporting ayahuasca to ceremonial locations.

The church issued a press release that stated that it is “the first non-Christian church to receive protection for its spiritual practices regarding ayahuasca.” The church expressed its hope that the settlement “has positive implications and paves the way for other ancestral and syncretic religions.”

Other cases:

In Church of the Holy Light of Queen v. Mukasey, two ayahuasca churches that are American branches of successors of the Santo Daime religion, the oldest of the Brazilian ayahuasca religions, were granted a permanent injunction by the district court that allowed them to import and use ayahuasca, called Daime by the churches. Church of the Holy Light of the Queen v. Mukasey, 615 F. Supp. 2d 1210, 1219 (D. Or. 2009), vacated sub nom. Church of Holy Light of Queen v. Holder, 443 F. App’x 302 (9th Cir. 2011) (to limit scope of injunction). The district court found that consuming ayahuasca tea is “an arduous path that is not suitable for most people,” and that the participants were screened to “select only those who are serious about the Santo Daime religion, and to turn away would-be recreational users or thrill-seekers.” Id. at 1216. The court also observed, “In Brazil, thousands of people consume hoasca or Daime tea several times each month. The government of Brazil would not allow the UDV and Santo Daime churches to operate if there was evidence that Daime tea or hoasca was killing church members.” Id. at 1218. The Ninth Circuit Court of Appeals upheld the injunction insofar as it enjoined the government from prohibiting the importation, storage, and use of their sacrament.

In Church of the Celestial Heart v. Garland, 1:23-cv-00545, (E.D. Cal. January 9, 2024), the plaintiffs succeeded in convincing the court that Religious Freedom Restoration Act claims against federal government defendants do not require DEA administrative factfinding and adjudicatory functions, or create an implied exhaustion of administrative remedies for court review. The court in the Church of the Celestial Heart case upheld a cause of action to protect an ayahuasca church to seek redress for federal enforcement activity and in so doing, did not give much reason for confidence in the DEA exemption process.

In Church of the Celestial Heart v. Garland, a U.S. magistrate judge in California denied a federal government motion to dismiss a complaint by an ayahuasca church. The decision contains information that the federal authorities have not been frequently initiating or pursuing prosecutions involving ceremonial experiences with ayahuasca. The Drug Enforcement Administration submitted pleadings that minimized its role in law enforcement with respect to ayahuasca churches in that case and other cases discussed in that opinion.

Although it had found sufficient allegations to find standing based on actual enforcement action, it proceeded to examine the criteria for standing in the pre-enforcement context. Despite a substantial number of border seizures of plant medicine materials, there were very few prosecutions following seizures and interception of plant medicine materials. The agency would provide information about the intended recipients and content to state prosecutors, who have tended to be disinterested in pursuing charges.

The court held that the plaintiffs could not be required to pursue an application for an exemption from the Controlled Substances Act in the Drug Enforcement Administration’s administrative process as the government was urging. (Opinion at 47). The court held that by pursuing, the Drug Enforcement Administration exemption process the church would lose options to obtain preliminary relief available in court under the Religious Freedom Restoration Act. (Opinion at 46–47). Moreover, the church would be restricted in holding its ceremonies because parties seeking religious exemptions were precluded by law from using prohibited substances like ayahuasca until they obtain an exemption and proceed with registration. Id. (citing DEA Guidance at 2: “Activity Prohibited Until Final Determination. No petitioner may engage in any activity prohibited under the Controlled Substances Act or its regulations unless the petition has been granted and the petitioner has applied for and received a DEA Certificate of Registration.”). The court also observed that the guidance allows the agency to suspend or revoke protection, “without detailed separate guidelines or specific protections except for aversion to general principles.” (Opinion at 47).

The trial court denied a motion to dismiss, holding that there was a valid cause of action under Religious Freedom Restoration Act, 42 U.S.C. §§ 2000bb-1(a). This is a favorable decision for religious freedom, bringing important fundamental rights before the courts as anticipated under the Religious Freedom Restoration Act. It also revealed that federal and state authorities have not appeared eager to bring many enforcement actions against churches with natural psychedelic sacraments. See, also, Arizona Yage Assembly v. Attorney General, 595 F. Supp. 3d 869 (D. Ariz. 2022).

The Religious Freedom Restoration Act states that courts have the authority to perform the delicate balancing of interests with formal proof standards. The courts are more likely to apply strict scrutiny constitutional review in a way that is more promising and less complex than the administrative process used by the DEA, as the courts had been applying First Amendment protection before Employment Division, Department of Human Resources of Oregon v. Smith, 494 U.S. 872 (1990). Arguments for court adjudication can be supported by the May 2024 Governmental Accountability Office report which criticized the DEA for not having regulations or an effective and timely processes for making these decisions.

To avoid prosecution, or succeed in establishing the right to worship with entheogenic plants, best practices to be observed include having a structure with appropriate leadership and education, adherence to guiding principles, an understanding of the worldview, teachings, or tenets of the community, practices that inspire reverence and respect for the medicine, its traditions, and other members, and upholding spiritual traditions. It is especially important to reduce risks and promote beneficial experience with preparation, careful administration, and integration of the experience with community support. It is beneficial to have organizational documents and protocols for abuses of power or other misconduct, to promote diversity, screening and support for health and mental health concerns.

The Sacred Plant Alliance advises communities with psychedelic plant and fungi medicine sacraments in ceremony to have a congregation in place and a leader with seven or more years of experience with entheogenic sacraments. The Sacred Plant Alliance was formed in 2020 and it is a 501(c)(3) not for profit corporation of 12 to 15 member churches. It has member communities with psychedelic knowledge and offers mutual support and guidance toward risk mitigation practices and guidance about vision and inclusive practices, and helping organizations withstand scrutiny as sincere and entitled to protection for the free exercise of religion. Sacred Plant Alliance has committees like health and safety, outreach and reciprocity, membership, and ethics. The Sacred Plant Alliance recommends that spiritual communities have a not-for-profit structure, that and have models of authenticity with opportunities to learn. Member churches are encouraged to adopt ways of regulating themselves with authenticity and accountability through peer review and recourse to conflict resolution with the Sacred Plant Alliance.

The legacy of past prohibitionist approaches has created a substantial issue with a lack of experience for leadership, and the need for developing leadership among racial and ethnic minorities in North America. Psychedelic group and individual settings for healthy adults are likely to evolve and develop with myriad influences, reaching in differing directions and coalescing sometimes when their ways find common ground. A group could meet in a retreat setting with careful leadership that should be able to include multiple spiritual frameworks with such moral precepts and self-discipline, but without a rigid or fundamentalist viewpoint particular to an insular religion. With experience and the examples of churches like Church of the Celestial Heart, Church of the Holy Light of the Queen, and Church of the Eagle and Condor, and insight from the Sacred Plant Alliance, organizations have viable resources for meeting standards for constitutional protection, such as information about shared leadership and how to maintain best practices for risk reduction.

In many ways, the Indigenous traditions in the Americas can provide an appropriate context and example of the psychedelic experience for people descended from other traditions, including Black Americans. A faith may evolve from experience with psychedelics that is the most inclusive and true to the visionary experience of the individual. Ideas from core shamanism, the paths of righteous conduct from Buddhism, Christianity, Islam, Hinduism, and Indigenous traditions are likely to evolve toward a more open and universal set of principles and guidelines. Environmental stewardship and trauma-informed understandings from psychotherapy and self-help traditions can be incorporated into orientation and integration sessions in group settings providing safe containers for celebratory and exploratory uses.

The AIMS Right to Try and rescheduling of psilocybin issues:

The AIMS cases involve persistent efforts to access psilocybin for end-of-life distress treatment. Advanced Integrative Medical Science Institute, PLLC v. United States Drug Enforcement Agency, (9th Cir. no. 22–1568) (AIMS II), involves an effort to prescribe psilocybin for palliative care in end-of-life existential distress. Dr. Sunil Aggarwal, a physical medicine physician working at an outpatient clinic who focuses his practice on oncology, psychiatry, neurology, and pain management treatment, is seeking to invoke the Right to Try Act, 21 USC § 360bbb, which has parallel state laws in many jurisdictions. These laws were enacted to help patients with end-of-life distress. An appeal involving the Drug Enforcement Administration’s authority under the Federal Right to Try Act to deny the efforts by Dr. Aggarwal to prescribe psilocybin was argued before the Ninth Circuit on the 19th of August. He filed the suit after being unable to acquire synthetic psilocybin from pharmaceutical companies and being denied permission or authorization from the Drug Enforcement Administration (DEA).

Dr. Aggarwal has been seeking to treat patients with terminal conditions with psilocybin under the 2018 Federal Right to Try Act since 2020, offering several proposals to the DEA. The AIMS plaintiffs have an associated case on appeal in the Ninth Circuit, no. 22–1718 (AIMS III), which involves a petition filed by AIMS in 2022 to reschedule psilocybin from Schedule I to Schedule II of the Controlled Substances Act. There are numerous organizations and professionals supporting rescheduling in amicus briefs. The Food and Drug Administration granted “breakthrough therapy” status for psilocybin to treat major depressive disorder in 2019, for Usona Institute and Compass Pathways.

Shane Pennington argued the appeal in this case, which involves the issue whether the federal government must allow patients access to psilocybin, notwithstanding its Schedule I status, to help with anxiety, depression, and distress in end-of-life palliative care. Seven states and the District of Columbia filed an amicus brief in support of the clinic’s arguments favoring access to psilocybin for patients with terminal conditions.

The DEA attorney, Thomas Pulham, advanced the position that the Right to Try Act does not provide any exemptions from the Controlled Substances Act or its implementing regulations. He conceded that the agency’s follow-up response to an inquiry represented a final agency order subject to appeal. In response to questioning during argument, he also conceded that the government could have granted some kind of waiver by rule. The government relied on psilocybin’s Schedule I status to support its position is that there is no pathway for access to psilocybin apart from research protocols, as well as the absence of references in the Right to Try Act to the Controlled Substances Act. The argument included discussion of section 822(d) the Controlled Substances Act, which provides for waiver of federal law: “The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.” Counsel for Dr. Aggarwal argued that this to prescribe psilocybin was argued before the Ninth Circuit on the 19th of August. The Food and Drug Administration has granted “breakthrough therapy” status for psilocybin to treat major depressive disorder in 2019.

The agency conceded that it could accommodate the request for access, but that it was not required to do so because the examples of exceptions are limited to clinical experimentation. The court was averse to finding a silent exception or an implied repeal in the absence of a specific exemption for Right to Try laws, and seemed disposed to require an explicit exception in the Right to Try Act to use controlled substances. The court appeared uncomfortable with the minimal record available for review, however, and to be looking for a way to remand the case and avoid ruling on the issue. In response to one question, the attorney for the DEA said that the agency is considering the rescheduling petition very carefully, and that the agency was told by the office of legal counsel that its criteria for exemption were too narrow.

Soul Quest Liability Issues:

In the Begley v. Soul Quest Church of Mother Earth, Inc., case, the Orlando jury rendered a large liability verdict against Soul Quest and its founder. On May 15, 2024, the trial jury returned a $15,048,526.25 verdict against Soul Quest Church of Mother Earth, Inc., and Christopher Young (principal owner of Soul Quest) finding liability for failure to exercise ordinary care in causing Brandon Begley’s death. The jury found that Mr. Young’s instructions to Brandon caused the hyponatremia, and his refusal to call medical attention as he had seizures had precluded an opportunity for paramedics to save his life.

The jury concluded that Soul Quest was 40% liable and that Mr. Young was 60% liable for the verdict. The jury rejected the defense’s contention that Brandon was negligent in causing his death. The verdict was to be shared by each of the decedent’s parents. The jury rejected Mr. Young’s claim that the decedent had misrepresented a prior medical history,

The court had excluded exculpatory documents under unique circumstances, and a significant litigation about the ruling that two exculpatory documents were inadmissible. Mr. William Chapman, who represented the plaintiff estate, said that the releases were poorly written. A waiver document that the decedent had signed did not identify Soul Quest as the party to be released. It had been borrowed from another organization involved with soil conservation, so the wrong party was released. The trial court held that a second exculpatory document did not have enough specificity to be enforceable.

Mr. Chapman said that the trial judge tried to keep the case a negligence and products liability cause of action. Mr. Chapman said that there was a concept of in pari delicto that came up in the discussion of the waiver, and consideration of what the decedent had known, to bear on his own responsibility and assumption of risk. With respect to the products liability claim, the contributory negligence defense does not apply.

Mr. Chapman said that he thought that if Soul Quest had followed through on safety protocols it had represented to be in place, there would not have been any need for a waiver in the case. He said he is not opposed to having a safe place with protocols. He said that a specific and detailed release would be more likely to be enforceable. He stated that the practice of members signing releases makes it look more like a business than a purported religion.

Soul Quest closed in August 2024 to pursue bankruptcy protection. After the March 2018 incident with Mr. Begley that resulted in the wrongful death that would close its doors, Soul Quest developed appropriate safety measures and trained facilitators, practitioners, and integration coaches who provided services for regular ceremonies. The structure of leadership did not maintain the continuity of leadership and community that would be the best examples of sustainability.

The challenges to safe consumption of psychedelic plant medicines include inexperience, concern about law enforcement and exposure, insufficient care to the need for support structures, appropriate screening, unrealistic expectations, and insufficient integration. To anticipate and mitigate these risks and dangers, it is important for entheogenic churches to receive guidance about the appropriate and conscientious efforts to present safe containers for religious experiences and transformation toward community healing with the benefit of psychedelic medicines.

The Government Accountability Office May 2024 Report Urging Improvement of the Religious Exemption Program of the Drug Enforcement Administration:

The DEA administrative process concerning the consideration of religious exemption from the Controlled Substances Act for use of psilocybin for religious, Indigenous, or spiritual practices under the Religious Freedom Restoration Act was strongly criticized in a May 2024 Government Accountability Office report. In a 46-page report with appendices, the Government Accountability Office discusses the impact of Controlled Substances Act enforcement in jurisdictions that allow psilocybin use and possession, and barriers to accessing the psychedelic for medical use, research purposes and for religious purposes pursuant to the free exercise of religion. The report informed Congress about severe deficiencies in the religious exemptions petition process for psilocybin mushrooms and other controlled substances, and its recommendations for better procedures in the religious exemption process.

The Government Accountability Office report was based on an investigation requested by the U.S. Congress in a statement accompanying the 2023 appropriations act. The investigation responded to concerns raised by numerous stakeholders regarding the timeliness of determinations, the clarity of the considerations for exemption, and the lack of direction provided to applicants about the information their petitions should include. The 2022 spending act report directed the investigation to determine the following:

Psilocybin Report. The Committee directs GAO to report to Congress within one year of the date of enactment of this Act on the barriers to State, local, and Tribal programs that incorporate psilocybin products, including for therapeutic use and religious, Indigenous, or spiritual practices. The report shall: (1) review the impact of Controlled Substances Act enforcement on psilocybin use legally sanctioned by States, local governments, and Tribes; (2) identify barriers to accessing therapeutic use of psilocybin in States that have made such use legal under State law; (3) recommend ways to improve the processes used to obtain Federal authorization to conduct research with psilocybin-related substances; and (4) identify barriers to legal access to and use of psilocybin for religious, Indigenous, or spiritual practices under the Religious Freedom Restoration Act.

The Government Accountability Office reviewed the use of psilocybin, data on enforcement, and barriers to the legal access and use of psilocybin for religious practices under the Religious Freedom Restoration Act of 1993.

The report detailed the DEA registration process for individuals and entities interested in working with Schedule I substances, like psilocybin, for study, which have inhibited research, including inspection, record keeping, inventory, storage, and disposal requirements for all manufacturers, distributors, researchers, practitioners, and pharmacists. It noted that numerous clinical studies are underway to investigate the benefits of synthetic psilocybin for depression, headaches, fibromyalgia, pain, substance use and eating disorders, obsessive-compulsive disorder, and post-traumatic stress disorder. The report suggested appropriate legislation to facilitate research. It noted that Expanded Access legislation is limited by requirements of review by the Food and Drug Administration and institutional review bords, and that Right to Try laws are not providing access to psilocybin, notwithstanding the breakthrough therapy designation granted to the Usona Institute’s clinical trials and those of Compass Pathways. It described several impediments to research including FDA, institutional, and state government approval requirements, and DEA authorization and oversight requirements.

The report noted that the DEA investigations of crimes involving psilocybin made up very few of the agency’s investigations, about three percent, or 24 out of 13,865 over a six-year period, and amounted to under two percent of the seizures of material.

The report concluded that it could not find evidence of any tribal nation in the United States with historical involvement with using psilocybin for sacramental practices. The Department of the Interior and the Bureau of Indian Affairs told investigators that to their knowledge, no federally-recognized tribes have legalized psilocybin for religious or spiritual purposes at this time. The report states that Government Accountability Office representatives reached out to eleven tribes about the issue and that one responded. (Report at 5–7).

The Religious Exemption Process of the DEA and Findings of Deficiency

The investigation relied for input on four organizations, officials from the Food and Drug Administration and the Drug Enforcement Administration, and nine individuals from law firms and advocacy organizations. The attorneys and advocates pointed out problems with timeframes, lack of clear guidance, burdensome information requirements, a perception of unreliability and communication problems affecting the DEA administrative exemption process. (Report at 36–37). Five of the nine did not believe that the DEA would be likely to grant exemptions for the religious use of psilocybin and expressed the view that the agency was skeptical of non-western religious beliefs. (Report at 42).

The report discussed the pathway for spiritual or religious use of controlled substances, and the Religious Freedom Restoration Act provisions which provide claims and defenses to protect against any federal government activity that places a substantial burden on a sincere religious belief. Upon such a showing, the burden of proof shifts to the government to demonstrate that its burdensome actions further a compelling governmental interest by the least restrictive means. (Government Accountability Office report at 29) (citing Gonzales v. O Centro Espirita Beneficente União do Vegetal, 546 U.S. 418 (2006), which upheld the right of practitioners in the branch of the União do Vegetal church in New Mexico to use ayahuasca as a sacrament under the free exercise of religion clause of the first amendment as revived by the Religious Freedom Restoration Act).

The report found that aspects of the DEA’s exemption review process, which purport to apply the Religious Freedom Restoration Act provisions, are unclear to petitioners. (Report at 35). The report found that the exemption process is overly burdensome and is missing explanations about what information is needed and standards for review.

The report discussed a 2009 DEA guidance document, which was updated in November 2020, for applications for religious exemptions from the Controlled Substances Act. The report found that the guidance does not define the considerations, standards or set time frames for making responses, and that there is no mechanism for status updates or final rulemaking procedures. (Report at 43). The report found that it is not clear what would be considered “sincerity,” especially where psilocybin has been used for a long time but there is not any documentation to show it was used. (Report at 37). “DEA’s guidance does not provide the standard the agency will use to assess ‘religious sincerity’ or other aspects of the application.” (Report at 37). The report gave an example of an investigative file showed confusion by the field agent because of this lack of clarity of what is a sufficient showing of belief system, structure, and practice to support a finding of sincerity. (Report at 37).

The report noted that from 2016 to January 2024, 24 petitions for religious exemption from the Controlled Substances Act had been filed under the Drug Enforcement Administration’s process, six for psilocybin, and as of January, the agency had not granted any religious exemptions. The Drug Enforcement Administration (DEA) had not acted on some exemption applications that had been pending for three to seven years.

There is a requirement of a case-by-case analysis for exemptions, and the agency may not simply rely on the Schedule I classification to support denial of exemptions. In the exemption procedure, the report noted, a sworn petition, preferably with supporting documents, is needed, and demonstrate that the application of the would be a substantial burden on the sincere exercise of religion (Report at 35). The petition for exemption is directed to the Diversion Control Division of the DEA. It may be submitted by email and may contain attached documents, a written statement and supporting information to show the burden on sincere exercise of religion. (Report at 35). The application must describe the nature of the religion, each practice associated with any use, possession, and manufacture, importation, exportation, dispensing, use, or possession of a controlled substance, its nature, and the amounts, conditions, and locations of each such transaction or interaction. (Report at 31–32).

The report stated that a certificate of registration is required before entering onto any activity with psychedelics like psilocybin, unless it is waived by the DEA. Id. at 32 (citing 21 C.F.R. § 1307.03). The attorney general may waive the registration requirement. (Report at 36). The petitioner “is required to abide by the Act and its regulations for the duration of the evaluation according to DEA guidance. (Report at 35). This means to comply with requirements that require not using controlled substances, or abstaining from consuming the church’s sacrament, during the application process. (Report at 36).

The report found that the agency had an indeterminate process with exemption requests, with examples of 24 requests over eight years from 2016 to 2024, with no exemptions granted. Three of the six exemption applications for psilocybin were withdrawn, one after waiting four years. (Report at 39). There were requests pending during the investigation for up to three years, and past unsuccessful applicants had waited almost five years and almost eight years. (Report at 38–39). The investigation received information that the DEA did not answer questions while the petition is pending, give updates or anticipated dates to anticipate its decisions, or identify local office contact personnel. (Report at 38).

The Diversion Control Division will return the application if it is incomplete, and applications will be considered withdrawn if the responses are not received withing 60 days. (Report at 36). The assistant administrator of the Diversion Control Division will give a response in writing, which the agency deems to be a final determination, for administrative law purposes, under 21 U.S.C. § 877, which would be reviewable in a federal court of appeals of the principal location of the petitioner within 30 days. (Report at 36).

One of the report’s observations about the DEA exemption process for religious organizations was that it was not guided by rulemaking and the agency never followed through on creating formal rules for the process. The agency’s Diversion Control Division had drafted a notice of proposed rulemaking in 2019 for RFRA exemption petitions and that in fall 2013 there was a unified agenda of regulatory actions that listed as a DEA priority to accommodate religious entities and to amend the application and hearing procedures, but that “DEA has no estimated for issuing the notice.” (Report at 33). There had been no activity since the draft notice in 2019, apparently, since the proposed rulemaking notice was reviewed by the Office of the Administrator. (Report at 44).

The DEA asserted that it followed consistent procedures for investigations, with on-site visits and interviews. When a petitioner invokes the exemption process, the report states that there will be an investigation that includes the background of the petitioner, and headquarters decides when the investigation is complete. (Report at 34–35). A field report will issue to the Diversion Control Division, which weighs the public interest and religious sincerity. The DEA examines the nature of the religion, its practices involving psychedelics as sacraments, its history, beliefs, structure, practices, membership, rituals, holidays, leadership, organizations, and other factors its investigators use to consider whether it is a sincere religion. (Report at 35–36). The division may order further investigation before issuing a decision whether to grant the petition. (Report at 33–34).

The DEA told the Government Accountability Office that it has “put in place processes aimed at reducing processing times” and that it was planning to streamline its process further and ensure consistency in approaching regulations. (Report at 42). Performance Audit concludes that the agency, “should more clearly communicate the types of information that the Religious Freedom Restoration Act petitioners should provide to allow DEA to evaluate petitions for religious sincerity.” It also states that the agency should “more clearly communicate the standards and relevant factors” when making its determinations, and “establish timeframes for DEA to make determinations on completed religious exemption petitions.” The report also urges the DEA to provide “information for petitioners to be able to receive updates on the agency’s process related to exemption reviews.”

The report states that the Government Accountability Office intends to measure progress toward meeting its four recommendations including timeframes for determining religious exemption claims, communicating what types of information are considered, disclosing the standards and factors for decision, and implementing a process for providing updates on the review process. Each of the four recommendations is attached to a status tracker. “When we confirm what actions the agency has taken in response to this recommendation,” the Government Accountability Office says, “we will provide updated information.”

It is very refreshing to see that the views of advocates have been taken into consideration as the recommendations were considered. The social change from the decriminalization and adult use programs with organic psilocybin have created some political pressure to have viable programs in place that are not purely prohibitionist.

Reflecting on the flaws in the process that led to the recommendations, an absence of rules, findings that reveal the need for a status tracker, and a pattern of rejections, it does not seem advisable to engage in the DEA administrative procedure for exemption from the Controlled Substances Act for religious and spiritual experience with psychedelics. Invoking the procedure would probably be a disadvantage for a meritorious applicant for religious exemption from the Controlled Substances Act for religious purposes. Moreover, the process is demanding, it requires discontinuing using the psychedelic sacrament and opens the organization to intrusive and burdensome record keeping for the DEA, far more than would be expected of mainstream religions. A party would be more likely to prevail by insisting on redress in federal court as a defense to enforcement and assert rights under the Religious Freedom Restoration Act with its right to judicial findings of fact and conclusion of law. Invoking the administrative process creates the implicit legal admission that it is a valid process, and gives the findings of the agency undue deference on appeal.