California psychedelic therapy law could legalize medical use of psilocybin, MDMA, DMT, and mescaline

Senator Scott Wiener unveils therapeutic psychedelic bill in response to Governor Newsom's veto of 2023 decriminalization bill. SB 1012 could regulate medical use of five psychedelic drugs

*Updated Feb 7, 2024 with statements from Senator Wiener’s press release.

Early Tuesday morning, California lawmakers unveiled a bill called the Regulated Psychedelic-assisted Therapy Act (SB 1012).

Introduced by Senator Scott Wiener, the bill would legalize supervised, medical use of three psychedelic substances, including psilocybin, psilocin, and 3,4-methylenedioxymethamphetamine (MDMA). Regulators could later add dimethyltryptamine (DMT), mescaline (of non-peyote origin), and psilocybin mushroom-producing fungal spores or mycelia.

All products would be regulated by a new department, the Division of Regulated Psychedelic Substances Control, housed within the California Business, Consumer Services, and Housing Agency.

The division would adopt regulations for psilocybin, psilocin, and MDMA by January 1, 2026. At least two years later, in 2028, the division could adopt regulations for DMT, mescaline, and psilocybin mushroom-producing fungal spores and mycelium, if recommended by an advisory committee.

SB 1012 would create a nine-member professional licensing body, the Board of Regulated Psychedelic Facilitators, by April 1, 2025. It would operate alongside state medical, dental, veterinary, and other professional licensing bodies. The board would license and regulate psychedelic facilitators, who would have the lengthy title regulated psychedelic-assisted therapy facilitators.

Many terms defined by SB 1012 are preceded by the phrase regulated psychedelic-assisted therapy. Senator Wiener likely wants to distinguish this bill from his previous attempts to decriminalize psychedelics, through SB 58 and SB 519.

In September, both houses of the California Legislature approved Wiener’s SB 58, making it the first state legislature to enact a psychedelic decriminalization bill. Previously, decriminalization had only been approved by voter ballot initiative. However, Governor Gavin Newsom vetoed SB 58 in October.

According to Newsom, “California should immediately begin work to set up regulated treatment guidelines - replete with dosing information, therapeutic guidelines, rules to prevent against exploitation during guided treatments, and medical clearance of no underlying psychoses.” He said SB 58 “would decriminalize possession prior to these guidelines going into place, and I cannot sign it.”

SB 1012 delivers on Wiener’s promise to fulfill Newsom’s request for a medical framework. Compared to psychedelic laws of Oregon and Colorado, which legalize whole plants and fungi and exclude synthetic products, SB 1012 appears oriented toward pharmaceutical development. Initially, it would legalize only psychedelic chemicals rather than plants and fungi that produce them. It seems that only psilocybin mushroom-producing spores and mycelia could be added, but not before 2028, and their inclusion isn’t guaranteed.

Wiener’s bill would be the first to regulate the supervised use of MDMA. But it’s unclear where MDMA would be synthesize if SB 1012 is enacted. Two months ago, the California-based drug company Lykos Therapeutics (formerly known as MAPS PBA) submitted a new drug application to the Food and Drug Administration (FDA), seeking approval to market MDMA for treating post-traumatic stress disorder. Its proprietary formulation could receive FDA approval this year.

In addition to forming a new agency division and professional licensing board, Wiener’s SB 1012 would form a committee to advise these bodies on regulating MDMA and other substances.

Notably, SB 1012 is the first psychedelic law to address potential conflicts of interest among officials drafting industry rules. A board candidate is disqualified “if the person or the person’s immediate family owns an economic interest in a college, school, or institution engaged in regulated psychedelic-assisted therapy education. It defines “immediate family” as one’s spouse, domestic partner, parent, child, or child’s spouse or domestic partner.

This policy may be a response to undisclosed conflicts of interest in Oregon. In 2022, Tom Eckert resigned as chair of the Oregon Psilocybin Advisory Board when journalists alleged he was abusing his board position to make rules governing his psychedelic training business, and that of his romantic partner Rachel Aidan, who was CEO of the Synthesis Institute.

Though the addition of language regarding conflicts of interest is an improvement over Oregon and Colorado laws, SB 1012 overlooks the potential conflicts of advisory committee members. Further, the exclusions it raises focus only on economic interests in training programs, excluding other psychedelic businesses, such as product manufacturers, administration centers, and testing labs. Some members of Colorado’s natural medicine advisory board have such financial interests, which often go undisclosed.

How else does SB 1012 compare to the psychedelic programs of Oregon and Colorado? Wiener’s bill is a conglomeration of features from each state but appears more heavily influenced by Colorado’s Natural Medicine Health Act and Senate Bill 290, which overhauled the Act last year.

SB 1012 rejects the term clients adopted in Oregon in favor of participants as used in Colorado. Instead of service centers or healing centers, Wiener’s bill describes psychedelic-assisted therapy clinics or centers. Similar linguistic inconsistencies have caused confusion among regulators and advisory boards, and California’s addition of new terminology adds complexity.

Like Colorado’s law, SB 1012 creates the possibility for psychedelic administration at other approved locations, potentially including people’s homes, which is prohibited in Oregon. In theory, that could increase accessible for people with disabilities and those who have difficulty traveling to licensed facilities. However, the prospect of home administration has been a thorny issue for Colorado’s natural medicine advisory board, with some members pushing for heavy oversight or excluding it from the program.

Both Oregon and Colorado define psychedelic services to include three distinct sessions (preparation, administration, and integration). Colorado requires at least one integration session, where facilitators and participants meet to discuss participants’ psychedelic experience. Integration sessions are optional in Oregon and need only be offered by facilitators.

In addition to requiring integration, SB 1012 provides a more detailed definition of the process. In California, integration would consist of “counseling” provided by facilitators or others trained in “postpsychedelic support” to help participants “ground themselves and feel oriented, better understand their psychedelic experience, and apply insights from their experience to healthy behavioral change in their daily life.”

SB 1012 adds additional required elements to the definition of psychedelic services, including a safety screen prior to administration and follow up sessions. Follow ups are meetings between participants and facilitators up to 36 hours after administration “to assess well-being, screen for adverse reactions and, if needed, make referrals to needed care, additional psychosocial support, or other interventions.”

Compared to past legislation, Wiener’s bill includes unprecedented detail regarding data collection from participants. It describes expansive reporting of de-identified data to “comprehensively measure its success, safety, quality, impact on individuals’ well-being and public health, including adverse events experienced during, immediately after, or after the passage of time with information about substance, dosage, and other contextual information.”

I’ve previously described ethical and legal concerns regarding state-mandated data collection about substance use that remains federally illegal. Oregon’s psilocybin law originally included robust protections for client confidentiality. Under most circumstances, no client information could leave service centers. However, a 2023 legislative amendment allowed aggregated data reporting to the state, and subsequent rules required it for all clients. Reporting only limited, aggregated data provides some protection for clients. By comparison, the expansive reporting of de-identified data under Wiener’s bill is much riskier, with greater potential for clients to be re-identified. See Broken Promises of Privacy: Responding to the Surprising Failures of Anonymization on the shortcomings of de-identification, including the ease with which it is reversed.

Another key departure from Oregon’s law is SB 1012’s lack of boundaries between conventional healthcare and psychedelic services. Oregon prohibits medical use of psilocybin. Service centers and facilitators cannot make medical claims, they are prohibited from diagnosing or treating health conditions, and they cannot operate within licensed healthcare facilities. The New Approach PAC (New Approach), which commissioned its drafting, also wrote Colorado’s law, where it removed these limitations. This week, New Approach’s sister organization, the Healing Advocacy Fund, praised removal of the restrictions, which are absent from Wiener’s SB 1012 and a 2024 Massachusetts ballot initiative that is also supported by New Approach.

Blending psychedelics with conventional healthcare before their approval by the U.S. Food and Drug Administration (FDA) is a growing state-level trend. But it creates significant legal challenges for regulators, facilitators, and business operators. With FDA-approved psychedelics like MDMA and psilocybin on the horizon, laws like SB 1012 increasing put state-regulated psychedelics on a collision course with FDA.

There are others unresolved implications. Healthcare facilities that receive federal funding from Medicare or Medicaid prohibit Schedule I controlled substances like medical marijuana from their premises. They will likely do the same for psychedelics. Making therapeutic claims about psychedelics or advertising them as therapies likely violates the federal Food, Drug, and Cosmetic Act. In recent years, the FDA has sent many warning letters to cannabis product manufacturers making therapeutic claims.

Medical professionals licensed by the Drug Enforcement Administration (DEA) may be hesitant to enter state psychedelic industries out of fear of losing their licenses. In December the DEA warned Georgia pharmacies not to dispense medical marijuana. By making cannabis available through pharmacies, Georgia blends conventional healthcare with Schedule I controlled substances, more than any other state. Typically, medical professionals have little or no involvement with cannabis. But Georgia’s unconventional approach caught the DEA’s attention. The agency could find emerging state psychedelic laws equally problematic.

In addition to these legal complexities, the social benefits of supervised psychedelic use remain unclear. During the campaign to pass Oregon’s psychedelic law, supporters said it would address the state’s mental health crisis. However, after opening last summer, the program largely serves tourists from out of state. Few Oregonians can afford its high prices, which range from $1,500 to $3,500 for a single, standard dose of psilocybin. Many turn instead to unregulated, underground psychedelic markets.

SB 1012 makes similar promises. It says “California’s current approach to mental health has failed to fulfill its promise. Californians deserve more tools to address mental health issues.” In a Tuesday press release, Wiener wrote, “We know psychedelic therapy saves lives, and safe and controlled access to these innovative treatments will be transformative for so many Californians seeking relief from mental health and addiction challenges.” Can Wiener deliver on that promise? Will his proposal deliver transformative mental health change or primarily create a psychedelic tourism industry? Could it be financially viable, or would it become a financial burden on the state?

In addition to being cost prohibitive for clients, the economic future of Oregon’s psilocybin program is uncertain. Though promised as being self-sufficient by 2023, it cost Oregon taxpayers $3.1 million last year (in addition to millions spent on its two-year development period). California is a different, and much larger, market than Oregon. Nevertheless, important lessons could be learned from Oregon’s financial challenges.

Unlike the proposed Massachusetts program, which would implement a tax on psychedelic sales, SB 1012 would rely on revenue from business license fees and financial penalties assessed by regulators. A similar arrangement prompted the Oregon Health Authority to set license fees high, in hopes of covering its expenses. Service centers pay $10,000 a year and most facilitators pay $2,000. Due to these and other financial barriers, potential operators have abandoned their plans to enter the Oregon market (or gone out of business), reducing program revenue.

Other choices by the drafters of Oregon’s law left potential program revenue off the table. They chose to exempt facilitator training programs from annual licensing. Even a modest fee could have boosted program funds.

Like the original version of Colorado’s law, Wiener’s SB 1012 allows private donors to fund the state psychedelic program. That could help compensate for a budget shortfall, but it might also allow drug companies and other interested parties to make financial contributions, raising ethical concerns regarding a potential quid pro quo.

SB 1012 contains other unique features worth exploring further, and the bill will likely undergo significant change as it makes its way through legislative committees. Follow Psychedelic Week for more news regarding Senator Wiener’s therapeutic bill.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School and the Florida Bar Health Law Section Professor at the Florida State University College of Law. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.