Oregon Legalized Supported Adult Use of Psilocybin, Not Psychedelic Assisted Therapy
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Oregon Legalized Supported Adult Use of Psilocybin, Not Psychedelic Assisted Therapy
Under Oregon law, psilocybin providers cannot diagnose or treat health conditions, make medical claims, operate within healthcare facilities, or exercise the privileges of licensed health professions
During the 2020 presidential election, over fifty-five percent of Oregon voters approved Measure 109, also called the Oregon Psilocybin Services Act. With this historic vote, Oregon became the first state to legalize the production, sale, and supervised administration of psilocybin, a psychedelic substance produced by over 200 species of fungi.
Passing Measure 109 triggered a two-year development period that started in January of 2021. Governor Kate Brown appointed members to the Oregon Psilocybin Advisory Board. Over the following year, the board made recommendations for regulating the statewide psilocybin industry. Based on those suggestions, the Oregon Health Authority (OHA), the governing state agency, published final rules on December 27, 2022.
On January 2, 2023, the OHA started accepting licensing applications from businesses and individuals hoping to work in the psilocybin industry. Last Friday, the agency issued the first psilocybin service center license to a business called EPIC Healing Eugene, in Eugene, Oregon. The company will start hosting psilocybin sessions in June.
Despite having been approved by voters over two years ago, Measure 109 generates considerable confusion among experts, the media, and the public. Journalists often report that Oregon legalized psilocybin assisted therapy or the sale of magic mushrooms for medical use. But that’s not the case.
Measure 109’s approach is best described as supported adult use rather than medical use or psychedelic assisted therapy (medical use and supported adult use are two different varieties of psychedelic law emerging across the country).
Starting this summer, adults aged 21 and older will be permitted to consume psilocybin with support from trained professionals called facilitators. Though they will be licensed to administer psilocybin, under Oregon law, facilitators cannot act as healthcare providers, and supported adult use cannot constitute therapy or medical care.
To emphasize these distinctions, Measure 109 calls people who receive psilocybin clients instead of patients. The services they receive are defined as psilocybin services instead of therapy, and the professionals who provide them are called facilitators rather than therapists. When facilitators obtain informed consent from clients to provide psilocybin services, the required informed consent document requires them to acknowledge that those services “are not a medical or clinical treatment” (See 333-333-5040(1)(2), Informed Consent).
Under Oregon law, psilocybin service centers cannot operate within healthcare facilities (See 333-333-4300(2)(f), Licensed Premises Location Requirements). Facilitators are prohibited from diagnosing or treating health conditions (See 333-333-5130(1), Facilitator Scope of Practice). In fact, under a section of the law titled Dishonest Conduct, facilitators are barred from making health-related claims (See 333-333-6040(c), Dishonest Conduct).
If facilitators hold professional licenses in fields like nursing or medicine, they cannot exercise the privileges of those licenses while providing psilocybin services (See 333-333-5130(2), Facilitator Scope of Practice). Oregon law defines those services broadly to include three stages.
Preparatory sessions are intended to prepare clients for their psilocybin experiences, which can be emotionally challenging and may pose other risks. Administration sessions provide psilocybin under facilitator supervision. Integration sessions help clients process or “integrate” their experiences.
The law’s broad conception of psilocybin services, and the prohibition on practicing the privileges of other healthcare licenses while providing them, means psychiatrists and psychotherapists cannot provide psychoanalysis or cognitive behavior therapy alongside psilocybin, even during regulated preparatory or integration sessions.
Despite clear distinctions between Oregon’s psilocybin services and medical care, some people and organizations repeatedly give the false impression that the services established by Measure 109 are therapeutic. In some cases, one might attribute their statements to honest confusion. Conflicting public narratives can make it difficult to discern the truth. However, some actors misrepresenting the program surely know better, and they have no excuse for misleading the public.
The Healing Advocacy Fund, a lobbying firm that influences psilocybin programs throughout the country, is one of the worst offenders. Despite the non-therapeutic nature of the program, the Fund’s website liberally uses the term psilocybin therapy. Its homepage states, “[f]or those struggling to heal from depression, anxiety or substance use disorder, psilocybin therapy can offer hope.”
Farther down the page, an infographic says, “[i]n 2020, Oregon voters approved the nation’s first psilocybin therapy program. In 2023, Oregonians suffering from depression, anxiety or addiction[,] or approaching end of their life will gain access to this ‘breakthrough therapy’ demonstrated to provide healing and hope.”
The Healing Advocacy Fund’s Executive Director Sam Chapman did not respond to Psychedelic Week’s request for comment on his organization’s framing of Oregon’s psilocybin program. State Senator Elizabeth Steiner makes similar representations.
A family medicine physician employed by Oregon Health Science University (OHSU), Steiner worked with Chapman on the campaign to pass Measure 109. This spring, she invited Chapman to testify alongside her in support of her psychedelic data collection bill, SB 303.
During testimony before the Oregon legislature, Steiner and Chapman represented Oregon’s psilocybin services as medical or therapeutic. Based on these and other portrayals, journalists have perpetuated the false narrative that Oregon legalized magic mushrooms for therapeutic use.
Steiner responded to Psychedelic Week’s request for comment by referring me to Tess Sager, Communications Director for the Oregon Senate. I asked Sager about Steiner’s choice to frame psilocybin services as therapeutic. Sager asked me to point out sections of Oregon law that prohibit psilocybin’s therapeutics use. When I cited Health Authority Regulations from Chapter 333, Division 333 (Sections 4300, 5040, 5130, and 6040), Sager did not respond.
In addition to lobbyists and politicians, businesses may contribute to the mischaracterization of psilocybin services. Tom Eckert helped draft Measure 109 and formerly served as Chair of the Oregon Psilocybin Advisory Board. In March 2021, Eckert founded a company called InnerTrek to train aspiring facilitators. Innertrek’s website described its training as preparation for “Oregon’s newly legal psilocybin therapy and wellness framework.”
Psychedelic Week spoke with Nathan Howard, the company’s Director of Operations. To InnerTrek’s credit, Howard expressed concern regarding mischaracterizations of Oregon’s program. “We're trying to remove language where we've erroneously referred to Psilocybin Services as psilocybin therapy, since the session itself cannot and should not contain therapy,” said Howard.
Howard explained further that when he and others have referred to psilocybin services as therapy, it has largely been out of convenience rather than malice. At the close of our email conversation, Howard double checked to ensure that all traces of the term psilocybin therapy had been scrubbed from InnerTrek’s website.
One might wonder whether any of this matters. Who cares whether psilocybin centers describe their programs as services or therapy? The distinction is far more than semantic.
Perhaps most importantly, in addition to being illegal under state and federal law, misidentifying one’s services as therapeutic gives clients the wrong impression. They might believe they are being treated for medical conditions, with a substance approved by the Food and Drug Administration (FDA), when in fact they are not. Such misrepresentations undermine client autonomy—If clients don’t fully understand what they are consenting to, then they cannot provide fully informed consent.
According to InnerTrek’s Howard, “we should be moving away from using [the term] psilocybin therapy as a community - and are trying to as a school - because it can distort expectations, be confusing, and in the session itself, is absolutely not what practitioners are doing or should be doing . . . the words are important because they begin to shape the expectations of prospective clients.”
In addition to being illegal and potentially harmful, framing Oregon’s services as therapeutic may jeopardize the entire program. If psilocybin businesses market their products and services as therapies, they could violate the federal Food Drug and Cosmetic Act (FD&C Act), which prohibits making false medical claims. Recently, the FDA relied on the FD&C Act to issue warning letters to companies allegedly making false claims about a substance called kratom.
According to an FDA warning letter dated June 22, 2022, the agency accused a company called Kratom Exchange of violating the FD&C Act by making false medical claims. According to the FDA letter, “[y]ou market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal.” The same concerns apply to companies that market psilocybin products and services as unapproved therapies in Oregon.
The FDA’s warning letter highlights statements made on the Kratom Exchange website, which resemble those of the Healing Advocacy Fund homepage, such as “[k]ratom can help with opioid addiction during winter,” and “a wide range of users that suffer from depression have reported that it helps their anxiety and depression.” The agency warned Kratom Exchange to cease and desist, stating, “[f]ailure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.”
Some people in Oregon’s emerging psilocybin industry believe the federal government is not interested in the program. They point to a perceived lack of federal intervention in state cannabis markets. However, in the past few years, the FDA has sent similar warning letters to numerous companies, including those that market cannabidiol (CBD) and other cannabis products, such as Delta-8 THC. In 2022 alone, the agency sent thirty warning letters to companies that market CBD-related products.
By framing Oregon psilocybin services as therapeutic, Chapman, Steiner, and the Healing Advocacy Fund threaten psilocybin clients, businesses, and the entire statewide program. Because they declined to comment for this story, one can only speculate regarding their motivations.
It appears that Steiner chooses to frame Oregon’s services as therapeutic to generate support for her data collection bill, SB 303, through which she hopes her employer OHSU can analyze the outcomes of psilocybin services. At a hearing before the Senate Committee on Healthcare on February 27, Steiner claimed that service centers will provide psilocybin therapy to clients. “Soon, sometime this year, we will see these service centers opening their doors for clients who want to pursue this as a possible therapy,” said Steiner. “We will only know whether psilocybin therapy is effective in the real world if we track the kinds of data that were outlined for you here.”
Committee Chair Deb Patterson asked Steiner whether her data collection bill was intended to measure the effectiveness of psilocybin in treating specific health conditions. Steiner responded with an emphatic, “yes.”
How can Steiner so confidently misrepresent Oregon’s psilocybin services before state lawmakers? She likely feels obligated to describe the services as therapeutic to support her narrative that widespread data collection is necessary to determine the effectiveness of those services. If the truth is revealed that the services are non-therapeutic, then her bill is less justified.
“We want to be able to use that information [the data collected under SB 303] to see whether these experimental drugs are actually useful for people in treating these very hard to treat conditions,” Steiner told Patterson. “So, it’s very important, that if we care about using psilocybin as a therapeutic intervention, that we have the ability to track whether it is actually working.”
Steiner might also be influenced by Chapman, whose motivations are less clear. More than anyone, Chapman is aware that Oregon’s services are non-therapeutic by law. Yet he continues to make statements that mislead the media and aspiring business owners and clients.
If Steiner and Chapman’s statements were made by psilocybin facilitators or service center operators, they would violate state law, jeopardizing their psilocybin business licenses. They might also violate the FD&C Act, warranting FDA intervention.
One might wonder why anyone would pay for non-therapeutic psilocybin services. Like many practices that fall outside of healthcare—such as yoga, massage, and meditation—psilocybin services could be used as an adjunct to medical treatment and a healthy lifestyle to promote physical and mental wellness. Clients might also utilize psilocybin for personal, creative, or spiritual growth.
There’s nothing wrong with receiving psilocybin services in hopes that they might elevate one’s mood or alleviate symptoms of anxiety or addiction. However, it’s a different matter to approach them with this expectation. Moreover, lobbyists, politicians, and businesses should not describe Oregon’s program as something it is not—medical or therapeutic—to achieve their own ends.
When Oregon voters passed Measure 109, they did not legalize psilocybin-assisted therapy, and psilocybin facilitators are not medical researchers, psychiatrists, or therapists. Instead, Oregon’s supported adult use model offers something new and different, which draws upon Western science and traditional knowledge. One benefit of supported adult use as a regulatory approach is its flexibility. In Oregon, a variety of individuals can train to become psilocybin facilitators, including life coaches, artists, and clergy members. Healthcare providers can also participate if they leave their medical licenses at the door.
Misrepresenting the program jeopardizes this bold experiment, endangering clients and businesses. Time will tell what cost Oregonians will pay for these misrepresentations. It could be with their livelihood, and in the worst cases, their health.
*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 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.
Oregon Legalized Supported Adult Use of Psilocybin, Not Psychedelic Assisted Therapy
10/10.
Fantastic research to hold the emerging industry accountable. Thank you