This article was originally published in Law360 on December 14, 2022 and is republished here with permission.
Ten years after Coloradans voted for their state to be one of the first to legalize recreational cannabis, Colorado is again making history as the second state in the country to legalize therapeutic psychedelics for adults.
With a growing body of scientific research evidencing the efficacy and safety of certain entheogens — better known as psychedelic plants and fungi — in psychotherapy to treat mental health conditions, such as depression, anxiety, post-traumatic stress disorder and suicidality, states and localities are beginning to take steps to allow their citizens safe access to psychedelics for therapeutic purpose.
For instance, in 2020, Oregon became the first state to regulate therapeutic psilocybin sessions for adults 21 and older in licensed, clinical settings through the Oregon Psilocybin Services Act. Oregon’s psilocybin program launches Jan. 2, 2023.
On the city level, in September, San Francisco joined the list of growing cities, including Ann Arbor, Michigan; Denver; Detroit; Oakland, California; Seattle; Washington, D.C., and others, to decriminalize the personal adult use of entheogens.
In November, Colorado voters approved Proposition 122 with nearly 54% of the votes, enacting the Natural Medicine Health Act of 2022.
The NMHA allows adults 21 and older access to supervised or facilitated therapeutic sessions using certain entheogens including psilocybin, psilocin, mescaline (excluding peyote), ibogaine and dimethyltryptamine, defined in the NMHA as natural medicines, that are administered and supervised by a licensed individual in state-approved settings — e.g., licensed healing centers, also known as natural medicines services.
The NMHA also decriminalized the personal use of natural medicines for adults 21 years and older. Personal use contemplates that adults may legally grow, gather and gift natural medicines. This broader decriminalization appears to recognize the ceremonial use of natural medicines by indigenous and other communities in Colorado.
Now that therapeutic psychedelics are legal in Colorado, what should be expected next? Below is a summary of key provisions of the NMHA, including dates and next steps as Colorado establishes the parameters of the regulated NMHA program.
Coloradans do not need a certain medical or mental health diagnosis to access natural medicine services. In fact, the NMHA does not mention a diagnosis in any capacity.
By Jan. 31, 2023, the Colorado Department of Regulatory Agencies must establish the Natural Medicine Advisory Board, and the governor, with the consent of the Colorado Senate, must appoint the initial 15 members to the board. The primary role of the board is to advise DORA as to implementation of the NMHA program.
DORA has until Jan. 1, 2024, to adopt rules and establish the qualifications, education and training requirements that facilitators must meet to obtain licensure to provide natural medicine services.
By Sept. 30, 2024, DORA must adopt rules to implement the NMHA program and begin accepting applications for licensure of facilitators, healing centers, entities to test natural medicines and any categories of licensure as determined by DORA. The NMHA does not include a residency requirement for licensure, but such requirement could be included in the rules.
An individual cannot have a financial interest in more than five healing centers. A healing center is an entity licensed by DORA to provide natural medicine services or products and supplies related to natural medicine services. Notably, “individual” is not defined in the NMHA, which suggests corporations may be excluded from this limitation.
DORA must develop and implement a public education campaign related to the use of natural medicine, which includes training for law enforcement, first responders, emergency medical services, social services and fire services.
DORA must also engage in a study of the regulation of dosage for off-site use of natural medicines and report findings to the state Legislature.
Localities cannot ban or prohibit licensed facilities from providing natural medicine services within their jurisdictions.
Employers are not required to permit or accommodate the use, consumption, possession, transfer, display, transportation or growing of natural medicines in the workplace.
From the launch of the NMHA program until June 1, 2026, natural medicines are limited to psilocybin and psilocin. After June 1, 2026, upon recommendation by the board, DORA may add one of more of the following to the types of natural medicine that can be provided under the NMHA program: dimethyltryptamine, Ibogaine and mescaline (excluding peyote).
Two things to watch for in the forthcoming rules and implementation of the NMHA program; (1) a focus on social equity and (2) access to natural medicine services.
Social Equity
Seemingly applying lessons learned from the rollout of the state’s cannabis programs, the NMHA expressly requires DORA to prioritize equity and inclusivity as it establishes rules to implement the NMHA program.
Specifically, DORA is required to adopt rules which: (1) establish procedures, policies and programs to ensure the NMHA program is equitable and inclusive; (2) promote the licensing of and provision of natural medicine services to:
- Persons from communities that have been disproportionally harmed by high rates of controlled substances, including cannabis;
- Persons who face barriers to access to health care;
- Persons who have traditional or indigenous history with natural medicines; and
- Persons who are veterans by, offering, at a minimum, reduced fees for licensure and training, incentivizing the provision of natural medicine services at a reduced cost to low income individuals, and incentivizing geographic and cultural diversity in licensing and the provision of and availability of natural medicine services.
In addition, DORA is prohibited from imposing unreasonable financial or logistical barriers that would prevent individuals with lower income from applying for a license. As mentioned above, an individual cannot own more than five licensed healing centers. DORA may define individual to include a corporation or other legal business entity, which would arguably level the playing field in this budding market.
Access to Natural Medicines
Scientific data is showing that natural medicines have the potential to be incredibly beneficial for those suffering from mental health conditions and other ailments. However, the cost of natural medicine services may limit or exclude the ability of those in our communities who need such services the most to access these medicines.
The NMHA requires that natural medicine services are administered on-site at a licensed facility by a licensed facilitator who must supervise the administration session. Depending upon the size of the dose, an individual may be at a licensed facility for hours.
The cost of the natural medicines themselves coupled with the cost of a facilitator administering and supervising the administration session could lead to natural medicine services being cost prohibitive for most.
DORA should consider this reality as it develops rules to implement the NMHA program. It is crucial that the state prioritizes creating a model that is safe and allows access to every individual who wants or needs natural medicine services, but also allows the therapeutic psychedelics industry to be successful.
As Colorado establishes the regulatory framework to implement the NMHA, and as scientific data continues to build that evidences the efficacy and safety of psychedelics in the treatment of mental health conditions and other ailments, we anticipate that some other states may introduce similar laws permitting regulated access to psychedelics in the near future.
