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September 5, 2024 by Arsalan Shah, PharmD, MBA

TL;DR

    1. The Natural Medicine Health Act (NMHA) legalizes the personal use and possession of natural psychedelics like psilocybin in Colorado and establishes licensed “healing centers” for guided psychedelic experiences.

    2. The Colorado Natural Medicine Advisory Board (NMAB) is finalizing regulations, including those outlined in SB23-290, which focus on licensing, safety, and equity provisions for the state’s emerging psychedelic therapy program.

    3. Colorado’s approach is more expansive and accessible than Oregon’s, with a focus on equity, streamlined licensing, and potential inclusion of other natural medicines in the future.

Colorado: Natural Medicine Health Act

Colorado has long been at the forefront of drug policy reform, and the passage of the Natural Medicine Health Act (NMHA) in 2022 marks a significant step forward in the regulation and therapeutic use of psychedelics. As the state approaches the full implementation of this landmark legislation, it’s worth exploring what the NMHA entails, recent developments, and what the future holds for regulated psychedelic therapy in Colorado.

What is the Natural Medicine Health Act?

The NMHA, approved by Colorado voters in November 2022, legalized the personal use and possession of certain natural psychedelics, such as psilocybin mushrooms, for individuals aged 21 and over. The act also established a framework for the creation of licensed “healing centers” where adults can undergo guided psychedelic experiences under the supervision of trained facilitators.

Recent Developments and Current State of Affairs

As of 2024, the Colorado Natural Medicine Advisory Board (NMAB) has been working diligently to finalize the regulations that will govern the state’s emerging psychedelic services industry. The NMAB is tasked with making recommendations on various aspects of the program, from the licensing and training of facilitators to the operational rules for healing centers. The board’s work is essential to ensure that the program is both effective and accessible, while also addressing concerns around safety and equity​.

A significant development was the passage of SB 23-290, a 70-page bill that builds upon the NMHA, adding details on licensing, safety protocols, and equity provisions. This bill has sparked both optimism and controversy, as stakeholders debate its implications for the future of psychedelic therapy in the state. The NMAB is also considering the inclusion of other natural medicines, such as mescaline and ibogaine, though psilocybin remains the primary focus as the state prepares for the program’s official launch on January 1, 2025​.

Key Aspects of the Program

The Colorado Department of Revenue’s (DOR) Natural Medicine Division released over 100 pages of final rules governing Natural Medicine Businesses, focusing on key areas to shape the program. These rules encompass various facets of the industry, from the establishment of license fees and types to the specific regulations for healing centers, cultivation, and product manufacturing.

License Types

Four primary facility licenses have been established: Regulated Natural Medicine Cultivation, Regulated Natural Medicine Product Manufacturing, Regulated Natural Medicine Testing Facility, and Healing Center. Owners and handlers of natural medicines also require individual licenses.

Facilitator Licensing and Training

Facilitators who guide psychedelic experiences must undergo a comprehensive training program. The NMAB has proposed a unified training curriculum, though facilitators can expand their scope of practice with additional licenses regulated by separate bodies, such as psychotherapy licenses​.The training is designed to ensure facilitators are equipped to manage a wide range of scenarios, from therapeutic sessions to more exploratory experiences.

Healing Centers

These centers will be the cornerstone of Colorado’s psychedelic services, providing a controlled environment where individuals can safely engage in psychedelic experiences. Healing centers will have to adhere to strict operational guidelines, including emergency protocols and the secure storage of natural medicines. Only psilocybin from Psilocybe cubensis sub-strains will be allowed in the initial phase, with the possibility of expanding to other natural medicines in the future.

Cultivation and Manufacturing

The rules outline a tiered approach to cultivation, with licenses catering to different scales of operation. Manufacturing licenses are necessary for producing regulated natural medicine products, with strict guidelines on what can be produced and how.

Product Testing and Safety

 All natural medicines used in healing centers must undergo third-party testing to ensure their safety and consistency. The program prohibits the use of any additives that could alter the potency or effects of the substances. This rigorous testing regime is intended to protect consumers and maintain the integrity of the therapy sessions​. Testing facilities are also permitted to operate alongside marijuana testing facilities, with plans to expand testing to personal use products in the future.

Equity Provisions

One of the key goals of the NMHA is to make psychedelic therapy accessible to a wide range of individuals, particularly those from marginalized communities. The NMAB is working on recommendations that would reduce barriers to entry, such as licensing fees, and provide support for individuals and communities historically excluded from healthcare opportunities.

Comparisions to the Oregon Model

Oregon was the first state to legalize and regulate psilocybin therapy with the passage of Measure 109 in 2020. While Colorado’s NMHA is similar in many respects, there are key differences. Colorado’s model is more expansive, potentially allowing for a wider range of natural medicines beyond psilocybin. Additionally, Colorado’s approach to facilitator training is designed to be more accessible, with tiered licensing that accommodates individuals with certain professional training & licenses.

Another significant distinction lies in the regulatory frameworks. While Oregon’s model has been criticized for its complexity and high costs, which some argue could limit accessibility, Colorado’s NMHA includes specific provisions aimed at avoiding these pitfalls. For instance, the NMAB is working on recommendations that would streamline the licensing process and reduce barriers to entry, particularly for communities historically marginalized in healthcare​.

Challenges and Controversies

Despite the optimism surrounding the NMHA, several challenges remain. The act has faced criticism from some for potentially paving the way for commercialization that could prioritize profit over public health. Moreover, the federal illegality of psychedelics continues to pose a significant risk, especially in terms of potential conflicts between state and federal law.

There are also ongoing debates about the role of indigenous practices and how they should be respected and integrated into the regulated system. Colorado’s approach to this issue, including the establishment of a Federally Recognized American Tribes and Indigenous Working Group, suggests a commitment to ensuring that indigenous voices are heard in the policymaking process.

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