Colorado Natural Medicine Advisory Bulletin #9: February/March 2024

By Vicente LLP, Psychedelic Alpha

Mar 20, 2024

Vicente LLP is proud to collaborate with Psychedelic Alpha—an independent newsletter and community in the field of psychedelics—on the Colorado Natural Medicine Health Act Tracker, which includes high-level statistics, anticipated recommendations, and regularly published Natural Medicine Advisory Bulletins. The bulletins will provide updates from Natural Medicine Advisory Board meetings, along with other important information related to the implementation of the NMHA and psychedelics reform in Colorado.

On February 16th, 2024, Colorado’s Natural Medicine Advisory Board (“NMAB”) met for its first look at draft rules based on recommendations the Board adopted in January. The Department of Regulatory Agencies (“DORA”) presented draft rules focused on facilitator licensing and training programs. It is important to note that these are draft rules and are not yet complete or official. Some topics – such as ethical rules, standards of practice, and disciplinary procedures are notably absent.

Even in their current form, these draft rules mark a significant milestone in the development of Colorado’s regulated natural medicine market, giving Coloradans the first glimpse into how regulatory agencies will implement the Natural Medicine Health Act approved by voters in November 2022. They also represent a leap forward for regulated psychedelics more broadly, providing a framework for integrating psychedelic healing into traditional healthcare systems by permitting medical and mental health professionals to incorporate psychedelic care in their existing practices. This framework is a significant improvement from that seen in Oregon, where psilocybin services and mental health care are separated by law.

During February’s meeting of the NMAB, Board members provided feedback on the draft rules. Based in part on feedback from the Board, DORA released an updated version of the rules on February 23rd. The rules were posted in conjunction with a notice of a Virtual Stakeholder Meeting, which took place on March 8, covered below.

For a 5-minute overview of the draft rules, read this high-level overview. For an in-depth breakdown with commentary from the Vicente, see this detailed breakdown.

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Natural Medicine Advisory Board: February 16th, 2024

Administratively, February’s meeting of the NMAB saw the introduction of a monthly consolidated subcommittee meeting. In this new schedule, subcommittees with outstanding recommendation needs will convene in a single meeting on the second Friday of each month to flesh out the details of the remaining subjects. The full NMAB will continue to meet on the 3rd Friday of each month, where the primary focus will be to review and give feedback on draft rule language from DOR and DORA. Topics awaiting recommendations from the Board include data collection and authorized locations other than healing centers where natural medicine services may be provided. State officials expect formal rulemaking to begin in May, a slightly later date than originally anticipated. Still, regulators are on track to meet their goal of effective rules by October 2024, ahead of the statutory deadline of December 31st, 2024.

The Natural Medicine Advisory Board will meet again on Friday, March 15th at 1pm MST.

Department of Revenue Listening Session #10: February 23rd, 2024

The Department of Revenue’s tenth Listening Session was designated as a “Catch-all” meeting to revisit subjects the Department felt needed additional information on and provide a final informal opportunity for the public to raise subjects the Department should consider prior to formal rulemaking. The meeting began with some administrative updates, with the biggest news coming in the reveal of the Department’s full public meeting schedule for the remainder of 2024. Formal rulemaking proceedings will begin on March 20th, when the Department will hold its first rulemaking working group. A total of eight working group sessions are scheduled through July 2024. The Department also introduced a new full-time Senior Policy Advisor, Amelia Myers.

The first agenda item for public comment was licensing and equity considerations. To guide the conversation, DOR provided the following prompts.

What kind of information should applicants be required to submit regarding financial interests?
What kind of information should applicants be required to submit regarding financial interests?
Is a tiered model for cultivation an appropriate strategy to proactively address concerns related to overproduction?
Are there any unique concerns or considerations to allowing a cultivation facility or manufacturing facility to co-locate with other license types (For example, occupational health and safety concerns).
Occupational Licensing: Should the Division consider incorporating any aspects of Oregon’s established framework for issuing worker permits? See Rule 475A.480
Equity Considerations: Should applicants for Natural Medicine Operation licenses be required to submit an Equity Impact Plan with initial and renewal applications? (For example: Outlining how the licensee will support equity and inclusion while avoiding commercialization and exploitation.)

Members of the public spoke in favor of worker permits generally, with several drawing comparisons to Oregon’s program and Colorado’s cannabis worker badges. Speakers urged the Department to be discerning in who is required to obtain a worker permit. A general consensus emerged that permit requirements should be limited to individuals who handle or have unrestricted access to natural medicine and not be broadly required for all employees of a licensed premises.

Most speakers supported allowing co-location of multiple natural medicine business licenses. Allowing cultivation to take place at a Healing Center would not only provide a unique opportunity for participants to connect with natural medicine, it would also reduce costs associated with transportation and simplify inventory tracking. This would be doubly beneficial, reducing costs to participants and potentially benefiting businesses, which are prevented from writing off expenses such as transportation under federal tax law. Co-location of a production facility would be less straightforward, particularly if the production facility is using flammable solvents to produce extractions, as some speakers advocated for.

Another important consideration related to licensing is the need for a flexible concept of Healing Centers. Commenters raised a range of scenarios that necessitate a nuanced approach, such as mental health practices that would like to offer natural medicine services only occasionally, properties that may host retreats only occasionally, and potential shared resources, such as bathrooms and office space.

On the subject of Equity Impact Plans, which would require licensed businesses to submit a plan describing how their operations will benefit the broader community, most speakers were in favor. Several speakers urged regulators to encourage licensed natural medicine businesses to engage in Indigenous reciprocity and benefit-sharing as part of an Equity Impact Plan. Additionally, some speakers supported publishing plans to increase public accountability.

Regarding equity more broadly, speakers voiced concerns that over-regulation and high costs to enter and remain in the market work against the broader idea of equity.

The subject of tiered production licenses elicited more divergent responses. Generally speaking, tiered production licenses restrict the amount of natural medicine that a licensee may produce. On one side of the debate are concerns about overproduction, which could lead to a race-to-the-bottom in pricing and create an unsustainable market for cultivators and producers. On the other hand, restricting production at the outset of the program could prevent the market from developing naturally and stifle innovation. With so many unknowns, such as what types and quantities of products facilitators and participants will ultimately prefer, limiting production at this point may be premature, according to some speakers. One suggestion, supported by several attendees, would be to bifurcate cultivation and production licenses into small and large-scale growers. Under this model, commercial-scale cultivation and production licenses would be limited, while small-scale licenses, such as those for single facilitators cultivating relatively small quantities of natural medicine, would be widely available. Such a model could also have positive equity impacts, potentially allowing a lower license fee for smaller cultivators.

The Department provided the following questions to guide discussion around inventory tracking:

What inventory tracking mechanisms used by other industries could serve as models for tracking regulated natural medicine?
At what point should regulated natural medicine be required to be tracked? (For example: from inoculation through administration vs. from harvest through administration).
How should the Division track any natural medicine that is ultimately not administered during an administration session? For example, how should licensees handle any natural medicine that is left after an administration session?

Here, the primary debate centered around when tracking should begin. Some members advocated the position that tracking should begin when a substrate produces mushroom fruits, as psilocybin production begins at that point. Supporters cited the fact that spores and liquid culture, which do not contain psilocybin and are currently sold openly, would be impossible and costly to track. There was a general consensus that the specific item to be tracked is consumable psilocybin, and any tracking program should be designed with that idea as a starting point. Testing and tracking non-consumable materials, such as spores, liquid cultures, and grain spawn, would be not only pointless but would drastically increase costs. One speaker urged the Department to clearly define the goals of an inventory tracking system as preventing consumer fraud. According to the speaker, preventing diversion is a fool’s errand given the unlimited cultivation allowed under the personal use aspects of law. Instead, regulators should ensure that participants receive accurate information about the products they are consuming in the regulated market.

Packaging and labeling requirements were not discussed much, though there was some discussion around testing as it relates to tracking. A few speakers concurred on the need to test individual batches for safety.

Though not specifically on the agenda, several meeting attendees raised the issue of microdosing, urging regulators to find a way to permit microdosing in the regulated market.

Department of Revenue Listening Session #11: March 4th, 2024

The Department of Revenue’s final Listening Session focused on explaining the requirement of the formal rulemaking process, as defined by the Colorado Administrative Procedure Act (“APA”). Generally, any rules promulgated by state regulatory agencies must 1) Be within the scope of the agency’s authority delegated by statute; 2) Comply with the formal requirements of the APA; and 3) Not violate the Colorado constitution or other statutory provisions.

The APA requires “early stakeholder feedback” from a “representative group of participants,” including opportunities for written and oral comment. To satisfy this requirement, the Department will host eight “Rulemaking Working Groups” in addition to the 11 Listening Sessions already conducted. These working groups will provide feedback on draft rules, which will be revised based on the groups’ feedback. Following the final work group meeting, a Notice of Permanent Rulemaking will be filed in the Colorado Register. This all-day meeting will be the final opportunity for public input on the Department’s proposed rules. The State Licensing Authority will then review the entire record, consisting of all listening sessions and work group meetings, related to each proposed rule. After reviewing the record, the SLA has 180 days to adopt, reject, or recommend changes to proposed rules. Adopted rules will be submitted to the Colorado Attorney General’s office for an opinion, which must be provided in 20 days. Rules are then submitted to the Office of Legislative Legal Counsel Rule Review to ensure compliance with the Colorado Constitution and statutes. Finally, rules are published in the Colorado Register and become effective 20 days from publication. The Department is currently targeting July 25th, 2024 for the Permanent Rulemaking Hearing.

After describing formal statutory rulemaking requirements, DOR officials moved to a more nuanced discussion of their rulemaking process. Under DOR’s guiding principles, rules should be transparent, systematic, operable, and defensible. The Department anticipates an iterative rulemaking process, beginning with mandatory rules the department is required to promulgate. Additionally, the Department will employ an open-forum style discussion in working group meetings. This is a departure from previous MED rulemaking meetings, in which certain stakeholders were designated as primary speakers. Instead, DOR will allow all working group members to participate, utilizing timekeeping tools to ensure discussion is fairly and evenly distributed. Those who wish to speak in a work group meeting must sign up via a form and will be limited to three minutes per comment, though multiple comments per meeting will be permitted.

The Department then invited partner agencies DORA and CDPHE to give updates on their anticipated rulemaking timelines. DORA Sr. Advisor on Natural Medicine Sam Bahrami briefly mentioned DORA’s upcoming Stakeholder Feedback Meeting (covered below) on March 8th. DORA is responsible for rules related to facilitator qualification, licensing, and training.

Heather Krug of CDPHE then described her department’s rulemaking timeline. CDPHE, which is responsible for establishing testing standards and laboratory certifications, anticipates a rulemaking hearing in October 2024. CDPHE will request a permanent rulemaking hearing following DOR’s work group sessions on testing and cultivation, as those sessions will inform CDPHE rules. Under this timeline, CDPHE testing and laboratory rules would be effective in December 2024. CDPHE is also constructing a website specific to their work related to the natural medicine program.

Department of Regulatory Agencies Stakeholder Engagement Meeting: March 8th, 2024

On Friday, March 8th, the Department of Regulatory Agencies (“DORA”) held its first Stakeholder Engagement meeting. This meeting marked the first opportunity for members of the general public to provide comments and feedback on draft rule language related to facilitator licensing and training. The most common feedback items included a need for clarity and specifics on accelerated licensure pathways, aversion to rules regarding physician clearance for certain participants, and the overarching need to allow group and residential facilitation.

Licensing

If sheer number of comments is any indicator, the public’s biggest concern is the overly restrictive and cost-imposing nature of a requirement that participants meeting certain risk factors receive clearance or referral by a medical professional before receiving natural medicine. Many members of the public, including several attorneys and medical professionals, urged DORA to forgo codifying a strict list of medical conditions in favor of a screening tool. Dr. John Treem, physician and founder of the Psychedelic Public Policy Partnership, noted that many of the conditions listed in the draft rules are not medically defined, which will lead to confusion for both participants and facilitators. Those conditions include “severe suicidal ideation”, “cardiovascular disease”, and “severe chronic illness.”

Quite a few speakers supported the inclusion of naturopathic doctors, who possess diagnosing and treating authority in Colorado, under the Clinical Facilitator framework. Fewer, though still a significant number, speakers supported including registered nurses (RNs). One member opposed the inclusion of RNs, claiming diagnosing and treating is outside the scope of that profession. In contrast, at least one speaker urged removing language restricting Clinical Facilitator licenses to professionals with “diagnosing and treating authority” from the rules completely, given that a Clinical Facilitator should not be diagnosing a participant for any conditions. One speaker requested that Recreational Therapists be included under the Clinical Facilitator framework.

Many speakers also questioned the inclusion of language requiring approval for patients taking psychotropic medications. In addition to the term “psychotropic” being overly broad, clinical research has shown little evidence of increased safety risks when natural medicine is combined with common medications, such as SSRIs. According to one speaker, current research has shown that SSRIs may blunt the effects of natural medicine, but has not demonstrated any safety concerns. It was, however, agreed that lithium is the only medication for which natural medicine is truly contraindicated. By requiring additional medical appointments, or seeing a Clinical Facilitator, for participants taking psychotropic medications (other than lithium), there will be no appreciable gain in safety and a significant increase in cost and barriers to access, according to one speaker.

Another oft-mentioned concern related to accelerated licensure pathways. Speakers requested clearer rules on educational equivalencies for other psychedelic-assisted modalities, training programs, and countries. Regarding legacy facilitators, several participants emphasized the need to ensure legacy facilitators have a clear, unambiguous pathway to licensure.

Additional Licenses

Several speakers spoke in favor of more flexibility in licensing. Multiple comments evidenced a desire for a category of licensure clearly directed to spiritual facilitation. One speaker suggested allowing some type of research license that would be available to university students and researchers interested in conducting research on natural medicine.

Training programs

The most frequent feedback related to training program rules was a concern that the rules favor larger, established educational institutions. Requirements such as governing bodies, multiple faculty members, and specific student resources could push non-profit, sole proprietors, and smaller training programs out of the market, according to many who spoke on the issue. Several commenters expressed concerns about the costs of training generally.

Education

Opinions diverged when it came to the educational aspect of facilitator training. Most members of the public in attendance voiced support for the current 150-hour curriculum. Some even favored an increase, citing the gravity of facilitation work as requiring robust training. The alternative view, that the current hour requirement is too high, was in the minority. Supporters of this position generally felt that the curriculum as drafted is too costly and that facilitation can be taught effectively in less time. Suggested additions to the curriculum included training on microdosing, harm reduction, business management, group facilitation, and the interaction of natural medicine with a woman’s menstrual cycle. One commenter expressed concern that certain concepts in the current curriculum could be viewed as religious, and thus not appropriate for state-mandated education. Additional suggestions included separating training on Colorado natural medicine rules from ethical training and making that component available online at no cost.

Practicum

Suggested modifications to the 40-hour practicum requirement included removing language suggesting a practicum consist of 5-6 administration sessions, adding a requirement that some amount of practicum hours be met through preparation and integration sessions, and adding a requirement that some hours be met by co-facilitating or assisting in facilitation. Nearly all comments related to practicum changes came from associates of Naropa University.

Indigenous Concerns

At a high level, many speakers voiced concern that Indigenous communities should be consulted and considered more in the rules the state is drafting. Specifically, speakers suggested that DORA actively solicit input from Indigenous communities, and that Indigenous Distinguished Educators be permitted to provide an ethical attestation or evidence in lieu of the 25-hour ethical training requirement. Several speakers expressed concern that the spirit of natural medicines may be offended if the rules do not adequately respect and honor indigenous wisdom and traditions and guard against exploitative, extractive, and commercializing practices.

Members of the public also expressed some general concerns to DORA officials. One commenter emphasized the need to consider the effects of rules as they may impact rural communities. Another commenter questioned whether the state plans to address a growing market that is operating under the exemptions allowing remuneration for “bona fide harm reduction and support services” allowed under the personal use provisions of the Natural Medicine Health Act. According to this commenter, this market ranges from small-time facilitators to large-scale luxury retreats.

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As formal rulemaking approaches, there will be increasing opportunities for public engagement. Stay tuned to our Natural Medicine Advisory Bulletin for the latest news on Colorado’s natural medicine program, as well as upcoming opportunities to get involved.

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Psychedelic Alpha's Colorado Natural Medicine Health Act Tracker webpage and bulletins are dedicated to being a clearinghouse for the implementation of Colorado’s Natural Medicine Health Act, with a focus on the work of the Natural Medicine Advisory Board and its subcommittees.

Read the Natural Medicine Advisory Bulletin #1: Background

Read the Natural Medicine Advisory Bulletin #2: July 2023

Read the Natural Medicine Advisory Bulletin #3: August 2023

Read the Natural Medicine Advisory Bulletin #4: September 2023

Read the Natural Medicine Advisory Bulletin #5: October 2023

Read the Natural Medicine Advisory Bulletin #6: November 2023

Read the Natural Medicine Advisory Bulletin #7: December 2023

Read the Natural Medicine Advisory Bulletin #8: January 2024

Read the Natural Medicine Advisory Bulletin #8.1: Recommendation Round-Up

View the Colorado Natural Medicine Health Act Tracker webpage

View the Colorado Natural Medicine Advisory Bulletin webpage