Colorado Natural Medicine Advisory Bulletin #1: Background

By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha

Aug 14, 2023

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.

What is the Natural Medicine Advisory Board?

The Natural Medicine Advisory Board (NMAB), established under Colorado’s Natural Medicine Health Act (NMHA), consists of 15 members who offer their expertise (and opinions) to the state rulemaking agencies tasked with implementing the NMHA.

These members bring a wide range of knowledge, covering areas such as indigenous and religious use of natural medicine, cultivation, licensing, public health, drug policy, mental health, emergency services, harm reduction, healthcare insurance, criminal justice reform, and veterans’ issues. The board’s primary task is to make recommendations to the state regarding public health, education, efficacy, cultural responsibility, training and licensing requirements for facilitators, equitable access, regulatory frameworks, data collection and reporting, and the addition of other types of natural medicine to the Regulated Access Program.1

Other responsibilities of the board include regularly reviewing new data and research into natural medicines to make recommendations to the state legislature regarding insurance coverage of natural medicines for the treatment of mental health conditions; regularly reviewing sustainability issues related to natural medicines; and publication of an annual report describing the board’s activities.2

The NMAB was appointed by the Governor and confirmed by the Senate. The official list of NMAB members can be found on the Department of Regulatory Agencies’ website here, and additional background on the NAMB members can be found in this Denver Post article.  

How Does the Board Work?

It is important to note that the NMAB does not directly create the rules governing natural medicine access. Instead, its role is to recommend rules to the Department of Regulatory Agencies (“DORA”) and the Department of Revenue (DOR).

To effectively address the complex questions faced by state regulators, the NMAB divided its work into six subcommittees, each focusing on specific areas of expertise. These subcommittees rely on their own knowledge, outside experts, and community stakeholders to answer questions and provide recommendations to the full board. Originally, the subcommittees only had members of the NMAB on them. However, a number of non-voting members have recently been added to the subcommittees. Following the creation of the subcommittees, DORA provided a list of questions for each subcommittee to address. These questions can be found here.

Having prioritized the questions in their purview and identified knowledge gaps, the six subcommittees have started hearing testimony from guests with additional expertise. From here the subcommittees will adopt recommendations on rules to present to the full NMAB. Recommendations made by the NMAB regarding facilitator licensing will go to the Director of the Division of Professional Occupations within DORA. Recommendations around businesses involved in cultivation, production, testing, or healing center facilities will go to the State Licensing Authority (“SLA”) within DOR.

From there, rules adopted by the Director or the SLA enter the official Colorado rulemaking process. This process requires state agencies to file a Notice of Proposed Rulemaking in the Colorado Register which “shall state the time, place, and nature of public rule-making proceedings that shall not be held less than twenty days after such publication, the authority under which the rule is proposed, and either the terms or the substance of the proposed rule or a description of the subjects and issues involved.”3 While the NMAB no longer has a statutory deadline to make recommendations, state agencies must promulgate rules in time to begin granting licenses for regulated natural medicine businesses by December 31, 2024.

Until now there has been little opportunity for the public at large to participate in the activities of the board. While all meetings are freely accessible via Zoom, the public is not welcome to participate unless directly asked. Further, the board and its subcommittees will sometimes enter closed-door executive sessions to discuss sensitive or confidential topics. Additionally, all NMAB members had to sign a code of conduct that limits their ability to speak with members of the public about NAMB business. This code of conduct has frustrated some members of the press.

Notably, questions from board members about public involvement and the level of contact permissible between members were discussed outside of the public view. Although meetings can be viewed by the public, to date the meetings have not been recorded. Staff from the Department of Regulatory Agencies have indicated meetings may be recorded in the future, but the department has yet to make a firm commitment.

At this stage in the process, the NMAB subcommittees are hearing testimony from community stakeholders and subject-matter experts related to their priority questions and focus areas. To participate in one of these subcommittees or request to testify to a subcommittee, use this form. To sign up for updates on the official rulemaking process, including notices of public hearings, use this form.

What Has the Board Done So Far?

Beginning in April, the board has met in full three times, with subcommittees having met a total of 30 times as of July 11th. Full board meetings have been mostly administrative with the actual details of implementation being hashed out in subcommittees.

What Are the Board's Subcommittees?

Products, Research, and Data

Voting NMAB Members:  Dr. Bradley Connor, PhD, Councilmember Skippy Mesirow, Lundy, MA, LPC; Billy Wynne, JD, Dr. Sue Sisley, MD

Non-Voting NMAB Members: None

Non-Voting Participants:

  • Scott Hansen (Lab Director, Ajna Labs)
  • Duncan Mackie (Researcher, Bud & Mary’s)
  • Nathan Wilkes (Public Health & Data Expert)
  • Ken Kassenbrock, MD, PhD (Former professor of Mycology)
  • Peter Hendricks (UAB Professor & Researcher)
  • Daniel Storey (CEO, CDMC Labs)
  • Emily Friesiger (Mycologist)
  • Hamilton Pevec (Business Owner)

Prioritized Questions

This subcommittee addresses questions {link to questions} related to natural medicine cultivation, manufacturing of natural medicine products, and outcome analysis. Consumer safety, regulatory workability, and innovation in natural medicine products are key considerations. Here the subcommittee is taking cues both from Oregon’s Psilocybin Services rules and Colorado’s Marijuana Enforcement Division around additives and adulterants for natural medicine and natural medicine products. To aid in the process, the subcommittee has invited guests from a psilocybin extraction company, Colorado’s Marijuana Enforcement Division, and a mushroom cultivation company. To date, eight non-voting participants have joined the subcommittee on an ongoing basis to present perspectives from industry stakeholders, including companies that intend to cultivate, test, and produce natural medicine products. Recommendations from this subcommittee may bear on traditional methods of consuming natural medicine, such as cacao and brewed teas, as well as the creation of a new industry of natural medicine products. It remains to be determined which activities will require a production license.

During the June 28th meeting, the group unofficially decided to recommend that cultivated natural medicine be limited to Psilocybe cubensis and sub-strains of the species. They are also poised to recommend against an in-house testing requirement for cultivators and producers.

During the same meeting, the group uncovered several ambiguities in the law that potentially affect their course of action. Chief among them—what are the limits of extraction and modification of psilocybin under SB23-290? Does preparing natural medicine in a smoothie or drink mixture require a production license? Is there any scenario in which natural medicine products may be consumed outside of the supervision of licensed facilitators? This last question highlights a unique challenge for the NMAB—any given recommendation may change based on other rules that have yet to be determined. In this case, SB23-290 restricts the amount of natural medicine that healing centers may transfer to a participant to an amount determined by the SLA while also allowing the SLA to make exemptions to that amount.4 Despite the intention of the campaign and state lawmakers to clearly only permit the use natural medicine under the supervision of a licensed facilitator, the subcommittee felt there might be a possibility that a participant may bring natural medicine products home with them. Any recommendation about packaging of products hinges on whether or not the product may find its way outside of a healing center.

Indigenous and Religious Use and Outreach

Voting NMAB Members Dr. Clarissa Pinkola-Estés, Skippy Mesirow, Ricardo Baca, Dr. Tina Gonzalez, Dr. Sofia Chavez

Non-voting NMAB Members: None

Prioritized Questions

Chaired by Dr. Clarissa Pinkola-Estes, this subcommittee focuses on defining Indigenous, religious, and spiritual uses within legal boundaries. It also looks to protect against commercialization and safeguard Indigenous practices while preventing exploitation. So far, the group has taken expansive views of Indigenous, religious, and spiritual groups. As of the June 13th meeting, the subcommittee has developed the following working definitions:

Indigenous Use
Natural Medicine traditions referring to a distinct culture, society, or people’s practice of natural medicines. Groups and individuals who practice traditional ancestral medicines. This comprises medicinal aspects of traditional knowledge that developed over generations in various societies, including indigenous people, before the era of modern medicine.

Religious Use
Organized religious group practice under the care, protection and ethical oversight of a recognized religious group to support the deepening of existing teaching in that tradition.

Spiritual Use
Personal and/or group practice oriented towards cultivating connection and unification with self, others, and environment.

To inform this work, the group recently heard testimony from representatives of The Church of the Eagle and the Condor, a group with indigenous roots practicing the use of natural medicines. The subcommittee also heard from a student of the Shipibo Ayahuasca tradition. One big-picture concern for this group is avoiding the detrimental commercialization of natural medicine and the cultures traditionally associated. Another large problem is balancing the protection of Indigenous, religious, and spiritual uses while guarding against bad actors attempting to claim those protections.

Distinct from this subcommittee is the Federally Recognized American Tribes and Indigenous Community Working Group created by SB23-290. The working group is directed by law to advise the NMAB and DORA on issues such as avoiding misappropriation and exploitation of natural medicine, conservation, and communication with federally recognized tribes.5 The Indigenous Community Working Group is still under formation, and it remains to be seen how the two groups will overlap.

Emergency Response, Safety, and Ethics

Voting NMAB Members: William Dunn, Dr. Josh Goodwin, Dr. Bradley Connor, Dr. Alisa Hannum, Sheriff David Lucero, Dr. Clarissa Pinkola Estés

Non-voting NMAB Members: None

Prioritized Questions

Ensuring the safety of individuals consuming natural medicine through the regulated access program is the primary concern of this subcommittee. This includes facilities regulations for healing centers where natural medicine will be administered, ethics and disclosure requirements for both clients and healing centers, safety plans, and how emergency services should respond to emergencies arising within the context of natural medicine administration. Thus far the subcommittee has leaned heavily on Oregon Health Authority’s (OHA) rules for psilocybin service centers, which track closely with Colorado’s psilocybin healing centers. The group has even directly adopted (unofficially at this point) some language from OHA for recommendation to Colorado regulators. While the subcommittee has yet to adopt any recommendations by official motion, they have indicated that they will recommend Emergency Services be activated for any call coming from a healing center.

As part of the June 14th meeting, the subcommittee identified significant overlap with Harm Reduction and Public Safety. The NMAB will consider merging the two in July 2023.

Harm Reduction and Public Safety

Members: Will Dunn, Sheriff David Lucero, Ricardo Baca, Dr. Tina Gonzales, Dr. Clarissa Pinkola Estés

Non-voting NMAB Members: None

Prioritized Questions

This subcommittee aims to provide accurate information on natural medicine risks and promote harm reduction. This includes education for first responders, packaging and labeling requirements for natural medicine products, health and safety information that must be disclosed prior to the administration of natural medicine, and rules regulating the behavior of licensed facilitators administering natural medicine. The subcommittee’s top priority is developing a harm reduction training curriculum for EMS and law enforcement. On June 9th the group heard from Sara Gael, a harm reduction officer with MAPS who has been working with Denver PD and the Denver Psilocybin Task Force on just such a curriculum. The subcommittee intends to use that training as a basis for any state-wide harm reduction training for first responders.

Secondary questions the group has yet to address include what information will be required on the packaging of natural medicine products and what kind of marking will be required on natural medicine-containing products for identification.

Public Health and Health Equity

Members: Lundy, Billy Wynne, Dr. Tina Gonzales, Dr. Joshua Goodwin, Commissioner Wendy Buxton-Andrade

Non-voting NMAB Members: Dr. Clarissa Pinkola-Estes

Non-voting Participants:

  • Jon Treem, MD – UCHealth Palliative Care
  • Melissa Palmer – LCSW, ACHP-SW, APHSW-C, JD, CU Anschutz
  • Pablo Otaola – Founder of Thriving Culture, DEI expert
  • Gillian Jones – Veteran, Neurologist
  • Victor Cabral – Director of Policy and Regulatory Affairs at Fluence, MSW, LSW, CCTP-I
  • Liana Gillooly – Strategic Initiatives Officer, MAPS

Prioritized Questions

Focused on equity, this subcommittee aims to ensure fair licensing and access to natural medicine services. They explore recommendations to increase equity, potentially through subsidies or funding from the state. Efforts are also underway to integrate natural medicine services into the state’s Medicaid program.

After a first phase of prioritizing questions and defining their scope in May, the subcommittee turned to developing a definition of Health Equity to guide their work. Armed with a working definition of health equity, the group has been exploring programs the NMAB could recommend to increase equity in licensing and access. On the licensing front, the subcommittee heard from Colorado’s Cannabis Business Office on social equity initiatives in the regulated cannabis market during the June 15th meeting. A major obstacle to standing up equity-increasing programs in licensing is the statutory requirement that licensing fees reflect the direct cost of administering the natural medicine market. In practice that puts common equity-increasing initiatives, such as subsidizing some licenses with the fees from others, off-limits to the NMAB. Undeterred, the subcommittee is now exploring initiatives that can be built out and ready to be implemented as soon as the natural medicine market goes live. The group will also consider making recommendations to the general assembly to appropriate funding for equity programs.

In regard to equity in access, the cost of natural medicine services looms as the largest barrier. On this front, the subcommittee is gearing up to make the case for coverage of natural medicine services by Health First Colorado, the state’s Medicaid program. The subcommittee plans to meet with representatives from Colorado’s Department of Health Care Policy and Financing, which oversees the program, in the coming weeks.

Qualifications, Licensing, and Training

Voting NMAB Members: Dr. Alisa Hannum, Lundy, Dr. Clarissa Pinkola Estés, Dr. Sue Sisley, Billy Wynne, Skippy Mesirow, Dr. Sofia Chavez, Dr. Bradley Connor, Katina Banks

Non-voting NMAB Members: None

Non-voting Participants:

  • Hadas Alterman: Director of Government Affairs, American Psychedelic Practitioner’s Association
  • Jamie Beachy: Director of Education, Naropa Psychedelic Studies
  • James Eshelman: Founder, Center for All Directions
  • Bia Labate; Executive Director, Chacruna Institute
  • Sara Gael: MAPS Harm Reduction Officer; Denver Psilocybin Mushroom Policy Review Panel member
  • Will Van Derveer, MD: Co-founder, Integrative Psychiatry Center; MAPS Study Physician
  • Shannon Hughes: CSU professor; Nowak Society board member
  • Matthew Kester: Doctor of Acupuncture & Chinese Medicine

Prioritized Questions

Who can facilitate natural medicine services? This deceptively simple question lies at the heart of the Qualifications, Licensing, and Training subcommittee. This subcommittee examines the qualifications and training required for individuals facilitating natural medicine services. They explore licensing models based on qualifications, training, service types, and client profiles. The subcommittee aims to avoid hierarchical thinking and find solutions to include experienced practitioners who lack formal Western education.

SB23-290 suggests that the NMAB consider tiers of licensing based on qualifications, training, type of service provided, and type of participant receiving services. Following the passage of SB23-290, the question of licensing tiers jumped to the top priority for the subcommittee given that any questions of qualifications and training will be tied to licensing levels. Before drafting any frameworks, the committee unofficially elected to use “spheres” in place of “tiers” in an effort to avoid hierarchical thinking.

With that language change out of the way, the subcommittee began contemplating what multiple-sphere licensing might look like. Board members Skippy Mesirow, Billy Wynne, and Dr. Alissa Hannum each developed a potential framework. The three models were combined and presented to the full NMAB on June 16. Following that meeting, eight non-voting participants representing various stakeholders joined the subcommittee and voiced concerns about the combined model. Among these concerns are the potential to exclude legacy or traditional natural medicine practitioners. These practitioners may lack the typical markers of Western education but possess experience that would otherwise qualify them to work with certain populations of clients. The subcommittee has yet to find a solution to this problem but has demonstrated a keen interest in solving it.

A more existential question, raised in the June 29th meeting, is whether a medical professional facilitating natural medicine services can practice medicine in combination with those services. Thus far, the drafted licensing schemes have all in some form relied upon medical professionals taking part in the regulated market. However, without a clear moat of protection from federal penalties, physicians will be unlikely to assume the risks associated with working with schedule 1 substances.

What’s Next for the Natural Medicine Advisory Board?

While no specific timeline has been mandated for the NMAB or its subcommittees to make recommendations as of June 2023, progress is expected to accelerate soon. State regulatory agencies are anticipated to establish schedules for official rulemaking proceedings, likely to be discussed in the  NMAB meeting on July 21, 2023. Subcommittees will continue their regular meetings to develop recommendations based on their areas of expertise. Ultimately, the recommendations approved by the NMAB will be proposed to the state agencies and undergo the official rulemaking process, including public readings and comment periods, before the regulations are codified.

Upcoming meetings of the NMAB and subcommittees can be found here.

Read the Natural Medicine Advisory Bulletin #2: July 2023

View the Colorado Natural Medicine Health Act Tracker webpage

View the Colorado Natural Medicine Advisory Bulletin webpage 

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