Colorado Natural Medicine Advisory Bulletin #6: November 2023
By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Dec 13, 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.
With just weeks remaining to submit the required annual progress report to the state, the pressure is on for the Natural Medicine Advisory Board to tighten up their recommendations and close any remaining gaps. Following a jam-packed month of meetings in October, the stage was set for an explosive November. Those expecting fireworks may have found themselves disappointed by the cancellation of two subcommittee meetings and a brief, mostly administrative meeting of the full board, however there was certainly enough action to keep the public on the edge of their seats.
One of the most surprising, and potentially disappointing, moves came from the Emergency Response, Safety, and Ethics subcommittee. As of the November meeting, they are looking to recommend two tiers of prescribed session length and a maximum dose of 30mg of psilocybin analyte. Under this framework any dose of psilocybin analyte of less than 10mg will require facilitator supervision for a minimum of three hours, effectively prohibiting microdosing in the regulated market due to the cost and time associated with what is, by definition, a dose where the effects of psilocybin are not consciously felt. Equally outrageous is the recommendation of a 30mg upper limit, roughly equivalent to 3-4 grams of dried mushrooms. Oregon, by contrast, prescribes six tiers of session length and a maximum dose of 50mg of psilocybin analyte. The current set of recommendations from the NMAB is a surefire way to guarantee a thriving underground market by forcing anyone seeking the benefits of microdosing or a deep spiritual experience out of the regulated space. This will likely come as a surprise to many who have been counting on the NMAB to create a more robust and inclusive program in Colorado.
Another significant update coming out of November was the introduction of consolidated draft recommendations. The document, compiled by DORA staff, represents the cumulative work of the NMAB and its subcommittees to date. While the public is understandably eager to get the full picture of what the regulated natural medicine program in Colorado will look like, DORA program director Lorey Bratten has been diligent in insisting that the document is still a work in progress and should not be relied upon for any reason. Indeed, the November version of the document is already outdated based on the month’s activity.
Even at this stage, new questions continue to arise, begging quick but thoughtful answers before the annual report is due. How many types of facilitator license will there actually be? Will Colorado follow Oregon in prescribing minimum administration session lengths? Will the board recommend only natural medicine grown in Colorado be allowed in the regulated program? If so, what impacts does that have down the line if the board recommends the addition of a natural medicine that cannot reasonably be grown in Colorado? Creation of Colorado’s legal market for psychedelics is beginning to look fractal in nature, with each decision opening up a new level of questions.
For the first meeting in November, Dr. Bradley Conner chaired the Emergency Response, Safety, and Ethics subcommittee in place of William Dunn. The subcommittee welcomed one new guest, Dr. Nicholas Cozzi. Dr. Cozzi is a psychopharmacologist and co-founder of the Alexander Shulgin Research Institute.
Dr. Cozzi gave a presentation summarizing several studies to date on the relationship between dose and subjective experience regarding psilocybin. He concluded that 30mg of psilocybin is a reasonable upper bound, beyond which desirable effects do not increase and potential adverse events increase. Next, Dr. Cozzi discussed a study of the stability of psilocybin which indicates a significant degradation in the first four weeks of harvest regardless of temperature or light exposure. Dr. Conner raised that the study mentioned did not control for humidity, which the NMAB has been told through expert testimony is a critical variable in degradation. Following this presentation, the subcommittee discussed possible testing-related implications, such as recommending that potency testing occur one month after harvest to ensure accurate dosing.
Next, the subcommittee moved to potential screening tools for participant safety. Dr. Alisa Hannum expressed a desire to begin drafting questions for a screening questionnaire that would inform facilitator decisions on when collaboration with, or referral to, a different level of facilitator would be required. The group briefly discussed Oregon’s intake screening and screening tools developed by the World Health Organization. Dr. Conner will review available screening tools and draft a questionnaire for the December subcommittee meeting and Dr. Hannum will begin work on a flowchart to guide facilitators on contraindications.
Next, the subcommittee began reviewing the consolidated draft recommendations for instances where their input was needed. First, they discussed a set of rules for Healing Centers dictating minimum durations of administration sessions based on dosage level. The subcommittee felt that the Oregon framework was overly prescriptive and opted for two tiers of minimum session duration with facilitator discretion to extend. They also indicated a desire to have previous presenter Dr. Ben Malcom return to advise on the possibility of allowing larger doses for participants on SSRI medications. The subcommittee appears poised to recommend the following regarding session duration and dosage:
- Up to 10mg of psilocybin analyte: Minimum session of 3 hours, longer at facilitator discretion
- 11-30mg of psilocybin analyte: Minimum session of 5 hours, longer at facilitator discretion
- Maximum dose of 30mg psilocybin analyte
If these recommendations are adopted, it would create a much more restrictive program than Oregon by decreasing the maximum dose and effectively prohibiting microdosing. Under Oregon’s rules a dose of 2.5mg of psilocybin or less only requires supervision for one hour for the first session, with a 30 minute supervision requirement for subsequent sessions. Even with these more flexible rules, many in Oregon have complained that the cost of a microdose session, during which the participant should not experience acute effects of psilocybin, is prohibitively expensive. Requiring three hours of facilitator time for even sub-perceptual doses will all but guarantee a de facto underground market for microdosing. The upper limit recommendation of 30mg (roughly 3-4 grams of dried mushrooms) will also disappoint many members of the psychedelic community by disallowing high doses, typically associated with meaningful spiritual experiences, in the regulated market. The NMAB arrived at the maximum dose based on Dr. Cozzi’s presentation indicating that adverse events increase beyond 30mg, but they don’t appear to have considered the effect of such a restriction on the underground market. Participants will seek higher doses for spiritual growth, and if it’s true adverse events increase beyond the 30mg threshold, wouldn’t it be preferable for those to occur under the supervision of a trained facilitator? As it stands, these recommendations push both ends of the dosage spectrum, each of which have their own unique healing properties, into the underground market.
The subcommittee revisited the subject of allowing emotional support animals in Healing Centers & administration sessions. Several members expressed that support animals are not trained in the same ways as service animals and could pose issues. They tentatively settled on allowing Healing Centers discretion to allow support animals in individual administration sessions (disallowing support animals completely in group administration) and anticipate additional recommendations for healing centers that choose to do so. They will attempt to speak with a veterinarian to understand animal reactions to human consumption of natural medicine.
Next, the subcommittee discussed preparation session requirements. Regarding how close in time a preparation and administration session must occur, they decided on 14 days as the maximum allowable time from a preparation session to an administration session. They also identified a need to conduct an “imminent risk” assessment immediately prior to administration. This would be a short questionnaire designed to check for suicidal ideation, hospitalizations, homicidality, and other acute risk factors having arisen since the preparation session. Small modifications were made to clarify recommendations that preparation sessions must be conducted confidentially with each participant and that telephone preparation sessions would not be allowed (virtual video preparation sessions would be allowed). The subject of virtual preparation sessions, and potentially recording, opened the question of procedures and rules around storing and providing video recordings to participants. Currently, the recommended language establishes that the participant owns any recording as part of their medical record and has unrestricted access. Sara Gael, who has experience as a facilitator in MAPS trials, cautioned against providing raw video files to participants that can be used in ways a facilitator would not consent to. The subcommittee chose to adjourn here and discuss that question at a later date.
The next meeting is scheduled for December 13th, 2023 at 1pm MST.
The first segment of the November meeting of Products, Research, and Data was dedicated to review of the subcommittee’s current draft recommendations. In light of the information regarding psilocybin degradation presented in the November meeting of Emergency Response, Safety, and Ethics, the subcommittee engaged in a lengthy discussion around potency testing.
The guiding light with regards to potency testing is how to ensure the participant is receiving an accurate amount of an active ingredient. This led to many more questions around the ideal time to test for potency, what the appropriate size of a testing sample is, how to ensure representative samples, and how to avoid “potency inflation” – a phenomenon seen in cannabis wherein producers attempt to game testing mechanisms to get higher potency results. The subcommittee settled on draft language that will prescribe a sample size of 2.5g of material for every 1kg of harvest with the sample consisting of a variety of caps, stems and sizes. They will also recommend that the regulator conduct a potency test as part of the yearly, random test of mycotoxins and heavy metals. The goal of a yearly, 3rd-party potency test is to catch potency inflation that may occur through sampling bias by cultivators. Considering how small the market will be and that there are no retail sales, is potency inflation really going to be an issue here?
Additionally, the subcommittee will recommend a combination of labeling and facilitator training on interpreting label information to best ensure accurate dosing. As of November, label information will include:
- Actual psilocybin and psilocin content
- Total potential psilocin (determined by an equation representing conversion of psilocybin to psilocin in the body)
- Date of harvest
- Date of potency test
Next, the subcommittee discussed the set of recommendations related to cultivation. Skippy Mesirow expressed the concerns of the Indigenous and Religious Use and Outreach subcommittee that prohibiting outdoor cultivation may be offensive to people who value a connection to nature in natural medicine. Several non-voting participants expressed that there is not a need to prohibit outdoor cultivation outright, even suggesting that natural medicine grown through traditional, non-laboratory methods may be desirable for some participants. Acknowledging that the climate of Colorado essentially prevents outdoor cultivation, chair Dr. Conner expressed willingness to drop the prohibition contingent upon either clarification from statute or through a different recommendation that only natural medicine cultivated in Colorado be permitted in the regulated program. This opened up an interesting future issue for the board: If the board recommends certain additions to the program which cannot be cultivated in Colorado, where will that natural medicine come from? Importing plants that contain Schedule I substances from other states or countries will certainly prove dicey without federal cooperation.
Finally, the subcommittee began addressing the data component of their namesake. While no concrete recommendations were formed, high-level considerations such as anonymizing data, who owns & stewards the data, legal protections, mandatory vs. elective data collection, desired data points, and funding/costs were discussed. Broadly the subcommittee agreed that a comprehensive data collection system could facilitate valuable research and that such a program requires diligence and care. To understand this better, the subcommittee hopes to speak with a representative from Oregon regarding their data collection program.
The next meeting is scheduled for December 20th, 2023 at 1pm MST.
November’s meeting of the full Natural Medicine Advisory Board began with a brief administrative update from recently-appointed program director Lorey Bratten, mostly around new document-sharing procedures for the board. Ms. Bratten was followed by Ashely Moller of the Colorado Attorney General’s office, who encouraged the board to submit legal questions to the AG’s office prior to the next board meeting in anticipation of addressing them in a closed-to-the-public executive session.
Next, Department of Revenue representatives Dominique Mendiola and Allison Robinette gave an update on the Department’s current and future work related to the regulated natural medicine program. Ms. Mendiola gave a high-level recap of two of the Department’s Listening Sessions on the subject of First Responder Training. One big outcome of these two sessions was the identification of professions the Department should target with education campaigns which include veterinarians, EMS dispatchers, mental health professionals, harm reduction workers, crisis response teams, and emergency room staff. A second area coming into focus is the content of the education campaigns the Department will run. Feedback from the listening sessions has indicated a number of important education components including the limits of currently in place personal use allowances, adverse events & risk mitigation, serotonin syndrome, cultural information related to natural medicine, and specific information first responders will need to effectively assist in the event of a psychedelic crisis. Ms. Robinette then gave a forward-looking overview of the coming months with an emphasis on the official rulemaking process and the specific procedural steps required by the Colorado Administrative Procedure Act. With a goal of having effective rules in place by October 1st, 2024, the Department aims to file Notices of Permanent Rulemaking between March 1st and June 30th of 2024. DOR will conduct listening sessions through the end of 2024 and stakeholder work groups throughout the rulemaking process. The Department will continue its current consultation with the NMAB through February 2024.
Next came a highly anticipated segment of the meeting – a review of the consolidated draft recommendations of each subcommittee of the NMAB. To kick off this segment Program Director Lorey Bratten read a preamble disclaimer that the document is subject to change and should not be relied upon by the public for any purpose. Board Chair Lundy reminded the members of the NMAB of their request for initial draft recommendations for this meeting. Lundy indicated that the document was still a work in progress, allowing the subcommittee chairs to give an update on the status of their draft recommendations.
Dr. Bradley Conner gave the update for Emergency Response, Safety, and Ethics. Having spent significant time on the Facilitator Code of Ethics, that work is paused pending adjustments that will be made based on recommendations from other subcommittees. Before the December NMAB meeting the subcommittee will finalize draft recommendations around preparation, administration, and integration sessions as well as administration session lengths related to dose.
Dr. Conner also gave an update for Products, Research, and Data. Draft recommendations regarding batch sizes and testing procedures will be updated by the December NMAB meeting. The subcommittee is in the early stages of drafting recommendations on data and research but is focused there.
Despite Public Health & Health Equity not meeting in November, Billy Wynne mentioned two changes since October. The first is that the subcommittee will recommend that the state produce a health equity report only to the extent it does not increase license costs. The second is that the subcommittee will recommend the state partner with a 3rd party vendor to allow payment over time of license fees.
The Indigenous and Religious Use and Outreach Subcommittee also did not meet in November. Members Skippy Upton-Mesirow and Clarissa Pinkola-Estés reiterated the requests of that subcommittee that outdoor cultivation be permitted and that Federally Recognized Tribes and Indigenous groups be permitted to participate in the for-profit regulated model.
Dr. Alisa Hannum gave the update for the Qualifications, Licensing, and Training subcommittee primarily recognizing three areas that the subcommittee is still working on. First, the allocation of training hours will likely see a shift of some number of ethical training into a supervised consultation period and out of the classroom. Second, the addition of a training license is all but agreed upon however the subcommittee is still working out when in the overall training curriculum that license would be available. Third, the subcommittee is committed to offering accelerated training options, particularly for facilitators licensed in Oregon, but the specifics of doing so are still being worked out. Finally, Dr. Hannum identified a gap in the need to license supervisors, indicating a possible additional “consultant”-type license. The subcommittee will revisit this subject in December after hearing from the Attorney General’s office.
NMAB Chair Lundy closed the meeting with several reminders and requests. They plan to submit draft recommendations to the state following the December NMAB meeting. Recognizing that several subcommittees will meet after the full board in December the consolidated recommendations document will be subject to change until January. Lundy and Ashely Moller requested that board members review the full schedule of 2024 NMAB meetings to ensure they will be able to regularly attend and consider stepping down from the board if they are unable.
The next meeting of the Natural Medicine Advisory Board is scheduled for December 15th, 2023 at 1pm MST.
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