Written by Jeff Fitzgerald and Vicente LLP as part of our Colorado Natural Medicine Health Act Tracker.
Having completed its initial round of listening sessions in October 2023, the Department of Revenue’s (“DOR”) Natural Medicine Division (“DNM”) once again engaged the public over the course of five additional sessions, beginning in mid-November. To date, these sessions remain the primary method through which the public at large can participate in the creation of the natural medicine program by providing input on subjects the Department will be regulating.
One significant change in the way DOR conducted this series was by providing an option for in-person participation, in addition to virtual participation. The second series also increased the session length to 90-120 minutes, up from the initial 60-minute sessions. The general format remained the same, with DOR providing resources and sample discussion questions for each session topic. For new attendees, the Department gives a brief overview of the law generally, as well as the specific statutory mandate for the subject of the Listening Session at the start of each session. The sessions then open up for the public to share thoughts, concerns, and information that may be helpful to the Department.
The Department intends to publish the first rulemaking hearing notices in the spring of 2024 – the first step in the official rulemaking process. Prior to the start of official rulemaking, the Department will conduct two additional listening sessions.
A catch-all meeting to revisit previously-covered topics and address any residual subjects will take place on Friday, February 23rd from 9am-12pm MST. The final Listening Session will occur on Monday, March 4th, from 1-3pm MST and focus on the Department’s official duties, rulemaking priorities, and the rulemaking process generally.
Recordings and summaries of past Listening Sessions, as well as upcoming sessions can be found on the Department of Revenue’s website. Parties interested in providing information to the Department are asked to reach out to the Natural Medicine Division’s Director of Policy & Regulatory Affairs, Allison Robinette, at allison.robinette@state.co.us
Listening Session #6 – First Responder Training
The first session, a follow-up to a session in the first round, focused on natural medicine-related training materials for first responders, which the Department is charged with in C.R.S. 44-50-2021. DOR representatives began by summarizing the previous session’s insights around target audiences and curriculum components. In addition to law enforcement and EMS services, DOR will consider developing training materials for veterinarians, dispatchers, mental health professionals, harm reduction groups, hospital and emergency room workers, and mobile crisis services.
Regarding the contents of training, the department has generated an extensive list of subjects it is considering, including:
- Knowing the current law, including personal use allowances and prohibitions
- Grounds for search, seizure, arrest
- Types of natural medicine products
- Cultural attitudes and beliefs around natural medicine
- Adverse events
- Risks such as serotonin syndrome
- Risk mitigation and harm reduction
- Terminology to use and avoid
- Cultural practices, such as purging when consuming some natural medicines
- Behavioral health considerations like reducing arrests and involuntary commitment
- Online training from the Behavioral Health Administration (BHA)
- Triaging protocols
- Unarmed response
- Questions first responders should ask when responding to a natural-medicine-related call
- Fundamentals of psychedelic crisis
- Potential differences in response if responding to a healing center versus a residence
- Liability of first responders related to responding to a natural-medicine-related call
Natural Medicine Division head Dominique Mendiola then described the Department’s phase 1 plan for the development of training materials. The initial approach will focus on developing materials to support existing programs, such as Colorado’s POST program, rather than developing entirely new or separate programs. As part of this initial phase, DOR will meet with first responder groups to gauge the extent of existing materials, inform training the Department will need to develop, and assess opportunities to add natural medicine-related training into existing training programs. As an example, Ms. Mediola used the POST training on cannabis. POST’s cannabis training seeks to provide law enforcement a comprehensive understanding of the legal cannabis landscape in Colorado, including civil liability, rules around home grows, and rules for law enforcement when conducting traffic stops. Additional goals of the Department’s first phase are to analyze funding needs and collect data regarding what is possible utilizing current resources.
The meeting then turned to the public comment and discussion segment on the following questions and subjects:
- What research/data is currently available to inform development of training materials for first responders?
- What primary subjects should first responder training materials cover? For example:
- Know the law – Personal Possession and Consumption
- Identifying Impairment (does the existing Drug Recognition Expert training program appropriately cover natural medicines?)
- Crisis & Harm Reduction Services
- What are the perceived gaps in existing training materials?
- Through the lens and perspectives of indigenous, religious, and spiritual use of natural medicines: What specific subject-matter should be incorporated into training materials?
Several members of the public offered to assist the Department, while others inquired as to more substantial ways to get involved with the ongoing creation of the natural medicine program.
Curriculum suggestions from the public included trauma and nervous system responses, differentiating between challenging experiences and true mental health emergencies, when to use rescue medications such as benzodiazepines, withdrawal reactions from other substances, and potential drug interactions with natural medicine
Members of the public also inquired about when rules will be finalized, what guidance the Department is relying on, other training the Department will develop, and the extent of reporting for critical incidents. DOR representatives gave noncommittal answers to most questions, reciting general rulemaking timelines and statutory authority rather than giving specific answers.
***
Listening Session #7 – Data Collection and Public Education Campaigns
The November 29th Listening Session introduced data collection as a new subject and the subject of public education campaigns from the previous series.
Department representatives began by giving an overview of its statutory -mandate with regards to data collection. Under C.R.S. 44-50-202,2 the department must request available data on law enforcement incidences, adverse health events, impacts to healthcare systems, consumer protection claims, and behavioral health impacts. The Department’s initial approach, driven in part by prior experience in regulating the cannabis market, is to define the scope of data collection the Department will undertake. From there, the Department will assess existing data resources within the state that can be leveraged to support its goals. By reaching out to other state agencies to determine what data is already being collected, the Department has identified several existing resources that it can utilize. The Colorado Bureau of Investigation’s crime dashboard includes law enforcement data related to hallucinogens. Behavioral Health Administration reporting includes critical incidents and adverse health events. The Attorney General’s office contains a Consumer Protection unit that collects data on bad products and services. Ms. Robinette further explained that the current law does not provide funding for data collection, pushing the Department to rely on existing systems to the greatest extent possible. The Department will work to define the scope of the broad categories of data enumerated in statute, for example what specifically “law enforcement incidents” and “impacts to healthcare systems” will encompass. The Department will identify gaps in current datasets and report annually on the status of its program, potentially using those gaps to push for funding specific to data collection.
The next segment of the meeting consisted of two presentations. The first presentation came from Dr. Andrew Monte of the Rocky Mountain Poison and Drug Safety Center (“RMPDS”), describing the goals and needs of a comprehensive data collection program. Broadly, Dr. Monte described the primary goals of a data collection program as maximizing safety and availability of natural medicine. He described the increasing presence of psychedelics in popular culture, combined with existing misconceptions and dearth of recent data as key drivers behind the need for robust data collection. Accepting the premise that increased access will invariably be accompanied by an increase in adverse events, Dr. Monte positioned a robust data collection program as a counterweight to misinformation and disproportionate, inaccurate media reporting of adverse events. Dr. Monte advocated for a “mosaic” approach to data collection like the one utilized by RMPDS. This approach weaves together data from multiple sources to tell a more complete story than can be understood from any single source. Examples of data points in a mosaic system for natural medicine would include behavioral health impacts, health system impacts, financial impacts, law enforcement incidences, consumer protection claims, access to care, and issues of public health or newsworthy importance. By combining multiple data sources into a holistic view, DOR will be able to answer consumer questions, speak to the efficacy of current regulations, identify ways to improve the program, and defend the program against critics and challenges. Concluding the presentation, Dr. Monte positioned a lack of data as a threat to the longevity of the program. He also identified potential limitations, such as an absence of psilocybin-specific hospital codes, which could lead to data contamination. For example, a patient indicating they had consumed psilocybin several days ago could cause an unrelated emergency room visit to be included in adverse event data. He urged that the data collection framework should be flexible and able evolve over time in order to answer new questions as they arise.
The second presentation was given by Dr. Scott Thompson of the University of Colorado Anschutz School of Medicine. Dr. Thompson presented a more detailed vision of a potential data collection framework for the natural medicine industry. Dr. Thompson positioned Colorado’s data collection program as having unique opportunities to expand the existing understanding of treating mental health conditions, improve healthcare, provide feedback to healthcare providers, encourage insurance coverage of natural medicine services, shape best practices in the natural medicine program, advance the reputation of Colorado universities, and foster the growth of a “psychedelic biotech innovation economy”.
Describing the current state of psychedelic research, Dr. Thompson emphasized that clinical trials are limited in their applicability due to stringent exclusion criteria, asserting that a single year of the natural medicine program in Colorado will surpass all clinical studies combined in the number of participants treated.
Dr. Thompson’s proposed plan mirrored Dr. Monte’s “mosaic” data system by suggesting data be collected from “participants, providers, and suppliers in a fully integrated manner.” He suggested using collection methods that minimize barriers such as web-based systems with phone interfaces. He also suggested that the database make anonymized data available for real-time analysis and export to both public and private users. Finally, he suggested that the collection, storage, and analysis of data be managed as a public benefit collaboration between the Colorado School of Medicine, RMPDS, and other University of Colorado system partners.
Dr. Thompson identified two outstanding issues – how much data to collect, and how to fund collection and analysis. Regarding how much data to collect, Dr. Thompson suggested incentivizing opting-in to a second tier of data collection, above the minimal data that the state can compel via rule or statute. Regarding how to fund the program, he suggested charging private entities for access to the data. He also provided a list of suggested data points to collect.
The ensuing Q&A session elicited pushback from multiple members of the public. Concerns included compulsory data collection as a barrier to seeking care, general aversion to government data collection, risks of data collection such as de-anonymization, and the potential for re-traumatization that could be caused by forced data collection. DOR officials responded to concerns by emphasizing that the programs described in the presentations do not represent any official decisions by the Department, and that the Department’s statutory mandate only extends as far as requesting data. Dr. Thompson responded to concerns by clarifying that any data collection should be done with informed consent, stating that participants can be incentivized to opt-in to data collection by appealing to their sense of community and good will. In a particularly pointed public comment, one member of the public, who claims to be helping build out Oregon’s data collection program, described two competing goals of a data collection program as 1) good psychedelic research and, 2) managing a program’s safety and efficacy. They expressed concerns about the way in which Oregon’s SB 303 attempted to accomplish both, saying that the bill has resulted in marginalized communities being discouraged from accessing psilocybin services in Oregon. Heidi Prendergast, director of the Healing Advocacy Fund in Oregon, offered clarification on SB 303. Ms. Prendergast explained that SB 303 was necessary to answer basic questions about the state of the Psilocybin Services program, and that the bill only requires anonymized data reporting at a high level.
Next, Dominique Mendiola recapped the previous Listening Session on public education campaigns. DOR’s initial approach in this area is to compile existing resources into a repository and focus on the currently-in-force personal use provisions of the law, with an eye towards educating the public on what the law does and does not permit. Initial public education campaigns will involve collaborations with other state agencies such as the Department of Education, Department of Transportation and Department of Public Health and Environment.
The meeting then moved into open discussion, guided by the following prompts:
- What sensitivities should DOR be aware of when collecting data and what measures can we put in place to mitigate any participation concerns? For example: Are there particular participant or facilitator concerns about providing feedback and data regarding natural medicine services?
- How can the state incentivize participant and facilitator participation in data collection efforts?
- What types of considerations should potential participants think about in determining whether to pursue personal use of natural medicines or participating in regulated natural medicine services with a facilitator?
- What initial steps must occur to ensure education campaign materials appropriately address potential risks and benefits associated with natural medicine? For example, studies, literature review, et cetera.
The ensuing discussion was fairly contentious, with many members of the public expressing strong feelings regarding data collection. Mason Marks, a law professor in Florida and frequent critic of all efforts to regulate psychedelics, pushed back on Heidi Prendergast’s characterization of SB 303 as mandating any data collection in Oregon. Healing Advocacy Fund representatives once more clarified that that the bill was necessary to understand fundamental questions about Oregon’s Psilocybin Services program – such as how many people have accessed psilocybin services and whether the program is equitable – and that the bill only requires aggregated data, protecting client identities. Mr. Marks also encouraged DOR to include data privacy experts in the conversation and reiterated a strong opposition to mandatory data collection, asserting that it would incentivise people to avoid the regulated market. In response, Ms. Mendiola reminded the public that the Department is statutorily required to report certain data when available and is not required to compel collection of participant data.
On the topic of public education campaigns, members of the public suggested including information on dosing and potential differences in effects of various strains of psilocybin mushrooms while ensuring information can be recognized as reliable.
***
Listening Session #8 – Cultivation & Manufacturing Practices
The third session of the second round of Listening Sessions revisited the subject of cultivation and manufacturing practices. DOR representatives began by reviewing the State Licensing Authority’s mandatory rulemaking requirements. The Department must promulgate rules regarding types of natural medicine products, requirements for licensed premises, transportation requirements, packaging and labeling requirements, and potential limitations on production quantities. DOR interprets this authority to encompass occupational health rules, manufacturing and cultivation practices, waste management, and security-related rules.
DOR representatives also recapped the previous session on cultivation & manufacturing. Big-picture subjects in that session included flush metrics and definitions, composition and degradation of final products, and synthetic products. More nuanced topics included the pros and cons of allowing or disallowing certain substrate materials, variations in strains of P. cubensis, common existing product types, limitations on the quantity of licenses, and inventory tracking considerations.
Kaitlyn Urso of the Colorado Department of Public Health & Environment (“CDPHE”) gave a presentation on potential environmental impacts of psilocybin production and provided some related recommendations. Impacts related to energy consumption, air and water quality, and land use should be minimal to negligible, given the nature of mushroom cultivation. Relative to cannabis production, cultivation of mushrooms requires a small fraction of the water, energy, and space. CDPHE’s primary cultivation-related concerns are unintentional spreading of spores and persistence of psilocybin in wastewater. In a short Q&A session, several members of the public more versed in mushroom cultivation tempered these concerns. Spore spread can be controlled by harvesting mushrooms before spores are released and by using proper air filtration methods, which is itself a necessary condition for a successful cultivation operation. One speaker pointed out that, due to personal use allowances, residential cultivation will render any facility-level regulations to control wastewater contamination futile. To be effective, any mitigation efforts would need to be implemented at the municipal level or above. Several members also pointed out that psilocybin degrades rapidly in water and offered opinions that psilocybin contamination in wastewater will be a non-issue. One speaker suggested requiring spent substrates to be treated in such a way that they cannot re-colonize or produce additional mushrooms when composted or otherwise disposed of.
The session then turned to open comment on the following DOR-provided discussion questions.
- What occupational health and safety risks need to be considered in the cultivation and manufacturing of psilocybin/products?
- Should regulations restrict growing mediums or substrates? (For example, prohibiting the use of manure?)
- How should regulations define and/or categorize cultivated psilocybin (e.g. by batch, by flush, any weight limits, or time limits?)
- What types of products should be permitted (or prohibited) within the regulated space?
- If initial rules restrict solvents that are permitted in manufacturing Natural Medicine Products, which solvents should be expressly permitted? What products/ processes require those solvents?
- What waste management practices are most critical to ensuring proper disposal? Is requiring that all waste be treated, for example with autoclaving, a reasonable measure to ensure that any remaining psilocybin, psilocin, or mycelium is neutralized and cannot produce additional fruiting bodies once disposed?
On the subject of flushes & batches, mushroom cultivators participating in the session described a variety of processes and nomenclatures. The main question DOR is facing in this area is how to define a “batch” for testing and labeling purposes, a task that is significantly more complex than the equivalent in cannabis. In cannabis, a batch is simply cannabis of the same strain that is harvested at the same time.3 Individual plants can only be harvested once, and cannabis potency is generally evenly distributed throughout a single plant. In mushroom cultivation, the closest equivalent to a single plant of cannabis is a unit of colonized substrate material, which may be a bag, tub, or cake. That unit may produce multiple flushes (essentially, batches) of mushrooms over the course of several days or weeks. Many units may be inoculated on the same day from the same genetic source as part of one colloquial “batch”. Further complicating the picture, potency can vary between flushes. There did not appear to be consensus amongst participants on the best way to define “batch” for the purposes of testing, however most participants agreed on the concept of a flush.
Regarding substrates, several members of the public encouraged allowing manure as a substrate because it is cheap, environmentally friendly, and commonly used. Conversely, several speakers supported disallowing manure for safety and potential negative public perception. In response to health concerns related to manure, those in favor pointed out that many agricultural foods are grown using manure and that thorough end-product testing should mitigate any heightened health risk from manure-based cultivation, albeit at an increased cost.
Regarding product types, several members of the public asserted that vaping psilocybin is possible but did not make strong statements on whether such products should be permitted. It was less clear to the participants if a transdermal administration is feasible. Several participants urged the Department to allow alternate routes of administration for participants who may not be able to swallow.
Regarding product packaging and labeling, there was some confusion amongst the public about whether natural medicine will be permitted to be taken outside of a healing center. If it is not, child-proof packaging and extensive labeling would be superfluous and wasteful according to some participants. If natural medicine is permitted to leave a healing center, which is likely given current draft NMAB recommendations permitting residential administration of natural medicine, the packaging requirements should be more robust, according to several speakers. Psilocybin, total potential psilocin4, and solvents (if used to produce a concentrated product) were suggested for inclusion on product labels.
Only one member of the public spoke on occupational and safety hazards for cultivators. They identified dust from grinding mushrooms, hazardous solvents, and increased potential for microbial growth in the humid cultivation environment, as safety issues warranting regulatory consideration.
Shelf life and potency degradation were also discussed briefly. Dan Huson of Rose City Labs, a testing operation in Oregon, cited anecdotes of homogenized (ground up) mushroom samples containing 0% psilocybin after having been stored incorrectly. Conversely, according to Mr. Huson, homogenized products stored correctly may be shelf-stable for 6 months, and whole mushrooms stored properly may be shelf-stable for over a year.
Concluding the session, Dominique Mendiola of DOR shared that the Department expects one additional round of listening sessions prior to formal rulemaking. Those sessions may include draft rule language for the public to provide feedback on.
***
Listening Session #9 – Business Structures and Licensing
The final listening session of 2023 focused on business structures and licensing in the regulated natural medicine market. The session began with DOR representatives reviewing the statutory rulemaking directives in this area. Under CRS 44-50-103, the Department must promulgate rules related to licensing procedures; issuance, denial, and renewal of licenses; prohibited and permissible financial interests; oversight of licensees; qualifications and eligibility requirements; fees related to applications and licenses; co-location of licenses with healing center licenses or other healthcare facilities; and environmental and social governance criteria. The Department also noted license restrictions it has already identified. Colorado law prohibits the Department from issuing licenses for natural medicine businesses that are located within 1,000 feet of a school, that conflict with local zoning laws, or that would be co-located with cannabis or liquor licenses. Additionally, the Department will not impose a residency requirement for applicants.
Kyle Lambert of the Marijuana Enforcement Division and Natural Medicine Division spoke about license eligibility, application procedures, and restricted financial interests. Using Oregon’s definition of an applicant, Mr. Lambert discussed how DOR’s Natural Medicine Division is thinking about licenses and application processes in Colorado. According to Mr. Lambert, the Department will consider aspects of licensure such as tax compliance, fingerprinting and background checks, how to define the scope of “financial interests”, and allowing or disallowing advertising for natural medicine services. He also discussed factors that may impact an applicant’s eligibility, including exercising the privileges of licensure without being licensed or violating personal use provisions, such as selling natural medicine.
The Department provided the following groups of discussion prompts:
- General licensing considerations:
- What minimum qualifications should owner license applicants be required to demonstrate in the licensing applications?
- How should the Division define financial interests for purposes of ensuring compliance with the statutory provision restricting any one person from having a financial interest in more than five licenses? (For example, owners, investors, financing agreements, et cetera?)
- What kind of information should applicants be required to submit regarding financial interests?
- Should the Division require employees (or certain employees) working at Natural Medicine Businesses (cultivation facilities, manufacturing facilities, healing centers, testing facilities) to obtain a license?
- Healing Center licensing:
- What types of business models for healing centers should the Division expect? (For example, clinic-type settings, retreat-type settings, outdoor vs. indoor, et cetera)
- Should we anticipate a person applying for a Healing Center license that is ot also licensed as a facilitator?
- What other license privileges may be necessary or desired for Healing Centers? (For example, the ability for a healing center to transport natural medicine to a facilitator at authorized locations other than a healing center)
- Cultivation and Manufacturing facilities licensing:
- 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 to co-locate with other license types (For example, occupational health and safety concerns).
- Are there any unique concerns or consideration to allowing a manufacturing facility to co-locate with other license types?
Many members of the public encouraged the Department to create flexible regulations that would allow for unconventional business structures and relationships. Suggestions included allowing cooperative and community-owned business models, broadly defining healing centers to accommodate a variety of locations and modalities, flexible rules regarding co-location of licenses to allow for creative solutions to federal rules related to controlled substances, allowances for religious nonprofits, and ensuring that facilitators are not dependent on relationships with healing centers. Multiple speakers encouraged the Department to consider mental health professionals, many of whom may want to integrate natural medicine services into their existing practices without becoming full time facilitators. Others shared concerns that overly rigid requirements would fuel an unregulated gray market and could limit facilitator autonomy in where and how they can offer natural medicine services.
Several participants shared divergent views on production limits. Those against limits or tiered cultivation licenses expressed a need for natural medicine to be used in R&D and facilitator autonomy in determining the correct dose for a participant as weighing against limiting cultivation and production quantities. Conversely, supporters of production limits worried about overproduction, which could lead to waste, diversion, and unsustainable markets like those seen recently in cannabis.
Regarding licensing eligibility, several speakers were concerned about potential repercussions stemming from fingerprinting and background check requirements. DOR representative Allison Robinette clarified that the law requires fingerprinting and background checks to be conducted by Colorado agencies or approved third parties, and that applicant information is kept confidential. Additionally, the Natural Medicine Code requires only that the Department conduct background checks and does not prescribe specific disqualifying events.
The subject of advertising was touched on briefly. Two speakers encouraged the Department to permit and regulate advertising to ensure those seeking natural medicine services receive accurate, verified information regarding regulated natural medicine services, enabling them to differentiate between regulated and unregulated offerings. One participant encouraged prohibiting advertisements from making medical claims. The Colorado director of the Healing Advocacy Fund, a non-profit group supporting the natural medicine program, shared the view that an advertising prohibition in Oregon is negatively affecting the psilocybin services market in that state.
Other suggestions from the public included requiring ethics training for healing center operators, restricting co-location of production facilities based on the hazards of the production occurring, allowing co-location with other therapeutic modalities such as acupuncture and massage, separate testing rules for laboratories conducting R&D, and educating the public on the history and traditions associated with natural medicine.
More information about the Department of Revenue’s Natural Medicine Division, including upcoming Listening Sessions can be found on the Department’s website. Parties interested in providing information to the Department are asked to reach out to the Natural Medicine Division’s Director of Policy & Regulatory Affairs, Allison Robinette, at allison.robinette@state.co.us.
Weekly Bulletins
Join our newsletter to have our Weekly Bulletin delivered to your inbox every Friday evening. We summarise the week’s most important developments and share our Weekend Reading suggestions.
- C.R.S. § 44-50-202(1)(h) The State Licensing Authority shall . . . develop and promote training materials for first responders and multi-responders, including law enforcement, emergency medical providers, social services providers, and fire fighters.
- C.R.S. § 44-50-202(7) The State Licensing Authority, in coordination with other relevant agencies, shall request available and relevant Data concerning law enforcement incidences, adverse health events, impacts to health care systems, consumer protection claims, and behavioral health impacts related to natural Medicine.
- 1 CCR 212-2 “Harvest Batch” means a specifically identified quantity of processed Retail Marijuana that is uniform in strain, cultivated utilizing the same Pesticide and other agricultural chemicals and harvested at the same time.
- A measure of overall product strength calculated using a formula which accounts for the natural conversion of psilocybin to psilocin in the body.
