Coming into the final weeks of Colorado’s initial push to establish rules for the state’s regulated Natural Medicine program, rulemaking proceedings climbed to their highest frequency. The week of July 8 saw a total of six natural medicine-related meetings, the busiest week since work began. The Natural Medicine Advisory Board (“NMAB”), as well as the Federally Recognized Tribes and Indigenous Community Working Group, are continuing to develop recommendations, and the Department of Revenue (“DOR”) has concluded its initial rulemaking, having released a final set of consolidated draft rules and held final public comment.

DOR has done an exceptional job of incorporating public feedback into rules, for which we are grateful. Additionally, DORA officials have recently clarified two questions related to accelerated facilitator licensure. First, facilitators applying for licensure through the Occupational Credential Portability Program are not required to complete the 25-hour module on Colorado law and ethics, as previously thought. Second, Approved Facilitator Training Programs are able to assess and grant coursework equivalencies for the purposes of accelerated licensure, which DORA may audit. Until now, many had assumed that DORA would individually review each application for accelerated licensure, a potentially significant bottleneck.

Since Bulletin 12, the following meetings have taken place:

• July 8: DORA final rulemaking hearing – Facilitator discipline and participant outcome data rules
• July 9: DOR rulemaking work group – Catch-all and inventory tracking
• July 10: Third meeting of the Federally Recognized Tribes and Indigenous Community Working Group
• July 11: CDPHE rulemaking hearing – Natural Medicine testing laboratory certification and testing rules
• July 11: DOR local government roundtable
• July 12: Meeting of the Natural Medicine Advisory Board’s combined subcommittee
• July 19: Meeting of the full Natural Medicine Advisory Board
• July 25: DOR final rulemaking hearing – All Natural Medicine Business Rules
• August 9: Meeting of the Natural Medicine Advisory Board’s combined subcommittee*
• August 14: Fourth meeting of the Federally Recognized Tribes and Indigenous Community Working Group*
• August 16: Meeting of the full Natural Medicine Advisory Board*

In this Bulletin, we’ll unpack July’s meetings. Since this Bulletin was written, final versions of all rules have been submitted by regulators. For a complete look at the program, check out Bulletin 13.5.

In This Issue:

• July 9: DOR Rulemaking Work Group
• July 8: DORA Final Rulemaking Hearing
• July 10: Federally Recognized Tribes and Indigenous Community Working Group
• July 11: CDPHE: Laboratory Certification & Testing Procedures
• July 12: NMAB Combined Subcommittee Meeting
• July 19: Full Natural Medicine Advisory Board Meeting
• July 25: Final Rulemaking Hearing – Natural Medicine Businesses
• Upcoming Public Engagement Opportunities
• Visit our Colorado Natural Medicine Health Act Tracker

July 9: DOR Rulemaking Work Group

DOR’s final rulemaking working group consisted of two sessions. The morning session focused on rules related to inventory tracking, enforcement, discipline, applications, and licensing procedures. During this session, public stakeholders asked the regulators to consider a handful of changes, including:

• Allowing licensed Natural Medicine Testing Facilities to test unregulated products
• Increasing accessibility and equity by only requiring full licensing fees to be paid upon license approval
• Allowing more methods of inventory tracking
• Increasing penalties for releasing sensitive participant data

After a break for lunch, DOR officials provided an overview of recent changes related to testing, manufacturing, cultivation, and Healing Centers, followed by a period of open public comment on all rules. Common stakeholder feedback included:

• Permitting manufacturers to use heat in certain extraction processes
• Expanding permitted product types
• Clarifying that Healing Centers may be co-located with therapist’s offices and other wellness business
• Increasing cultivation limits for standard and micro-cultivators
• Refining and clarifying rules to permit multi-use spaces
• Reducing packaging and labeling restrictions
• Clarifying language related to additives in manufactured products

Much of this stakeholder feedback was reflected in the final draft rules released on July 18.

July 8: DORA Final Rulemaking Hearing

On July 8, DORA held a final rulemaking hearing on the third set of rules related to the profession of facilitation, the last of three parallel proceedings. These rules cover disciplinary actions and the unlicensed practice of facilitation, as well as some additions to prior data collection rules.

Public stakeholders broadly supported data collection that supports measuring participant outcomes, with several commenters emphasizing the need to ensure sensitive participant data is protected. On the discipline side, several speakers took issue with confusingly worded rules related to the unlicensed practice of facilitation. Hopefully, DORA will adjust these rules in the final version to ensure the public can easily understand what conduct is allowed. 

July 10: Federally Recognized Tribes and Indigenous Community Working Group

July 10 marked the third meeting of the Federally Recognized Tribes and Indigenous Community Working Group established by SB23-290. The working group is tasked with providing input on four specific subjects related to the legalization and regulation of Natural Medicine in Colorado.

1. Avoiding misappropriation and exploitation
2. Avoiding excessive commercialization
3. Conservation issues associated with legalization and regulation, including possible depletion of peyote
4. Best practices and open communication between Federally Recognized Tribes, the NMAB, regulators, and law enforcement

While similar in nature to the advisory function of the NMAB, the working group takes the format of an open discussion led by a moderator. Each month, the group discusses one of the four areas required by SB23-290. Between meetings, members expand on discussion themes in surveys, with an opportunity to review and discuss them at the following meeting. After the group has met and discussed each theme, the group will draft an initial report of their findings, followed by further discussion on each theme before the report is finalized.

During July’s meeting, the group revisited June’s theme of misappropriation and exploitation. Responses to the discussion question “How are we defining “misappropriation?” included:

• Integrating prayers/songs into therapy or sessions; the etymology of ‘misappropriation’
• Advertising Native American Church ceremony in Colorado Springs for thousands of dollars
• Native American Churches in Hawaii including marijuana and mushrooms in their ceremonies
• Examples of DEA tracking of controlled substances (credentials and identification checks)

Moving into the discussion, Navajo Nation leader Frank Dayish expressed that the Nation opposes the legalization of peyote in any form, as well as a desire for the Nation to be consulted by Colorado regulators. Belinda Eriacho read a written statement, in which she discussed extraction and indigenous protocols of respect and reciprocity. In her view, the current format of the Working Group is yet another example of the extraction of Indigenous knowledge in service of the State without respect for reciprocity protocols. Daniel Castro felt that 150 hours of training for facilitators is too low, especially in the area of ethics, which requires 10 hours of training. He also questioned how Colorado can legalize plant medicines that are not native to the area. A representative from the Attorney general’s office explained that Colorado may control what happens within its borders, which did not seem wholly responsive to the question.

Santiago Guerrero brought the conversation back to peyote, asking what the state does about illegal peyote use or what enforcement mechanisms exist to stop illegal peyote use. During June’s meeting, the group expressed concern about a group in Colorado Springs that appears to be openly charging for peyote ceremonies under the banner of the Native American Church. The response from the Attorney General’s office was again not wholly satisfying, pointing to regulatory actions and potential criminal charges as legal enforcement mechanisms, but not providing specifics on how current peyote-protecting laws are enforced. Before taking a break, DORA Program Director Lorrey Bratten reminded the group that Natural Medicine is currently limited to psilocybin-containing mushrooms and that the group may find that it recommends against the inclusion of other Natural Medicines in the future.

Following a break, the working group received a presentation from Ariel Clark, an attorney with expertise in psychedelics. Ms. Clark began by posing a question—how will rules that are currently being developed respect the group's findings? In Ms. Clark’s opinion, the working group should have been convened much earlier in the rulemaking process. She pointed to a Rand Corporation publication about growing psychedelic interest, in which the authors express concern that the voices of Indigenous communities may not be meaningfully respected as legalization progresses.

Next, Ms. Clark discussed consent when making decisions that impact Indigenous communities. Ms. Clark emphasized any actions taken related to Natural Medicine should be done so with free, prior, and informed consent of affected communities. Ms. Clark noted that while Colorado has not yet included mescaline, DMT, and ibogaine in the regulated framework, decriminalization of these substances can still have an impact on communities that have traditionally used them. She also emphasized that Colorado has a unique opportunity to engage in a respectful consent process around Natural Medicine moving forward. In her view, this should include consultation and participation, which are crucial aspects of a genuine consent process. Additionally, leaders must be willing to accept and integrate feedback received in this process, even when doing so is difficult. Ms. Clark then briefly touched on international laws related to Indigenous Knowledge. Although the US is not a party to many international agreements recognizing the rights of Indigenous Peoples, these agreements can serve as models for state lawmakers.

Ms. Clark also discussed the Rights of Nature, or More Than Human Rights (“MOTH”), which she felt has been overlooked in Colorado’s laws. Under this framework, non-human entities, such as natural medicines themselves, have rights that must be considered in decisions. The framework is rooted in an Indigenous perspective, requiring respect and responsibility to Mother Earth while using Western notions of “rights” to fit within the Western legal paradigm.

During the final portion of her presentation, Ms. Clark provided the group with seven specific recommendations. 

First, any further action related to other Natural Medicines should include free, prior, and informed consent processes. This could mean accepting that indigenous communities do not want their medicines brought into the regulated space, or that the recommendations of indigenous communities must actually be followed, not just considered. According to Ms. Clark, any consent process must be indigenous-led and indigenous-informed, sharing examples where similar, complicated consent processes have already been navigated as potential blueprints.

Second, there must be meaningful participation and decision-making [by Indigenous groups] In ongoing regulatory roll-out.

Third, Ms. Clark recommended allowing synthetics as “biological alternatives” to keystone medicines, such as mescaline, DMT, and ibogaine. While this could help protect against overcommercialization and conservation-related harms, Colorado law currently prohibits the use of synthetics.

Fourth, strict and effective regulations related to marketing and branding should exist. Ms. Clark shared stories of cannabis legalization, where early actors held reverence towards the plant, communities, and relationships. As commercialization happened, the plant was commodified, in part by marketing and branding. Ms. Clark suggested simple, black-and-white packaging, limiting font styles and images, and other restrictions that keep labeling and marketing to product information only.

Fifth, Ms. Clark suggested including seats in decision-making spaces for the medicines themselves. Ms. Clark gave an example of a UK-based company that provides a board seat to nature itself. She urged the group to recommend that Colorado give psilocybin and other medicines a voice in the process as stakeholders.

Sixth, Ms. Clark identified the need for cross-cultural education. It may be wise to encourage education on the inherent rights of Indigenous peoples, traditional knowledge, conservation issues, and the worldview that Natural Medicine is sacred. This will lead to better health outcomes and help people shift from a consumption mentality to one of honoring.

Seventh, the working group should develop concrete recommendations to implement the Rights of Nature in Colorado’s regulated Natural Medicine program.

Before moving on to July’s theme of avoiding overcommercialization, the group briefly revisited the topic of misappropriation. Ms. Eriacho felt that it would be helpful for the group to understand federal and state laws related to peyote and what decriminalization means in a practical sense. She also pointed out Colorado’s preexisting religious use of peyote exemption and suggested the working group make a recommendation regarding peyote.

Daniel Castro posed a question to the group: How should or shouldn’t the group represent the voices of people outside of the United States or current recognized tribes. He shared his hesitancy to speak on behalf of medicines that were outside of his own traditions. To put a point on this, Mr. Castro shared that he had recently received a letter, signed by four consuls from the Shipibo nation, stating they have not consented to the use of their medicine in the North by any institution. Mr. Castro also spoke in favor of opening communication with the Navajo Nation.

Moving on to July’s theme, avoiding overcommercialization, the moderator sought examples of overcommercialization or recommendations on how to avoid it. One member shared their experience with the decriminalized psilocybin market in Oakland. She spoke of a lack of reverence for medicine, references to “getting high,” and brand marketing as both evidence and drivers of commercialization.

Darwin Whiteman shared a story about the inception of the Native American Church. In the story, the Cheyenne people help a sick white child by providing him with peyote. Many years later, the boy returned, helping establish the Native American Church at a time when peyote use was highly persecuted. According to Mr. Whiteman, the moral is that natural medicine and human beings share a symbiotic relationship in healing. 

Several group members expressed support for packaging and labeling restrictions, arguing that colorful and appealing marketing leads to commercialization. Other examples of commercialization and exploitation that were shared included:

• Companies patenting slightly modified psychedelic molecules
• Mushroom tourism in Huautla de Jiménez, the home of Maria Sabina
• Other plant medicines which have been commodified, such as tobacco, leading to harm
• Appropriation of the term “shaman”

The group also supported the idea of integrating cross-cultural education into the regulated space, sensing both an opportunity and a need to share the Indigenous understanding of Natural Medicine as more than just an inanimate object. The group hopes that, by imparting an understanding of Natural Medicines as part of a larger ecosystem of interconnected relationships, the broader public will treat these medicines with reverence, and thus be less inclined to commercialize or commodify them.

Group members raised several additional concerns, including how indigeneity is being used to sell Natural Medicine, as well as the “weaponization of indigeneity” being used as a license to speak on behalf of natural medicines that are outside of a person or group’s traditions.

July 11: CDPHE: Laboratory Certification & Testing Procedures

The Colorado Department of Health and Environment (”CDPHE”) is tasked with developing regulations that ensure the competency of Natural Medicine Testing Facilities to provide accurate testing of Natural Medicine, such as testing procedures, equipment maintenance, and certification standards. CDPHE released draft rules on July 1, with a subsequent public rulemaking hearing held on July 11. The meeting was relatively straightforward, with a CDPHE representative giving a general overview of each of the 14 rules before a brief period of public comment.

Of the handful of public comments, only two fell within the scope of the CDPHE rules. Regarding proficiency testing, CDPHE indicated that, ideally, a laboratory would complete proficiency testing for all required analytes. However, recognizing that proficiency testing may not be available for all compounds for some time, the Department has framed proficiency testing rules broadly to permit flexibility. A laboratory employee commented that one of the currently required analytes, a synthetic analog of psilocybin often found in adulterated products, would be especially difficult to develop proficiency testing for.

Questions that fell outside the scope of the rules related to procedures for failed Natural Medicine tests, reporting, and collaboration with federal agencies. CDPHE was unable to answer these questions, given its narrow role in the Natural Medicine program. Essentially, testing laboratories is the only aspect of the program that CDPHE will interface with, and ensuring that laboratories are capable of performing accurate testing is the extent of the relationship. 

July 12: NMAB Combined Subcommittee Meeting

The July 12 meeting of the combined subcommittee began with DORA Program Director Lorey Bratten providing updates on behalf of both DORA and DOR. Director Bratten noted DOR’s upcoming local government roundtable and July 25 final rulemaking hearing. Dr. Sue Sisley raised concerns about DOR’s current limit of one kilogram for cultivators, asking Director Bratten to ensure the NMAB has an opportunity to discuss the limit at the July 19 meeting of the Board.

Dr. Bradley Conner made a point of sharing his dissatisfaction with the fact that DOR has not given absolute deference to NMAB recommendations in some draft rules. According to Dr. Conner, he has expressed his displeasure at DOR’s receptiveness to public feedback to Director Bratten. At least one other member expressed a similar feeling, despite frequently acknowledging the advisory nature of the Board in the past. The sentiment that the members of an advisory board, who often have less expertise than public stakeholders and regulators, should have the absolute and final say on a subject, could be considered offensive to the process of public engagement that voters approved with the Natural Medicine Health Act.

While awaiting a guest speaker’s arrival, the subcommittee engaged in an open-ended discussion. Dr. Tina Gonzales raised the subject of a lineage-based accelerated licensure pathway. The suggestion, which did not make it into the first round of rules, was originally put forth by the Indigenous and Religious Use and Outreach subcommittee. Dr. Gonzales would like regulators to re-examine the suggestion and seek clarification on whether the working group or the combined subcommittee would be a more appropriate place to continue that conversation. Director Bratten indicated that the subcommittee would likely be more appropriate, as the focus of the working group is somewhat different, though the perspective of the group could be helpful for the subcommittee. Subcommittee members universally supported engaging with the working group, preferably as a whole, rather than a single representative speaking on behalf of the group. Director Bratten and the Attorney General’s office will explore the formal requirements for bringing the working group and subcommittee together. Director Bratten also reminded the subcommittee of the current accelerated licensure pathway for legacy healers, stating that DORA intends to consult with the board in the coming months to develop guidance documents for approving legacy healers.

Dr. Sue Sisley directed two questions to the representative from the Attorney General’s office. First, Dr. Sisley asked for an update on a months-old request for the state to formally request a memo from the US Attorney’s office. The Attorney General’s office did not have an update on this item but stated they would follow up on it.

Dr. Sisley also wanted to know if the next steps for the Board’s recent legislative recommendation to the state legislature could be moved forward. The discussion identified two possible options. First, a legislator could introduce the recommendations as a bill. As the Board is not permitted to engage directly with the legislature, the crucial question is how the recommendation can get in front of potential sponsors. An alternative pathway is to go through the Governor’s office, by way of the Special Advisor on Natural Medicine. Director Bratten offered to replay the concerns to the Special Advisor.

The primary agenda item consisted of a presentation and discussion with guest Nathan Howard. Mr. Howard is a founding member of the Sheri Eckert Foundation. Named for one of the co-creators of Oregon’s Measure 109, the Foundation is a 501c3 organization with a mission “to ensure that Oregon’s evolving psychedelic ecosystem is accessible to participants from diverse backgrounds, financial means, and geographies around the state and country.” Mr. Howard spoke about the foundation’s primary initiative, the Psilocybin Access Fund (“PAF”), as well as several complementary initiatives. The foundation has already provided $300,000 to fund the training of 75 facilitators in Oregon. The foundation’s current initiative focuses on funding psilocybin services and seeks to raise and distribute $1 million in grants to historically underserved populations. In tandem, the foundation is validating the benefits and safety of psilocybin therapy through its Psilocybin Therapy Insurance Initiative. Through a partnership with OPEN, the initiative collects voluntary participant outcome data, with the goal of providing evidence to induce insurance payors to cover psilocybin services. 

Mr. Howard also provided a firsthand look into the overall health of the Psilocybin Services program in Oregon. According to Mr. Howard, the market is trending towards group administration, which provides significant cost and resource advantages. Innertrek, a Psilocybin Service Center Mr. Howard is affiliated with, charges around $1200 per person for a group administration session. By Mr. Howard’s account, this works out to less than half of the cost of cognitive behavioral therapy per hour.

Subcommittee members then engaged in a wide-ranging conversation with Mr. Howard.  First, subcommittee chair Dr. Brad Conner requested details on the mechanics of the PAF, seeking to understand how Colorado might follow suit. As a 501c3, the PAF cannot use funds to pay for psilocybin directly. Instead, the Fund pays facilitators for services provided while coordinating the delivery of donated psilocybin. Funding is provided both by large institutional donors as well as smaller donors, often psilocybin businesses, through social equity plans.

Mr. Howard provided his perspective on recent media coverage claiming that Oregon’s program is struggling. According to Mr. Howard, while some of the concerns have merit, media reports are largely overblown. In his view, the market is still finding an equilibrium, with 2024 being the first year the program has been fully operational. Discussing opportunities for improvement in Oregon, Mr. Howard identified the state’s single-license framework as a significant issue. Without a Clinical Facilitator license to ensure higher levels of care, other professionals are reluctant to refer their clients to psilocybin services. Thankfully, Colorado’s framework already addresses the issue by providing for Clinical Facilitator licenses.

When asked what is stopping insurance from covering psilocybin service in Oregon, Mr. Howard pointed to a lack of data. According to Mr. Howard, insurance companies could choose to cover at least the services portion of psilocybin services at any time, if they saw value in doing so. Interestingly, Mr. Howard shared that, while outside of the single, required preparation and integration sessions, some facilitators are billing additional preparation and integration sessions to insurance as therapy sessions.

Dr. Sisley asked about Adverse Event reporting in Oregon, a recent hot topic in Colorado. According to Mr. Howard, there is no official state-level data for adverse events, though he mentioned the Healing Advocacy Fund has been researching adverse events at the grassroots level. Anecdotally, Mr. Howard reported hearing of intense trips, which may not be considered “adverse events” in other cultures but are labeled as adverse events from the Western medical viewpoint. Mr. Howard reported hearing of individuals attempting to physically leave a service center, as well as complaints against facilitators for not intervening in these intense experiences, despite non-directiveness being agreed upon by the client and facilitator. Mr. Howard identified several factors he believes contribute to these reports. First, there is a general lack of knowledge in both clients and many facilitators as to how intense a certain dose of psilocybin can be. Second, some training programs fail because they are not discerning enough in who they accept or diligent enough in their training, leading to facilitators providing doses that they have never taken themselves. Additionally, Oregon does not require a safety screen of any kind. Combined, these factors can result in inexperienced facilitators providing doses they don’t fully understand to clients who should not be receiving them. The solution, in Mr. Howard’s view, is to create a culture that values safety, even where regulations don’t require it. Luckily, Colorado has already taken several cues from Oregon, requiring safety screens for participants, as well as ongoing consultation for new facilitators to ensure they are supported as they gain experience.

As part of the broader discussion around adverse events, Dr. Sisely asked whether Mr. Howard had heard reports of sexual misconduct by facilitators. He personally had not. However, the discussion turned to Colorado’s complaint procedures and reporting. Director Bratten indicated that disciplinary actions taken against a licensee are made public only after a disciplinary board finding. For conduct that does not rise to the level of disciplinary action, regulators may choose to issue a Confidential Letter of Concern, which is a non-public method of resolving complaints. This system was lauded by Mr. Howard as a significant improvement over Oregon’s.

Skippy Upton-Mesirow wanted to know the most significant cost drivers of psilocybin services, and where Mr. Howard saw the biggest potential for cost savings. Citing facilitator time as the most significant cost, Mr. Howard felt that group administrations and multiple-day retreats offer the most significant cost reductions. Speaking about current rules regarding group size and facilitator ratios in Oregon, Mr. Howard felt that the rules were working adequately, though he would like more flexibility over time. He noted that in some regards, starting with rigid rules, which are then revised to be more flexible, can be advantageous when first developing a collective baseline understanding of an unfamiliar subject such as psilocybin services. Mr. Howard shared a report of regulated microdosing being used in groups for activities such as community building and meditation and spoke positively about Oregon’s allowance for group and remote preparation and integration sessions.

Mr. Mesirow noted that, if secondary preparation and integration sessions are able to be billed to insurance as therapy, demand may be higher for Clinical Facilitators than initially anticipated. Mr. Mesirow also inquired about the costs of 1:1 sessions. In Oregon, on-on-one administration ranges from $800-$3000, with corresponding variation in the amount of preparation work included and advanced qualifications of the facilitator. Discussion demographics, Mr. Howard reported that most clients receiving psilocybin services are from out of state, while all facilitators are currently Oregon residents. Finally, Mr. Howard suggested partnering with local institutions to fund the Board’s desired Participant Outcome Database.

Dr. Sophia Chavez voiced support for group administration and emphasized the need to support communities engaging in microdosing, specifically by finding ways to document the benefits communities of color are experiencing. Dr. Tina Gonzales inquired about the specific data points collected in Oregon, hoping to learn where Colorado could improve over Oregon to demonstrate positive outcomes. Without getting into specifics, Mr. Howard explained that the data collected under Oregon’s SB-303 mandate is basic quantitative data about the program itself. To bridge the gap, the Psilocybin Therapy Insurance Initiative collects data that is qualitative in nature in hopes of better understanding how outcomes relate to an individual’s experience, history, and personal circumstances.

Closing out the discussion, Mr. Howard thanked subcommittee member William Dunn for his services as a paramedic, noted a first responder-centric group administration initiative in Oregon, and encouraged Colorado to consider a similar program. Before Mr. Howard departed, Dr. Clarissa Pinkola-Estes asked that Mr. Howard return to speak about the specifics of the Innertrek training program.

Following the conversation with Mr. Howard, the subcommittee was set to discuss a payment plan option for facilitator training programs. Unfortunately, the subject that NMAB chair Lundy had passionately advocated for was dismissed quickly. In doing so, Dr. Conner alluded to a conversation with Director Bratten indicating that a payment plan would not be feasible. Instead, Director Bratten shared that training program applications were exceeding expectations, with at least five applications having been submitted at the time of the meeting.  While she was not able to give a specific figure, Director Bratten stated that she expects facilitator license fees to be less than the initial estimate, which was around $3,000. This would put the total cost of facilitator licensure at $10-$12k for a training program and license fee. Apparently satisfied with the current state of affairs, Dr. Conner suggested revisiting the topic at a later date to ensure there is equity and diversity in training programs. Dr. Sophia Chavez suggested that the state develop a program to assist programs in getting approved. Director Bratten reminded the group of the legacy healer accelerated licensure pathway and DPO’s general disposition of not denying licenses.

For the final segment of the meeting, Director Bratten walked the subcommittee through DORA’s complete rules related to the practice of facilitation. Ms. Bratten explained any divergence from initial Board recommendations, such as where public feedback, Colorado law, or practicality required additions or modifications. Director Bratten emphasized that the Department’s rules adhered to the Board’s recommendations as closely as possible while noting that DORA and the Board may need to reexamine recommendations and rules related to supervised practice. According to Director Bratten, feedback has indicated that current supervised practice rules will be difficult to satisfy in the early stages of the program. Ms. Bratten requested the subcommittee’s assistance in developing documents, such as informed consent and safety screening documents, that the Department will provide. Finally, Director Bratten Noted that, although rules currently require facilitators to collect participant data, collection and storage mechanisms for the information have yet to be determined.

July 19: Full Natural Medicine Advisory Board Meeting

DORA Program Director Bratten kicked off July’s meeting of the full Natural Medicine Advisory Board with rulemaking updates, celebrating the completion of DORA’s initial three rulemaking proceedings and complementing the Board on their work. Ms. Bratten also shared that one facilitator training program has received full approval, with an additional five applications pending. DORA will begin work on facilitator applications in the coming weeks.

The Department of Revenue update took a different tone. Seemingly in response to recent criticism from some Board members, DOR officials explained in detail their responsibilities under the Natural Medicine Health Act, as well as the Colorado Administrative Procedure Act (“APA”). In justifying divergences from NMAB recommendation, the Department pointed to a statutory responsibility to ensure Regulated Natural Medicine is safe, as well as their duty under the APA to solicit feedback from a diverse group of stakeholders – which includes the public. Unfortunately, the most vocal critic of DOR’s rules, Dr. Brad Conner, was not in attendance. Subcommittee guest Nate Howard returned to briefly discuss the Sheri Eckert Foundation and the Psilocybin Access Fund with the wider NMAB.

While much of July’s meeting was devoted to updates, the Board was asked to weigh in on two potential changes to supervised practice (practicum) requirements. First, whether training programs should be permitted to offer supervised practice hours concurrently with didactic training. Current rules require that students complete the core 150 hours of didactic education prior to beginning the 40 hours of practicum. This seemingly simple question led to a lengthy and nuanced discussion on whether certain types of practicum hours should be tied to the completion of specific didactic modules, such as ethics training. Broadly, the board agreed that experiencing natural medicine or shadowing an experienced facilitator as they provide facilitation services can happen at any point, but any practicum hours where the student is actually facilitating for a participant should require completion of all 150 didactic education hours. Additionally, the Board agreed that at least some practicum hours must be gained through student-leading facilitation, although the Board did not agree on an exact number. Ultimately, the Board adopted a recommendation to amend the rules, permitting concurrent didactic and practicum hours, with around 15 hours reserved for post-didactic training where the student provides facilitation services. DORA will draft amended rule language for Board discussion in August.

Second, the Board was asked to weigh on practicum locations. According to the Attorney General’s office, current rule language only permits practicum to take place at licensed Healing Centers. After state officials confirmed that current rules permit facilitation to take place outside of Healing Centers, the Board quickly adopted a recommendation to allow practicum to take place outside of licensed Healing Centers, in line with rules that permit facilitation at other authorized locations.

July 25: Final Rulemaking Hearing – Natural Medicine Businesses

Coming into the final hearing for all rules related to Natural Medicine Businesses, several changes were needed to ensure that Colorado’s Natural Medicine program is as accessible, equitable, and sustainable as possible. These areas included permitting personal use testing, reducing unnecessary packaging restrictions, permitting common additives in manufactured products, and further refining rules in some areas, such as cultivation, to ensure participation in the market is economically viable.

DOR’s Natural Medicine Division anticipated some of the big questions. On the subject of data collection and outcome reporting, NMD Senior Director Dominique Mendiola assured the public that the Department is continuing conversations around outcome reporting, but the current lack of funding, as well as the Division’s need to prioritize its mandatory responsibilities, meant that reporting to the degree desired would not make it into the first round of rules. Officials provided welcome clarification on a handful of questions the public has been wondering about, stating that nothing in the rules is intended to prevent discretionary disposal of natural medicine or to prevent testing labs from retaining samples to conduct stability testing over time.

During the two-part meeting, regulators walked the public through a high-level overview of the rules, occasionally providing additional context, such as the reasoning behind a certain decision or responding to previously received public comments. For example, cooperative-ownership business structures are permissible, however financial interest and owner license rules would still apply. Officials also emphasized changes the Division had made in response to public feedback, such as flexible security rules permitting low-cost surveillance systems.

During the first round of public comments, two speakers opposed allowing chocolate and soft confections to be manufactured Natural Medicine Products, claiming they place children in danger. The speakers made these claims in spite of the fact that regulated products are tightly controlled and only accessible to adults under supervision by licensed individuals—a fact underscored by several supporters of expanded product types.

Additional concerns raised by the public included:

• High financial penalties for violations
• Financial burdens imposed by requiring Facilitators to obtain an additional Natural Medicine Handler license
• A poorly worded rule that would subject businesses to liability for possessing or testing adulterated Natural medicine without knowledge

During the afternoon session, the public expressed high-level concerns that excessive paperwork and recordkeeping may discourage participation in the regulated market. Speakers supported additional products, urged more permissive rules regarding extractions, decreased the frequency of contaminant testing, and permitted microdosing in the regulated space.

While the first round of rulemaking has concluded the process remains ongoing. The Natural Medicine Division will hold a stakeholder engagement meeting related to proposed fees for Natural Medicine Businesses on August 28th, with a final hearing on September 16. Already, the NMAB and regulators have identified areas where rules may need to be added or changed, as well as statutes that may need amending. As the Board continues to meet and make recommendations, stay tuned to this blog for updates, as well as future opportunities to help refine and improve the regulated program in Colorado.

For a holistic summary of the program’s key aspects, check out Bulletin 13.5.

Upcoming Public Engagement Opportunities