As of August 9, 2024, Colorado regulators have completed the first round of rulemaking for the state’s regulated Natural Medicine program, laying the foundation for the program’s launch on January 1, 2025. While some rules are still awaiting approval by the Attorney General, these final rules provide the full picture of Colorado’s regulated Natural Medicine program. Thank you to the staff at DORA, DOR, the Attorney General’s office, Natural Medicine Advisory Board members and participants, and each member of the public who contributed to the creation of this new program for state access to natural psychedelic medicines. In this article, we’ll take a holistic view of the program, outlining the contours and summarizing the key components.
First, a quick primer on Colorado’s regulatory framework.
The program requires regulation of the profession of facilitation, which includes training and licensing facilitators, as well as overseeing training programs. Regulators must license the operations of businesses necessary to support the profession of facilitation, such as businesses that will administer, cultivate, manufacture, and test the natural medicine used in the program. It is also important to note that, while Colorado’s program may include additional natural medicines in the future, Natural Medicine currently means only psilocin and psilocybin, naturally occurring in psilocybin-containing mushrooms, which is reflected in the first round of rules.
Administratively, these duties are divided between two regulatory agencies. The Office of Natural Medicine (“Office”), part of the Department of Regulatory Agencies’ (“DORA”) Division of Professions and Occupations, oversees the profession of facilitation. Rules promulgated by the Office set standards for education, training programs, professional conduct, and disciplinary procedures. The Division of Natural Medicine (“Division”) within the Department of Revenue (“DOR”) is tasked with overseeing Natural Medicine Businesses, which enable the profession of facilitation. Natural Medicine Businesses are those that cultivate, manufacture, and test natural medicine, as well as Healing Centers where facilitators will provide Natural Medicine Services.
To sum it up, DORA regulates the conduct of facilitators in all instances, while DOR regulates any activity occurring within a Natural Medicine Business.
In This Issue:
The Practice of Facilitation
DORA’s Office of Natural Medicine oversees the professional facilitators that will provide Natural Medicine Services. The Office’s authority includes establishing and enforcing rules related to qualifications, training, licensing, scope of practice, and ethics.
License Fees
License fees for training programs have been set at $10,000 for the first year. Fees for other licenses have not been set. Stay tuned.
License Types
The Office will issue two full-scope licenses and two ancillary licenses. Full-scope licenses, which may provide Natural Medicine Services independently, are “Facilitator” and “Clinical Facilitator.” The Facilitator license is available to any individual who completes the education and experiential requirements. The Clinical Facilitator License is available to applicants who complete the same training requirements as a facilitator and possess a secondary license with “authority to diagnose and treat” physical or behavioral health conditions.
Two ancillary licenses are also defined. A “Distinguished Educator” license, available to individuals with significant experience providing Natural Medicine Services, allows a licensee to provide Natural Medicine Services within the context of a training program. Under the current rules, a Training license is available to individuals who complete the required 150 hours of didactic education and permits a licensee to charge for Natural Medicine Services provided during a supervised consultation period. Neither a Distinguished Educator or Training license is considered full-scope, meaning licensees may not provide Natural Medicine Services independently.
Scope of Practice
Scope of Practice rules define the circumstances under which a Facilitator or Clinical Facilitator may provide Natural Medicine Services to a given Participant. Prior to an Administration Session, all facilitators are required to conduct a safety screen with each Participant. If the safety screen identifies risk factors associated with the use of Natural Medicine for that participant, the facilitator’s scope of practice will dictate whether they may provide Natural Medicine Services to the Participant by default, or if additional steps are necessary. Risk factors may be physical health conditions, mental health conditions, or medication interactions. If treatment of the risk factor is outside the facilitator’s scope of practice, they may still provide Natural Medicine Services if the participant receives the opinion of a third party that is licensed to treat the risk factor. Third-party opinions may be in the form of a direct referral, medical clearance, or consultation and risk review. So long as the participant understands and consents to any risks, a facilitator may provide Natural Medicine Services if the above steps are followed.
In practice, this means that a participant with risk factors will need a third-party opinion to receive Natural Medicine Services from a single-licensed Facilitator. Whether a participant can receive Natural Medicine Services from a Clinical Facilitator without a third-party opinion will depend on the specific risk factor and the Clinical Facilitator’s secondary license.
Standards of Practice
Standards of Practice rules are, in essence, the ethical code of conduct facilitators must abide by. They include:
- Required documentation and disclosures
- Confidentiality and storage of participant records
- Informed consent processes and disclosures
- Permitted and prohibited use of physical touch
- Prohibitions on discrimination and exploitation
- Prohibitions on sexual, romantic, financial, or otherwise conflicting relationships with participants and participants’ immediate family
- Prohibitions on accepting fees for referrals
- Requirements around a Facilitators state of mind, including a prohibition on consuming Natural Medicine while providing Natural Medicine Services
- Maintaining competency as a facilitator
- Administration session duration, based on dosage
Rules also establish a facilitator’s responsibilities with regard to preparation, administration, and integration sessions, including group administration and integration. Notably, these rules permit administration outside of Healing Centers, as well as group administration.
Residential Facilitation
Final rules permit Natural Medicine Services to be provided in the private residences of participants, as well as “other authorized locations,” so long as at least one participant is legally entitled to occupy the residence. Participants must consent to either a second facilitator or video recording during an Administration Session outside of a Healing Center. Prior to administration at a private residence, facilitators must take appropriate measures to ensure the environment is suitable for Natural Medicine Services, such as being free of hazards, weapons, and uncontrolled animals. Additionally, minors may not be present. Facilitators are not permitted to use unregulated natural medicine in any Administration Session, including in a private residence. Facilitators may receive up to 750mg of total psilocin in regulated natural medicine from a Natural Medicine Products Manufacturing Facility, Natural Medicine Cultivation Facility, or Healing Center. Facilitators are responsible for maintaining custody of Regulated Natural Medicine before and after any Administration Session that occurs outside of a Healing Center.
Facilitator Education and Experience
As a baseline, all Facilitators and Clinical Facilitators must complete 150 hours of didactic education, 40 hours of supervised practice (practicum), and 50 hours of consultation. A training license is required for the consultation period. The 150 hour curriculum is broken into 14 required courses, with required topics prescribed by rule. Rules also set requirements for supervised practice hours, such as mandatory and permissible types of supervised practice, supervisor qualifications, distribution of hours, procedures for practicum sites, and the extent to which virtual and alternative training is permissible.
Educational Equivalence Pathways
Facilitators licensed in another jurisdiction, such as Oregon, for at least one year, may apply for licensure via an Occupational Credential Portability Program. Unlicensed applicants with experience providing Natural Medicine may also apply for accelerated licensure by petition, which grants exemptions from licensure requirements based on prior education and experience. Approved training programs can certify equivalent experience in any of the accelerated tracks.
Facilitator Training Programs
Training programs must receive approval from the Office of Natural Medicine to ensure graduating students are eligible for licensure. Rules establish standards for the approval of programs, such as requirements for organization and administration of the program, as well as program responsibilities and recordkeeping requirements. Rules also establish the privileges of “approved” status and set minimum education standards, documentation requirements, enrollment limits, and faculty composition. Finally, rules establish procedures for application, denial, revocation, maintenance, reinstatement of “Approved” status, pre-approval of programs, and for student transfer between programs.
Unlicensed Practice of Facilitation and Facilitator Discipline
Rules define grounds for disciplinary action against a licensed facilitator, including certain felonies and misdemeanors, abuse of alcohol or controlled substances, violations of laws or regulations related to Natural Medicine, misrepresentation and deception, unprofessional or dishonest conduct, unlicensed practice of Facilitation, aiding or abetting the unlicensed practice of facilitation, and failure to report certain required events. Licensees are required to report criminal convictions and any instance of unprofessional or dishonest conduct. “Unprofessional or dishonest conduct” encompasses crimes involving dishonesty or willful misrepresentation, crimes related to the practice of facilitation, and disciplinary actions taken against a facilitator by another jurisdiction or licensing board.
Natural Medicine Businesses
Final rules from DOR’s Natural Medicine Division governing Natural Medicine Businesses come in at just over 100 pages. For the purposes of this article, we’ve focused on key aspects that form the overall shape of the program. We’ve omitted some rules, such as procedures for applications, product recalls and embargoes, declaratory orders, recordkeeping, disciplinary actions and appeals, inspections, and general rules like sanitation and security requirements.
License Fees
License fees for Natural Medicine Businesses will be established during a second round of rulemaking, anticipated in late summer 2024.
License Types
The Division will issue four primary types of facility licenses: Regulated Natural Medicine Cultivation, Regulated Natural Medicine Product Manufacturing, Regulated Natural Medicine Testing Facility, and Healing Center. Additionally, the Division will issue and require individual licenses for all owners of Natural Medicine Businesses and employees or contractors that directly handle natural medicine.
Owner & Natural Medicine Handler Licenses
Owners of Natural Medicine Businesses that are natural persons must be over twenty-one and may not have been convicted of certain violent crimes or crimes related to Natural Medicine in Colorado. Additionally, publicly traded companies are prohibited from owning Natural Medicine Business Licenses. Owners must disclose certain financial interests, and may not hold a financial interest in more than five Natural Medicine Business licenses.
Individuals who directly handle natural medicine or who have unrestricted access to natural medicine are required to obtain a Natural Medicine Handler License. Notably, this includes any Facilitator who may handle natural medicine at a Healing Center. Rules establish qualifications and requirements for Owner and Natural Medicine Handler licenses.
Healing Centers
Natural Medicine Services may be provided in Healing Centers, facilities specifically licensed by the Department of Revenue for the provision of Natural Medicine Services. The final rules provide for two categories of Healing Centers based on the amount of Natural Medicine the Healing Center keeps on hand. This bifurcation anticipates two distinct models of Healing Centers. One model mirrors Oregon’s Psilocybin Service Centers. Providing Natural Medicine Services will be the primary focus of these businesses, which will likely serve multiple participants daily and maintain multiple facilitators on staff.
The second model is unique to Colorado, made possible by the Natural Medicine Health Act expressly permitting Natural Medicine Services for the treatment of mental health conditions. In this model, a mental or behavioral health professional may offer Natural Medicine Services as a part of their existing therapy or wellness practice (or any other type of business, with a few exceptions). These micro-healing centers, defined as those storing less than 750mg of total psilocin, are subject to significantly reduced security and surveillance requirements. All Healing Centers must employ or contract with a DORA-licensed facilitator at all times.
Food and Beverages
During an Administration Session, Healing Centers may mix natural medicine with water, fruit juice, or pre-packaged items for the purpose of consumption. Participants may consume pre-packaged food and beverages, including fresh fruits and vegetables, during Administration Sessions. A Healing Center that is separately licensed under state and local food establishment requirements may provide prepared food before or after Administration Sessions.
Co-Location and Multi-Use Spaces
Healing Centers are expressly permitted to be co-located with healthcare facilities and are not prohibited from being co-located with other types of businesses. Additionally, flexible rules allow a Healing Center to be utilized for purposes other than Natural Medicine Services. Rules expressly permit Administration Areas to be used for other purposes when Regulated Natural Medicine is not present and simply require that Regulated Natural Medicine be appropriately stored when a Natural Medicine Business is not operating. Additionally, a Natural Medicine Business may operate on the same parcel as a marijuana or alcohol license, so long the licensed premises of each license do not overlap. Rules permit the co-location of Healing Centers with cultivation facilities, as well as manufacturing facilities that do not utilize hazardous or flammable substances.
Cultivation
Cultivation licensing reflects the same tiered approach in business models, offering multiple tiers for different business models. The standard cultivation tier may store up to 5 kilograms of dried, whole mushrooms at a time. Micro-cultivators may store up to 750 grams of dried whole mushrooms, sufficient for a small therapy practice or solo facilitator to cultivate their own Regulated Natural Medicine. Cultivators may petition for a ceiling higher than 5 kilograms upon a showing of a commercial need.
Manufacturing
A Natural Medicine Product Manufacturing license is required to produce any Regulated Natural Medicine Product, which includes anything other than whole, dried mushrooms. By default, a manufacturer may produce capsules and tea bags. Natural Medicine Product Manufacturers may receive an Extraction Endorsement, which permits the production of chocolate, gummies, pressed tablets for oral consumption, as well as tinctures for sublingual administration.
Natural Medicine Testing Facilities
Natural Medicine Testing Facilities are expressly permitted to be co-located with marijuana testing facilities, allowing a laboratory to serve both the Natural Medicine and marijuana markets. Unfortunately, licensed Natural Medicine Testing Facilities are currently prohibited from testing unregulated Natural Medicine, however the Division has indicated it intends to address personal use testing at a later date. Natural Medicine Testing Facilities must be certified by the Colorado Department of Health and Environment as well as accredited in each test type the facility performs.
Required Testing
Potency Testing
Each Harvest Lot of cultivated Natural Medicine, or Production Batch of manufactured products, must be submitted for Tryptamine Content Analysis (colloquially, “potency testing”). Tryptamine Content Analysis must measure the levels of Psilocybin, Psilocin, Baeocystin, Aeruginascin, and Norbaeocystin. Each Harvest Lot or Production Batch must also be free of 4-AcO-DMT, a synthetic tryptamine often found in counterfeit or adulterated mushroom products.
Contaminant Testing
Testing for the biological contaminants salmonella and Shiga toxin-producing Escherichia coli (STEC) must be conducted every 30 days. The Division may require testing for pesticides, heavy metals, or mycotoxins on request.
Optional Testing
Natural Medicine Businesses may voluntarily conduct testing for heavy metals, pesticides, solvents, or mycotoxins. They may also conduct testing to establish shelf stability and for research and development.
Packaging and Labeling
Packaging and labeling restrictions are intended to prevent consumption by minors in the event of diversion, as well as misappropriation or commercialization of Indigenous culture. Colors, pictures, and cartoon images are prohibited from labels, as well as the words “candy” or “candies.” Regulated Natural Medicine and Regulated Natural Medicine Products intended for participant consumption must be packaged in child-resistant containers. Labels must include the following information:
- Psilocybe cubensis strain type
- Net contents in dried weight of whole fruiting bodies, or total psilocin for manufactured products
- Total Psilocin content in milligrams
- Date tryptamine content analysis was performed
- Harvest or production date
- A statement that tryptamine content must be re-tested every nine months unless an expiration date has been established
- For Regulated Natural Medicine Products, any ingredients including allergens
- Natural Medicine Business name and License number
- Harvest Lot and/or Production Lot number
- A Drug Interaction Warning
Marketing
As with packaging and labeling rules, marketing rules prohibit advertisements that appeal to minors or that appropriate Indigenous culture. Additionally, advertisements may not be false, misleading, or deceptive, and may not claim Natural Medicine is safe because it has been tested. Natural Medicine Businesses must maintain audience composition data to ensure advertisements do not target audiences under 21.
Transportation and Inventory Tracking
Natural Medicine Businesses are required to report all cultivation, production, destruction, and transfer of Regulated Natural Medicine, Regulated Natural Products, and Regulated Natural Medicine Waste each month. Only licensed individuals may transfer or transport natural medicine.
Enforcement and Penalties
Division rules establish procedures for the investigation and enforcement of violations. Penalties include sanctions against the licensee, including suspension, revocation, restrictions, and monetary fines. Level I violations, the most severe, are those that have “an immediate or potential negative effect on public health, safety, or welfare.” Level I violations include adulteration of natural medicine, diversion, transfer to minors, mislabeling, and improperly releasing personally identifiable information of participants.
Upcoming Public Engagement Opportunities
While these rules establish the pillars of Colorado’s program, the process remains ongoing. The Natural Medicine Division will hold a stakeholder engagement meeting related to proposed fees for Natural Medicine Businesses on August 28, 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.
August 28, 2024 @ 3-5 p.m MT: Stakeholder Engagement Meeting: Application and Licensing Fees — Natural Medicine Businesses (in-person and virtual)
September 16, 2024: Final Hearing: Application and Licensing Fees — Natural Medicine Businesses (in-person and virtual)
