Natural Medicine Advisory Bulletin 13.5: The Birth of a Regulated Psychedelics Program

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 FeesLicense fees for Natural Medicine Businesses will be established during a second round of rulemaking, anticipated in late summer 2024.License TypesThe Division will issue four primary types of facility license: 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 Business and employees or contractors that directly handle natural medicine.Owner & Natural Medicine Handler LicensesOwners 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 that directly handle natural medicine, or that have unrestricted access to natural medicine, are required to obtain a Natural Medicine Handler License. Notably, this includes any Facilitator that may handle natural medicine at a Healing Center. Rules establish qualifications and requirements for Owner and Natural Medicine Handler licenses.Healing CentersNatural Medicine Services may be provided in Healing Centers, facilities specifically licensed by the Department of Revenue for the provision of Natural Medicine Services.  Final rules provide for two categories of Healing Center, 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 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 BeveragesDuring 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 SpacesHealing Centers are expressly permitted to be co-located with health-care 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 co-location of Healing Centers with cultivation facilities, as well as manufacturing facilities that do not utilize hazardous or flammable substances.CultivationCultivation 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.ManufacturingA 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 production of chocolate, gummies, pressed tablets for oral consumption, as well as tinctures for sublingual administration.Natural Medicine Testing FacilitiesNatural 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 TestingPotency TestingEach 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 TestingTesting for the biological contaminants salmonella and Shiga toxin producing Escherichia coli (STEC) must be conducted every 30 days. Testing for pesticides, heavy metals, or mycotoxins may be required by the Division on request.Optional TestingNatural Medicine Businesses may voluntarily conduct testing for heavy metals, pesticides, solvents, or mycotoxins. Natural Medicine Businesses may also conduct testing for the purposes of establishing shelf-stability, as well as for research and development.Packaging and LabelingPackaging 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 Product 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 had been established;For Regulated Natural Medicine Product, any ingredients including allergens;Natural Medicine Business name and License numberHarvest Lot and/or Production Lot number;A Drug Interaction Warning.MarketingAs 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 TrackingNatural Medicine Businesses are required to report all cultivation, production, destruction, and transfer of Regulated Natural Medicine, Regulated Natural Product, and Regulated Natural Medicine Waste each month. Only licensed individuals may transfer or transport natural medicine.Enforcement and PenaltiesDivision rules establish procedures for 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.



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