Natural Medicine Advisory Bulletin #8.1: Recommendation Round-up

***Production, Cultivation, and TestingThe Products, Research, and Data subcommittee, which produced the following recommendations, relied heavily on outside experts in the form of non-voting participants in the development of their recommendations. Recognizing the limitations of their knowledge, many recommendations in this area take the form of giving a general direction to state regulators, while leaving the regulators significant discretion in the specific implementation. Conversely, where the Board did make specific prescriptions in recommendations, they were often overly restrictive and based on fear of the unknown. Recommendations which restrict participants and facilitators from combining natural medicine with other ingredients, while targeted towards unsafe combinations, are overly broad and prohibitive. Banning common methods of extraction and limiting natural medicine products to only those which can be orally consumed effectively excludes many palliative care and end-of-life participants from realizing the benefits of natural medicine. It’s disappointing to see the Board base their recommendations off of fear of the unknown rather than the reality of what is happening right now in the psychedelic healing ecosystem. If the regulators adopt these recommendations, the regulated program will be at a huge disadvantage compared to the unregulated community healing model.  CultivationLike Oregon, Colorado will only permit Psilocybe cubensis to be cultivated and sold in the regulated market. All strains of P. Cubensis will be permitted, but no other species of psilocybin-containing mushroom will be permitted. While there are arguments for allowing other species, this recommendation strikes the right balance, as other species are less well-studied and permitting them would inflate regulatory overhead.  Only two other specific rule recommendations were made regarding cultivation. First, that pesticides and fungicides be prohibited during cultivation, but if the regulator chooses to permit them, they should be included on product labels. Here the Board has made a sensible recommendation. Proper indoor mushroom cultivation should not require the use of chemical agents. Second, only additives which “do not increase harm”, such as inactive ingredients from the FDA’s inactive ingredient database, or additives that encourage cultivation without increasing harm, should be permitted to be added to substrates. The Board deferred any additional rules regarding the specifics of cultivation to the Department of Revenue, including rules regarding allowable substrates. Given that cultivating mushrooms by its very nature requires a high degree of cleanliness for success, regulators will hopefully avoid overly burdensome rules and direct their efforts towards a testing program that ensures the safety of natural medicine being sold.Electing not to recommend specific cultivation rules, the Board instead recommended that the FDA’s Mushroom Good Agricultural Practices (MGAP) be recommended to cultivators as a best practice guide. Overall, this is a sound recommendation that makes sense. While the MGAP standards are targeted to non-psychoactive food mushrooms, many aspects of mushroom cultivation are substantially similar across species and the standards will encourage safe, effective mushroom cultivation. Given that some requirements are only relevant to industrial-scale production, and would impose significant burdens on small-scale cultivators, not making them required is logical and reasonable. No need to reinvent the wheel at the expense of additional regulatory burdens. The Board did not take a specific stance on outdoor cultivation, recommending that if regulators choose to permit cultivation outdoors, the requirements set forth by regulators should reflect the inherent difficulties and safety risks involved. Given the arid climate in most of Colorado, it will be interesting to watch if outdoor cultivation will be commercially successful in the state. If regulators do allow outdoor cultivation, they should take measures to ensure additional regulatory overhead does not inflate the overall cost of the program. Regarding storage of natural medicine, the Board recommended that cultivators should follow “best practices.” Currently accepted best practices for the storage of psilocybin-containing products are to store them at room temperature in darkness and away from moisture or with devices to absorb moisture to improve the stability of the active ingredients in the products. This general recommendation reflects that current knowledge regarding psilocybin degradation is incomplete, and assumes that best practices will evolve as more studies are conducted.ProductionRecommendations regarding natural medicine-containing products were some of the most disappointing in the first round of recommendations. While the Board understandably wants to protect participants from unsafe and untested products, which was seen in the cannabis industry, the nature of the regulated natural medicine program is of a different type. Again, we see unfounded fear drive the recommendations and not a knowledge of the best practices utilized in the current psychedelic healing movement. With facilitators and healing centers serving as an intermediate check on products between producers and participants, there is room for sensible, measured introduction of new products. In this area, regulators will hopefully recognize this reality and make space for alternative products to meet the needs of all Coloradans. Otherwise everyone will be driven to continue to operate in the underground so they can utilize the medicines they prefer. Extractions using solvents are effectively banned under the Board’s recommendation with only water and fruit juice being permitted solvents. While this allows for some ultrasonic extractions and the common method of consuming mushrooms with citrus juice, the recommendation is unnecessarily restrictive and based on fear. In a similarly restrictive vein, products available in the regulated market shall be restricted to fruiting body mushrooms and powdered fruiting body mushrooms. Production of natural medicine products using solvent-free extractions will be required to follow Colorado food safety standards. Here again, the Board’s well-intentioned eye towards safety has hamstrung innovation in the natural medicine market, especially considering that the same goals could have been achieved through proper testing protocols. If these recommendations stand, the regulated market might not be viable. Additives that increase harm or intoxicating effects of natural medicine are prohibited. This recommendation, while also well-intentioned, is unhelpfully vague. Regulators, or courts, will be left to determine what exactly increases “intoxicating effects.” It is additionally problematic as many ingredients commonly used in microdosing protocols, for example niacin and lion’s mane, may be prohibited under this recommendation. Arguably the most disappointing recommendation of all limits products in the natural medicine market to only those which may be orally ingested. While the recommendation does allow for alternative methods of consumption to be introduced, it would require peer-reviewed safety research before any new products may be introduced. In addition to stifling innovation by imposing substantial costs of peer-reviewed studies on producers, this recommendation flies in the face of the voters who approved the Natural Medicine Health Act, which lists “end-of-life distress” in the legislative declaration as one of the many conditions natural medicine may alleviate. Given that many individuals experiencing end-of-life distress are beset by conditions which prevent them from swallowing, this recommendation is both frustrating and heartbreaking to many Coloradans, and will surely contribute to a thriving underground market.Labeling of ProductsThankfully, product labeling remains relatively uncontroversial. Products sold in the regulated market will be labeled with the following information:Date of harvest.Actual content, in mg, of psilocybin and psilocin.Total psychoactive compound, expressed in terms of psilocin.Date of potency test.Statement that the labeled potency reflects the maximum possible and that potency may decline over time.Best-by date, reflective of recent research regarding potency degradation.Testing Program FrameworkWhen it came to testing, the Board again relied heavily on the non-voting participants including several mycologists and professionals in the testing industry. Here, the overall testing regime is sensible and avoids undue burdens. Some specifics were left to regulators, which is arguably a good thing, given that DOR and CDPHE have the benefit of years of experience in building and refining the testing regime for the marijuana market in Colorado. Potency testing will be required on each harvest batch and will measure actual psilocybin and psilocin content. A “harvest batch” is defined as all mushrooms harvested from a single flush of a single inoculation. For every 1 kg of dried, harvested mushrooms cultivated, 2.5g of dry material will be submitted for potency testing. Samples must represent the heterogeneity of the batch, including caps, stems and different sizes of mushroom. Potency retesting should occur every nine months for unused natural medicine and natural medicine products. If, upon retesting, there is a decrease in potency of more than 15%, the product should be relabeled with the new maximum potency. If there is an increase in potency, the batch should be destroyed.Species testing will be conducted randomly once per year through regular site visits by regulatory authorities. Testing for heavy metals, pesticides, solvents, microbials, and mycotoxins will be conducted randomly once per year through regular site visits by regulatory authorities. Failure of any of these tests will result in destruction of the sample and batch. Additionally, licensed cultivators may be required to work with the regulatory agency to develop a remediation plan and comply with said plan before submitting any additional products for testing. The regulator may impose additional testing for the failure of any test, at its discretion. In-house testing will be permitted, but not required.Recommendations for Licensed Testing FacilitiesRecommendations regarding accreditation and standards for licensed testing facilities are also likely to be uncontroversial. The Board recommended that licensed testing facilities should meet International Organization for Standardization (ISO) 17025 standards for lab testing or similar newly developed standards that are particularly relevant to the testing of natural medicines. The Department of Revenue, in collaboration with CDPHE, will develop a proficiency testing program for testing licenses. Due to the nascent nature of the natural medicine market and resulting lack of true 3rd-party proficiency tests, the initial proficiency testing program may consist of round-robin testing and subsequent annual testing.The Board also recommended that licensed testing facilities be required to participate in proficiency testing provided by ISO 17043 accredited proficiency testing providers.



Source link