Natural Medicine Advisory Bulletin 11.6: June 14th Subcommittee: Problems with Products

This was the question directed to state regulators from the chair of the Natural Medicine Advisory Board’s (“NMAB”) combined subcommittee, Dr. Bradley Conner, during the final twenty minutes of the subcommittee’s June 14th meeting. The question revealed a significant misunderstanding between regulators and some Board members over the extent to which manufactured Natural Medicine products would be permitted in Colorado’s regulated Natural Medicine program. According to Dr. Conner, the Board had intended to recommend that no manufactured products be permitted, for at least the first year of the program. If that was the Board’s intent, it would fly in the face of the law, which clearly allows Natural Medicine Products, as well as significant public appetite for manufactured products. After this misunderstanding was revealed, NMAB member Dr. Sue Sisley expressed “serious concerns” about restricting the allowable forms of Natural Medicine so severely, and urged her fellow subcommittee members to address the issue quickly. In doing so, Dr. Sisley emphasized the need to respond to significant public pushback, as well as negative repercussions that could result from prohibiting manufactured products in the regulated market. Unfortunately, Dr. Sisley’s concerns were not heard, and further subcommittee discussion was postponed for another month.To understand why this meeting shocked some members of the public, some background may be needed. On June 6th, the Department of Revenue (“DOR”) released proposed rules for cultivation and manufacturing licenses, based largely on recommendations submitted by the NMAB in January. While cultivation-related rules were relatively benign, manufacturing rules contained several restrictions that, if adopted, could stifle Colorado’s regulated Natural Medicine program before it gets off the ground. Specifically, the proposed rules prohibit:All products other than whole or powdered mushrooms, tea, and chocolates;All routes of administration, other than orally-consumed products;All methods of extraction, other than water or fruit juice.During the course of a lengthy stakeholder engagement meeting, held on June 12th, public opposition to the proposed rules was abundantly clear. Over several hours, dozens of commenters raised concerns that the proposed rules would restrict access to Natural Medicine, prohibit common and beneficial methods of consumption, make accurate dosing close to impossible, and fuel participation in the unregulated market.The rules proposed by DOR reflect an attempt to reconcile the recommendations adopted by the Board in January, with the Department’s statutory mandate to issue Natural Medicine Product Manufacturer licenses. There is, however, reason to doubt that the Board understood the recommendations it adopted in January as completely prohibiting all manufactured products. Understandably, the Board did not individually discuss over 100 recommendations. Instead, the Board adopted nearly 60 pages of recommendations in one fell swoop. Though efficient, this course of action relied heavily on work done in subcommittees, and at the very least assumed that a subcommittee would not put forth for Board consideration a recommendation that directly contravenes the law as approved by voters. Given the far-reaching effects of restricting manufactured products in a nascent market, more careful consideration by the full Board is warranted. Unfortunately, neither the adoption of the consolidated recommendations by the Board in January, nor last week’s subcommittee provided that consideration.Coming into the June 14th meeting, the subcommittee’s agenda primarily consisted of reviewing and responding to feedback given by DOR and the Colorado Department of Public Health and Environment (“CDPHE”) on several Board recommendations related to cultivation, manufacturing, and testing. Discussions on testing and manufacturing were relatively straightforward, with the subcommittee generally acquiescing to regulatory need for discretion in testing, while rejecting changes that would increase costs to participants.However, as the discussion moved to products-related questions such as re-testing, additives, and extractions, it became apparent that subcommittee chair Dr. Bradley Conner and state officials held divergent views on what regulated Natural Medicine products in Colorado would look like – or if they would even exist. As the meeting progressed, it became increasingly clear that regulators were seeking answers to questions that Dr. Conner considered to be moot, a result of his view that manufactured products were prohibited by the Board’s recommendations.In response to a CDPHE concern that the recommended frequency of contaminant testing is too low to adequately protect public health in manufactured products, Dr. Conner pointed to the recommendation that only whole fruiting bodies or powdered mushrooms be permitted, thus avoiding the potential contamination from manufacturing processes that CDPHE is concerned about. CDPHE also sought clarification on why the board would recommend the use of food safety handling practices in extractions, if other recommendations preclude products that would utilize extractions. In Dr. Conner’s view, the original Products subcommittee did not intend to allow products that “sit on shelves,” but presumably wanted to permit combining Natural Medicine with fruit juice and water, which could be considered an extraction, albeit under a tortured definition.Seeking clarification of a prior NMAB recommendation that facilitators and Healing Centers be permitted to “prepare” Natural Medicine for consumption by a participant, DOR and CDPHE suggested the Board more clearly delineate preparation from manufacturing. In response, Dr. Conner asked regulators “When you say manufacture, what is it that you actually mean?” According to DOR and CDPHE representatives, regulators view “manufacturing” as producing pre-packaged Natural Medicine products, such as a premade teabag, while “preparation” is limited to preparing a final product for consumption, such as adding boiling water to a premade teabag. At this point, both Dr. Conner and state regulators seemed to realize that they had both been operating from different vantage points. After clarifying his perspective that the recommendation limiting products to “whole fruiting bodies and powdered mushrooms” meant exactly that, and not products made with whole fruiting bodies or powdered mushrooms, Dr. Conner asked if DOR could simply refrain from issuing production licenses. According to DOR’s Allison Robinette, the Department is required to begin accepting applications for all Natural Medicine Business Licenses by January 1st, 2025, including manufacturing licenses.Unfortunately, the subcommittee did not have a chance to address this newly-discovered disparity due to time constraints. Dr. Sue Sisley, a palliative care research doctor, expressed her serious concerns about the limitations on products and emphasized the need to address stakeholder feedback quickly. Dr. Sisley requested that the subcommittee find a way to continue the discussion outside of the meeting, due to the urgency and significance of the issue. Unfortunately, instead of engaging with those concerns, Dr. Conner pushed forward a decision to revisit the topic of manufactured products on July 12th, just six days before DOR must submit a final version of the rules.The question remains – did the NMAB really intend to prohibit all manufactured Natural Medicine products? It seems reasonable that the majority of the Board, the public, and regulators all interpreted the initial set of product-related recommendations as allowing products made using whole fruiting bodies or powdered mushrooms, not that those would be the only forms of Natural Medicine permitted in the state.DOR will share stakeholder feedback related to product restrictions at the June 21st meeting of the full Natural Medicine Advisory Board. Hopefully, the larger group will engage meaningfully with the subject, and with the significant amount of public feedback.



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