Under Oregon’s Proposed Rules, Legal Psilocybin Will Be All-Natural, Organic, and GMO-Free

The 2020 ballot initiative that made Oregon the first state to legalize psilocybin use instructed by the Oregon Health Authority (OHA) to complete the regulations necessary to implement that policy within two years. The OHA, which plans to begin accepting applications from psilocybin manufacturers and “service centers” on January 2, is on track to comply with that requirement. Its proposed regulations should interest psychedelic fans and drug policy reformers, since they represent a groundbreaking effort to establish rules for producing, distributing, and consuming the main active ingredient in “magic mushrooms,” which the federal government has banned since 1968.

Measure 109, aka the Oregon Psilocybin Services Act, envisions businesses where adults 21 or older can legally take the drug under the supervision of a “facilitator” after completing a “preparation session.” It says the “clients” of those “psilocybin service centers” need not have a specific medical or psychiatric diagnosis, leaving the door open for anyone interested in the experience for psychological, spiritual, intellectual, or recreational reasons.

That is a striking departure from the approach taken by the Food and Drug Administration (FDA), which has deemed psilocybin a “breakthrough therapy” for treatment-resistant depression and may eventually approve it for that purpose. Even when psilocybin is available as a prescription drug, its legal use will be limited to patients who qualify for that diagnosis or another medical or quasi-medical label.

Oregon’s proposed regulations, which are open to public comment until April 22, also differ from the FDA model in prohibiting synthetic psilocybin, specifying that the drug must be not only from fungi but from a single species: Psilocybe cubensis, which is one of hundreds that contain psilocybin. The rules also restrict growing media (prohibiting manure and wood chips because of concerns about microbial contamination); the solvents that can be used for extraction (allowing only water, vegetable glycerin, acetic acids, ethanol, and methanol); the forms in which extracts can be sold (banning those that “appeal to minors,” such as “products in the shape of an animal, vehicle, person or character”); and the way in which those extracts may be consumed (specifying that they “must be consumed orally”).

That last requirement, which explicitly rules out “transdermal patches, inhalers, nasal sprays, suppositories and injections,” could prove problematic. “Studies have shown that psilocybin therapy is effective in relieving emotional and existential distress at the end of life for 65-85% of terminally ill people in clinical trials, when administered properly,” Harris Bricken managing partner Vince Sliwoski notes on the firm’s Psychedelics Law Blog. “Many terminal patients cannot swallow….If OHA sticks to this ‘oral only’ stricture in the final rules—based on a restrictive reading of Measure 109 or for any other reason—you can expect some other reason—and perhaps even contro intervention.”

The OHA’s proposed regulations include some other weird or questionable elements. They say “manufacturers are prohibited from applying pesticides to fungi or growing medium,” for instance, while also requiring rejection of any extract batch when testing “detects the presence of a pesticide above action levels in any sample.” If it is possible to use pesticides but still comply with the latter rule, you might wonder, why is an outright ban necessary? Manufacturers also would be prohibited from “producing psilocybin by using genetically modified organisms such as bacteria,” a rule that seems even more dubious.

Measure 109 charges the OHA with setting training requirements for facilitators, including coverage of “social and cultural considerations.” The authority arguably went overboard with that mission.

The OHA plans to require that trip sitters complete a 120-hour, nine-module curriculum administered by licensed trainers, including 12 hours on “Cultural Equity in relation to Psilocybin Services.” Under that heading are topics such as “cultural equity, its relationship to health equity and social determinants of health”; “racial justice, including the impact of race and privilege on health outcomes and the impact of systemic racism on individuals and communities”; “the impact of drug policy on individuals and communities”; and the “history of systemic inequity, including systemic inequity in delivery of healthcare, mental health and behavioral health services.”

However one might quibble with the details of the OHA regulations, Measure 109 is creating an option that did not previously exist: Service center customers will be able to legally consume psilocybin of known provenance and dose, produced in sanitary conditions subject to rules that provide assurances of quality and safety that are generally hard to come by in the black market. And psychedelic users who rebel at the OHA’s requirements can still resort to self-help. Oregon voters made that option less legally perilous on the same day they passed Measure 109, when they also approved a trailblazing ballot measure that eliminated criminal penalties for drug use.

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