Thoughtful Expansion – Oregon Issues First Psilocybin Edibles Endorsement to Licensed Manufacturer

Foley Hoag LLP - Cannabis and the Law
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Foley Hoag LLP - Cannabis and the Law

As many states and municipalities around the country grapple with the ever-increasing popularity of psilocybin-based products, a few have staked out leading positions in what may be the next wave of psychoactive products to become widely accepted medical therapies. Five years ago, the City of Denver made waves, becoming the first major city to decriminalize possession of psilocybin. The ripples from that watershed vote eventually led to the passage of a statewide ballot initiative to decriminalize the substance in Colorado. The next major leap was Oregon, which, in 2020, became the first state in the nation to pass a ballot initiative establishing a framework for legal psilocybin sales and consumption within the state. The state’s first psilocybin service centers were licensed in 2023 by the Oregon Psilocybin Services section (“OPS”) of the Oregon Health Authority and commenced operations in the summer of last year.

The OPS simultaneously issued licenses to other essential participants in the state’s licensed psilocybin market, including manufacturers, facilitators (individuals who support clients through psilocybin services) and testing laboratories. As of July 29, 2024, the OPS had issued 33 service center licenses, 13 manufacturer licenses, 352 facilitator licenses, and 1 testing laboratory license.

Pursuant to section 475A.295 of the Oregon Psilocybin Services Act (“OPSA”), manufacturing licensees must apply for one or more specific endorsement types, including fungi cultivation, psilocybin extraction, and edible psilocybin production and a manufacturer “may only engage in a type of manufacturing activity if the psilocybin product manufacturer has received an endorsement from the [OPS] for that type of manufacturing activity.” As has been reported by several news outlets, OPS has issued the first edible production endorsement to a manufacturing licensee. Billing itself as the first “legal psilocybin edible manufacturer” in the state, Spiritus Oregon has developed an edible product line including chocolates and gummies ranging from 2mg of psilocybin per serving up to 25 mg per serving. In accordance with the OPSA, Spiritus Oregon and any other manufacturers that may in the future receive edibles endorsements from OPS must also hold a Food Safety License from the Oregon Department of Agriculture.

The developing legal psilocybin market in Oregon will no doubt buoy the hopes of grassroots organizers across the country who continue to advocate for decriminalization and legalization. Although psilocybin remains a Schedule I controlled substance under the federal Controlled Substance Act, these grassroots organizers have been undeterred and continue to push for legal access to psilocybin products. On that score, in just a few months, voters in the Commonwealth of Massachusetts will have the opportunity to “vote yes” on Question 4, which would allow for legal, regulated access to certain psychedelic substances, including psilocybin. If the ballot initiative passes, a new law (“The Natural Psychedelic Substances Act”) would allow persons aged 21 and older to grow, possess, and use certain natural psychedelic substances in certain circumstances. Like Oregon’s program, these substances could be purchased at an approved location under the supervision of a licensed facilitator. We will continue to monitor the ballot initiative in Massachusetts as well as the growing momentum toward decriminalization/legalization of psilocybin and other psychedelic therapies across the country.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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