Allay Consulting October Newsletter: Entheogens & What Future Compliance May Look Like

Entheogens & What Future Compliance May Look Like

Psychedelics, aka entheogens. Everyone has an opinion. From the superb kaleidoscope shapes, or making that concert even more memorable, or to digging a bit deeper within yourself for self-healing, entheogens can be a game changer. For some, these experiences are life changing, especially if it means improving well-being and life-satisfaction. Thanks to many published clinical trials, benefits of using entheogens such as psilocybin include reducing anxiety and depression, successful addiction interruption, PTSD treatment, and many others. With increased awareness of the benefits of psilocybin and other entheogens, we are observing an acceptance of entheogens followed by decriminalization and future legalization.

With the passing of Ballot Measure 109 in November 2020, Oregon legalized the manufacturing, transportation, delivery, sale, and purchase of psilocybin products. Several other cities have decriminalized, yet Oregon is the only state to legalize psilocybin mushrooms. We are expecting a similar roll-out of regulations as cannabis with a focus on compliance to keep the public safe and companies in business. With so many other types of psychedelics (aka entheogens), we will dive further into common psychedelics, cities who have decriminalized, and the future compliance of hallucinogenic plant and fungi.


What are Entheogens?

Psychedelics are often grouped together to include natural plants and fungi – and some include synthetic substances. These hallucinogenic plants and fungi are often referred to as “entheogens”: en (within) theo (divine) and gen (creates). Entheogens means “creating the divine within”. If you were to chat with a person who is well acquainted with psychedelics, they’d likely say entheogens are natural plants that provides you with a spiritual experience (Steinhardt, 2020). In an article published by DoubleBlind, the word “entheogen” was created in the 1950’s to rebrand “psychedelic” to reframe value and perceived validity in a more positive neutral term. Articulating an immense spiritual experience through one word can be difficult, however the word entheogen feels right.


Common Entheogens

While the recent political attention has been on mushrooms containing psilocybin and psilocin, there are plenty of other psychedelic natural plants. Surprisingly, there are thousands of plants and fungi that induce psychotropic effects. Below is a short list of the most common entheogens, some are detailed in various decriminalization movements.

Morning Glory Seeds – yes, the crawling vine plant that blossoms beautiful bright purple-blue flowers. Beware, some seeds are coated with an antifungal chemical.

Iboga – has been demonstrated to interrupt substance use disorders

Salvia – aka sage, but not the same sage found in your cupboard

LSD – a synthetic chemical comprised of a substance found in ergot fungus

San Pedro cactus – a striking cactus that can grow anywhere between 10ft to 20ft tall and blooms impressive white flowers

Peyote – the earliest record of peyote is dated back to 3780-3660 BCE in ancient Native American tombs

Ayahuasca – described as a profound and transformative experience

“Decriminalize Nature” is a common phrase we see from cities attempting to pass decriminalization. Within the last two years, there are multiple cities and states making changes to decriminalize nature, specifically entheogens!


Cities Who Have Decriminalized forms of Entheogens Not to be confused with Legalized!

Cities across the United States are decriminalizing entheogens. Reminder – these cities have not fully legalized any commercial activity (except the state or Oregon). Please note that there are religious exemptions for using of psychedelics.

2019 – Denver, Colorado decriminalized psilocybin mushrooms

2019 – Oakland, California decriminalized psilocybin mushrooms and peyote

2020 – Santa Cruz, California decriminalized psilocybin mushrooms

2020 – Ann Arbor, Michigan decriminalized entheogenic plants or plants compounds

2020  state of Oregon LEGALIZED psilocybin mushrooms via Ballot Measure 109

2020 – District of Columbia decriminalized psilocybin mushrooms, ayahuasca, and mescaline

2021 – Washtenaw County, Michigan decriminalized entheogenic plants

2021 – Somerville, Massachusetts decriminalized the possession of entheogenic plants, including psilocybin mushrooms and ibogaine

2021 – Cambridge, Massachusetts decriminalized entheogenic plants and fungi like ayahuasca, ibogaine and psilocybin mushrooms

2021 – Northampton, Massachusetts decriminalized entheogens like psilocybin and ayahuasca

2021 – Seattle, Washington decriminalized enforcing all entheogen-related activities


Potential Future Compliance with Entheogens

The only state to legalize entheogens, specifically psilocybin mushrooms, is Oregon. The Oregon Health Authority Public Health Division’s Center for Health Protection (OHA) created a new section called, “Oregon Psilocybin Services” to handle the regulatory roll-out. The OHA will regulate the manufacturing, transportation, delivery, sale, and purchase of psilocybin products. The section will determine the regulatory framework and implementation over a 2-year time frame. The OHA will begin taking applications for licenses beginning January 2, 2023. Although we are extremely grateful for Oregon’s legalization, the community does not yet have a well painted picture of how psilocybin will be regulated.

We believe the future set of Oregon’s psilocybin regulations will be a combination of current guidelines used by other regulated industries. This may include combining several sets of regulations: cannabis regulations, USDA, and FDA along with unique local/city specific requirements.

Aspects of current cannabis regulations may be imposed on the psilocybin legalized community. A major part adopted from cannabis may include the traceability & reporting of mushrooms. Traceability is encouraged from the FDA yet heavily enforced from cannabis state regulators. The mushroom traceability program may incorporate aspects from the manufacturer, laboratory, service center and facilitator license types all the way through the customer. Most states require cannabis companies to use a state issued traceability platform to help track each product with the intention of limiting products entering the non-regulated market.

The United States Department of Agriculture (USDA) has a division that provides audits for the production of non-psychedelic mushrooms. Although the USDA doesn’t regulate the mushroom industry, the department provides audit programs and good agricultural practices. These guidelines may provide the psilocybin community insight into how Oregon may regulate mushroom cultivation best practices.

The FDA has established standards for the growing, harvesting, packing, and holding of produce for human consumption. Yes, the FDA categorizes mushrooms as produce. This falls under FDA’s Produce Safety Rule. These standards may support many aspects of the psilocybin industry to ensure the safety of the product and ultimately the safety of the end consumer.

FDA’s Current Good Manufacturing Practices (cGMP) would be applicable once the mushroom is harvested from the growing medium and then processed. These are the same cGMPs that are applicable in any traditional food or hemp product manufacturing facility. cGMP requires a systematic quality approach to manufacturing, including the development and implementation of procedures and documentation for the design, monitoring, and control of all manufacturing processes. Not only does cGMP help businesses prevent hazards such as contamination or errors, it also ensures that products are safe for consumers, every time.

Though these are only projected applicable standards and regulations, it gives the entheogen community a head start on which sets of regulations to apply. We will ultimately have to wait and see how Oregon rolls out their two-year development period to see their regulations. If you don’t want to wait for Oregon’s roll-out, be proactive with compliance with Allay Consulting! For compliance support and implementing cGMPs, please reach out to Allay Consulting.



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