Entheogens and What Future Compliance May Look Like

Blogs | <b>Stuck on Compliance</b>

Psychedelics, also known as 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, the benefits of using entheogens such as psilocybin include reducing anxiety and depression, successful addiction interruption, post-traumatic stress disorder (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 roll-outs of regulations similar to those of cannabis with a focus on compliance to keep the public safe and companies in business. With so many other types of psychedelics (entheogens), we will dive further into common psychedelics, cities that have decriminalized, and the future compliance of hallucinogenic plant and fungi. The Oregon-proposed rules have been released, and all information about their psilocybin program can be found online (1). This is a very exciting time for the industry!

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 provide you with a spiritual experience (2). In an article published by DoubleBlind magazine word “entheogen” was created in the 1950s to rebrand “psychedelic” to reframe value and perceived validity in a more positive, neutral term (2). 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 gloryseeds – 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 – also known as sage, but not the same sage found in your cupboard

Lysergic acid diethylamide (LSD) – a synthetic chemical comprised of a substance found in ergot fungus

San Pedro cactus – a striking cactus that can grow anywhere between 10–20 feet 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 have been multiple cities and states making changes to decriminalize nature, specifically entheogens!

Cities across the United States are decriminalizing entheogens. Reminder: these cities have not fully legalized any commercial activity (except the state of Oregon). Please note that there are sometimes religious exemptions for using of psychedelics in different states and tribal lands as well.

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 plant 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

2021 – Detroit, Michigan is the latest city to decriminalize, making the personal possession and therapeutic use of entheogenic plants by adults the city’s lowest law-enforcement priority

Potential Future Compliance with Entheogens

The only state to legalize entheogens, specifically psilocybin mushrooms, is Oregon at this time. 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 two-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.There are a lot of issues that the proposed rules have that will need to be addressed before their finalized version is released.

Keep in mind that regulations are not set in stone and are more of a work in progress. Just because something isn’t working for us now, doesn’t mean it can’t change. Consider for a minute the Colorado cannabis regulations. They have changed several times and we still are changing them every year. When you legalize something for the first time it won’t be perfect, so make sure you speak up when regulations are open to public comment in the future, so we can try to find a more efficient set of regulations that will benefit the industry as a whole.

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, the US Department of Agriculture (USDA), current good manufacturing practices (cGMP), good agricultural and collecting practice (GACP), and Food and Drug Administration (FDA) along with unique local or 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 and 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 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.

The FDA’s cGMPs 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, but it also ensures that products are safe for consumers, every time.

The other set of regulations that are also relevant are GACP in fungi cultivation facilities. There are several accredited certification companies that are offering a mushroom cultivation specific GACP certification. Many companies that are wanting to get into psilocybin are already working towards this certification in their functional mushroom cultivations to stand out when putting in an application for psylocibin production. It’s definitely a good idea to think about implementing these practices from the start to be able to better compete once licenses become available.

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 long development period to see their finalized regulations. I personally have high hopes for all the possibilities of this amazing industry!

References

  1. https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Pages/Oregon-Psilocybin-Services.aspx
  2. https://doubleblindmag.com/what-does-entheogen-actually-mean/

About the Author

Kim Stuck is the CEO and founder of Allay Consulting. Direct correspondence to: kim.stuck@allayconsulting.com