McAllister Law Office – Psychedelic Law Update – June 2024

McAllister Law Office – Psychedelic Law Update – June 2024

1. With Sean McAllister as one of their lawyers, The Church of The Eagle and The Condor is recognized as the third religious organization authorized to use ayahuasca in the United States. 

In a career highlight, I was honored to one of five lawyers representing The Church of The Eagle and The Condor (“CEC”) in their lawsuit against the U.S. government to gain an exemption form the federal Controlled Substances Act to use ayahuasca in a spiritual context. The other lawyers were Jack Silver, Martha Hartney, Gil Carrasco, and Izzy Ali. In April 2024, the federal government formally settled the case by granting CEC the right to import, manufacture, and distribute ayahuasca for spiritual purposes. The settlement can be found here: Church of Eagle and Condor Settlement.

This is the first non-Christian based religious organization to gain this recognition in the U.S. and the first church involving an American ayahuasquero who trained under a Shipibo shaman for many years in the Amazon. For more information, see this article. I am grateful to the entire legal team and most importantly the bravery of CEC for pursuing this historic result. I continue to consult with numerous organizations using psychedelics for spiritual purposes. At this time, other than ketamine, the only way to have a federal right to use psychedelics is through this religious route.

Contact me if you want more information on this important topic. 

2. MDMA: FDA Advisory Panel Recommends Against Approving MDMA for PTSD

For several decades now, our friends at MAPS have been working on getting MDMA approved for PTSD through the FDA drug approval process. FDA is scheduled to make a final decision on approving or denying the drug by August 11, 2024. In advance of that final decision, a FDA Advisory Panel met to provide a non-binding recommendation to FDA on whether the psychedelic drug and corresponding therapy should be approved. Unfortunately, this FDA Advisory Panel members recommend against approval of MDMA as a treatment for PTSD. See this article. Please understand that this doesn’t mean it won’t happen now or in the near future, but it certainly is a setback. Approximately 80% of the time, FDA follows the recommendations of this Advisory Panel, so there still is a small chance FDA will approve MDMA in spite of this recommendation.

The issues focused on by the Advisory Panel were largely outside the scope of the efficacy, issues like ethical concerns, the validity of results when patients obviously know they are getting the drug (unblinding), etc. My opinion is this decision shows the institutional resistance to psychedelic medicines and Advisory Panel members took the opportunity to play it safe and ignored the compelling data on efficacy. MDMA will be approved at some point, but my best estimate is that it may be slowed down 18-24 months by FDA to gather more data. I’m working with many therapists and doctors to prepare for MDMA legalization, so reach out to me if you want to discuss MDMA.

For more on this topic, see a recent podcast where I discuss this issue. See this YouTube video (starting at minute 3.25). 

3. Colorado State Regulated Psilocybin: Rulemaking partially complete and ongoing 

Rulemaking for the Colorado Natural Medicine Health Act continues and is accelerating through the summer. The Department of Regulatory Agencies has finalized the rules for licensing of psychedelic Facilitators. A summary of those rules from our friends at Healing Advocacy Fund is found here: Document. I have done my own summary of the rules that can be obtained after doing a consultation with me on what roll out looks like. My main concern is that very few people will be able to be immediately licensed and we may see the opening of the program without many licensed Facilitators. Contact me for more information or to determine if you qualify for immediate licensure. 

The Department of Revenue Natural Medicine Division (“NMD”) is the state agency that will regulate all of the brick and mortar licenses: healing centers, cultivation licenses, testing labs, etc.  NMD has released draft rules for healing centers and cultivation licenses, which can be seen here: Document.

Contact me for a consultation on the details of these rules. The final rulemaking hearing for these rules and others through NMD will be on July 25, 2024 and you can join the meeting virtually or in person:

Virtual Option:
Join Zoom Meeting 
Meeting ID: 837 9704 7107 
One tap mobile +17193594580,,83797047107# US +16694449171,,83797047107# US

In Person Option:
Red Rocks Conference Room
1707 Cole Blvd., Ste. 300
Lakewood, CO 80401

You can expect all of the state rules will be final by October 2024, with applications being available in late December 2024. I’ll be working with many applicants to prepare and submit applications under this new system. Contact me for more information on this. 

4. Colorado state decriminalization efforts: state begins crack down on selling Natural Medicines 

My firm represents many practitioners working in the decriminalization area of the Natural Medicine Health Act. When drafting the law, myself and the other co-authors wanted to allow some ability for people to be paid for bona fide harm reduction and bona fide support services used concurrently with the sharing of natural medicines. The most obvious examples of this are people being paid to provide direct counseling, spiritual guidance, coaching, or other service while someone is using natural medicines. The legislature modified these provisions in 2023 to be clear that people could not advertise the sharing of natural medicines or the services provided, but left many of the definitions and scope of these provisions unclear. Many practitioners and lawyers firmly believe the law allows for a broader reading of bona fide support services to include educational services, and support services like microdosing clubs or shared grow facilities. However, these models are starting to come under attack from the state.

The state Department of Revenue Natural Medicine Division has begun sending out cease and desist letters to people they believe are violating the letter and the spirit of the decriminalization provisions under state law. These letters reiterate that advertising the sharing of natural medicines or services provided is prohibited by state law. The letters explain that people running companies with very thin support services tied to the sharing of natural medicines are violating the law by engaging in commercial and business activities. The letters threaten a variety of enforcement actions, including formal cease and desist civil litigation, criminal investigations and prosecutions, and negative licensing consequences for those engaged in illegal decriminalization activities if they later apply for licensure under the regulated program in Colorado.

I urge any of my clients who are working under the decriminalization provisions to contact me to discuss the implications of these enforcement actions.  

5. Upcoming Events to see Sean McAllister

I will be giving a public talk on July 9, 2024, at the Plant Magic Café in Denver, Colorado, 925 E 17th Ave, in person only from 630-8pm, discussing “Legal Review of New NMHA Rules for Facilitators and Healing Centers.” The cost of the event is $75 and you can register in advance here: Registration Link 

Similarly, on August 13, 2024, I will be giving an overview of Psychedelic Law at the AICPA Cannabis Industry Conference, in person, at the Gaylord Hotel, in Denver, Colorado. For more information, see this link.

On August 20, 2024, I’ll be presenting an overview on a Chacruna Institute webinar of psychedelic law as part of their “Roots of Psychedelic Therapy: Shamanism, Ritual and Traditional Uses of Sacred Plants.” For more information, see this link.