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Post Tag: Policy

Posted on October 12, 2026October 12, 2026

Weekly Psychedelic Policy Briefing: October 12, 2026

In this week’s psychedelic policy briefing, investigative journalist and Psychedelic State(s) of America founder Jack Gorsline breaks down the details of three policy developments. First, the Food and Drug Administration is soliciting public feedback on how to safely structure and monitor the initial federally funded clinical trials involving ibogaine. Second, Compass Pathways executives have discussed launch pricing for COMP360, the company’s psilocybin treatment, as Compass works to complete its new drug application this quarter. Third, state-level cannabis regulators are expressing frustration over unanswered questions from the Drug Enforcement Administration regarding marijuana’s rescheduling. Any psychedelic drug the FDA approves will also depend on DEA action, and on DEA coordination with states, before it reaches patients.

Federal Regulatory: FDA Seeks Public Input on Ibogaine Trial Design

On October 5, the Food and Drug Administration issued a formal request for information under docket FDA-2026-N-10429, seeking input from researchers, clinicians, prospective sponsors, patients, and the broader public regarding the safety, dosing, and oversight of early-phase ibogaine clinical trials. These federally backed trials, funded by the National Institute on Drug Abuse and the Advanced Research Projects Agency for Health (ARPA-H), are expected to enroll adults with post-traumatic stress disorder (PTSD) and opioid use disorder (OUD), aligning with Executive Order 14401 signed in April. The only related study the notice says FDA has allowed to proceed is an early-phase trial of noribogaine, an ibogaine derivative, for alcohol use disorder. Because ibogaine presents severe cardiac risks, particularly QTc interval prolongation, which is linked to fatal ventricular arrhythmias and death, the agency has outlined strict preliminary safety measures. Under this proposed framework, small cohorts would receive a single dose each, escalating from one group to the next, with a starting dose not exceeding 10 mg/kg. The notice also asks commenters whether 10 mg/kg is the right ceiling. Administration would occur in an inpatient setting equipped for continuous cardiac rhythm monitoring, advanced life support, and emergency pacing, with continuous monitoring that could last up to 36 hours and an inpatient stay of at least that long. At least two staff members, including one licensed mental health professional, would closely supervise each patient during the drug’s acute effects. Low potassium, calcium, or magnesium levels would need to be corrected prior to dosing, and trial sponsors could explore whether intravenous magnesium pretreatment mitigates these cardiac risks.

The agency clarified that these guidelines do not establish legally binding requirements and will not predetermine the outcome of any investigational new drug applications. For OUD patients, FDA’s draft design would have participants stop opioid agonist treatments like buprenorphine and methadone before receiving ibogaine, prompting the FDA to ask for advice on managing the associated risks, such as a dangerous loss of opioid tolerance. The agency noted it is not seeking comments on ibogaine’s legalization, religious use, or its status as a Schedule I drug. Separately, ARPA-H is requesting proposals for early-phase ibogaine trials through its ASCENT-IBO program, an initiative not explicitly named in the FDA notice. The deadline for submitting comments to the FDA docket is November 20.

Industry: Compass Pathways Talks Pricing as Psilocybin NDA Nears Completion

Compass Pathways has reported positive results from two Phase 3 studies, COMP005 and COMP006, for its synthetic psilocybin formulation, COMP360, aimed at treatment-resistant depression. The COMP005 trial evaluated a single 25 mg dose against a placebo, while COMP006 assessed two fixed doses administered three weeks apart. In July, the company shared six-month data from the COMP006 trial demonstrating lasting therapeutic benefits, and indicated that its rolling new drug application was in progress with final submission anticipated in the fourth quarter of this year. Having been granted a rolling submission in April along with a Commissioner’s National Priority Voucher, Compass anticipates the federal review period could be condensed to just one or two months.

Psychedelic Alpha reported that company executives have discussed launch pricing and insurance payer reimbursement strategies, drawing comparisons to Spravato, an esketamine nasal spray produced by Johnson & Johnson. Spravato’s label requires a strict Risk Evaluation and Mitigation Strategy (REMS) program involving twice-weekly treatments initially, followed by ongoing sessions that require at least two hours of in-clinic monitoring. Compass is positioning COMP360 against that schedule: in COMP006, two doses produced benefits that lasted at least six months, and the company argues patients may need only a few treatments a year. If approved, COMP360 would not become immediately available to patients. The company projects a commercial rollout in the first half of 2027, which remains contingent upon both FDA approval and the subsequent rescheduling of the product by the DEA.

Psychedelic-Adjacent: State Regulators Say DEA Hasn’t Answered Their Rescheduling Questions

State cannabis regulators are reporting a lack of communication from the DEA regarding the implementation of the April 2026 order from Attorney General Todd Blanche that moved state-licensed medical marijuana and FDA-approved marijuana products to Schedule III, as covered by Marijuana Moment on October 7. During a public meeting the prior week, the executive director of the Georgia Access to Medical Cannabis Commission said the DEA told the commission it was not able to comment on state labeling proposals designed to match federal warning requirements. The chair of the Vermont Cannabis Control Board noted that a national association of state regulators has faced “radio silence” after submitting a list of questions to the agency. The regulators’ primary concerns involve DEA registration and product labeling protocols. Vermont officials also highlighted a need for federal tax guidance, which would need to be issued by tax authorities rather than the DEA. Maryland regulators pointed out that the April order already exempts state medical marijuana businesses from the Section 280E tax penalty for the 2026 fiscal year.

In the background, two federal legal proceedings concerning marijuana rescheduling remain unresolved. On September 29, a DEA administrative law judge paused a separate hearing on broad marijuana rescheduling, giving the government until October 13 to respond to opposition motions. Meanwhile, the Justice Department and groups challenging the April order, such as Smart Approaches to Marijuana, submitted a joint proposed briefing schedule to the U.S. Court of Appeals for the D.C. Circuit on October 9. If the court adopts this timeline, opening briefs would be due on November 24, with final briefs expected by February 19, 2027. An FDA-approved psychedelic would not go through this litigation. It follows a faster statutory track. Under 21 U.S.C. § 811(j), the attorney general must issue an interim final scheduling rule within 90 days after a drug is approved and the Department of Health and Human Services recommends placing it in Schedule II through V. Compass has said its launch depends on this step, and on states. The company says states home to about 90% of U.S. patients intend to reschedule within 30 days of DEA action, which assumes the kind of DEA coordination that state cannabis regulators say they are not getting. Currently, neither MDMA nor psilocybin is approved, and both remain investigational.

Disclosures and Editorial Transparency Psychedelic State(s) of America (PSA), established by author Jack Gorsline, engages in collaborative initiatives with the Psychedelic Bar Association and maintains active educational and editorial partnerships with Psychedelics Today.

Posted on October 7, 2026October 7, 2026

Kenneth Tupper, PhD: Harm Reduction, Drug Education, Canadian Ayahuasca, and Psychedelic Public Health

Dr Kenneth Tupper - Psychedelics Today - Episode 658

Kenneth Tupper has spent decades working at the intersection of drug policy, public health, harm reduction, education, and psychedelics.

In this episode, Joe Moore talks with Tupper about his early work with DanceSafe and drug checking, British Columbia’s overdose crisis and experiment with decriminalization, and what the psychedelic field can learn from decades of harm reduction work and research.

They also dig into Tupper’s academic work on psychedelics and education, the idea of entheogens as “plant teachers,” ayahuasca policy in Canada, problems with conventional drug education, and the limits of treating psychedelics exclusively as medicines.

The conversation eventually widens into a bigger question: What does it actually mean to educate people well about drugs, altered states, and consciousness?

Enjoy the show.

Recorded August 25, 2026

Disclaimer: Intro and promotional audio in this episode were generated using synthetic voice technology. The interview itself is unaltered.


Show Notes (Machine Generated)

Kenneth Tupper’s career has followed two parallel tracks: psychedelic scholarship and public health. Long before the current psychedelic resurgence, he was studying the idea of entheogens as tools for learning and examining how Indigenous traditions understand plants such as ayahuasca, peyote, and psilocybin as teachers. At the same time, work with DanceSafe and early pill testing drew him into harm reduction and eventually into more than two decades of public-health and drug-policy work in British Columbia.

Tupper and Joe revisit the early history of drug checking and the logic behind harm reduction: if people are going to use drugs, providing accurate information and reducing preventable risks can save lives. That discussion leads into supervised consumption sites, pharmaceutical alternatives to illicit opioids, fentanyl, the toxic drug supply, naloxone, and the difficult reality of people surviving overdoses while sustaining hypoxic or anoxic brain injuries.

They also examine British Columbia’s experiment with drug decriminalization. Tupper describes the limits of decriminalizing possession without simultaneously addressing housing, healthcare, treatment options, the illicit supply, and other social conditions. The conversation contrasts British Columbia with Portugal and explores why drug policy interventions cannot easily be transplanted from one social and historical context into another.

From there, the discussion turns directly toward psychedelics. Tupper argues that psychedelic public health should involve more than clinical treatment. Psychedelics may have roles in health promotion, community building, education, rites of passage, and helping people who are not necessarily diagnosed with a psychiatric disorder. At the same time, wider access creates a need for better harm-reduction information, screening, preparation, and attention to set, setting, and the larger social environment in which psychedelic experiences occur.

Drug education becomes one of the central themes of the episode. Tupper compares the history of drug education with sex education and argues that drug education has remained unusually tied to prescribed behavioral outcomes—particularly abstinence. Rather than simply telling young people what not to do, he asks what genuine education about drugs might look like when curiosity, experimentation, risk, pleasure, and real-world access are acknowledged.

That question connects back to Tupper’s longstanding work on what he calls entheogenic education. Drawing on educational thinkers including John Dewey and Lev Vygotsky, he discusses psychedelics as potential “cognitive tools” and considers how experiential education might offer models beyond conventional schooling. Joe and Tupper also discuss how AI may force an even deeper reconsideration of education when reading, writing, calculation, and information retrieval can increasingly be outsourced to machines.

The final part of the conversation focuses heavily on ayahuasca. Tupper discusses his doctoral research into the Canadian government’s handling of a Santo Daime religious exemption, the difficulty of fitting ceremonial entheogen use into modern drug-control frameworks, and tensions between religious, biomedical, Indigenous, and public-health ways of understanding ayahuasca.

Joe and Tupper also examine consent and safety around ayahuasca admixtures. Traditional brews can vary significantly in composition, raising difficult questions about informed consent, standardization, cultural autonomy, and how Western participants can make informed decisions when entering practices developed in very different cultural contexts.

The episode closes with a broader discussion of knowledge itself. Tupper argues for taking scientific methods seriously without assuming that Western science represents the only legitimate way of knowing. As psychedelics, Indigenous knowledge, AI, ecological crisis, and modern medicine increasingly intersect, he sees questions of epistemology—how we know what we know—as becoming increasingly important.


In This Episode

  • Kenneth Tupper’s path from psychedelic scholarship into harm reduction and public health
  • Why he adopted the term entheogen in his early academic work
  • Jonathan Ott and the politics of psychedelic language
  • The early days of DanceSafe and pill testing
  • Why drug checking became a public-health intervention
  • Supervised consumption sites and their limitations
  • Fentanyl and British Columbia’s toxic drug crisis
  • Naloxone, overdose survival, and hypoxic brain injury
  • Why addiction cannot be reduced to a simple pharmacological model
  • British Columbia’s experiment with drug decriminalization
  • Why the Portuguese model cannot simply be copied elsewhere
  • Psychedelics as one tool within a larger public-health system
  • Psychedelic access in Canada compared with Colorado and Oregon
  • The risks of over-medicalizing psychedelics
  • Psychedelics for health promotion rather than only diagnosed illness
  • Why traditional drug education has struggled
  • Drug education versus sex education
  • Abstinence, harm reduction, and genuine education
  • John Dewey, experiential learning, and progressive education
  • Lev Vygotsky and the idea of cognitive tools
  • What AI may do to conventional schooling
  • Psychedelics as educational tools and rites of passage
  • Dennis McKenna’s influence on Tupper’s ayahuasca research
  • Santo Daime and religious exemptions for ayahuasca in Canada
  • Why ayahuasca does not fit neatly into conventional drug policy
  • Consent and transparency around ayahuasca admixtures
  • Safety, lineage, power, and sexual misconduct in ceremonial settings
  • Indigenous and biomedical models of healing
  • Science, epistemology, and multiple ways of knowing
  • Tupper’s experience with ibogaine
  • Why he coined the term “intonicated”

Links

Kenneth Tupper
Kenneth Tupper’s website

Kenneth Tupper – Research & Publications
Publications

Intonicated Podcast — Tupper’s podcast on altered states, healing, learning, and wellbeing. Apple Podcasts
Listen to Intonicated on Apple Podcasts

DanceSafe
DanceSafe


Transcript

Joe Moore (00:11): Everybody, welcome back to Psychedelics Today. Joe Moore here, joined by Kenneth Tupper. How are you doing today?

Kenneth Tupper (00:17): Great. Nice to be here. Thanks, Joe.

Joe Moore (00:19): Absolutely. So you’re joining us today from the glorious Vancouver Island, is that right?

Kenneth Tupper (00:25): Correct. Victoria, British Columbia, traditional territories of the Songhees, Esquimalt, and Songhees First Nations.

Joe Moore (00:33): Gorgeous. Thank you. And I’m… I’m going to try to introduce you a little bit here, but we’ll have you kind of tee yourself up a bit. But we met at the Psychedelic Safety Institute Summit at UC Berkeley. Stacey Wallen helped put that together with a few others. It was a pretty big event. And maybe we can chat about this later, but it was the first ever event I went to that felt like AI was a backbone component to the event, which was fascinating. I don’t, you know, at times uncomfortable, but also like, you know, I was respecting just how skillfully it was employed. But let’s talk about you. You’ve got a long career in harm reduction. You’ve been able to volunteer not only with DanceSafe, but many other harm reduction groups. And then you spent some time in the British Columbian government doing harm reduction work. Is that right?

Kenneth Tupper (01:28): Over twenty years, yep.

Joe Moore (01:31): That’s a bit. So thanks for all that hard work. How do you like to describe your career, your position in the ecosystem here?

Kenneth Tupper (01:42): So predating my public health career was an academic interest in psychedelics, or the term that I used originally was entheogen. And not in the health or healing space, but education. I was interested in advancing some understanding of the metaphor of plant teachers in traditional indigenous uses of plants like ayahuasca, peyote, or psilocybin mushrooms. And then from that got into accidentally harm reduction. I didn’t even know the term at the time, but, uh, working with dance safe, running a dance safe chapter, uh, and getting involved in pill testing. And then through that, through connections, got into public health, um, and continued to sort of advance the academic work that I was doing on the side, but it was sort of two parallel trajectories, but both in the area of sort of drug policy. So my PhD, uh, ended up being on ayahuasca and the sort of public policy implications of its emergence of the Amazon. But my work in government was in the harm reduction space, prevention writ large, but prevention of what? This is one of the questions I asked, you know, preventing harms or preventing use or preventing quote abuse, a term that I find problematic for a number of reasons. And yeah, and then also got into some clinical related work like opiate agonist treatment, methadone, which back in the day was kind of debated whether it’s more of a treatment or a harm reduction intervention. Some people fell on one side or the other. In some ways it’s both. Yeah, so that kind of defines, and then the last ten years working primarily on the toxic drug crisis or opioid overdose crisis here in British Columbia, which is one of the hardest hit provinces in Canada. And then still sort of keeping my toe in the world of psychedelics in and out, more out for the past number of years for a variety of more personal reasons, but coming back in and that Psychedelic Safety Institute Summit was part of that. And yeah, that’s me in a nutshell.

Joe Moore (03:50): So I have a confession i’ll make on this show for the first time ever i am just now for the first time reading jonathan ott’s pharmacotheon and i’m a bit embarrassed um that i’m just getting around to it now because his analysis uh commentary is just writing is so helpful and good and he he uh was one of the team that helped push this word and theogen And I’m just, right before this, I was working through his description of, you know, why entheogen as a term. I find it interesting. And I don’t know, I just, anything that smells a little religious, I push back from, as if psyche doesn’t have those religious connotations anyway. But, you know, in our strange times, I kind of use the psychedelic term as kind of like, in a way, to just be loud and proud about it, kind of leveraging gay rights movement kind of logic a bit. But I don’t know, and sorry to go down something so banal as defining why you might wanna use a term like entheogen, but could you talk about that a little bit?

Kenneth Tupper (05:07): Absolutely. And, you know, I could talk all afternoon about this. Language is sort of the world in which I swam academically. Critical discourse analysis was my sort of methodology for looking at public policy and the sort of way that language is invested with power overtly in public policy and law. of course there’s micro powers and sort of everyday everyday language and discourse but for me personally the term entheogen was more sort of politically convenient in advancing an interest in this topic in through university structures in the late nineties early two thousands when the word psychedelic i mean being in the closet was the safe place to be at the time uh being more out was was sort of risky uh endeavor in terms of you know getting academic respectability um and i i found the term entheogen very helpful. So I’d come across it and reading Jonathan Ott’s work and others at the time. I found it really helpful for framing traditional indigenous uses of plants versus the more sort of white powder application of a biomedical paradigm or psychotherapeutic paradigm. And I still actually find it a helpful heuristic of distinguishing entheogenic healing from psychedelic medicine with those sort of broad separations. Of course, there’s lots of intersections and hybridities across them as well. And in some ways, you know, it’s resonant of the failure of modern Western medicine to recognize the spiritual dimension in healing and health, something that I would argue in many most traditional indigenous cultures is seen to be, you know, synonymous, that those two concepts are completely intertwined, that the shaman functions both as a priest and And they’ve got the power of healing medicine man, as well as that spiritual intersection. So for me personally, that was why I ran with it. And there’s a nice assonance with entheogenic education.

Joe Moore (07:13): Well, at a later date, I’d have to dig in more on this. But I want to focus on this interesting harm reduction thread. it’s cool it’s really important to me as well um i jokingly almost renamed the show drug war today a few times like i just it’s all i really wanted to talk about um for a lot of reasons uh so back in the day you called it pill checking like it wasn’t drug testing testing pill testing that’s interesting and it was just like ravers or was it all sorts of people that you were supporting

Kenneth Tupper (07:51): The places we were doing it was at raves as they were called you know big electronic dance parties and my understanding is that’s kind of the well there was deeper origin i think back in the early seventies there was some what we’d call drug checking happening in places like uh hate ashbury um free clinic and so there’s some very sort of early moves towards it but it really kind of got lost in the shuffle for for many years and sort of the reagan era war on drugs but then With the rise of MDMA use or ecstasy use in the nineties and the illicit market that had no quality control or safety built into it, pill testing was obviously a way to discern whether or not you had actual MDMA in the so-called ecstasy pill that you bought. And for me, it was just a kind of no-brainer thing to do. Because in British Columbia, at least at that time, there was fake pills circulating, PMMA, paramethoxy methamphetamine, and others, sometimes just methamphetamine, things that were either cut in or completely sold as replacements for. But the idea that Offering people a way to learn what they think they’ve got was just an obvious good thing to do. But I found myself on the wrong side of law enforcement’s perspective on that. They threatened to shut us down regularly and got into media battles about And I didn’t even know what the term harm reduction was at the time. But it was through that work that I got introduced to people who were doing HIV prevention and trying to open Vancouver’s first supervised injection site back in the early two thousands. And that was sort of my pathway into the world of public health.

Joe Moore (09:32): So were you involved with any of the American DanceSafe folks at that point?

Kenneth Tupper (09:37): Yeah, we were kind of an affiliate. So Emmanuel Sverios, I think was leading things and sort of we’re in touch sort of regularly, but in order that the cards, the information cards that were given out and sort of loosely followed the protocols and procedures that were set out by an American, the OG DanceSafe. But we were somewhat autonomous as well and obviously worked in our local ecosystem.

Joe Moore (10:01): That’s super interesting. Never really thought about that would have operated in the early days and then um this supervised injection site thing i find fascinating i think dr carl hart did a really good job in his books kind of popularizing the concept and somewhat normalizing the concept where i recall some of the swiss cases where people were able to maintain a habit for effectively many decades without any real health consequences and or their family noticing And that’s because they had clean supplies. They were able to do that.

Kenneth Tupper (10:40): Well, actually, the critique I have of supervised injection sites is they actually don’t touch the supply side of things.

Joe Moore (10:47): I think this one does, but I think in Canadian markets. But you might know better.

Kenneth Tupper (10:53): Yeah, so as it was set up, the people who used it had to procure illicitly off-site on the street market and then come in and use under medical supervision. So they could get sterile syringes, have an overdose responded to, have other wound care. I mean, there’s a fully sort of wraparound healthcare and social service connection built into the site, which was part of the argument for putting it in place, was giving people a point of access instead of puddle water in the back alley. They’re using sterile syringes under nurses’ supervision with lots of connections and a lot of effectiveness in terms of what it was set out to do. But in terms of still relying on the illicit supply, it didn’t do as much as it could have done if they had offered people a pure pharmaceutical product of a known quantity, which is what was missing from that. But you’re right, I think some of the European models provided heroin prescription or diacetylmorphine

Joe Moore (11:49): Right. And I, you just kind of rattled my world puddle water. I never really kind of went that far, but I totally understand. It’s probably factual.

Kenneth Tupper (12:00): No, that’s exactly what was happening.

Joe Moore (12:02): My God. So yeah, this is, this is the not quite far part, far enough part that I think we all kind of want to address in psychedelia because it’s, you know, it’s complicated if you’re, being sold what you think is LSD and you’re buying something like two five I n bomb that can just harm you, kill you. And, you know, the experience might be fine the first ten times. But there’s, yeah, there’s just really difficult math and data behind this.

Kenneth Tupper (12:35): Well, let me sort of jump on that tangent for a second. So one of the realizations that I came to over the last decade with the toxic drug crisis, the opioid overdose crisis, was the sort of failure, the blind spot in the history of public health to recognize one of the most important interventions that was advanced over the last two hundred years, which is really all modern public health has been going since the mid-nineteenth century. And you know, we can count on one hand the number of big top five global interventions, immunization and vaccinations, clean drinking water, hand washing. But another key one that we’ve forgotten is the passage of pure food and rugs legislation. So prior to the eighteen eighties to nineteen twenties, that was a period of a couple of decades where that form of legislation got put in place around you know developed world prior to that there was no quality control or consumer safety standards you took your life in your hands when you bought a sandwich on the street or a drink at the bar and there was a public health sort of progressivist movement at that time to ensure that people who are selling things foods beverages and patent medicines that was before a pharmaceutical industry got sort of standardized were selling what they said they were selling. And prior to that, there was a lot of risk involved in just taking, buying anything and consuming it. So these Pure Food and Drugs Acts came in place. I think in the U.S. it was like—[captioning error in source]. That’s a whole separate, let’s put that in a pin for a second. But the sort of consumer safety logic got applied across the entire consumer marketplace throughout the twentieth century. So children’s toys, automobiles, hang gliding equipment, snowboarding helmets, all of these things allow you to engage in sometimes very risky activities. But insofar as you’re a consumer in the marketplace, you’re protected by these quality control measures. There’s one area that we’ve left completely out of that logic. And it was the psychoactive substances used for non-medical purposes. And I describe it as a fascist logic of we are going to allow people to die preventable deaths to serve as a lesson to others not to engage in morally objectionable behavior. And it’s just it’s unconscionable when you think about it from that perspective. So we learned the lesson with alcohol. There was an attempt, obviously, federally, most famously in the US. But here in Canada, we had prohibition of alcohol in every province. It was never done federally except Quebec. But it was quickly realized to be a colossal failure. So here in British Columbia, we had prohibition for four years from nineteen seventeen to nineteen twenty one. and then repealed it. And actually, a lot of British Columbians made a lot of money selling alcohol to the US before you guys repealed. But we didn’t learn the lesson and apply it to opium. And there’s a direct connection between opium to carfentanil and whatever’s coming next, the novel opioids that are being cooked up in research chemist labs. So the cat and mouse game in the illicit market is always going to be, one by the mouse, right? They’re innovative, and especially now with AI and combinatorial chemistry, the kinds of proliferation of new psychoactive substances on the horizon is frightening. So the idea that we’re going to prohibit and criminalize our way out of these public health issues is, I think, deeply mistaken.

Joe Moore (16:02): Yeah, I remember Leonard Picard telling me about predicting, in a way, in a paper, the fentanyl crisis. We chatted about it again a couple years ago in the show, and he talked about this kind of proliferation of technology and this wave of molecules that’s coming. It’s nothing to trifle with. In BC, when you were part of the government, were you all kind of looking forward to this at all, in a way predicting it or planning?

Kenneth Tupper (16:41): No, certainly wasn’t sort of on my radar. I think law enforcement folks were onto it sooner because they were picking up, you know, precursors and that sort of thing in large quantities. I remember fentanyl kind of coming on my radar in about twenty twelve when it started showing up in the postmortem toxicology reports by our coroner service. And again, it had been reported in small scale by police and seizures, but the fact that it was sort of emerging in sort of street level use and that people were dying from it was how it really first emerged in consciousness. And there was a kind of uptick in overdose deaths, again, at the time attributed to heroin, heroin overdose deaths. we realized over not too long was that heroin was being supplanted by fentanyl. And so when there was a public health emergency declared in twenty sixteen here in B.C. by our chief medical health officer, and that’s when a lot of resources were mobilized to try to deal with it. But by that time, it was already kind of proliferating across North America. I think it was on the radar in the United States by that time. Part of it attributable to overprescribing of opioids, certainly there was a concern that there was a lot of people who’d gotten a taste of opioids through pain management offerings that were probably not now in retrospect considered to be best practice in how to help people who are navigating chronic low back pain or something like that. Because there’s a phenomenon called hyperalgesia where people actually get exacerbated pain from regular use of opioids but the fact that fentanyl was now emerging into the illicit heroin supply was tragically only discerned by people’s deaths and that’s where i was able to kind of resurrect the idea of pill testing or it wasn’t called again pill testing was the idea i first called it drug testing but Lots of folks pointed out that that also refers to hair samples being pulled to detect illicit drug use by parents and their teens or something. So we called it drug checking. That’s the preferred term.

Joe Moore (18:42): Cool. Well, that’s really, really helpful and interesting. I wonder what organizations are going to start looking at that. It is a grave, I think… moral issue and national security issue honestly um leonard’s point was what if some of these new drugs just transcend people’s ability to fight addiction you know just kind of like doing the sci-fi thing with addiction um to to a degree and i like a kind of pleasure machine function of like so so incapacitating and hard-hitting that you just can’t there’s no effective treatments

Kenneth Tupper (19:26): Right.

Joe Moore (19:26): Like why we think that about methamphetamines. But what if we were able to do like twenty X

Kenneth Tupper (19:33): I have no doubt it’s coming and I share Leonard’s concern that that’s probably on the not too distant horizon. Although, you know, the idea of addiction itself is complicated in terms of, you know, what leads to chronic dependent patterns of use of any substance or not even just substances, behaviors as well. It’s a sort of complex mix of bio, psycho, social, spiritual, environmental, milieu of things that really sort of defies some of the simplistic attempts to medicalize, which is why I would argue modern medicine hasn’t been that effective at treating addiction. In fact, some of the best treatments are simple substitutions, right? So nicotine replacement therapy for tobacco or methadone for opioids, although I think we found methadone isn’t quite as effective as it used to be now that fentanyl and other novel opioid analogs are sort of stronger than good old-fashioned heroin or diacetylmorphine

Joe Moore (20:31): So for a psychedelic audience that’s not really sure how this is related to psychedelics can you can you give us um a sort of rundown from your perspective on how it is

Kenneth Tupper (20:43): So coming from a broad public, and that’s sort of my angle in my interest in psychedelics is in that kind of public health intersection, or at least it’s kind of these two parallel paths are emergent now on my horizon. One is the basic harm reduction of people who are using as, you know, information ecosystems continue to kind of democratize people learn about these things through non sort of non-standardized channels of mainstream media, there’s a lot of excitement and rightly so. People start sharing stories of healing, of benefit. But it leads to a lot of use that might be risky or ways that people could harness these tools, and I’ll use that metaphor sort of advisedly, with greater respect if they’re aware that there’s risks associated with it, not just in the supply side, but also in the sort of way that setting matrix, an important addition to that. I think Betty Eisner came up with that additional term. So again, the broader environment in which one’s situated. So that’s one side of it. And then the other is, I would argue, a health promotion side of looking at being… I don’t think we need to necessarily reserve these substances just to people who have a diagnosed illness, that there’s ways to be better than well or to get ahead of trajectories of things like metabolic disease or incipient mental health issues like depression, anxiety, eating disorders, where earlier upstream intervention is probably warranted. And again, there’s lots of opportunity that these can be studied and hopefully deployed for not letting things get to the point of crisis in someone’s life, but then they need to seek help for.

Joe Moore (22:28): Right.

Kenneth Tupper (22:34): That’s the psychedelic safety summit was i think primarily focused on that harm reduction side of the first part um but there was some discussion also yeah the ways to look at how these and one of my interests has always been looking at traditional indigenous uses because we don’t need to reinvent the wheel you know these tools again have been used for thousands of years there’s ways to you know use them for community integration intergenerational education knowledge sharing, community bonding, social cohesion. It’s such a thing that’s so needed today, could be really, really helpful for dealing with some of the malaises of modernity that we’re all experiencing.

Joe Moore (23:18): Yeah. So let’s see, because you’ve been inside public health, I’m curious about this kind of somewhat clinical rollout right now of psychedelics in places like colorado and oregon um i know there’s some interesting proliferation of businesses in british columbia though i think they’re moving to mexico in real time for probably assorted reasons but what um what kind of public health things um do are folks trying to be mindful of um when looking at this kind of a rollout.

Kenneth Tupper (24:04): So the clinical rollout of psychedelics in Canada is actually, I would say, behind what’s happening in places like Colorado, Oregon. I understand New Mexico is coming online. There’s, I think, advancements that have happened in terms of broader public offerings that aren’t quite in place here in Canada. We have, in terms of legal access, primarily ketamine because it’s an off-label use of an already approved medication. There’s clinical trials happening in a number of internationally, a number of the big players are funding clinical trials. So there’s some of that access. There’s quite a bit of underground use, but again, that’s sort of outside the mainstream medical system. There’s also online dispensaries or actually some even in-store dispensaries that are offering things like mushrooms and five MEO DMT vape pens and other things that are to varying degrees, offering harm reduction advice and information for their clients. So it’s a real kind of plethora of ways to access. And again, a lot of interest, I think, both on the clinician side and on the potential patient side. But the legitimate avenues are still relatively few and far between, which is why there’s such a thing as medical tourism or psychedelic tourism, people heading to South America, Central America for ceremonies of various sorts. Ibogaine clinics, of course, are a big thing. in Mexico, and including one I personally was able to visit last year that was co-founded by a couple of Canadians, Ambio Life Sciences. Shout out to Jonathan and Trevor, who’ve done some amazing work on building, I think, somewhat respectable and safe in terms of the medical oversight offering. But I know there’s a number of other clinics that are trying to do that, and probably lots more that… aren’t quite holding up to the sort of degrees of standard that you’d want to have in place. So for that public health question, I think that’s, you know, it’s incumbent on all of us to think about a sort of health system stewardship lens, or at least that’s the phrase that I use set up by the World Health Organization. But what are all the sort of pieces that need to be covered off in terms of planning and delivering for this to reach a broad scale? There’s a big lag time between when something becomes an evidence-based treatment, and this is true for all kinds of medical interventions, a big lag time between when it is recognized as best practice and probably the best treatment available and when it actually reaches mainstream penetration of the health system. It’s decades. I think the average I’ve heard is seventeen years. So there’s ways to expedite that and see how to advance rollout with safety and efficacy always a primary consideration, but also recognizing there’s things like health equity issues, who’s got access, who doesn’t have access, and for what reasons. And of course, that’s, again, true of the broader medical system. So I know you’ve talked a lot to folks about these kinds of issues on psychedelics today.

Joe Moore (27:07): Yeah, it’s… endlessly complicated sometimes it feels really simple but like the actual execution is really difficult so let’s see are you anticipating any sort of pushback in Canada around psychedelics perhaps

Kenneth Tupper (27:36): I think we’re probably slow walking at this pace relative to the fast tracking that we’re seeing in the US and might partly be in reaction to the fast tracking that’s happening in the US. I think the associations of the administration in Washington pushing forward in a whole bunch of different directions might actually cause our… folks in Ottawa to double-cross every T, triple-dot every I, just to ensure that they’re not caught up in the hype and excitement of what might be fast and furious. So it’s hard to say. I’m not privy to any particular discussions or decisions that are happening at that level right now. It wouldn’t surprise me if there’s going to be a sort of, let’s go slowly and cautiously. But it seems to all be moving forward. I think there’s a sort of tipping point that was crossed probably a few years ago in terms of recognition that these, we threw the baby out with the bathwater back in the late sixties, early seventies. And just a reminder to Canadian listeners and anyone else is that psychedelics were pioneered in Canada. Psychedelic medicine, the offering of LSD as treatment for alcoholism was pioneered in Saskatchewan. In fact, the word psychedelic itself was coined in Saskatchewan by Humphrey Osmond, a British psychiatrist who was recruited there in the nineteen fifties. So we’ve got this kind of long patriotic history of doing this kind of work, but it got caught up in the, you know, nineteen sixties counterculture. uh non-medical use scared a lot of folks north and south of the border as well as the you know imposition of randomized control trials and there were some methodological challenges in the history of science that led to uh restrictions on psychedelic research or folks who are trying to push that forward really resisted the rct design because of the you know challenges with placebo that are still sort of a confounder today but we don’t talk about as much um

Joe Moore (29:36): Yeah, I find that funny that we’re still dealing with the same issue. I wonder. I hope some people have some good ideas.

Kenneth Tupper (29:45): I think there’s some bright minds who are at work trying to navigate those complexities in terms of research design. And ultimately, if they can persuade the regulatory authorities that they’ve managed to show efficacy in a way that allows it to be brought forward, then we can see at least begin to scale and do some sort of phase four pharmacovigilance. pharmacovigilance research. Once something’s approved, you can continue to do more research and see where things can be tweaked or refined. So I’m hopeful that that’s moving forward. Also, trepidatious of the kind of large pharmaceutical industry tentacles that are obviously looking not necessarily to maximize health and wellness for the population, but to maximize benefits for shareholders. So there’s also a difficult circle to square in that regard. But I’m confident there’s a big need and a big playing field. Lots of folks can be involved and hopefully see all sort of ships moving forward. That’s not too many metaphors mixed.

Joe Moore (30:51): So British Columbia famously had really great decriminalization laws, which allowed for, I think, harm reduction work to be done at a level I hadn’t really seen elsewhere in the world. And can you talk about that decriminalization and how perhaps it helped and if there has been a shift to that decriminalization legal status in British Columbia?

Kenneth Tupper (31:18): Yeah, I can’t get into the details as part of the decriminalization core planning table when it got implemented. So I won’t go into the details other than to say as part of the toxic drug crisis response, there was a willingness to try new things. And it was and that was one that was certainly being called for its implementation, I think, was challenging in the milieu of COVID-Nineteen emerging. We had two public health crises simultaneously. We had the pre-existing opioid overdose epidemic and then COVID-Nineteen came on top. So there was a lot of challenges with respect to the most vulnerable and marginalized people who use drugs and social distancing and all those kinds of things. And also there was, I think, an under-recognized element of almost a double edged sword of harm reduction in terms of getting naloxone out there broadly, supervised consumption sites, et cetera, did a great job of keeping people alive, but not necessarily resuscitation in this sort of vital few minutes post overdose that would prevent an anoxic or hypoxic brain injury. So that’s when somebody goes down from an opioid overdose, they’ve stopped breathing for seconds or minutes or longer than that, that is death, right? That’s what the ultimate death is. People dying from anoxia. But if you get naloxone and are revived, you may be suffering long-term cognitive impairment from an anoxic or hypoxic brain injury. And that’s irreversible damage. I mean, I’m not aware of any sort of interventions that can help when it’s a significant or severe injury like that. And sometimes it’s multiple survived overdoses that stack on top of each other. Of course, on top of potentially pre-existing mental health issues, maybe pre-existing congenital brain injuries like FASD, fetal alcohol spectrum disorder, or other traumatic brain injuries. People might have had concussions and often ongoing active addiction. So you’ve got this kind of clinical mix of presentation that when an anoxic brain injury gets added, it becomes really, really challenging. So coming back to your question about decriminalization, what we saw in the rollout of decriminalization simultaneously was a sort of increase in public disorder, public nuisance. And I know you guys see it in the streets of places like San Francisco, LA. The same kind of thing appeared here. And it led to a sort of backlash of a political shift. So decrim, it was a sort of federally exempted research project that basically didn’t get continued. So it’s kind of gone back to status quo with varying degrees of discretion by individual law enforcement officers as to whether they decide to intervene. And it was always just sort of simple possession charges that were decriminalized. So it didn’t do anything to deal with the supply chain itself. It was personal possession. And it was only certain drugs and up to a certain amount. So cocaine, methamphetamine, opioids, up to I think two and a half grams. It was an inclusive experiment, I would say. It was difficult to know whether the right mix of other interventions that could have helped people navigate trajectories of health and wellness might have been simultaneously in place. A lot of people point to Portugal and the Portuguese model of decrim that I think rightly so say wasn’t put in place fully here in British Columbia. The kinds of other elements of what was done in Portugal didn’t get implemented in terms of a real strong housing first, a lot of medical and other health supports that were kind of absent in what we did.

Joe Moore (35:07): Can you talk about why perhaps Portugal was successful?

Kenneth Tupper (35:12): I mean, I’m not an expert on this. I’m sure you’ve got lots of other folks who could tell you much more. But my understanding is it was just a different time and place. Street opioid use was a relatively small. Heroin or diacetylmorphine was the opioid of choice, or maybe diverted methadone, but not a huge kind of issue that we saw here in terms of fentanyl use and the proliferation of fentanyl in the heroin supply. That really sort of was a different beast, what we were dealing with. And again, just some of the social services, health services that were available and put in place in the Portuguese sort of, I think there was a really whole of government approach that took it very seriously. And they had, was it called dissuasion panels, other kind of alternative justice approaches that we kind of tried to replicate. We have drug courts here in BC that are obviously copied from the US. I think many things and broadly the addiction or drug use field help some people some of the time. Some people benefit from AA, twelve step models and all power to them, that’s great. I would never want to say don’t try that if it’s a path for somebody, but we know that it doesn’t help a lot of people a lot of the time and we need lots of different modalities. I would say the same thing is true with methadone or opioid agonist treatments. Some people respond really well. They’re life-saving and vital and that’s great, but there’s other people who don’t respond. And so it’s always looking for the non-responders or for people for whom that path isn’t necessarily working, what can we offer them instead? This is where I see psychedelics as another tool in the toolbox that maybe is really going to be helpful. And I particularly think of Ibogaine as something that could potentially deal with both an opioid addiction and a brain injury simultaneously, given the research that we’ve seen on TBI or traumatic brain injury, as well as what we know about opioid addiction treatment with ibuprofen. It’s a very promising medicine with some risks, obviously, that need to be managed and studied better.

Joe Moore (37:24): So let’s see. Have we missed anything on the kind of BC government side yet that might be important to cover?

Kenneth Tupper (37:36): Well, another area that it’s not so much BC government, it’s actually another area of my academic research. When I started my PhD, it wasn’t actually to do ayahuasca research originally. It was to do drug education research. I was sort of fascinated by the question of what do we teach kids in schools about drugs? uh a question that i don’t think has really been adequately answered yet you know and when i started uh doing this this sort of subject in terms of my academic research it was knowing that the just say no approach their program were kind of discredited in terms of the outcomes that were claimed certainly weren’t realized in academic research and studies. In fact, some critiques saying that it might actually do more harm than good. But what to do instead, is it just say yes, just say maybe, just say safely, just say with harm reduction, is not a clear-cut, you know, to me, it’s not a clear-cut path forward. And, you know, one of the questions I still have is, and I’ve got… girls, step-daughters, they’re thirteen and a half and it’s becoming real in terms of what they’re exposed to in the school environment. But I think there’s a lot to learn from sex education and I wrote a paper looking at the history of sex education and drug education in parallel over the last hundred and fifty years since public schooling became an institution both in the US and Canada going back to the nineteenth century and how drug education, the blueprint for it really emerged in the eighteen eighties with Women’s Christian Temperance Union delivering what they called scientific temperance instruction, and they very craftily used the word scientific to appeal to parents and administrators. But it really was the blueprint for what’s still done today. All use is abuse. There’s no such thing as responsible use. Use inevitably leads on the slippery slope to either prison or death, scare tactic type approaches. They were focused primarily on alcohol, but they also applied it to opium. And there really wasn’t much innovation. There has been a bit, I think. But when you look at sex education, It actually started later. It was very difficult to get sex education in schools. It was only after World War I with soldiers returning from Europe and venereal disease and the sexually transmitted infections in the roaring twenties became a concern was when sex education really got sort of embraced. Although at the time it was really focused on anti-premarital sex, heterosexual sex and anti-masturbation. And that was a huge, huge sort of push for early sex education. And again, we forget how big of an issue masturbation was just a hundred years ago or a hundred and fifty years ago. Believed to be a major cause of both mental and physical illness. So that was a big impetus for moving it forward. But then, you know, post-birth control and the swinging sixties, there was a real shift, not everywhere, there’s still conservative religious communities that push back on it, but a shift in sex education to a much more progressive approach. And then with HIV coming in the nineteen eighties, I think that’s really locked in an understanding that there’s ways to do sex education that are really vital for protecting people. But we haven’t seen that shift with drug education. It’s been much more challenging. But I describe them both as moral purity issues in the classroom. You know, there are two topics that just don’t really fit into school curricula in the way that… And sorry, I’m just going to go on another tangent. If you look at the history of education and pedagogy as a sort of philosophy of education in the nineteenth century, it was a Victorian era sort of rote memorization. Again, the beginnings of public schooling, desks in rows regimented by bells. regurgitate facts that are learned out of textbooks. And there was a big push against that in the early twentieth century with people like John Dewey and other progressive education reformers who talked about, we need experiential education, we need to stimulate natural curiosity. Instead of reading about a tree and a leaf in a book, we need to get kids out in the field and touching real trees and leaves and then build on that to scaffold their education from there on. And that works great across the entire curriculum, arts, sciences, humanities. The two topics it doesn’t work so well for where we don’t really want to stimulate natural curiosity and get hands dirty and feet wet is sex and drugs. In fact, it’s just the opposite. What we ascribe for success in those two topics is abstinence, prescribed behavioral outcomes that really isn’t education anymore. It’s frankly indoctrination. And so it’s been a challenge. And parents expect schools to do something. you know, challenged teachers, often uncomfortable delivering those topics, so they’ll outsource to a nurse or a police officer to come in and, you know, do the talk. But, you know, kids, and especially now, it was challenging, you know, fifty years ago, but, you know, in the post-Internet age, and now with AI, who knows where it’s all going, but, you know, you can download hardcore porn or learn how to cook crystal meth with the click of a mouse. It’s a challenge.

Joe Moore (43:01): Right. And yeah, what is to be done in the face of that? I was on stage recently in Aspen at the Aspen Psychedelic Symposium with a professor from Stanford who focuses on drug education research. And I’ll pull her name up in just a moment here. But it was really impressive that she had data. Rana Hashemi? That could be it. I think she’s at Stanford. She’s one of the leading young voices in drug education and harm reduction. That could be her. Pull up her photo here. I like how the CV comes up first. But I think this is probably her. No, she’s a PhD candidate. No, this is like a full professor at Stanford, like a very impressive researcher. I’ll have the name in a moment. It’s on the end. aspen uh the aspen public radio website but it was it was just really cool to hear how developed the um data has become on drug education and from a reputable source who’s kind of on this um uh educate first over abstinence like let’s actually get you really knowledgeable so you can make decisions it’s kind of like respecting miners as like a real thinking people, as opposed to trying to lead with lying.

Kenneth Tupper (44:36): Yeah, exactly. I mean, that’s being, you know, respecting autonomy, respecting, but again, you know, information is critical, but not necessarily sufficient in terms of what we know, again, about harms and addiction and other things is it’s often to do with trauma, environment, ones raised in things that are extraneous, completely outside of school systems control, which is, again, one of the challenges for doing drug addiction. How do you do something universal for all kids when, you know, what works well in like the D.A.R.E. program, it works great for the kids who come to the front of the class and brought the apple for the teacher that day, you know, all squeaky clean, but the kids at the back of the class or didn’t come to class that day, didn’t have breakfast, you know, we need something different.

Joe Moore (45:18): Yeah, so I’m going to share my screen here, but it’s Bonnie Halpern Felsher. Oh, cool. Okay. And definitely somebody worth following, and you can actually catch her recording. We had a person who grew up in Aspen, is still quite young, on stage with us, Ronan. A person who I think lost their child, Trina, here. and I was able to moderate this one. And I find it interesting that I was included being childless, but I do drug education. So perhaps that was enough. But it was a really great.

Kenneth Tupper (45:59): We all have an interest in the future generations, whether we have offspring directly or not. We’re all going to be looking to young people to be leaders of tomorrow. So hopefully educating well is something we get passionate about.

Joe Moore (46:16): Yeah, and it was great to be involved in that. I was heartened by the audience’s response. Ronan, who was on stage, a younger guy with us, he said some really, really great stuff about how he navigated being in such a drug-rich environment like Aspen. And not just drug-rich, but everything’s available. You could be doing plenty of LSD if that was your thing. But, you know, I think he had a good encounter early enough that kind of, I don’t want to say scared straight because that’s kind of a stupid term, but, you know, you can get rattled with psychedelics and you might want to change your behavior, right?

Kenneth Tupper (47:03): Again, this is where I look to, you know, indigenous traditions as, you know, a form of intergenerational education and where elders model responsible youth lead ceremonial type practices that allow for rites of passage that frankly our societies are mostly lacking in terms of that kind of liminal experience in older adolescents, young adults. One of the jokes I make is that kids come into kindergarten full of wonder and awe and curiosity about the world. And if they have any of that left by twelfth grade, it’s usually despite their schooling, not because of it. And that’s where I think, again, a sort of circumspect, carefully moderated, led opportunity for psychedelics could, for many people, be really helpful in terms of rekindling that sense of meaning, purpose, wonder, awe. elements of what’s important for for human flourishing

Joe Moore (48:01): Yeah um it’s perhaps out of out of your scope but i’m sure you’ve thought about like what what would need to shift in the contemporary education paradigm in order to like help people stay a little bit more creative or interested

Kenneth Tupper (48:20): I distinguish between education and schooling. Those are two different concepts. So education is a much broader, more philosophical type of how do we raise young people into adults in a whole variety of different ways. Schooling is a much more narrow, again, construct that was part of the broader apparatus of things like hospitals, mental institutions, et cetera, put in place in the nineteenth century. So I don’t see psychedelics necessarily fitting into the school system as we’ve currently got it. But as a broader understanding of education, I was challenged with this question when I was actually working on my master’s thesis, where I was first developing these ideas around entheogenic education. One of my professors was Dr. Bruce Alexander. Shout out. He was a psychology professor who is most famous for the Rat Park studies that he did in the So he was on my master’s committee and he was, I’d say, the most enthusiastic or he was keen to, as he said, okay, you’ve persuaded me on the idea. How do you do it? What’s the implementation pathway here? And that was a challenge because I hadn’t really thought, I was more sort of trying to frame a theoretical foundation for even discussing the topic. But sort of came to the idea and conversation with a friend of the idea of, and he coined this phrase, instead of outward bound, something like inward bound, which would be, an experiential education program like Outward Bound, where maybe it’s, you know, a cohort of young people with some caring adults that do something, you know, a few days in nature, but it culminates with, you know, a peyote ceremony, ayahuasca ceremony, or psilocybin, you know, some sort of structured psychedelic experience that could, again, you probably, you would need careful screening and selection. It’s maybe not forever. And just this Outward Bound, is not for everybody. Some people for whom maybe that’s not an appropriate program. And there’s risk involved. I wouldn’t deny it. Same thing with Outward Bound. There’s been deaths of both leaders and participants in Outward Bound programs, but seen overall to be a broadly really sort of helpful way of conceptualizing your alternative approach to education that for many people, schools don’t just kind of fit the bill.

Joe Moore (50:27): Yeah, that would be really interesting. And just more enrichment and it’s hard, you know, we’re stretched thin everywhere with budgets, but is developing this next level of genius or next generation of genius creatives.

Kenneth Tupper (50:44): Well, I think it’s the biggest challenge is actually the advent of AI. And like, you know, when I was young, learning long division seemed kind of pointless when you had pocket calculators. But now it’s the entire, you know, reading, writing, and arithmetic is all outsourced to AI. What do we do with education? K through PhD, like the entire elementary, secondary, post-secondary ways of doing things are… dissolving in front of our eyes. And I know people that I talk to in universities and in school, like the mainstream public school systems are struggling. And I don’t have the answer other than I think it’s going to be a lot about social emotional development, socialization, just getting kids off screens for several hours a day is probably going to be an important piece of what it means to be educated in the future.

Joe Moore (51:30): Right.

Kenneth Tupper (51:33): I used as a foundation for my academic work a Soviet psychologist who is mostly not known about in the twentieth century. He was working in the nineteen tens, nineteen twenties in the Soviet Union named Lev Vygotsky. I think his work only got translated into English in the nineteen sixties but he kind of became big in education circles in the seventies and eighties and I picked up on his ideas and he developed a kind of alternative understanding of childhood development different from Piaget and Skinner and some of these other behavioral psychologists and child development experts that were dominant throughout the twentieth century in the West. He argued that becoming educated and developing is becoming versatile with cognitive tools. And that’s the term that I found really, really helpful. And he talked about literacy, reading, writing, numeracy, skill, those types of things as becoming performative with cognitive tools, that learning to read and write is learning how to use a cognitive tool. And literacy is not a natural thing to learn learning a language is a natural thing to learn spoken and you know we’ve spoken languages for hundreds nobody knows how long a hundred thousand years plus but literacy has only been around for like five thousand years there’s lots of ways that it can go wrong in terms of education and So that idea of cognitive tool I found really helpful to think about how to frame psychedelics or entheogens as ways to harness a particular kind of tool that has been respected and understood in other cultural traditions but lost from our own. and think about how to integrate those for potentially educational purposes as well as obviously healing purposes and see that obviously is a important component as well but to catalyze you know again creativity wonder awe sense of connectedness and it’s partly the not just the experience but the stories that are told about the experience so again in many indigenous traditions you’re taught you’re told stories about meeting your ancestor spirits and connecting with the you know animistic forest spirits that will happen for you when you have the opportunity to use uh you know the medicine of one’s community at the appropriate time and age and so the growing up with that kind of respect and anticipation is a kind of placebo enhancer for when the opportunity finally comes to have those experiences and you’re already well set and prepared for it. In contrast, you know, I think about my own introduction to these substances as a teenager, it’s almost the reverse. And in fact, it’s surprising how few people are harmed given the nocebo, the opposite of placebo is the nocebo effect of like, you know, anticipating something negative is going to happen, given all the kind of scare stories about LSD and, you know, in the seventies and eighties, people jumping out of windows or going blind from staring at the sun. The fact that people had primarily positive experiences is almost surprising given the stories that we were told as kids. And that’s sort of in retrospect how I look at my own sort of introduction to these things as playing with really powerful tools like they were toys because I had no cultural context for understanding them as tools. You know, it was really just, you know, let’s drop acid and look at the pretty colors and laugh. But sort of for me, it was like sensing this kind of cosmological awareness of something deeper that was… catalyzed in a way that was unexpected, but tremendously rewarding and valuable.

Joe Moore (55:27): So I’m seeing here in my notes that you were able to work with Dennis McKenna a little bit.

Kenneth Tupper (55:32): So I read, well, Part of my PhD topic came from Terence’s book, Food of the Gods. I remember in the mid-nineties reading that book and then Wade Davis’s book, One River. And in both of them, they talked about ayahuasca, something I’d never heard of. And the idea that indigenous peoples of the Amazon talked about learning from ayahuasca as a plant teacher. And I was struck that was where that kind of education metaphor hooked. Also, actually, Aldous Huxley’s book, Island. I’ll give a big shout out. That was another big influence. But Terrence McKay, I didn’t know anything about a brother of Terrence until in the early two thousands. Dennis published a paper called Ayahuasca and Human Destiny that I read. And it really resonated with what I was experiencing in my own encounters at that point with Ayahuasca. and found out that he actually had gone to the University of British Columbia for his PhD. It was his alma mater. He was an alumnus of UBC and had moved back to British Columbia at that point. So got an introduction and he signed on to be on my PhD dissertation committee, which I was tremendously grateful for. He’s a world’s expert on ethnobotany and ayahuasca specifically.

Joe Moore (56:44): That must’ve been really fun.

Kenneth Tupper (56:45): Yeah. He’s, he’s, he’s always fun to talk to. Very creative.

Joe Moore (56:50): That’s great. And, um, did you work on any ayahuasca issues in Canada?

Kenneth Tupper (56:57): So my PhD dissertation was looking at the Canadian government’s response to a application from a Brazilian church called the Santo Daime that had set up a chapter in Montreal as an offshoot of Brazilian mother churches and was seeking, we have in Canadian drug law, we have a controlled drugs and substance act. There’s something called a section fifty six exemption, which allows the minister to give an exemption to the drug law. It’s actually what allows supervised injection sites to operate. an exemption that allows them to operate legally. But there was this church application had been put forward for, and if you read the act, it says the minister may grant an exemption for medical, scientific, or purposes otherwise in the public interest. And it’s that third clause that’s actually really you know, broadly interpretable phrase. And the church put forward a religious freedom exemption, just basically said, we want to use our sacrament and import it, not just use, but we want to import our sacrament from Brazil and, you know, perform ceremonies for our congregation. And so I had the good fortune of encountering the applicant, Dr. Jessica Rochester in Montreal, and learning about her endeavor and ended up doing an access to information request, an FOI or Freedom of Information request that generated three hundred and eighty pages of internal Health Canada documents on their decision making from the sort of initial, what the hell is ayahuasca, because of course they’d never heard of it. to what I described as kind of a smoking gun document, which was a twenty-page issue analysis summary going through the evidence to date at that point of potential risks and harms. It was mostly unredacted, but there was a few key redactions, so I can’t make a conclusive determination, but it ultimately led to a recommendation for the exemption to be given. However, it took ten years from that point before they actually got the exemption because there was a change in political shift in Ottawa. That was when our previous prime minister, Stephen Harper, got elected. So the recommendation came forward just as he took office. And for the next ten years, there was a conservative government that did not look favorably on anything drug policy related. So it kind of got held up. There was also import-export conundrums, a catch-twenty-two between the government of Canada and the government of Brazil around who was going to authorize import versus export first. But ultimately, in the Santé d’Aimé in Montreal got their exemption and legally operate to this day. I think the Canadian government was looking at the U.S. Supreme Court decision around the Unio de Vegetal. A preliminary injunction that was held up or held to be in favor of the church and religious freedom down there. So it was an interesting topic to be working on in terms of, as I described it, looking at sort of how liberal democratic states, it was focused on Canada, but also broadly looking at like the Netherlands, the United States, Spain. There was other countries that were dealing with these same issues. trying to uphold competing principles of civil liberties, religious freedom, criminal justice, public health, economics, all these things kind of pulling in different directions with respect to ayahuasca, which is really kind of an outlier with respect to mainstream drug policy or drug laws, the architecture set up through the United Nations International Drug Control System, the three international treaties. And when you look at that whole apparatus, it’s really difficult to fold in ceremonial entheogen. And here I would use the word entheogen very sort of specifically for the Santo Daime practices because it is overtly spiritual. And ultimately Health Canada’s decision was very narrowly circumscribed for only ceremonial and religious uses. In fact, one of their key things was no health claims shall be made. This is not a medicine. There’s no medicinal opportunities here. It’s purely a sacramental use that has to be under the umbrella of religious practice.

Joe Moore (1:01:01): That’s interesting. Did the church object to that framing at all?

Kenneth Tupper (1:01:07): No, they were okay with it. I mean, they recognized that if they tried to fight it, it would be a… Health Canada would push back and say, well, if you’re making medical claims, then you’ve got to go and do a… Phase one, phase two, phase three clinical trials and a hundred million dollars. And, you know, so they were happy to stick with them, I think, in that sort of religious framing. And, you know, they were following the Santo Daime traditions of what was legally permissible in Brazil. And that was another advantage for them is that they kind of fit nicely into the box of what, Canada and the bureaucrats in Ottawa understood as religious practice. A shamanic type of use involving ayahuasca with a much more kind of diffuse history. The brew that is served in the Santo Daime is very sort of narrow and involves just two plants. Whereas in many indigenous traditions like Shipibo or Shuar, so many different words even for what is prepared as an ayahuasca brew. And the word ayahuasca, somebody said it’s kind of like the word casserole. There’s lots of things that you can put into it and still call it ayahuasca. There’s a few key things, but lots of other, you know, toy, tobacco, coca. There’s all kinds of plants that get mixed in.

Joe Moore (1:02:21): I’ve never heard the casserole analogy. It’s amazing. I have a paper I’d like to write, or at least I wanted to write an article on this concept of, it’s a tricky one. consent in ayahuasca spaces around admixtures and we just don’t know what’s in things and if it’s safe for me or is it even the thing that I signed up for? Have you bumped into any of those discussions?

Kenneth Tupper (1:02:54): Yeah, I mean, it’s obviously, and I’ve been in ceremonies where the brew has been very powerful in ways that, you know, weren’t necessarily sort of reminiscent of previous experiences that made me think, and, you know, whether or not the person pouring, leading the ceremony knows themselves what has gone into it often is questionable. So for sure there’s, but then the question comes up is okay well then how would one begin to standardize or regulate something like a traditional indigenous practice that defies that because the proprietary sort of recipe that is followed by a shaman cooking up in the jungle The idea you’re going to come in and impose, okay, you’re going to have this many, you know, chacruna, psychotria leaves and, you know, this amount of the ayahuasca vine and that’s it. Nothing else. It’s like anathema to their whole way of understanding what’s needed.

Joe Moore (1:03:47): Like sharing the recipe is super scary for them too, or just not appropriate.

Kenneth Tupper (1:03:52): Yeah. Yeah.

Joe Moore (1:03:54): It’s interesting. I thought about this from like a, okay, we’re selling to Westerners. Westerners can choose to go that way. but how do we make safer more kind of well-documented options available I remember ages ago people saying like yeah I don’t don’t really like the toe a blend but if I had something really bad happening I would go for that which is wild because that’s a pretty high dose scopolamine situation yeah um you know and people have been harmed from the nicotine in there from nicotine or rustica go ahead

Kenneth Tupper (1:04:23): There’s also, you know, the whole question of commensurability of Western biomedical understandings of what’s going on in an ayahuasca ceremony versus traditional indigenous understandings, which are, again, very diverse. Different indigenous groups have their own understandings of illness and disease, but mostly, I would say, incommensurable and diverse. There’s a naivety that I certainly experienced or became aware of in my youthful endeavor to get into research in this space that my hippie ideals of pink elephants and fluffy bunnies was fundamentally at odds with the deep, rich history of how ayahuasca has been used in the Amazon, which is one as much of assault sorcery, black magic, as it is for healing. An analogy I use is it’s like nuclear energy. It can be used for healing and helping nuclear medicine, but it can also be used for potential harm. Going down as a Wessner to the Amazon, as some people have described it, going into a war zone with magic darts flying all over the place shamans with you know intergenerational enmity that uh you know casting black magic and hexes on one another um and i know more than one westerner who’s gone down and felt they came back worse for the experience because of what’s been attributed to black magic so it’s again what sense to make of that i don’t know it’s a it’s a challenging challenging piece but uh certainly fascinating as well

Joe Moore (1:05:59): The final one is this fermenting of ayahuasca. And I’ve chatted with some experts on this and this idea of like, the more it ferments, the more wise it is in some traditions. And then like to kind of clean it up and get it ready for serving, it would be like a skim of the malt on the top and then boiling it and then serving it. And I think in some cultural containers, it’s totally cool. People have the gut biome for it. You bring somebody from Toronto and drop them in there, they are toast for potentially a while. And why Toronto? We’ll get into that on another episode. But I think it’s wild to think that people don’t… Consumers don’t know what they don’t know. And they don’t know to ask questions. And I think that’s a big deal.

Kenneth Tupper (1:06:56): Absolutely. And that’s why when I give public talks and this kind of thing, I always emphasize a harm reduction perspective and educating oneself, learning as much as you can before you know, entering and find out the lineage of the person you’re working with, who are they trained by. And especially for women, there’s also an awareness of sexual assault and, you know, predators, sort of shamans who claim to be something that they’re not and power dynamics. Shout out to the Women’s Visionary Congress who have a great website page on, it’s meant for women. I think it’s good advice for men as well. on how to protect yourself if you’re going into some kind of plant ceremony practice and a bunch of things that you need to consider and either ask questions of or take precautions on when you’re thinking about it and ultimately doing it if you go that way.

Joe Moore (1:07:51): Cool. And I think in terms of a closing thought around this philosophy of education background that you have and what might we take from that field of philosophy of education at this interesting juncture of psychedelic history?

Kenneth Tupper (1:08:14): Ooh, that’s a big question.

Joe Moore (1:08:16): Yeah.

Kenneth Tupper (1:08:17): Just that there’s more ways of knowing than… You know, it’s interesting. We live in a time of kind of the evaporation of truth and authority. Partly, I think, when you think about the idea of authority and authorship coming along with the printing press… the emergence of science as part of a function of the dissemination of knowledge through the printing press we’re now in a similar moment with with first you know the internet and social media and now ai is like this compressed time frame of reconceptualizing epistemology which is kind of the philosophy of knowledge what does it mean what does it mean to know something and how do we make claims of knowledge um and my part of my sort of enterprise was to broaden that idea of knowledge to be not just limited to Western scientific approaches. Although I still value, I was raised myself personally to be a scientist in my patrilineal tradition and still tremendously value that method for, for discerning ways of understanding the universe, but it’s not exclusive to what I think is valuable. And, you know, coming into deeper into the twenty-first century, thinking about the predicament of humans, you know, the, the reconciling ecology and economy, I would say is one of the crises of our times. It’s not global warming per se, it’s more how do we manage an infinite growth paradigm of economy with the finite limitations of planetary systems. I don’t personally think it’s going to be going to the moon or to Mars. I think it’s more figuring out how to live sustainably on the planet we’ve got and you know maybe that’s a hippie idealistic thing but i feel like these kinds of experiences these kinds of cognitive tools or plant teachers are our ways to help us uh navigate that path forward uh or at least was maybe fifty years ago maybe we’re past a point for no return now i don’t know right this is like big questions that we need to ask ourselves

Joe Moore (1:10:14): Absolutely yeah um anything you want to leave folks with or

Kenneth Tupper (1:10:19): If you’re interested in reading the academic thoughts I’ve put into all of this, you can find it on my website. Oh, I’ve got a podcast that I started as well. I’ll just maybe close with the title is Intonicated, a word that came to me in my Ibogaine experience last year where I was reflecting on the state of consciousness that I was in, understanding that if I was assessed by a medical professional, I would be deemed intoxicated for sure. I was unable to stand up, let alone drive a car. But I didn’t feel anything toxic happening. In fact, I felt the exact opposite. I felt there was this healing going through my body at a subcellular mitochondrial level, working spiritually, psychologically, physically, simultaneously. And I felt like there was a tonic happening. And I felt like I don’t feel intoxicated. I feel intonicated. and came to realize that after I came down and looked it up, no such word existed, but I felt like it was a good title for a podcast. So I started putting some interviews with friends and colleagues out there.

Joe Moore (1:11:22): I love this. And I think you have a level up on Jonathan Ott’s argument around shifting from toxicology or, sorry, intoxication to inebriation. I feel like Intonicated could be even better because it has less of those kind of baggage notes around opioids or anything.

Kenneth Tupper (1:11:41): Yeah, yeah. Thank you. I’d love to. Unfortunately, Jonathan Knott’s passed away, but I’m sure we would have had a good dialogue about the merits of that term.

Joe Moore (1:11:51): Right. All right. Ken, I thank you so much for doing this with me. I hope we can do more. I remember when we met, you were still working for the government and I wasn’t sure how to get you on the show.

Kenneth Tupper (1:12:06): Yeah, no, I’ve left government and a bit more if you’re free to speak and share. So I’m happy to be doing it here with you and psychedelics today audience.

Joe Moore (1:12:15): All right. Until next time. Thank you everybody for tuning in. We’ll see you next time. Bye-bye.


Frequently Asked Questions

Who is Kenneth Tupper?

Kenneth Tupper, PhD, is a Canadian public health researcher, drug-policy expert, educator, and psychedelic scholar. His work has included harm reduction, drug checking, the opioid overdose crisis, psychedelic policy, ayahuasca research, and the relationship between psychedelics and education.

What does Kenneth Tupper mean by “entheogenic education”?

Entheogenic education is Tupper’s framework for considering psychedelics and traditional psychoactive plants as potential tools for learning rather than viewing them exclusively as recreational drugs or medical treatments. His work draws partly on Indigenous traditions in which substances such as ayahuasca, peyote, and psilocybin mushrooms may be understood as teachers.

Why does Tupper criticize traditional drug education?

Tupper argues that much drug education has historically focused on achieving a predetermined behavioral outcome—usually abstinence—rather than genuinely educating young people about drugs. He contrasts this with more experiential approaches to education that encourage curiosity, critical thinking, and informed decision-making.

What does the episode say about British Columbia’s drug decriminalization experiment?

Tupper describes decriminalization as only one component of a much larger system. Removing criminal penalties for possession does not by itself address an unpredictable illicit drug supply, housing, healthcare, addiction treatment, mental health, or social services. The episode examines why policy outcomes depend heavily on what other supports are implemented at the same time.

What are the safety concerns around ayahuasca admixtures?

Ayahuasca preparations can vary significantly between traditions and practitioners. Joe and Tupper discuss questions around informed consent, additional plants in a brew, pharmacological interactions, practitioner transparency, cultural differences, and the difficulty of applying Western standardization requirements to traditional ceremonial practices.

Posted on September 30, 2026September 30, 2026

Weekly Psychedelic Policy Briefing: September 30th, 2026

In the latest Weekly Psychedelic Policy Briefing, Psychedelic State(s) of America founder and investigative journalist Jack Gorsline dives deep into the latest regulatory, legislative, and clinical landscape shifts shaping drug policy and medicine access.

The Drug Enforcement Administration proposed on Sept. 23 to place five tryptamines in Schedule I. One of them, 4-OH-DiPT, is the active compound in a postpartum depression drug candidate that FDA granted Breakthrough Therapy designation in February. The notice came nine days after the FDA held a public hearing on speeding psychedelic treatments to patients under Executive Order 14401.

In Oregon, the Oregon Health Authority dropped a proposal to double psilocybin license fees after public pushback, including from the state’s Psilocybin Advisory Board. It has not said how it will close a projected multimillion-dollar shortfall. And a Government Accountability Office audit found DEA followed HHS’s recommendation on every substance it finalized from 2020 through 2025, while neither agency has written procedures for how those decisions get made.

DEA Revives Proposal to Place Five Tryptamines in Schedule I, With HHS Support

DEA published a notice of proposed rulemaking on Sept. 23 to place 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT in Schedule I of the Controlled Substances Act. Administrator Terrance Cole signed it Sept. 11, three days before the FDA’s hearing. A final rule would require anyone handling the compounds, including researchers, to hold a Schedule I registration.

At least two of the compounds are in commercial development. Reunion Neuroscience announced Feb. 23 that FDA had granted Breakthrough Therapy designation to luvesilocin, its prodrug of 4-OH-DiPT, for postpartum depression. FDA says the designation is not a finding of safety or effectiveness, and Reunion says it plans a Phase 3 trial this year.. Mindstate Design Labs reported completing a Phase 1 study of MSD-001, its formulation of 5-MeO-MiPT, in July 2025. DEA’s economic analysis expects few researchers to be affected, citing the HHS finding that none of the five is subject to an investigational new drug application. The proposal does not mention luvesilocin or say whether listing 4-OH-DiPT would cover a prodrug of it.

The agency proposed the same rule change back in January 2022, but after announcing a hearing that July, DEA officials withdrew both notices to seek an updated HHS evaluation. HHS delivered that evaluation on April 2, 2026, recommending Schedule I for all five.

Research already underway would not stop at once. Under 21 U.S.C. 822(h), researchers registered for another Schedule I substance could continue if they apply to add these compounds within 90 days after a final rule takes effect. Others would have to stop until DEA registers them.

FDA tied its Sept. 14 hearing to Executive Order 14401, which directs HHS and FDA to accelerate psychedelic research and appropriate approvals, and its hearing notice excluded the scheduling status of any substance from discussion. On Sept. 8, HHS named Michael Davis, the former chief medical officer of psilocybin developer Usona Institute, permanent director of FDA’s Center for Drug Evaluation and Research, whose staff write the evaluations behind HHS scheduling recommendations.

Comments and hearing requests are due Oct. 23 in docket DEA-2026-1585. Then, DEA administrator Cole will decide whether to grant a hearing before an administrative law judge.

Oregon Health Authority Drops Proposal to Double Psilocybin License Fees

Following significant public backlash, the Oregon Health Authority announced on Sept. 22 that it will not file final rules from its current psilocybin rulemaking and will not adopt the proposed fee increases. It cited feedback from the rulemaking, including from the Oregon Psilocybin Advisory Board.

The proposal, originally proposed on June 26, would have doubled annual license fees for service centers and manufacturers to $20,000 and for facilitators to $4,000. It also would have raised worker permit fees from $25 to $200 and ended reduced fees, including those for veterans and low-income applicants, starting Jan. 1, 2027. 

Advocates across the state have previously said the fee-funded program is not self-sustaining, and warned that higher fees could cut the number of licensees and deepen the shortfall. A fiscal analysis OHA released under a records request projected a $3.8 million shortfall this biennium without the increase and $4.2 million if licensees quit rather than pay, the Oregon Capital Chronicle reported. OHA’s statement does not say how the program will be funded in lieu of raising the licensing fees.

The agency also said it will begin a new rulemaking in the coming weeks to consider the package’s non-fee changes. Those included an amendment barring licensed manufacturers from providing “information or instruction related to home cultivation.”

Amy Charlesworth, a licensed facilitator and military veteran, pointed to the home cultivation provisions. “OHA dropping this rulemaking is a win, but it does not mean we’ve won,” she told Psychedelic State(s) of America. The proposed rules “would have restricted licensees from ‘promoting’ or ‘encouraging’ unlawful or unregulated activity, including by ‘providing information or instruction related to home cultivation,'” she said. “That is not regulation of what happens inside a licensed service center. That reaches what we write, teach, publish, and say in public. If OHA brings these provisions back, we will be ready to challenge them.”

Sam Chapman, executive director of the Center for Psychedelic Policy, managed the 2020 Measure 109 campaign that created the program. “We asked Governor Kotek to give the legislature time to get this right, and now they have it,” Chapman told Psychedelic State(s) of America. “The program is working; the fee structure isn’t.” He said the center is preparing an economic analysis for the 2027 legislative session comparing state-supported psilocybin services with existing public mental health spending.

OHA noted in the announcement that the agency will post the new rulemaking to its psilocybin rules page in the coming weeks, with a planned effective date of Jan. 15, 2027.

GAO Finds DEA Followed HHS on Every Finalized Scheduling Decision Since 2020, Without Written Procedures

A Government Accountability Office audit (GAO-26-108623) published Sept. 23 examined all 208 substances the DEA acted on between 2020 and 2025. The report revealed a consistent record of following scientific recommendations paired with a limited scope of formalized procedural rules.

In all 95 instances where the Controlled Substances Act required a scientific and medical evaluation from HHS, the DEA obtained and considered one. All 84 substances that reached a final rule landed exactly where HHS recommended (an 84-for-84 record), with the remaining 11 under temporary orders.

When GAO investigators examined how the agencies reach these determinations, they found limited documentation in writing. The DEA has no written policy dictating who collects preliminary data, who conducts the statutory eight-factor analysis, or how staff weigh HHS recommendations. The FDA’s Controlled Substance Staff lacks formal written evaluation procedures. Furthermore, “potential for abuse,” the core statutory standard governing federal drug scheduling, is defined neither in federal law nor in FDA policy, leaving decisions to professional judgment and institutional memory. Meanwhile, the formal interagency agreement governing coordination between the FDA and the National Institute on Drug Abuse (NIDA) is more than 40 years old and references offices that have long ceased to exist.

For the psychiatric drug pipeline, the audit exposes the administrative vulnerabilities facing rescheduling petitions and investigational compounds. Although 21 U.S.C. 811(j) has required the DEA since 2015 to issue an interim final scheduling rule within 90 days of market approval for substances in Schedules II through V, GAO found the agency has no written procedures governing those reviews. Without codified procedures, new drug applications and rescheduling petitions for investigational substances like MDMA and psilocybin face significant uncertainty.

This article was produced in partnership with Psychedelic State(s) of America – a nonprofit-sponsored news organization dedicated to rigorous independent psychedelic journalism. Learn more about PSA’s Media Partnerships Program and donate to the PSA Media Fund here.

Posted on September 22, 2026September 22, 2026

Weekly Psychedelic Policy Briefing, September 21, 2026

A Split at the FDA, an Oversold VA Bill and Alabama’s Alabama’s rescheduling hold is lifted

In this week’s Psychedelic Policy Briefing, Psychedelic State(s) of America founder and investigative journalist Jack Gorsline covers three institutional developments. At a rare FDA part 15 hearing on psychedelics, speakers split over how tightly to control approved products while the federal panel listened in silence. The American Legion endorsed Senate bill S.4220 in terms the bill’s text does not support. And Alabama withdrew a four-month-old objection to federal medical marijuana rescheduling, a sequence that previews how state adoption of a future psilocybin or MDMA rescheduling could unfold.

FDA Hearing Exposes Differing Approaches to Regulating Psychedelics

The Food and Drug Administration convened a public hearing on Sept. 14 at its White Oak campus in Silver Spring, Maryland, titled “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.” The agency sought comment on provider training and credentialing, patient safety, access, and data collection and standardization. The four-hour hybrid session heard two-minute comments from about 80 speakers selected from more than 200 requests, and it opened a stretch of Washington meetings on psychedelics that continued the next day at the Advanced Research Projects Agency for Health (ARPA-H). A panel of federal staff from FDA, the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration (SAMSHA), the Veterans Health Administration and ARPA-H listened. No member of the panel asked a speaker a question, even though speakers finished ahead of schedule.

The hearing capped a run of federal activity. President Donald Trump signed Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” on April 18. FDA finalized its guidance “Psychedelic Drugs: Considerations for Clinical Investigations” on July 14. On Sept. 8, HHS named Michael Davis permanent director of the Center for Drug Evaluation and Research, a role he had held on an acting basis since May; Davis was chief medical officer of the Usona Institute, a nonprofit psilocybin developer, from December 2022 to June 2025. The same day, Definium Therapeutics announced that FDA had granted Breakthrough Therapy designation to DT120, its orally disintegrating lysergide (LSD) tablet, for major depressive disorder, the program’s second such designation after one for generalized anxiety disorder in 2024. On Sept. 9, Davis and three other CDER officials published “FDA’s New Framework for Psychedelic Drugs” in the New England Journal of Medicine, describing expedited programs and regulatory flexibility for psychedelic development. 

Testimony split over Risk Evaluation and Mitigation Strategies (REMS), the restrictions FDA can attach to an approval. Laurel Kilgour of the Psychedelic Bar Association urged the agency to study state-regulated access programs before setting controls. She argued that “REMS should not limit access to patient care,” noting that “the track records of regulatory frameworks that have been in place for multiple years in Oregon and Colorado are instructive about barriers to entry and how these programs are playing out in practice.” Kilgour told the panel that “meaningful choice among providers is itself a kind of safeguard, a consumer protection,” and asked FDA to keep credentialing requirements affordable for small, independent providers. Others argued for caution. Eddie Jacobs, a Johns Hopkins researcher, recommended “an initial safety floor anchored closely to the trial context” and acknowledged it could limit access in the short term. Lawrence Goldkind, a former FDA staffer, was one of several speakers who asked FDA to write labeling and REMS drug by drug.

Greg Hutchinson, executive chairman of Emyria Limited, which is listed on the Australian Securities Exchange, described the three years since Australia’s Therapeutic Goods Administration began allowing authorized psychiatrists to prescribe MDMA for PTSD and psilocybin for treatment-resistant depression outside clinical trials, on July 1, 2023. The pathway authorizes prescribers; the TGA has not evaluated or approved any product. Hutchinson said Emyria has conducted more than 500 dosing sessions, with treatment funded by the private insurer Medibank and by Australia’s Department of Veterans’ Affairs. “Real-world patients are more complex than trial patients, and we accept individuals that trials would typically exclude,” Hutchinson said, including patients with elevated blood pressure and personality disorders. “Trials set the starting point, but frontline providers armed with data advance the field.”

Sandy Samberg, a nurse practitioner and founder of the Psychedelic Education Partnership, testified that mainstream providers are not prepared for novel psychiatric treatments. She described a relative who had failed 10 depression medications and whose internist, psychiatrist, therapist and cardiologist all expressed confusion or reluctance about esketamine nasal spray, which FDA approved in March 2019. “Four highly trained, caring healthcare professionals, and not one of them felt equipped to help him navigate a treatment that had received FDA approval six years earlier,” Samberg said. She said specialized facilitator training is insufficient on its own and that “responsible integration also requires equipping a wide range of providers with the knowledge and confidence to discuss the evidence, risks, and contraindications, and make appropriate referrals.”

Jean C. Velez Rodriguez, a U.S. Marine Corps veteran and executive director of the Puerto Rico Institute for Psychedelic Science, Medicine, and Awareness (PRISMA), testified that 53% of respondents to a recent survey conducted by PRISMA reported lifetime psilocybin use. The figure describes that survey’s respondents, not Puerto Rico’s population. The National Survey on Drug Use and Health, which covers the 50 states and the District of Columbia, offers no comparison figure, because Puerto Rico’s roughly 3.2 million residents fall outside it. “Territory inclusion should be a foundational design requirement for any federally endorsed data repository or coordinated registry network,” Velez Rodriguez said. Without intentional engineering of those systems at the outset, Velez Rodriguez warned, “in our hands, we have a system that wasn’t built to see us.”

The testimony came six weeks after Gov. Jenniffer González-Colón signed Executive Order 2026-037, which directs Puerto Rico’s Department of Health to assess whether to create a pilot research program for ibogaine, MDMA and psilocybin but does not authorize clinical use of any of them.

Lakisha Jenkins-Samuels of the Kiona Foundation pointed to the medical cannabis rollout as a cautionary example. She asked for transparent botanical drug characterization, independent channels for reporting harms and a place for Indigenous lineage keepers in drafting the rules. “Keep space for the people who traditionally hold this medicine. They belong in the room where the rules are written,” Jenkins-Samuels said. “Community governance is safety infrastructure. Those are the simple facts.”

Her request lands alongside the Advancing Botanical Drug Development Act of 2026 (H.R. 10150), a House bill introduced Aug. 27 by Rep. Lauren Boebert, R-Colo., that would bar FDA for 12 years from approving generic or hybrid versions of a newly approved botanical drug product, a protection that would attach to the product rather than to the plant or its traditional use. 

The next day, on Sept. 15, ARPA-H held a Proposers’ Day in Washington for ASCENT-IBO, a funding opportunity for accelerated Phase I and Phase II trials of ibogaine in opioid use disorder. Matt Zorn, HHS deputy general counsel, addressed the session remotely and urged attendees to build teams pairing cardiologists and clinical trial operators with traditional knowledge holders. “A lot of you here today are worth more on a team than you are individually,” Zorn told the Proposers’ Day audience. “It’s our responsibility to move fast, it’s our responsibility to fail quickly,” he added, before warning, “We’re not going to fund someone who’s not going to move quickly.”

Zorn’s remarks come from a transcript of the session, which was not open to the press.

American Legion Endorses S.4220 but Describes a Stronger Bill Than Congress Wrote

At its 107th national convention in Louisville, Kentucky, held Aug. 28 to Sept. 3, the American Legion adopted a resolution titled “Novel Therapeutics for Mental Health Conditions and Traumatic Brain Injury” endorsing the Veterans Health Administration Novel Therapeutics Preparedness Act, S.4220. The resolution says the bill would establish “a dedicated VA Office of Novel Therapeutics and Centers of Excellence in each VA regional district.” 

However, the text of the bill does not say that. S.4220, introduced March 26 by Sen. Tim Sheehy, R-Mont., with Sens. Ruben Gallego, D-Ariz., Tammy Duckworth, D-Ill., and John Boozman, R-Ark., provides in section 7394 that the VA secretary “may designate one or more medical centers” as centers of excellence. That is discretionary and sets no number. The per-district language tracks section 7392(d)(11), which directs a new Office of Novel Therapeutics to identify at least one medical center in each Veterans Integrated Service Network for infrastructure and workforce readiness work. Identifying a site is not designating a center, and neither provision carries funding.

The bill would create the office, a Clinical Implementation Program for Emerging Therapeutics to test care delivery models, and a Veteran Advisory Committee, and it would direct VA to coordinate with DEA and other agencies on scheduling and reimbursement. It does not fund clinical trials or create patient access to any psychedelic. Its duties apply to approvals that have not yet occurred.

S.4220 was referred to the Senate Veterans’ Affairs Committee on March 26, and the committee held a hearing on April 29. As of Sept. 19, Congress.gov records no further action and no House companion bill has been filed.

Alabama Withdraws Its Objection to Federal Medical Marijuana Rescheduling After Four Months

As reported by Marijuana Moment, on Sept. 17, the Alabama State Committee of Public Health, the governing body of the Alabama Department of Public Health, voted unanimously to withdraw its objection to the federal rescheduling of medical marijuana, letting the Schedule III classification take effect in state law. 

The federal action was an order issued April 23 and published April 28 in the Federal Register that moved two categories from Schedule I to Schedule III: marijuana in an FDA-approved drug product and marijuana subject to a state medical marijuana license. Adult-use cannabis remains in Schedule I pending a separate DEA proceeding.

Under Alabama Code section 20-2-20(c), a federal rescheduling takes effect in the state 30 days after Federal Register publication unless the state health board objects; an objection requires published reasons, a hearing and a published decision. The committee objected May 21. “We certainly are going to do this,” State Health Officer Dr. Scott Harris told members at the time, asking for the objection to buy time for implementation. After a July 22 public hearing, Harris said in September that he saw no issues with the change and that the department’s legal team had resolved the agency’s concerns. The objection itself cited Alabama’s separate medical cannabis framework, which sits outside the health department’s jurisdiction.

Most states use a similar automatic adoption model, but the mechanics differ. In North Carolina, the state commission that controls scheduling decides at its next regular meeting held 30 days after Federal Register publication, and if it objects it has 180 days to begin rulemaking. In Wisconsin, any interested party can object, which stays the change until the Controlled Substances Board rules. If DEA reschedules psilocybin or MDMA after an FDA approval, state adoption will depend on each state’s version of that window, and Alabama shows a single state body can hold it open for months.

Disclosure: Psychedelic State(s) of America, which the author founded, collaborates with the Psychedelic Bar Association on events and joint video content. PBA’s Laurel Kilgour is quoted in the first item.

This article was produced in partnership with Psychedelic State(s) of America – a nonprofit-sponsored news organization dedicated to rigorous independent psychedelic journalism. Learn more about PSA’s Media Partnerships Program and donate to the PSA Media Fund here.

Posted on August 3, 2026August 3, 2026

Weekly Psychedelic Policy Briefing – August 2, 2026

Aug 3 policy brief - pen and ink louisana state house

In this week’s psychedelic policy briefing, Investigative Journalist Jack Gorsline unpacks a wave of state and federal momentum aimed at expanding alternative therapies for veterans and those battling addiction. On Capitol Hill, bipartisan lawmakers are leveraging the National Defense Authorization Act to extend military clinical trials for substances like psilocybin and MDMA, a move mirrored by the Department of Veterans Affairs’ ongoing push to expedite treatment research for PTSD. Meanwhile, at the state level, a pioneering Louisiana law officially took effect this week, utilizing opioid settlement funds to launch a highly regulated clinical pilot program targeting substance abuse and treatment-resistant mental health conditions.

AOC, Other Members of Congress Tout Psychedelic Benefits as Research Amendments Advance

Legislators from both parties are actively advocating for congressional bills designed to increase federal studies on psychedelic treatments for veterans and active-duty service members. The key provisions, attached to the House version of the 2027 fiscal year National Defense Authorization Act (NDAA)  extends Department of Defense clinical trials for six additional years, continuing studies through September 30, 2033. 

Proponents, including Rep. Alexandria Ocasio-Cortez (D-N.Y.), have highlighted the medical promise of these substances, emphasizing that MDMA has shown unique potential in treating severe, treatment-resistant post-traumatic stress disorder, while psilocybin holds promise for depression.

Rumored 2028 presidential hopeful Ocasio-Cortez recently remarked to Marijuana Moment that she supports expanded access to investigational therapies like psychedelics in part because, “there are so many people that have tried every single path available to them in order to get the healthcare that they need and they have not been able to access that.”

The newly approved amendments, which were co-sponsored by Representatives Jack Bergman (R-MI), Morgan Luttrell (R-TX), Lou Correa (D-CA), and Seth Moulton (D-MA), among others – would widen research pathways and codify aspects of a recent executive order targeting alternative therapies. In addition to prolonging DOD-backed trials involving substances like psilocybin, MDMA, and ibogaine for active-duty service members, the legislation directs the Department of Veterans Affairs to establish a dedicated oversight official within 90 days. It also requires federal agencies to coordinate on workforce readiness and issue comprehensive progress reports to lawmakers regarding emerging psychedelic-assisted treatments.

VA Secretary Highlights Psychedelic Progress

U.S. Department of Veterans Affairs Secretary Doug Collins recently praised the Trump administration’s advancements in developing psychedelic treatments for military veterans battling post-traumatic stress disorder and other mental health conditions. Speaking Wednesday following a roundtable discussion with veterans and Republican Rep. Anna Paulina Luna in Pinellas County, Florida, Collins highlighted the agency’s shift toward research-driven care rather than traditional approaches.

The push for alternative therapies follows an April 2026 executive order from President Donald Trump that directed health regulators to expedite the review of psychedelic treatments and increase research funding. The VA is currently participating in 20 active clinical trials investigating the efficacy of these therapies.

While the veterans’ mental health crisis has played a foundational role in moving the needle on Capitol Hill, the emerging data on psychedelics’ efficacy in treating complex conditions like Post Traumatic Stress Disorder (PTSD) continues to encourage lawmakers, advocates, and researchers alike. A recent, donor-funded clinical trial conducted at Ohio State University’s Center for Psychedelic Drug Research and Education featuring a cohort of exclusively military veterans with PTSD reported that nine of twelve participants (75%) met the study’s remission threshold one month after psilocybin-assisted therapy, in an open-label safety trial with no control group.

Luna, an Air Force veteran, emphasized that the therapy requires a comprehensive process rather than a simple prescription. She also credited the Trump administration and advocates like HHS Secretary Robert F. Kennedy Jr. for championing the initiative. The VA remains engaged in the research phase rather than broad access, observing strict protocols.

Louisiana Opioid Settlement Psychedelic Pilot Launches

As of August 1, 2026, a Louisiana law authorizing the creation of a psychedelic pilot program officially took effect, paving the way for expanded psychedelic clinical research in the state. The program, funded by the state’s opioid settlement money, became law without Governor Jeff Landry’s signature following SB 43’s unanimous passage by state lawmakers in May.

The initiative supports clinical trials exploring investigational treatments, including psilocybin, ibogaine, and MDMA. The Louisiana Department of Health will oversee the program, which focuses on patients suffering from opioid use disorders, as well as co-occurring substance use disorders, and “treatment-resistant neurological and mental health conditions.”  All clinical trials conducted under the new program must adhere to the Food and Drug Administration’s investigational drug approval process. Participating researchers are required to obtain permits from the Drug Enforcement Administration to study the Schedule I controlled substances. Patients will undergo physical and mental health screenings, and researchers must establish strict protocols for safety and adverse event reporting.

The legislation also authorizes state academic institutions to collaborate on the trials and mandates a revenue-sharing model. If a viable prescription therapy is developed and approved through the pilot program, a 20% state revenue-share on the drug’s profits will be returned to Louisiana, and the state will participate in a national drug development consortium.

This article was produced in partnership with Psychedelic State(s) of America – a nonprofit-sponsored news organization dedicated to rigorous independent psychedelic journalism. Learn more about PSA’s Media Partnerships Program and donate to the PSA Media Fund here.

Questions about this week’s psychedelic policy briefing

What psychedelic provisions are in the FY2027 NDAA?

The House-passed version of the National Defense Authorization Act extends the Defense Department’s psychedelic clinical trial program through September 30, 2033, codifies parts of President Trump’s April 2026 executive order on alternative therapies, and directs the Department of Veterans Affairs to name a dedicated oversight official within 90 days. The Senate has not taken up the provisions, and the two chambers must reconcile their versions before anything reaches the president.

Does the Louisiana psychedelic law legalize psychedelic therapy?

No. Senate Bill 43 funds clinical trials using opioid settlement money. Studies must go through the Food and Drug Administration’s investigational new drug process, and researchers need Drug Enforcement Administration registration to work with Schedule I substances. The law creates no legal access outside a trial.

Who qualifies for Louisiana’s psychedelic pilot program?

The statute names opioid use disorders, co-occurring substance use disorders, and treatment-resistant neurological or mental health conditions. Veterans with PTSD and traumatic brain injury motivated the bill politically but are not written into the eligibility language. The Louisiana Department of Health’s Office of Behavioral Health administers the program.

What does Louisiana get if a drug comes out of the pilot program?

If the trials produce an approved prescription therapy, the state receives a 20 percent share of the drug’s profits and joins a national drug development consortium. Louisiana is funding the research with money it received from opioid settlements.

Is the VA providing psychedelic therapy to veterans?

Not as care. The VA is running 20 active clinical trials on psychedelic therapies. Participation requires enrolling in a study, and Secretary Doug Collins has announced no timeline for broader availability.

What did the Ohio State psilocybin trial in veterans find?

Nine of twelve veterans with severe, treatment-resistant PTSD no longer met diagnostic criteria one month after two doses of psilocybin paired with roughly sixteen hours of therapy. It was an open-label pilot designed as a safety trial, with no control group and no blinding, and the PTSD outcomes were secondary endpoints. The trial ran at Ohio State University’s Center for Psychedelic Drug Research and Education and was not funded by the VA.

Posted on July 30, 2026July 30, 2026

Psychedelic Policy Briefing: Week of July 27th, 2026

As federal institutions gradually formalize pathways for psychedelic research, the broader landscape remains defined by steep friction.

In this week’s psychedelic policy briefing,  investigative journalist Jack Gorsline breaks down key developments from across the psychedelic industry, including a potential final death blow on Capitol Hill for expanding Right to Try access to schedule 1 drugs this term. 

Elsewhere in D.C., whispers are growing louder that a rumored reversal of the FDA’s previous request for new clinical trials before reevaluating a controversial biotech company’s patented MDMA formula. 

Just beyond the psychedelic bubble, a recently-advanced intellectual property-focused federal bill seeks to upend the status quo for patented pharmaceutical compounds, signaling a strong interest from congress in reigning in longstanding monopolistic business practices across the pharmaceutical industry.

Here are the three major developments shaping the beat this week.

U.S. House Passes NDAA Amendments to Extend Military Psychedelic Research Through 2033

As first reported by Marijuana Moment, on Wednesday July 22, The U.S. House of Representatives passed drug policy amendments as part of the National Defense Authorization Act (NDAA). The measure extends the Department of Defense’s (DOD) psychedelic therapy research initiative through 2033. The legislative package codifies executive directives aimed at expediting clinical trials for military service members struggling with treatment-resistant PTSD and traumatic brain injury (TBI).

The reform reflects a continued federal bifurcation: while House lawmakers advanced clinical psychedelic research for veterans, the House rules committee blocked proposed waivers for military recruits with prior cannabis infractions. The House also rejected a separate amendment  to the NDAA proposed by Rep. Nancy Mace (R-SC) and Rep. Madeline Dean (D-PA) that sought to solidify Right to Try access to Schedule I substances.

This congressional rejection of “Right to Try” access-focused NDAA amendment likely signals the end of the road for the Freedom to Heal Act of 2025 as well, which aimed to codify RTT Access to Schedule I substances like psilocybin, MDMA, and ibogaine. Filed on December 4, 2025 by Sen. Corey Booker (D-NJ) and Sen. Rand Paul (R-KY), the bill was backed prominently by advocacy organizations Reason for Hope, BrainFutures, and the Veteran Mental Health Leadership Coalition (VHMLC), the bill generated significant media coverage and a public endorsement from former Arizona Senator Kyrsten Sinema, who is the subject of a Department of Justice complaint alleging illegal lobbying activity. However, as I reported for DoubleBlind Magazine back in March, leaked email correspondence from key Senate Veteran Affairs Committee (SVAC) staffers appeared to indicate that the bill never had any legs in Congress. 

Rumors of FDA Re-Evaluation for Resilient Pharmaceuticals

Resilient Pharmaceuticals (formerly Lykos Therapeutics) is expected to be granted a full reevaluation of its MDMA-assisted therapy treatment from the FDA without being required to conduct new Phase III clinical trials. According to multiple sources with knowledge of the company’s ongoing negotiations with the FDA, Resilient could resubmit by the end of the year, or possibly even by the end of July. 

Psychedelic Alpha founder Josh Hardman first reported on a possible reevaluation of the original clinical data earlier this year, and noted on Twitter/X last week that a formal resubmission could happen by the end of July.

A reversal from the FDA would contrast with the agency’s request for Resilient to conduct new Phase III clinical trials in a Complete Response Letter (CRL) sent to the company following the initial rejection of its New Drug Application (NDA) for its patented MDMA formula. Additionally, three research studies evaluating long-term outcomes of Phase II clinical trial participants following MDMA-assisted therapy were formally retracted by Psychopharmacology in August 2024. The prominent academic journal cited “protocol violations amounting to unethical conduct… by researchers associated with this project.”

The retraction notice stated that the authors “confirmed they were aware of these violations… but did not disclose this information to the journal or remove data generated by this site from their analysis.”

Administrative and industry influence on the rumored reevaluation could have played a role as well. President Trump reportedly exerted significant influence on the FDA’s decision to approve flavored nicotine vapes earlier this year, and Trump has openly stated that a text from Podcaster Joe Rogan spurred his decision to sign a psychedelic research-focused Executive Order back in April. What’s more, one of Resilient’s largest shareholders is Venture Capitalist Antonio Gracias, a prominent Silicon Valley aly of SpaceX Founder Elon Musk who served alongside Musk as a Special Government Employee under Trump’s since-shuttered Department of Government Efficiency (DOGE) and helped lead a takeover of Resilient/Lykos in May 2025 after connecting with company founder Rick Doblin at Burning Man. 

Per reporting from The Guardian, it was at the annual festival in Black Rock City, Nevada that Gracias initially advised Doblin to cut his losses with Lykos altogether and start fresh, before ultimately teaming up with British billionaire hedge fund manager Christopher Hohn. 

MA Lawmakers Advance Two Competing Psychedelic Pilot Program Bills

Two bills designed to establish psychedelic-assisted therapy pilot programs in Massachusetts have advanced to the House Committee on Ways and Means. The Joint Committee on Health Care Financing recently issued favorable recommendations for House Bill 4200 and House Bill 2203, continuing the legislative momentum after both measures cleared the Joint Committee on Mental Health, Substance Use and Recovery. House Bill 4200, introduced by state Rep. James O’Day, would authorize the Department of Public Health to license a maximum of three mental health centers for supervised psychedelic treatments, mandating that the participating clinics remain independent from pharmaceutical companies and drug developers.

However, the push for a strictly medicalized rollout has sparked scrutiny over the growing influence of private capital. Control Z Health co-founder Colin Beatty testified alongside O’Day in June 2025 to support the pilot while harshly criticizing broader decriminalization efforts like Question 4, labeling adult-use access an “irrational exuberance.” While Beatty claimed his advocacy is rooted in a desire to provide humane medical care, grassroots activists like Jamie Morey and Graham Moore of Mass Healing have raised concerns regarding his previous addiction treatment venture, Column Health. 

A companion measure sponsored by state Rep. Marjorie Decker, House Bill 2203, would create a two-year psilocybin pilot program strictly for adults 21 and older. Following U.S. Food and Drug Administration guidelines, the initiative would partner university researchers with community groups to oversee clinical protocols and evaluate psilocybin’s effectiveness in treating depression, PTSD and end-of-life distress. State officials are expected to analyze the pilot’s community impact and the feasibility of eventual MassHealth coverage before the legislation goes before the full House for a vote.

These legislative advancements are unfolding in the wake of the scandal-plagued failure of a 2024 psychedelics-focused ballot initiative and alongside a notable spike in lobbying spending on Beacon Hill. As I’ve previously reported for Lucid News, Compass Pathways, a company pursuing FDA approval for a synthetic psilocybin drug, poured $54,000 into lobbying the governor’s office and the Executive Office of Veterans Services during the first half of 2025 — a significant jump from $32,100 the previous year. Traditional health care organizations are also spending heavily to mold the state’s upcoming psychedelic framework, with Health New England Inc. and the Massachusetts Association of Health Plans spending a combined $140,000 over the first six months of the year.

Legal & Corporate IP: Senate Passes S. 1041 to Curb Biologic Patent Thickets

On July 21, 2026, the United States Senate unanimously approved the bipartisan Affordable Prescriptions for Patients Act (S. 1041). The bill imposes a statutory cap of 20 patents that brand-name drug manufacturers can assert against biosimilar applicants during litigation. 

This proposed bill aims to crack down on “patent thickets,” a tactic used by pharmaceutical companies to prolong their monopolies on biologic drugs. Historically, large drug manufacturers have manipulated the patent system by registering numerous minor, overlapping patents for a single medication, effectively preventing cheaper alternatives from reaching the public. 

By removing these legal roadblocks, lawmakers expect the legislation to significantly lower out-of-pocket expenses for patients who depend on these crucial treatments. Additionally, opening up the market to more competition should save government healthcare programs like Medicare and Medicaid billions of dollars over time. The bill is now moving to the House of Representatives, where patient advocates are pressing for its rapid approval so these vital pricing reforms can quickly become law.

While the bill specifically pertains to “biologic patent thickets” – the precedent-setting nature of the bill signals an appetite from members of both political parties for broader patent thicketting reform in the future.

This article was produced in partnership with Psychedelic State(s) of America – a nonprofit-sponsored news organization dedicated to rigorous independent psychedelic journalism. Learn more about PSA’s Media Partnerships Program and donate to the PSA Media Fund here.

Posted on June 17, 2026June 17, 2026

Psychedelic Policy Briefing: Week of June 16, 2026

June 16 policy brief

Legislative Push Meets Bureaucratic Restraints

By Jack Gorsline

(WASHINGTON, D.C.) Federal psychedelic policy in 2026 is splitting in two directions at once. Lawmakers and military officials are building healthcare infrastructure for experimental therapeutics, while enforcement agencies freeze access pathways and move to criminalize new compounds. The same government that is fast-tracking psilocybin trials for veterans is using emergency powers to ban a ketamine analog that law enforcement has encountered 52 times in eight years.

Military and Congressional Infrastructure Pushes

The House Armed Services Committee has integrated new provisions into the Fiscal Year 2027 National Defense Authorization Act, directing military leadership to investigate access pathways to psychedelic therapies for service members. Pointing to President Donald Trump’s recent executive order on the issue that was signed on April 18, the committee is compelling the Department of Defense to track lawful research into treatments for conditions like post-traumatic stress disorder, explicitly instructing the DOD to examine naturally derived whole-mushroom compounds administered in therapeutic settings. The defense secretary must submit a detailed report by Feb. 1, 2027, evaluating clinical trial data, outlining the regulatory framework necessary for broader access, and projecting a timeline to launch pilot programs and expand clinical research starting in fiscal year 2027.

This legislative push follows a recent DOD award of $4.9 million to Emory University and UT Health San Antonio to study MDMA-assisted therapy for PTSD. The trial, which aims to enroll 100 active-duty military and reserve personnel to evaluate the synergistic effects of MDMA combined with prolonged exposure therapy, has already begun screening prospective participants for on-site research at Emory.

Concurrently, the Senate Veterans’ Affairs Committee (SVAC) reviewed the bipartisan Veterans Health Administration Novel Therapeutics Preparedness Act of 2026, known as S.4220, on April 29. Introduced by Sens. Tim Sheehy and Ruben Gallego, the legislation requires the Department of Veterans Affairs to establish an Office of Novel Therapeutics to develop clinical standards and readiness plans ahead of potential U.S. Food and Drug Administration (FDA) approvals for psychedelic compounds like psilocybin, ibogaine, and MDMA. The measure would also prohibit restrictive “step therapy” rules and establish a Veteran Advisory Committee to monitor patient safety.

Lawmakers and veteran advocates stressed the urgent need for these reforms, arguing that without proper infrastructure, veterans could wait years for care or risk their lives seeking dangerous, unregulated treatments abroad.

The push for this new VA infrastructure unfolds against a complex backdrop of federal funding threats, industry controversies, and rapid administrative action. While the administration’s proposed budget threatens major cuts to science agencies like the National Science Foundation and the National Institutes of Health (NIH), recent executive orders and FDA initiatives, such as awarding National Priority Vouchers to expedite reviews, are simultaneously accelerating the federal timeline for psychedelic medicines. At the same time, the growing psychedelics sector is facing heightened scrutiny, marked by ethics complaints over the mishandling of taxpayer data and alleged lobbying violations involving prominent political figures such as former Arizona Sen. Kyrsten Sinema and former California Rep. Mimi Walters, alongside her organization, The Association for Prescription Psychedelics (APP). 

As for the broader psychedelic policy reform landscape on Capitol Hill, S.4220 is among three bills focused on psychedelics being reviewed this legislative session. Another is the Innovative Therapies Centers of Excellence Act of 2026, a proposal from Sens. Gallego and McCormick (R-PA) designed to establish dedicated VA facilities for the advancement of psychedelic treatments.

DEA Regulatory Friction and Stagnation

While the military’s expanding interest in psychedelics draws mainstream media attention, a separate federal reform effort at the Drug Enforcement Administration has stalled. Attorney Kathryn Tucker, co-counsel representing Dr. Sunil Aggarwal’s petition to reschedule psilocybin from Schedule I to Schedule II, has voiced significant concerns over recent delays. Last fall, the petition appeared to be advancing rapidly when the DEA forwarded it to the Department of Health and Human Services for scientific review, three years after Aggarwal’s initial legal challenge.

Yet despite Trump’s executive order aiming to streamline access to psychedelic medicines, and an anticipated FDA approval decision on Compass Pathways’ synthetic psilocybin compound, COMP360, expected in late 2026 or early 2027, progress has ground to a halt. In response, Tucker recently filed another motion urging the DEA and the Justice Department to act immediately on the years-old petition to allow terminally ill patients access to psilocybin, arguing that further delays are unjustified given the drug’s FDA breakthrough therapy designation.

Compounding this slowdown, the DEA announced its intent to use emergency scheduling powers to classify 2-fluorodeschloroketamine, a structural analog of ketamine known as 2-FDCK, as a Schedule I substance, effectively banning it. While the DEA claims the compound poses an imminent hazard to public safety, critics and drug policy reform advocates argue the move is an overreach, pointing out that law enforcement has encountered the drug only 52 times over the last eight years. Attorney Robert Rush, founder of The Rights and Reason Project, told Filter Magazine following the DEA’s announcement of the move that using emergency powers to bypass standard public hearings and scientific review will stifle research into promising new mental health treatments while pushing individuals toward increasingly dangerous, unregulated illicit drug markets.

Ibogaine Sourcing Challenges and FDA Leadership Reshuffle

At the same time, top Trump administration officials recently acknowledged that expanded access to ibogaine could face delays because of difficulties sourcing the psychoactive alkaloid for clinical research. Testifying before the Senate Veterans’ Affairs Committee, Veterans Affairs Secretary Doug Collins highlighted the president’s recent executive order on psychedelics but noted that establishing a federal ibogaine supply poses logistical and financial challenges.

“We also have to have a federal source of sourcing the ibogaine, which we don’t have a costing on at this point,” Collins said. Despite the sourcing challenges, Collins said VA trials for MDMA are currently ahead of schedule. He emphasized the department is committed to exploring any treatment that helps veterans and is working with HHS to develop the rigorous clinical protocols required for the intensive therapies.

In a significant change for psychedelic drug developers seeking FDA approval over the next few years, the agency appointed Dr. Mike Davis as the new deputy director of its Center for Drug Evaluation and Research. A physician who recently served as chief medical officer for the psychedelic research group Usona Institute, Davis is returning to the FDA after previously working as a clinical team leader in its Psychiatry Division from 2018 to 2022. He rejoins the agency during a broader leadership transition. Former FDA Commissioner Marty Makary resigned on May 12, 2026, after clashing with the White House over Trump’s decision to approve flavored nicotine vapes, and former CDER Director Jacqueline Corrigan-Curay has retired.

The contradictions are not abstract. The VA is running MDMA trials ahead of schedule while the DEA moves to ban a ketamine analog without a public hearing. Congress is ordering the Pentagon to map access pathways to whole-mushroom psilocybin while a three-year-old rescheduling petition sits unanswered. And the administration’s own VA secretary has admitted there is no federal plan, and no price tag, for sourcing the ibogaine its veterans’ initiative depends on. Whatever reaches patients will be shaped less by the executive rhetoric than by which of these machines moves first.


Note: This article was produced in partnership with Psychedelic State(s) of America, a nonprofit-sponsored news organization dedicated to rigorous independent psychedelic journalism. Learn more about PSA’s Media Partnerships Program and donate to PSA’s Psychedelic Writers Guild Media Fund here.

Posted on June 11, 2026June 11, 2026

Psychedelic Policy Briefing: June 11, 2026

Policy Roundup June 11 2026

The first half of 2026 has brought a surge of psychedelic policy activity at every level of the U.S. government. According to PoliPsy’s Psychedelic Legislation Tracker, lawmakers have filed 111 psychedelic-related bills across 41 states this legislative term, along with seven federal bills on Capitol Hill. 

Through an expanded partnership between Psychedelics Today and Psychedelic State(s) of America, I’ll be writing a weekly briefing on essential psychedelic policy developments and political happenings in the U.S. and around the world.

In this inaugural briefing: Michigan lawmakers fight over whether $50 million in opioid settlement funds should pay for ibogaine research. Connecticut expands its psychedelic-assisted therapy pilot beyond veterans and first responders. Colorado Gov. Jared Polis signs an ibogaine pilot program into law, including a national first on Indigenous benefit sharing, while the state tightens its personal use rules. Tennessee enacts the ibogaine-focused HOPE Treatment Act. New York’s Medical Psilocybin Act stalls again. And Maryland funds an MDMA trial comparing group and individual therapy for veterans with PTSD.

Michigan Considers $50 Million in Opioid Settlement Funds for Ibogaine Research

Earlier this year, Michigan state Rep. Jaime Greene (R-Richmond) introduced House Bill 6020, which would allocate $50 million to research the therapeutic potential of ibogaine, a psychoactive alkaloid derived from the root bark of the iboga shrub. The proposed clinical trials would evaluate the drug’s effectiveness in treating opioid use disorder and trauma-related conditions, particularly among military veterans with PTSD, traumatic brain injuries, and chronic pain.

The fight is over the funding source: the Michigan Opioid Healing and Recovery Fund, a restricted state account holding part of the $1.8 billion Michigan received from national opioid settlements. The bill would establish a grant program and direct the state Department of Health and Human Services to form a research consortium of universities, health facilities, and other states. Greene argues that research institutions like the University of Michigan could deliver real clinical breakthroughs for people with opioid dependence.

Democratic lawmakers have pushed back, arguing the settlement dollars should be reserved for proven recovery methods. At a June 2 hearing of the House Families and Veterans Committee, state Reps. Mai Xiong and Carrie Rheingans noted that Michigan has rarely funded experimental clinical trials and argued that expensive, multi-year studies belong with federal funders like the National Institutes of Health or the U.S. Department of Veterans Affairs. Other lawmakers suggested the $50 million would do more good in recovery housing, clinician education, and harm reduction programs.

Connecticut Expands Psychedelic Therapy Pilot Program Beyond Veterans and First Responders

Last month, Connecticut Gov. Ned Lamont signed Senate Bill 191 into law, effectively expanding the state’s psychedelic-assisted therapy pilot program, first established in 2022 to study the mental health effects of substances including psilocybin and MDMA. The program was previously limited to veterans and first responders. The new law opens participation to any adult who meets the program’s clinical requirements, a change meant to resolve recruitment problems and broaden the research base. It also repeals a clause that would have automatically terminated the pilot upon federal approval of these drugs.

The expansion appears designed to prepare Connecticut’s mental health infrastructure for possible FDA approval of a psychedelic-assisted therapy, which some advocates expect as soon as 2027. Funding remains the open question. Connecticut for Accessible Psychedelic Medicine co-founder Victor Constanza told Psychedelic State(s) of America in an interview that the original pilot program has never received an appropriation from the state budget.

Colorado Signs Ibogaine Pilot Program Into Law as Personal Use Rules Tighten

Colorado Gov. Jared Polis signed House Bill 26-1325 last week, creating an ibogaine research pilot program within the state’s Behavioral Health Administration and building on the voter-approved 2022 Natural Medicine Health Act. Sponsored by state Reps. Jarvis Caldwell and Lisa Feret and state Sens. Matt Ball and Rod Pelton, the bipartisan law authorizes up to five research sites to study ibogaine as a treatment for trauma and substance use disorders. Polis called the measure a step toward implementing the will of voters and pointed to ibogaine’s potential to help veterans and other Coloradans recover.

The law also contains a national first. HB 26-1325 requires both pilot sites and future ibogaine licensees to establish benefit-sharing plans with Indigenous communities traditionally connected to the iboga plant. Those plans can include financial sharing, collaborative research, conservation support for iboga species and habitats, and community-identified development priorities. No other state psychedelic law has made benefit sharing a condition of participation.

That provision arrives against a history of friction. In a complaint filed last year, Indigenous leaders argued they had been systematically excluded from Colorado’s policymaking process and warned that implementation of the Natural Medicine Health Act prioritized corporate interests over cultural consultation, threatening the ecological survival and cultural sanctity of traditional plant medicines. Whether the new benefit-sharing requirement answers those concerns will depend on how regulators enforce it.

Tennessee Enacts HOPE Treatment Act for Ibogaine Research

On May 22nd, Gov. Bill Lee signed the Helping Open Pathways to Effective (HOPE) Treatment Act (SB 2149/HB 2075) into law. Sponsored by Sen. Page Walley (R-Savannah) and Rep. Bryan Terry (R-Murfreesboro), the act establishes a legal framework for FDA-authorized clinical trials of ibogaine in Tennessee. It does not legalize the substance, which remains Schedule I under federal law.

The law creates a Council on Emerging Behavioral Health Treatments to authorize qualified Tennessee hospitals, academic medical centers, and research institutions to join multi-state ibogaine trials. Participating institutions must demonstrate FDA compliance, outline safety protocols including cardiac screening, provide patient aftercare plans, and submit quarterly progress and financial reports. Ibogaine may be administered only within clinical trials at hospitals or qualified research facilities, under the supervision of a Tennessee-licensed physician.

Rather than appropriating state money, the act relies on a public-private partnership model. It also creates an Emerging Behavioral Health Treatment Innovation Fund, which will receive at least half of any state revenue generated from intellectual property rights tied to treatments developed through the trials.

Passage followed a sustained advocacy campaign by TN Voices, Americans for Ibogaine, and its state affiliate Tennessee for Ibogaine, including testimony from veterans who traveled to Mexico for ibogaine treatment because none is available legally in the United States. Tennessee becomes the fifth state to formally join the multi-state research effort, following similar laws in Oklahoma, Mississippi, and Texas over the past 18 months.

New York Medical Psilocybin Act Stalls Amid Budget Delays, Despite Praise for Novel Framework

New York lawmakers proposed a highly regulated, state-funded pilot program to provide medical psilocybin to 10,000 veterans, first responders, and patients with cluster headaches. The amended Medical Psilocybin Act incorporates elements of an earlier personal license bill, a shift praised by that bill’s original author, Allison Hoots, a New York psychedelic attorney and executive director of the Sacred Plant Alliance.

“While the original bill created access for people who were not addressing serious health conditions but rather focused on the standard of whether permit holders were healthy enough, the amended bill leans into the [personal license] components that had already existed to promote the benefits of a healthcare provider’s recommendation with individualized plans for therapeutic access,” Hoots previously told DoubleBlind Magazine. That individualized structure includes provisions allowing qualifying patients to take psilocybin home for conditions such as cluster headaches and end-of-life care.

The legislation was championed by a coalition including New Yorkers for Mental Health Alternatives, the Microdosing Collective, and New Approach PAC. (New Approach faces allegations of campaign finance violations raised by former staffers in connection with the 2024 reform campaign in Massachusetts, as reported by Lucid News.) Despite that backing and bipartisan support, coalition leaders confirmed the bill will not advance this session because of time constraints surrounding passage of the annual state budget. Advocates argue the condition-dependent expanded access model could become a template for other state legislatures next year.

Maryland Funds MDMA Trial Comparing Group and Individual Therapy, Amid Local Activist Frustrations

Maryland is advancing psychedelic-assisted therapy research even as the state’s broader reform efforts stall. As first reported by Psychedelic Alpha, the state is partnering with the mental health advocacy nonprofit Reason for Hope and Sunstone Therapies on a 52-patient study of MDMA-assisted therapy for military veterans with PTSD. Backed by a $1 million grant from Maryland’s Post-Traumatic Stress Disorder and Traumatic Brain Injury Alternative Therapies Fund and $525,000 from Reason for Hope, the 12-month trial will directly compare group and individual therapy models, testing whether group delivery can match individual outcomes at lower cost. That question sits at the center of whether these treatments can ever scale.

Legislative progress on broader access remains contested. As Lucid News first reported, lawmakers’ decision to extend the Maryland Task Force on Responsible Use of Natural Psychedelic Substances through 2027 has frustrated local activists, who argue that indefinite advisory periods function as political stall tactics. They are urging lawmakers to model future reform on states like Colorado, Oregon, and New Mexico.

That’s all for this week’s state-level psychedelic policy briefing. Stay tuned later this week for a federal policy briefing, and subscribe to Psychedelics Today and Psychedelic State(s) of America for reporting and analysis on policy developments in the United States and abroad.

Note: This article was produced in partnership with Psychedelic State(s) of America, a nonprofit-sponsored news organization dedicated to rigorous independent psychedelic journalism. Learn more about PSA’s Media Partnerships Program and donate to PSA’s Psychedelic Writers Guild Media Fund.

Search FAQ Section

What states are funding ibogaine research in 2026? Michigan is debating a $50 million allocation for ibogaine trials. Tennessee, Colorado, Oklahoma, Mississippi, and Texas have passed legislation authorizing FDA-supervised ibogaine clinical trials through consortium models.

Does the HOPE Treatment Act legalize ibogaine? No. Tennessee’s HOPE Treatment Act (SB 2149/HB 2075) establishes a legal framework for FDA-authorized research only. Ibogaine remains Schedule I under federal law; the act allows qualified institutions to participate in multi-state trials.

What makes Colorado’s ibogaine law different? Colorado’s HB 26-1325 includes the first state requirement for Indigenous benefit sharing as a condition of participating in an ibogaine program, covering financial sharing, collaborative research, and conservation support.

Which states have expanded psychedelic pilot programs? Connecticut expanded its psychedelic-assisted therapy pilot from veterans and first responders to any adult meeting clinical requirements. Maryland is funding a novel trial comparing group and individual MDMA-assisted therapy for veterans with PTSD.

Why did New York’s Medical Psilocybin Act stall? New York’s bill will not advance this legislative session due to time constraints around the annual state budget, despite bipartisan support and praise for its condition-dependent access model.

Posted on June 27, 2025

Victoria Litman – The Future of Psychedelic Regulation Is Local

PT610

In this episode, we sit down with Victoria Litman, M.Div., J.D., LL.M., to discuss why the future of psychedelic access in the United States is being shaped not by federal agencies, but by the bold actions of individual states. As a legal scholar and writer focusing on drug policy, Victoria breaks down the significance of the FDA’s 2024 rejection of psychedelic-assisted therapy, and why that decision might be less of a setback than it seems.

We explore how state-level initiatives like Oregon’s Psilocybin Services Act and Colorado’s Natural Medicine Health Act are setting the stage for a new model of access—one rooted in harm reduction, personal liberty, and existing regulatory infrastructure. Victoria discusses the importance of the Tenth Amendment and the Anti-Commandeering Doctrine, which allow states to move forward regardless of federal inaction.

Rather than waiting for slow-moving federal institutions, Victoria argues that states can build safe, scalable systems now—especially by leveraging cannabis infrastructure for psychedelic regulation. She also touches on the ethical and cultural implications of this transition, including protections for spiritual and religious use.

If you’re wondering what psychedelic policy will look like in the years ahead, this episode offers an insightful and hopeful roadmap.

Link to CATO article

Keeping Tabs

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