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Mississippi is no stranger to criticism or being the butt of jokes alleging its inability or refusal to adapt with the times. And, while some of these stereotypes have some support, Mississippi is quietly silencing some of its critics by becoming a pioneer in the plant-based medicine realm.

Beginning in 1968, Mississippi claimed host to the only federally authorized marijuana grow operation in the country on the Ole Miss campus, for research purposes. Sadly, Ole Miss’s federal contract to grow and research marijuana is set to end in 2028, but that program has laid the foundation for a state-funded research program that is expected to flourish in the years to come. In 2022, Mississippi became one of a handful of Deep South states to approve a full-fledged medical marijuana program. In 2025, the Mississippi Band of Choctaw Indians approved a referendum to legalize marijuana on tribal lands. Next legislative session, the state’s list of trailblazing achievements may grow thanks to the leadership of State Rep. Samuel Creekmore, who is promoting a path towards the authorization of state-funded FDA trials to explore how the plant-based, psychoactive substance Ibogaine can aid in treating a variety of disorders, including addiction and PTSD.

Creekmore, the chairman of Mississippi’s House Public Health Committee, penned a compelling op-ed earlier this summer urging Mississippians and fellow lawmakers to follow Texas’ lead and pass legislation that supports this form of unconventional treatment. Creekmore’s efforts did not go unnoticed; the Mississippi Legislature will hold a hearing on August 28 at 10 a.m. in Room 216 of the State Capitol to discuss the proposal. The hearing will feature testimony from patients, medical professionals, and veterans who have first-hand experience with Ibogaine treatment and field questions from attendees.

Ibogaine, like marijuana and other psychoactive substances shown to offer promising medicinal benefits, is currently a Schedule I substance under the Federal Controlled Substances Act. That designation, which is, per the act’s terms, reserved for drugs with no shown medicinal benefit and with a high propensity for addiction, has long prevented the research needed to unveil its benefits and potential side effects. But, led by the efforts of former Texas Gov. Rick Perry, Texas approved legislation last month to contribute $50 million in state funds to aid in Ibogaine clinical trials. Creekmore’s hope is that Mississippi follows a similar path and partners with Texas in these efforts.

We’ll be following this topic as it develops, so check back in with us for updates.

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Drugs are bad, m’kay. But what if they’re not? Psilocybin continues to be in the limelight for its potential medicinal uses, including most particularly its potential to combat the nation’s growing mental health crisis. Last week, we reported on the fact that President Trump’s surgeon general nominee was a potential proponent of the use of psychedelics like psilocybin. Now, another member of Trump’s administration has chimed in, and this time it’s someone from the Food and Drug Administration.

The head of the FDA has advised that “exploring the therapeutic potential for psychedelics such as psilocybin and ibogaine is a top priority for the Trump Administration.” According to FDA Administrator Matt Makary, who spoke on News Nation recently,

When it comes to some of these psychedelics and other plant-based therapies, I don’t think we’re listening to patients… I don’t think the medical establishment is listening to doctors. When I listen to the individuals who have tried some of these for real medical conditions—post-traumatic stress disorder, severe refractory depression—people tell me that they believe that psilocybin was successful. It was a curative, or significantly helped, their severe mood disorder.

People have told me that other psychedelics, like MDMA, have been helpful in treating PTSD. Doctors have told me that they’ve sent patients for this therapy… Ibogaine has been used to treat PTSD. There are trials now looking at it for traumatic brain injury—things we have had nothing for in the past. What have we had to treat traumatic brain injury and PTSD that has really had great results up until this time?

To be sure, Makary has said he is not necessarily endorsing these plant-based medicines but does think it’s important to be sure the FDA doesn’t “get in the way with red tape.”

We’ve become used to seeing administrative and executive officials, including the VA and members of Congress, acknowledging the potential benefits of psychedelics as medicine. But last year, under a different administration, FDA dealt a significant blow to the industry, deciding not to approve Lykos Therapeutics, Inc.’s MDMA-assisted PTSD therapy. Makary’s recent statements may mean a sea change for the FDA. We think it’s likely that companies supporting psychedelics research will be emboldened and may become more aggressive in seeking trials and approval under this administration. But much remains to be seen, and Makary has definitely left himself with plenty of ways out. Stay tuned.

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Earlier this month, President Trump tapped “physician-turned wellness influencer” Casey Means as his nominee for surgeon general. Means has close ties to Health and Human Services Secretary Robert F. Kennedy Jr., and Trump has touted her “impeccable” Make America Health Again (MAHA) credentials. We’ve written previously on what impact Trump’s second presidency could have on American cannabis and psychedelic policy, but Means’ public statements on cannabis and psychedelics got us pondering on how she may shift the conversation. 

We’ll start with the good news for those who are proponents of expanding access to psychedelics. Means has been vocal about her support of psychedelic therapy. In her 2024 book Good Energy: The Surprising Connection Between Metabolism and Limitless Health,Means touted her positive experience with psychedelics. She described her experience and encouraged those that felt so called “to explore intentional, guided psilocybin therapy.” She explained that “[s]trong scientific evidence suggests that this psychedelic therapy can be one of the most meaningful experiences of life for some people” as it had been for her. She states:

If the word psychedelics makes you cringe, I used to be in your position. I spent my childhood and young adult life being extremely judgmental about the use of any type of drug. But I became interested in plant medicine and psychedelics after learning more about their extensive traditional use, analyzing the groundbreaking research… Our brains are profoundly suffering in modern society right now, and I believe that anything that can safely increase neuroplasticity and ground us in more gratitude, awe, connection, and a sense of cosmic safety should be taken very seriously.

She went on to describe her experience on psylocibin as “bask[ing] in the moon’s bright rays… experience[ing] the embodiment of being one with the moon, every star, every atom in the grains of sand I was sitting on, and my mother in an inextricable and unbreakable chain of universal connectedness for which the human concept of ‘death’ was no match.”

She’s also referenced and advocated for the “plant medicine” psilocybin on her blog. In one post she explained that one of the modalities she has gone “deepest in” included “plant medicine (psilocybin).” 

But Means’ position on cannabis isn’t as rosy. Means has expressed opposition to marijuana, saying in her book that “people who use cannabis as well as tobacco products should stop these completely” because they will “hurt your mitochondria and vastly diminish your ability to make Good Energy.” She goes on in her book to say:

There has always been suffering in the world, but now we can see exponentially more of it than ever, all at once, on screens we hold in our beds and at the dinner table. In response, modern humans have looked for salvation and coping anywhere we can get a hit of dopamine-fueled ‘pleasure’ and distraction: things like processed sugar, alcohol, soda, refined carbs, vapes, cigarettes, weed, porn, dating apps, email, texts, casual sex, online gambling, video games, Instagram, TikTok, Snapchat, and the relentless novelty of experiences.

She remains critical on her blog as well. It’s not hard to read Means’ statements and assume that anyone using cannabis is doomed to end up like the character in Afroman’s hit 2000’s bop “Because I Got High.”

What this means (pun intended) for proponents of expanded access to cannabis and psychedelics is difficult to say for sure. 

As an initial matter, Means still has to be confirmed, and she’s already faced “pushback on multiple fronts.” Means has drawn criticism for not having a current medical license, including from former surgeon generals, as well as questions about whether she should even be eligible to be surgeon general.  She’s also received criticism from some in the MAHA camp for not taking a strong enough stance on other issues. In other words, in a political climate where nothing is certain, there is far from any guarantee that Means will be confirmed as the new surgeon general.

If she is confirmed, we think she’ll take the approach we’ve seen many proponents of psychedelics take to advance them as medicine. The political climate is ripe to do so. Bipartisan lawmakers this month asked Trump’s head of the U.S. Department of Veterans Affairs to meet with them “to discuss ways to provide access to psychedelic medicine for military veterans.”  At a cabinet meeting, VA Secretary Doug Collins advised Trump that his agency was “opening up the possibility of psychedelic treatment for veterans.” The leader of the MAHA movement, RFK Jr., even discussed the “wonderful experience” he had with LSD when he was younger.  

We remain skeptical that even with the confirmation of Means we will see significant psychedelic reform, but we do think it makes it more likely that we would see more science-based reform efforts, focused on scientific and medicinal benefits. We’re less sure about what it may mean for any meaningful cannabis reform. As Marijuana Moment noted on the issue recently, Trump endorsed rescheduling, industry banking access for cannabis businesses, and a Florida legalization ballot initiative, but these issues seem to have taken a backseat for key officials and lawmakers.

So, I guess that brings us back where it all begins. Does Means mean business when it comes to psychedelic or cannabis reform? And even if she does, is there the political interest and will amongst the relevant agencies and Congress to see those changes through? Only time will tell, but we’ll stay on top of it so you don’t have to. 

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Cannabis consumers can be forgiven for feeling the need for a more liberal cannabis policy as they weather this seemingly unending campaign cycle.

Republican presidential candidate Donald Trump recently made clear how he would be voting personally on the legalization of the recreational use of marijuana. Posting on Truth Social, Trump stated:

As a Floridian, I will be voting YES on Amendment 3 this November.

Amendment 3 would allow “adults 21 years or older to possess, purchase, or use marijuana products and marijuana accessories for non-medical personal consumption.” It would also allow medical marijuana treatment centers, as well as other state licensed entities, to acquire, cultivate, process, manufacture, sell, and distribute such products and accessories. Amendment 3 would also establish possession limits for personal use – allowing possession of up to 3 ounces and up to an additional 5 grams of concentrate.

So, what does that mean for the country more broadly? It appears Trump is not just a fan personally. In the same post, he spoke more broadly about his personal views and gave insight as to how friendly his administration may be to those in the cannabis industry. Trump stated:

As President, we will continue to focus on research to unlock the medical uses of marijuana to a Schedule 3 drug, and work with Congress to pass common sense laws, including safe banking for state authorized companies, and supporting states’ rights to pass marijuana laws, like in Florida, that work so well for their citizens.

In an interview, Trump doubled down.  He described medical marijuana as “amazing.” 

Indeed, Trump also seems to realize this is a political issue with substantial support from the American public. He has conceded that opposing marijuana legislation would be challenging, particularly in an election year.

Trump, who has historically touted a tough drug policy, certainly isn’t ready to sign off on carte blanche legalization though. He has made it clear that any legalization of marijuana should be done in a “safe way” with regulation and age restrictions. Trump also has expressed concerns about marijuana’s presence in public spaces, as well as potential safety issues. 

He was more coy about what he may do with regard to psychedelics. When psychedelics were mentioned in a recent interview, Trump was silent, choosing instead to laugh when interviewer Lex Friedman raised the idea that Congress would be better off if they took psychedelics. We can’t help but recognize the more libertarian view Trump is taking towards substances like marijuana. It’s hard to see how that is a negative sign about what a Trump administration may look like for those in the psychedelics industry.   

We doubt a second Trump administration would champion significant psychedelic reform, but if the first Trump administration is a guide then we also don’t think he would stand in the way of measured, science-based reform efforts. And that’s probably the biggest takeaway for psychedelic advocates trying to appeal to either candidate: Focus on the science and the medicinal benefits and not the recreational aspects. Marijuana may well prove a gateway drug when it comes to federal legalization of psychedelics, but we think the psychedelic industry would do well to move deliberately for the time being.

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We at Budding Trends have been optimistic, and then cautiously optimistic, that the legalization of psychedelics was close. This month, however, the U.S. Food and Drug Administration dealt a blow to our predictions. FDA decided not to approve Lykos Therapeutics, Inc.’s MDMA-assisted PTSD therapy at this time. Instead, FDA asked Lykos to further study the efficacy of the treatment. More specifically, FDA asked Lykos to conduct another Phase 3 trial to determine the drug’s efficacy and safety. Lykos intends to request reconsideration from FDA.

Some see this as a “huge blow to the field,” considering it a bellwether for other psychedelic drugs. Lykos’ CEO has called the decision “deeply disappointing” and stated that many of the requests from the agency “can be addressed with existing data, post-approval requirements or through reference to the scientific literature.” It is also, of course, disappointing to those individuals suffering from PTSD who may benefit from these treatments.

FDA’s Psychopharmacologic Drugs Advisory Committee vote earlier this summer made things difficult for the FDA, which historically sides with its advisors. Ultimately, it appears the FDA determined “there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.” But, the FDA also stated to NPR that it would “continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies.”

Others in the industry have more of a Lloyd Christmas outlook. This is not an outright denial of MDMA therapies, and it certainly is not a referendum on the psychedelics industry as a whole.

According to NPR, Dr. Mason Marks, law professor and senior fellow with Project on Psychedelics Law and Regulation at Harvard Law School’s Petrie-Flom Center, didn’t see this as “any sign that progress is going to be slowed;” instead, he stated that “it might intensify because the other companies might see an opportunity to really get in there and compete.” Marks was concerned that the limitations of the trial could have required the FDA to impose so many restrictions that it would have been “impractical” for the treatment to reach its intended audience.

Doug Drysdale, CEO of Cybin – a psilocybin-based drug development company – stated that he thought the decision would just be a “delay,” believing that the program was “fixable” and would “likely lead to an approval at some point.” He went on to state that while the decision was “disappointing for patients,” there was “no real readthrough . . . to other psychedelic programs. What Lykos is doing is quite different and unique to them, and ultimately, the [Complete Response Letter] came because the NDA submission was just incomplete.”

The CEO Of LSD-focused MindMed, Rob Barrow, was likewise optimistic, positing that the FDA’s decision “reinforces the need for rigor and the highest quality studies and ethics and safety in these studies to ensure that, if we’re successful in illustrating p-value and clinical response, that we can make sure that transitions into a strong case for approval.”

Do we still think psychedelics likely are on the path to legalization in some form? Lykos’s bid to use psychedelics to treat PTSD was the furthest along to obtain FDA approval, but there are still other options. So, yes, we’re telling you there’s a chance. 

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2023 was a momentous year for psychedelics, and it’s not just because we at Budding Trends started writing about them. There were wins for the psychedelic industry at the local, state, and federal levels, as well as in the private sector, particularly for proponents of their potential medicinal and therapeutic uses.

The Food and Drug Administration issued its first-ever guidance providing considerations for those developing psychedelic drugs for the treatment of medical conditions. The guidance describes basic considerations for the drug development process, including trial conduct, data collection, subject safety and drug application requirements. When publishing the guidance the FDA said that,“[p]sychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders… By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”

In December, President Joe Biden signed into law the 2024 National Defense Authorization Act (NDAA) directing the Department of Defense to begin clinical trials exploring the therapeutic potential of certain psychedelics for active-duty military service members. Obtaining federal funding for research with the support of bipartisan lawmakers is a positive indication of what may be to come.   

The House Veterans Affairs Subcommittee on Health held a hearing in November that focused on how psychedelics – including psilocybin and MDMA – can aid therapy for veterans facing mental health challenges. This was the first-ever congressional hearing on psychedelics. In her opening remarks, Rep. Marianette Miller-Meeks, a Republican congresswoman for Iowa and chair of the Subcommittee, said “psychedelic-assisted therapy is a groundbreaking clinical procedure that has the potential to transform the way we look at mental health care.” Rep. Julia Brownley, a Democratic congresswoman for California and the panel’s ranking member, made similar statements, saying “we are at the brink of a new era in which [psychedelics]—once stigmatize [sic] and misunderstood-are being examined for their potential to address mental health and addiction challenges.”

Federal courts weighed in as well. The Ninth Circuit kept alive a physician’s petition to reschedule psilocybin from Schedule I to Schedule II.

Momentum also continued at the state and local levels. Oregon opened its “first-of-its-kind legal market” for psilocybin, more widely known as magic mushrooms. The first licensed center opened in Eugene, Oregon, in June and at least 16 more service centers have opened since that time. It’s been reported that hundreds of people have used psilocybin legally in Oregon during that time. Hawaii’s Office of Wellness and Resilience announced the establishment of the Breakthrough Therapies Task Force, aimed at expanding therapeutic access to MDMT and psilocybin. In Colorado, Gov. Jared Polis signed a bill in May to “create a regulatory framework for legal psychedelics” under an initiative approved by voters in 2022. More specifically, the bill sets up regulations for the legalization law that focuses largely on regulations for using psychedelics in licensed healing centers under the guidance of facilitators. There’s been movement in other states as well, including in Arizona, Connecticut, Illinois, Iowa, Missouri, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, New York, North Carolina, Oklahoma, Texas, Vermont, and Wisconsin.  

The local jurisdictions of Eureka, California, Ferndale, Minnesota, Jefferson County, Washington, Portland, Maine, and Provincetown, Massachusetts all enacted psychedelic decriminalization laws this year.

It’s not just government that’s interested in psychedelics. We are seeing one of the first opportunities to legalize MDMA as a prescribed medicine. In December, the MAPS Public Benefit Corporation submitted a new drug application (NDA) to the Food and Drug Administration for the use of MDMA-assisted therapy for post-traumatic stress disorder. If the NDA is approved, the DEA would then need to reschedule MDMA accordingly. If that happens, MDMA would be the first true psychedelic to obtain FDA approval.  Some sources say FDA approval could be obtained in late 2024.  

And the MAPS Public Benefit Corporation isn’t the only group that pushed forward with research, believing that psychedelics hold significant therapeutic potential. The American Medical Association published the results of a clinical trial this year that “suggest efficacy and safety” of psilocybin-assisted psychotherapy for treatment of bipolar II disorder.” A separate study by the same group “showed that people with major depression experience clinically significant sustained reduction in their symptoms after just one dose.”  Researchers from Johns Hopkins, Ohio State University and Unlimited Findings likewise published the results of a study that they say demonstrates “persisting reductions” in depression, anxiety, and alcohol misuse, as well as “increases in emotional regulation, spiritual wellbeing and extraversion” with the use of psilocybin. This is just a sampling of the many studies that published research this year.

It’s not all roses for industry advocates though. While proponents of the industry were excited about the bill passed by the California legislature to decriminalize possession of “naturally occurring psychedelics,” Gov. Gavin Newsom vetoed the bill in October. And there are certainly other detractors.  As The New York Times reported, the American Psychiatric Association urged caution, saying that treatments should be limited to research studies for the time being. The DEA is trying again to ban two psychedelics — 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC). The next trip around the sun will certainly encounter similar roadblocks.

Public opinion continues to be in favor of the use of psychedelic therapy for therapeutic and medicinal uses, though. And the mental health crisis facing our country is not going anywhere. As reported by USA Today, “[n]early 50,000 people died by suicide in 2022 and 5.8 million emergency department visits were linked to mental, behavioral, and neurodevelopmental disorders in 2021.” While the data for 2023 has not been released, we doubt there will be much of a change. And we do know there is not enough funding or programming in place to combat the growing crisis. In the face of this landscape, we expect the momentum in favor of the psychedelic industry to continue – particularly as it relates to the push to use psychedelics for medicinal uses. We also think the industry will continue to see decriminalization at the local level and more widespread access in states that led the charge on cannabis, such as Colorado and California. 

2023 has been somewhat of a “renaissance” for psychedelics – it’s been one “that’s increasingly being shaped under a bipartisan framework, with Republicans frequently leading on the issue in Congress and state legislatures across the country.” Last year was a good one for supporters of psychedelics, and we predict 2024 will be a good trip for the industry, too.

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We told you it may be coming, though we were admittedly cynical about the ability to pass a bill funding psychedelic research given the current political landscape — a narrowly controlled Democratic Senate that is generally considered more conservative than the House and on the eve of an election year. But, it happened. Just before Christmas, President Joe Biden signed into law the 2024 National Defense Authorization Act to the tune of $886 billion. The NDAA passed through Congress with strong bipartisan support.

You may have read that the NDAA left out certain parts of the act that some in Congress claimed addressed “divisive social issues.” And it certainly left out certain provisions the cannabis industry would have liked to have seen included — including a separate section to create a medical cannabis pilot program for veterans. What you may not have realized, though, is what the NDAA did include, such as funding for psychedelic treatment studies for members of the U.S. military with post-traumatic stress disorder or traumatic brain injuries. 

Admittedly, the psychedelic component of the NDAA is small. But it shouldn’t be discounted. The law requires that the Department of Defense establish a process under which military service members with PTSD or traumatic brain injuries can participate in clinical trials involving psychedelics, including psilocybin and MDMA, as well as any “qualified plant-based alternative therapies.” The 2024 NDAA devotes $10 million to these efforts, which is certainly not an insignificant sum. DOD is also allowed to partner with eligible state or federal agencies and academic institutions to carry out the clinical trials. This could significantly expand the scope of the contemplated studies.

Under the new law, DOD is on a time clock. DOD must facilitate the process within 180 days of enactment. There are also reporting requirements. The secretary of defense is required to provide a report within one year of enactment with information about the trial’s participation and findings, and the secretary must continue to report every subsequent year for three years.

The entire act — including those provisions related to psychedelics — had strong bipartisan support. The bill related to psychedelics was added to the legislation by Texas Republican Morgan Lutrell, a member of the House Armed Services Committee and the NDAA Conference Committee, but co-sponsored by progressive Democrats Ro Khanna of California and Alexandria Ocasio-Cortez of New York. For proponents of the psychedelic industry, a compromise between a Texas Republican and AOC could be seen as a positive step forward for future legislation — at least as it relates to funding research. We think that the country’s continued focus on and concern for mental health will pave the way for even more research for psychedelics.   

Finally, we’d be remiss not to point out what the bill’s passage does not mean. This doesn’t mean that psychedelics will be readily available to veterans, let alone the general public any time soon. Nor does it mean that psychedelics will be legalized. But it does show support for broadening what we know about the medical capabilities of psychedelics.   Stay tuned to this space in the coming days for our recap of 2023 in psychedelics and some predictions about the year ahead.

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As we’ve discussed, the federal government seems to be getting on board with the legal use of psychedelics. So are many states. While states across the country are moving towards expanding legal (or at least decriminalized) access to psychedelics, we doubt it will come as any surprise to those experienced in the cannabis industry that states in the West seem to be leading the charge.  

Prime Time: Colorado and Oregon Lead the Charge

Colorado and Oregon have already legalized the use of certain psychedelics. Oregon was the first state to implement a legal system to obtain and use psilocybin. Oregon Psilocybin Services began accepting applications for licensure (manufacturing, laboratory, service centers, and facilitators) on January 2, 2023, and, according to its latest report, it had issued licenses to six service centers with expectations to issue “many more licenses over the coming months.” Once again at the forefront of legalization, Colorado voters passed a ballot measure – Proposition 122 – that would allow professionals to offer certain psychedelics starting in 2025.

California Dreamin’

California apparently does not intend to get left behind. Earlier this month, the California Legislature narrowly approved a bill to decriminalize the possession of a limited set of “naturally occurring psychedelics,” including psilocybin, DMT, and mescaline (excluding peyote). To be clear, the bill does not fully legalize the use of psychedelics. Instead, it means that police could not arrest people who are in possession of or use certain psychedelics. As we’ve seen with the federal government, the growing belief that psychedelics could help combat the growing mental health crisis seems to be an important motivation behind passing the legislation. To that end, the new bill will also trigger a regulatory process to craft policy proposals for group therapeutic use of psychedelics. Gov. Gavin Newsome has until October 14 to approve or veto the bill. If approved, it would go into effect January 1, 2025.

Hawaii to Research Allowing a Little Aloha

Demonstrating the wide breadth of approaches we can expect to see, Hawaii is taking another path, albeit with a similar goal to California. Hawaii’s Office of Wellness and Resilience recently announced the establishment of the Breakthrough Therapies Task Force, “which aims to assist [Hawaii] in expanding therapeutic access to two key substances: MDMT… and psilocybin.” The task force will address questions relating to supply, licensing for guides and integration coaches, administrative needs, safety, access, and affordability of care. The task force – which is comprised of local physicians, psychiatrists, mental health professionals, and government partners – met for the first time on August 29. Indicating his support for and the basis behind the initiative, the governor’s office specifically referenced the long history of the use of psychedelic plants by indigenous cultures, as well as the research that “has shown that both psilocybin and MDMT have significant and unprecedented efficacy in the clinical treatment of post-traumatic stress disorder (PTSD), addiction, end-of-life anxiety in terminal patients, eating disorders, treatment resistant depression, and more.” The task force will complete a final report by the end of 2023. We’re looking forward to seeing what they have to say.

What’s Next?

The moves by California and Hawaii deepen our beliefs that we are going to continue to see movement towards providing the American public with access to psychedelics for mental health purposes. And it looks like that’s what voters want. UC Berkeley’s psychedelics survey recently confirmed that “[t]he majority of voters are comfortable with psychedelic therapy being used to treat those suffering from terminal illnesses (80%), veterans (69%), and people suffering from treatment resistant depression and anxiety (67%),” though fewer (44%) are comfortable with “the open access to psychedelic therapy for a anyone over the age of 21.” Nearly half of those surveyed would support open access to psychedelic therapy.

A journey of a thousand miles begins with a single step, and the developments in these states represent important first steps. We have miles to go before we sleep, but if this budding trend continues, that sleep may be a little bit better in the future.

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Just as we did, the Food and Drug Administration has recognized the growing enthusiasm for exploring opportunities to use psychedelic medications to treat mental health disorders. In June, FDA issued for the first time draft guidance providing considerations for those developing psychedelic drugs for the treatment of medical conditions. The guidance explicitly focuses on “classic psychedelics,” which are “typically understood” as “5-HT2 agonists” like psilocybin and LSD, as well as entactogens or empathogens like MDMA. Has this put a wedge between psychedelics and cannabis?

The Nuts and Bolts of Psychedelic Research

In the guidance, FDA focuses on the “unusual characteristics” of psychedelic drugs – including the hypotheses that psychedelic drugs have “both rapid-onset and long-term benefits after only one or a few doses,” as well as the recognition that the development of psychedelic drugs in this manner is new and developing. The guidance addresses chemistry, manufacturing, and controls; nonclinical research; clinical pharmacology; and abuse potential.    

  • Chemistry, Manufacturing, and Controls: FDA makes clear that sponsors must provide sufficient chemistry, manufacturing, and controls information to ensure proper identification, quality, purity, and strength of the investigational drug substance and drug product. If plant material, algae, macroscopic fungi, or some combination is used, FDA refers readers to its Botanical Drug Development guidance.
  • Nonclinical: While FDA recommends that nonclinical programs for psychedelic drugs should follow recommendations outlined in the guidance Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, FDA also recognizes that there are unique considerations for psychedelics.
    • Recognizing that prior clinical studies may provide sufficient information about the lack of safety concerns with human exposure, it may be reasonable for clinical studies with certain psychedelics to be initiated under an IND. FDA clarifies, however, that psychedelics without an adequate history of clinical exposure should not be tested in humans until the safety has been established in nonclinical studies, which should be used to support further development of the use of psychedelic drugs.  If the treatment effect is not durable and repeat dosing is expected, nonclinical studies should be provided to support chronic or chronic-intermittent dosing.  The particular treatment paradigm will dictate the number and types of nonclinical studies needed to support approval.
  • Clinical Pharmacology: FDA also addresses clinical programs, highlighting the importance of considering the unique properties of psychedelics and their clinical aspects. These aspects include, for instance, the effect of a high-fat meal on the pharmacokinetics of an oral psychedelic drug, drug-drug and drug-disease interactions, long-term exposure to 5-HT2B agonists, and known pharmacodynamic interactions. Additionally, FDA suggests that sponsors take appropriate steps to characterize the dose-response relationship.
  • Clinical: FDA suggests that just like other drugs, the substantial evidence standard applies to psychedelics. But it does highlight the following unique considerations that it recognizes may present challenges and offers some suggestions:
    • The use of a traditional placebo may be difficult for assessing adequacy for psychedelics. Functional unblinding may be inevitable given the “intense perceptual disturbances that can develop.”
    • Blinded researchers and questionnaires should be considered.
    • Complementary trial designs should be considered – including for example “a trial using a low, middle, and high dose without a placebo” with a “placebo-controlled trial.”
    • Particularly unique in this arena is the fact that “[m]any of the psychedelic drug development programs involve administering the investigational drug and then engaging in a psychological support or psychotherapy.”  This additional variable complicates the assessment of effectiveness and presents a challenge for future labeling.
    • Subjects receiving active treatment with psychedelics may remain in a vulnerable state for as long as 12 hours; accordingly, safety-monitoring should be implemented and FDA endeavors to provide additional guidance on this subject.
    • Clear, informed consent should be utilized.
    • Sponsors should address mitigation of adverse events or serious risks during the clinical studies.
  • Abuse Potential Assessment: According to FDA, because psychedelics act on the central nervous system and produce psychoactive effects, abuse potential should be evaluated during drug development. FDA also highlights that activities associated with investigations under an ID for Schedule I controlled substances must comply with applicable DEA regulations.

The Implications of the Draft Guidance on the Cannabis Industry

We previously asked whether the advancement of the psychedelic industry was a zero-sum proposition vis-à-vis the cannabis industry or whether we would see a rising tide phenomenon for both of the new therapies. FDA’s draft guidance on psychedelic research raises that question anew.

In January of this year, FDA issued final guidance for clinical research for the development of human drugs containing cannabis or cannabis-derived compounds. When we compare the two, the draft psychedelic guidance seems to further the perception – right or wrong – that the research on the medical benefits of psychedelics has been more clinical in nature. While the psychedelic guidance focuses largely on parameters for clinical studies, the cannabis guidance focuses much more extensively on sourcing the cannabis. Some sources have attributed the difference in perception to the fact that psychedelics have been shown in some initial studies to have clinical benefits, while cannabis became mainstream largely through legislation as opposed to clinical studies. 

There are certainly positive takeaways for the cannabis industry though. A review of the psychedelics guidelines highlights a concern with respect to psychedelics that we have not seen as much with cannabis – the purported “high potential” for abuse with psychedelics. Additionally, we think much of this guidance could help sponsors and researchers looking for new ways to use cannabis medically (see Medical Marijuana Research Act; Medical Marijuana and Cannabidiol Research Expansion Act; VA Medicinal Cannabis Research Act of 2023). 

We’re bobbing on the surface, and time will tell whether the federal government advances psychedelics or cannabis more quickly as a therapeutic. We continue to think the psychedelic industry has the momentum, but it also faces new challenges that are all too familiar to the cannabis industry. We could have come so very far, but we suspect little will be accomplished in an election year. But stay tuned as we follow the progress of these novel therapies and the government’s acceptance of them, which we believe is a matter of when, not if.

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“It’s not about ‘having’ time. It’s about making time. If it matters, you will make time.” – Unknown

Stakeholders in the marijuana space have been anxiously awaiting news about rescheduling marijuana since the Biden administration announced its intention to consider rescheduling in August 2023. And while we are less than a year into the new Trump administration, there are increasingly fewer signals that rescheduling is a reality in the short term. There are also more questions about what rescheduling would look like should it eventually occur. 

Let’s level set on one thing: Regardless of how you perceive President Trump as a chief executive or a person, you’d be very rich if you could predict with any measure of certainty whether — and particularly when — he will do almost anything when it comes to policy positions. Congress? Not much more predictable. Heck, the current makeup can’t even keep the government open. So, we enter this discussion with a hefty dose of uncertainty by virtue of the makeup of our leadership. 

That said, for those operating in the cannabis industry, the questions of whether, and if so when, marijuana will be rescheduled are at least thought by many to be hugely consequential.

Being a cannabis-focused marketplace of ideas, we’ll give the rescheduling concept a shot.

President Trump’s Views on Marijuana and Rescheduling 

My personal view is that President Trump has many more issues occupying his thoughts other than marijuana reform. I really don’t think he cares much about it at all and likely won’t stand in the way of any actions taken by his administration or Congress to reform marijuana rules. Publicly, he has been difficult to pin down on the issue. And that’s not to say he hasn’t explained to some extent his views on marijuana; rather it is challenging, all though not necessarily impossible, to know where he stands.

As just one example, when Florida (his home state) was considering adult-use cannabis, President Trump posted on Truth Social that he would be voting in favor of a proposed amendment to the Florida Constitution that would have allowed adults age 21 years or older to possess, purchase, or use marijuana products and marijuana accessories for non-medical personal consumption.

In the same post, he spoke more broadly about his personal views and gave insight as to how friendly his administration may be to those in the cannabis industry. Trump stated:

As President, we will continue to focus on research to unlock the medical uses of marijuana to a Schedule 3 drug, and work with Congress to pass common sense laws, including safe banking for state authorized companies, and supporting states’ rights to pass marijuana laws, like in Florida, that work so well for their citizens.

In an interview, Trump doubled down. He described medical marijuana as “amazing.” 

On the other hand, Trump did not take steps to promote rescheduling marijuana during his first term, and, despite a great deal of noise and headlines, he has not affirmatively pushed for rescheduling at the federal level during his second term. Is that a signal that he is not serious about rescheduling or that he just hasn’t gotten around to it? Maybe neither, but maybe it’s worth examining the view of his key medical advisors to see if we can discern whether marijuana is a priority for the president.

What Do Trump’s Key Advisors Think About Marijuana Rescheduling?

This is where it somehow gets less clear. The key players in a rescheduling decision will be Secretary of Health and Human Services Robert Kennedy, Jr., DEA Administrator Terrance Cole, and Attorney General Pam Bondi. Let’s take a look at what each has said about rescheduling.

As part of her confirmation hearing, Bondi responded to a series of questions regarding whether she would continue the Biden administration’s efforts to reschedule marijuana with identical responses: “If confirmed, I will give the matter careful consideration after consulting with appropriate Department officials.” And look, I get it, the name of the game in a confirmation hearing is, for better or worse, to avoid saying things that will garner “no” votes. Still, her testimony is hardly an endorsement of rescheduling. It’s also worth noting that as Florida’s attorney general, Bondi opposed efforts to legalize medical cannabis in the state.

Cole testified at his confirmation hearing that he would make examining the rescheduling a priority under his tenure, but just last week the DEA stated in a court filing that the marijuana rescheduling process remains stalled at the stage it has been on for months.

And to round out the circular firing squad, Kennedy declined to endorse marijuana rescheduling during his confirmation hearings, instead stating that he would defer to the Department of Justice and DEA.

So, to wrap up this little vignette, we have the secretary of Health and Human Services saying that he will defer to a DEA administrator who has not been able to move rescheduling forward and an attorney general with, at best, mixed views on rescheduling. I suspect I speak for many interested in the outcome of the rescheduling debate when I ask who is going to make the first move, or whether these positions essentially equate to a shell game designed to draw out the process without anyone having to take a stance?

What About Congress Reforming Marijuana Policy?

You may also consider whether Congress has the appetite to take on the issue of marijuana reform. Bless your heart. Loyal Budding Trends readers (and our analytics suggest that there are dozens of you… dozens!) know that Congress has been considering marijuana reform efforts for more than a decade.

To get a sense of how frustratingly hopeless Congressional inaction has been, I’ll note that 70% of all Americans, and even a majority of Republicans, support some form of marijuana legalization, and yet Congress will not act. Tell me three other issues that 70% of Americans agree on right now that is not becoming law!

I think the answer may lie if we look at an episode of The West Wing. In it, the character played by the sublime Marlee Matlin used polling numbers on a proposed amendment banning flag burning to explain why it is important not just to ask how people view an issue but also how much they care about that issue. People who consume marijuana or make a living tied to the marijuana industry, as well as those who vehemently oppose marijuana use, obviously feel strongly about the issue of rescheduling. Maybe some of the Congressional inaction reflects that a sufficient number of constituents are not demonstrating that they care enough about the issue to move the needle. 

So, What’s It Gonna Be? Reschedule or Not?

As of this writing, I do not have confidence that the federal government will reschedule marijuana in the short term. The president is not making marijuana rescheduling a priority in his administration. His key advisors seem stuck in a game of chicken where nobody wants to take a stance and everyone appears to be looking for someone else to make the next move. And popular sentiment, while seemingly strong, has not yet shown that it can motivate our leaders to action.

Oh, and if I’m wrong (which has been known to happen) and the federal government does reschedule marijuana, I still do not have confidence that the market can reasonably predict how the federal government will treat marijuana differently than it does now, if at all. Check this out.

In the meantime, we’ll stay on it so you don’t have to. Thanks for stopping by.