Search results for: psychedelic

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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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I don’t know why I write things that encourage people to take my job. I’ll add that to the list for my next therapy session.

Back in 2022, I wrote “So You Want to Be a Cannabis Lawyer?” In it, I said that being a cannabis lawyer had been the most fun and most rewarding phase of my career, and that the only way to succeed at it was to become comfortable being uncomfortable.

That’s still true, but for different reasons.

In the original post, I laid out four things you needed to do: (1) become a subject matter expert; (2) get comfortable with discomfort; (3) learn to tell the serious clients from the rest; and (4) learn to think like clients who are wired to take risks you’ve been trained to avoid.

Nearly everything I wrote then still holds. But the ground underneath one of those points has shifted in a way big enough that the whole piece is worth revisiting — because the federal order moving DEA-approved medications and state-licensed medical marijuana from Schedule I to Schedule III has changed the calculation.

There’s a line in The Godfather Part II I keep coming back to. Hyman Roth, asked to account for a death he had every reason to be bitter about, refuses to complain. He doesn’t ask who gave the order, but says, “This is the business we’ve chosen.” That posture — owning the hard parts instead of treating them as somebody else’s fault — is exactly what I was getting at in 2022, and it’s exactly what rescheduling demands now. The order didn’t make this an easy business to choose. It changed what’s hard about it. So let me walk back through the original four points and tell you what’s the same and what isn’t.

  1. Become a subject matter expert — and the body of law just got bigger, not smaller. In 2022 I called this a good news/bad news situation: Cannabis is a novel area with a finite amount of law to know, but it’s constantly evolving. Rescheduling is the clearest proof of that I’ve ever seen. Overnight, a single order radiated into tax, banking, capital markets, advertising, intellectual property, clinical research, patient access, employment, interstate commerce, hemp, and psychedelics. We wrote 13 separate posts on it in Budding Trends and barely scratched the surface. If you were hoping the law would hold still long enough to master it, this is your answer: There is more to know now, not less, and staying abreast of the changing news and its implications for your clients matters more than it ever did.
  2. Get comfortable being uncomfortable — the discomfort just moved. I said in 2022 that cannabis law is riddled with contradictions and gray areas, and that the only honest way through was to tell the truth and the whole truth, explaining every risk against the client’s proposed benefit. That hasn’t changed — it’s just relocated. The old discomfort was advising clients operating in flat defiance of federal law. The new discomfort is subtler and easier to get wrong: explaining that the relief is real but conditional. The end of Section 280E for state-licensed medical operators may be the most consequential thing in the order, but the benefits aren’t self-executing; there’s a DEA registration pathway with a clock on it and specific requirements that don’t take care of themselves. Telling a client “Yes, this is genuinely good for you, and here is everything you still have to do and everything that could still go wrong” is its own kind of uncomfortable. Get comfortable with it or get busy doing something else. There’s no shame in not wanting to navigate these waters.
  3. Recognize the serious clients from the non-serious ones — and brace for more calls. In 2022 I warned that a niche practice draws a high volume of calls, many from people who aren’t serious, and that telling them apart takes judgment and experience. Rescheduling pours gasoline on that. Every favorable headline — 280E relief, easier banking, open doors at the trademark office — brings a wave of callers who heard “it’s legal now” and stopped reading. Your job is to use your expertise to figure out what’s actually being asked (the order helps medical operators in specific ways, but it has done nothing yet for adult use) and your judgment to decide whose name you want next to yours. The learning curve I described then is steeper now, because the gap between what people think the order did and what it actually did is wide.
  4. Think like your clients — but update your opening line. This is the point that has changed the most, and I want to be precise about it. In 2022 I wrote that the middle ground started with stating, clearly and unequivocally, that marijuana is a Schedule I narcotic under the federal Controlled Substances Act. For DEA-approved medications and state-licensed medical marijuana, that opening line is no longer accurate; those categories now sit in Schedule III, and a lawyer who still recites the old script will mislead a client about the law as it stands. But the underlying discipline survives intact. You still state the federal posture clearly and unequivocally — you just have to know which posture applies to which category. For adult-use operators, the Schedule I analysis hasn’t gone anywhere. Their status is still being fought over in an administrative process that won’t resolve on anyone’s preferred timeline. Thinking like your clients now means tracking which side of that line each one is on.

So here’s where rescheduling leaves a young lawyer weighing this path. The order didn’t end the frontier I described in 2022 — it moved it. The interesting, unresolved questions are still everywhere: What happens to the Dormant Commerce Clause now that medical marijuana is a federally lawful article of commerce for the first time? What does Schedule III mean inside an exam room? Does, after years of federal signals that flattered to deceive, the order finally justify optimism on psychedelics or is it just déjà vu in a new suit? If you need certainty to feel like a competent lawyer, the gap between what rescheduling promised and what it delivers will wear on you. If you can tell a client “Here’s what the order does, here’s what it doesn’t do, and here’s when we’ll know more” without flinching, there has never been a better time to come.

Being a cannabis lawyer is still not for everyone; in fact, it’s still not for most people. Rescheduling didn’t change that. But if you’re one of the few and the proud, the responsibilities that come with the job are richer now than they were when I first wrote this and so are the rewards. Nobody will make you choose this. That’s the whole point of Roth’s line. This is the business we’ve chosen — but it doesn’t mean you can’t have a little fun doing it.

Thanks for stopping by.

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In the summer of 2017, Phish lit up Madison Square Garden with a historic 13-night run. Your friends at Budding Trends believe the marijuana rescheduling decision calls for a rollout just as monumental, so we’ve created the Budding Trends Baker’s Dozen as a fitting homage.

Following the federal government’s move to reschedule medical marijuana from Schedule I to Schedule III under the Controlled Substances Act, Bradley’s Cannabis Industry team has cultivated a series of 13 consecutive blog posts, each zeroing in on a distinct area of law reshaped by the DEA’s final order.

From the high-impact world of banking and capital markets and the budding future of patient access and clinical research to what may be on the horizon for adult-use cannabis and even psychedelics, we’ve rolled through the issues that matter most and planted the seeds for what’s next.

Enjoy this roundup as we unpack 13 areas of the law that are poised to evolve in the wake of rescheduling.

1. Rescheduling Happened: What State-Licensed Medical Cannabis Operators Need to Know and Do Immediately

Ok, campers, rise and shine — the federal government has finally, albeit partially, rescheduled medical marijuana. If you are a state-licensed medical cannabis operator, this is good news in a number of ways. You’re no longer subject to 280E (and perhaps that will apply retroactively), and it should be easier to access capital from banks and investors. You’re also far less likely to find yourself running afoul of the law in the day-to-day operation of your business.

But, and this is significant, these benefits are not self-executing. State-licensed medical cannabis operators must register with the DEA (ideally within the next 60 days) and follow certain specific requirements set out in the acting attorney general’s final order.

2. Is the Most Impactful Part of Marijuana Rescheduling an Obscure Sentence in the Tax Code?

These days nobody agrees on anything. Until now. Since the announcement rescheduling state-licensed medical marijuana and FDA-approved medications containing marijuana from Schedule I to Schedule III, there has been near universal commentary that the most definitive — and perhaps most significant — implication of the change was removing the yoke of 280E from the backs of medical marijuana operators.

3. Will the Marijuana Industry’s Access to Banking and Capital Markets Expand with Rescheduling?

As with almost any other business, access to capital is the oxygen that drives almost everything else; without it, the business cannot afford to do the things it needs to do to be successful. With the recent rescheduling of state-licensed medical marijuana and FDA-approved marijuana products, will the medical marijuana industry finally have broader access to capital through banks and private investment?

The answer is a qualified yes, but with enough asterisks to fill a Phish setlist.

4. Will States with Adult-Use Marijuana Programs See a Renewed Surge Towards Medical Programs Following Rescheduling?

Rescheduling marijuana to Schedule III is a big deal for a lot of reasons we’ve covered extensively here at Budding Trends. But one question we haven’t fully unpacked yet: What does it mean for state medical programs in states that also have adult-use markets? Will patients who drifted toward recreational dispensaries find their way back into formal medical programs? We think the answer is yes, although the reasons are more layered than most people appreciate.

5. I Guess You Could Say That: Rescheduling and the Dawn of First Amendment Protection for Medical Marijuana Advertising

Historically, marijuana operators have been extraordinarily limited in their ability to advertise their products at both the federal and state level. We’ve written before about the interplay between businesses in the cannabis space and their right to free speech under the First Amendment. The rescheduling of marijuana to Schedule III status meaningfully shifts that dynamic.

6. Rescheduling and Intellectual Property: What Medical Marijuana Operators Can (and Can’t) Do at the USPTO Now

When the acting attorney general moved state-licensed medical marijuana and FDA-approved marijuana-containing products from Schedule I to Schedule III, the headlines focused on banking, taxation, and what the change might mean for operators day to day. But one consequential — and underreported — area of impact is intellectual property. For cannabis businesses that have spent years locked out of the federal IP system, rescheduling opens some doors. The catch? Not all of them, not for everyone, and not without careful navigation. Here’s a practical breakdown of what the Schedule III change actually means for medical marijuana operators at the USPTO — and where the obstacles remain.

7. From Lab to Dispensary: What Rescheduling Means for Marijuana Clinical Trials

Those of you who have been following along with our series on marijuana rescheduling know that on April 22, 2026, the DEA issued its long-awaited final order moving certain marijuana products — specifically state-licensed medical marijuana and FDA-approved marijuana products — from Schedule I to Schedule III. We’ve covered what the order means and doesn’t mean, what state-licensed medical marijuana operators need to know and do, and the tax implications. But rescheduling has me wondering — are we going to start hearing more about cannabis as medicine, and what does rescheduling mean for the future of cannabis clinical research? These aren’t just esoteric questions. I believe the answer to those questions will largely determine whether rescheduling will result in an influx of capital from pharmaceutical companies, be it cannabis-native biotech firms or established pharma players.

8. Doctor’s Orders: What Schedule III Means for Patient Access and Healthcare Facilities

Another industry that isn’t currently in the plant-touching realm that will be directly impacted by medical marijuana being rescheduled to Schedule III is the healthcare industry. This piece takes us to the story unfolding in exam rooms and hospital corridors across the country. Now that state-authorized medical marijuana has formally moved to Schedule III, physicians, pharmacists, hospitals, and healthcare systems are navigating new territory.

9. The Interstate Commerce and the Dormant Commerce Clause in Light of Rescheduling

On April 22, 2026, Acting Attorney General Todd Blanche issued a final order immediately placing both FDA-approved marijuana products and state-regulated medical marijuana products in Schedule III of the Controlled Substances Act. What happens to interstate commerce and the Dormant Commerce Clause when medical marijuana becomes a federally lawful article of commerce for the first time?

10. Adult-Use Marijuana to Be Rescheduled? Here’s What’s at Issue and How It Will Be Decided

There were massive cheers in the marijuana industry when Acting Attorney General Todd Blanche issued a final order last week that rescheduled FDA-approved marijuana medications and state-licensed medical marijuana. And for those two categories, there were great reasons to rejoice.

But what about adult-use/recreational cannabis operators, operators who hold both medical and adult-use marijuana licenses, or operators who have a single license authorizing medical and adult-use operations? That debate will formally begin during an administrative hearing on June 29 and is to conclude no later than July 15.

11. Schedule III and the Workplace: How Marijuana Rescheduling Could Reshape Employment Law

On April 22, 2026, Acting Attorney General Todd Blanche issued a final order immediately placing both FDA-approved marijuana products and state-regulated medical marijuana products in Schedule III of the Controlled Substances Act. A separate administrative hearing process on broader rescheduling of marijuana (namely, adult use/recreational) is scheduled to begin June 29, 2026.

The marijuana industry’s immediate focus, understandably, has been on the 280E tax relief for state-licensed medical operators and the new DEA registration pathway that the order contemplates. Those are consequential developments. But a final order of this magnitude does not limit itself to tax and licensing. What about the impact of rescheduling on the employment and discrimination areas of the law?

12. What Rescheduling Means for the Hemp Industry

In 2018, Congress opened a door for hemp through the 2018 Farm Bill. While the origin story is still subject to intense debate, it seems most likely that the intention of the 2018 Farm Bill — although not thoughtfully expressed in the plain text — was to make way for industrial hemp. The plain language, however, created an opportunity for consumable hemp products, and the intoxicating hemp industry was born. It didn’t take long for consumable hemp products to catch on like wildfire. We saw the industry fill a void and serious consumer demand, particularly in states that did not have state medicinal or adult-use marijuana programs.

13. What the Marijuana Rescheduling Order Means for Psychedelics

The story of federal psychedelic policy over the last few years has been, in many ways, the story of two tracks running parallel — and occasionally colliding. On one track: a growing body of clinical research, bipartisan political support, and patient advocates pushing for therapeutic access to psilocybin, MDMA, ibogaine, and other psychedelic compounds. On the other track: a federal Schedule I classification that has treated these substances as having no accepted medical use and a high potential for abuse — a classification that, as we’ve argued before, is increasingly difficult to defend with a straight face. So for those who have been following along here for a bit, our take on the April 2026 DEA rescheduling order may feel familiar and a little like déjà vu — federal signals that seem meaningful, caveats that keep the champagne corked, and a “we’ll believe it when we see it” posture that industry veterans have learned the hard way. But this time, I think the signals are different enough for us to take a fresh look through rose-colored glasses.

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This is the seventh of 13 posts describing the impacts of marijuana’s rescheduling. An homage to Phish’s historic run at Madison Square Garden in the Summer of 2017, Budding Trends Baker’s Dozen will address how rescheduling affects various areas of the law and our daily lives. Enjoy the run.

Those of you who have been following along with our series on marijuana rescheduling know that on April 22, 2026, the DEA issued its long-awaited final order moving certain marijuana products — specifically state-licensed medical marijuana and FDA-approved marijuana products — from Schedule I to Schedule III.  We’ve covered what the order means and doesn’t mean, what state-licensed medical marijuana operators need to know and do, and the tax implications. But rescheduling has me wondering — are we going to start hearing more about cannabis as medicine, and what does rescheduling mean for the future of cannabis clinical research? These aren’t just esoteric questions. I believe the answer to those questions will largely determine whether rescheduling will result in an influx of capital from pharmaceutical companies, be it cannabis-native biotech firms or established pharma players.

The Research Problem Under Schedule I

If you’ve spent any time in the cannabis space, you’ve heard practitioners, researchers, and patients alike lament the vicious cycle at the heart of the federal marijuana prohibition: In theory you couldn’t provide a data-backed argument for moving marijuana off Schedule I without clinical trial data, but you couldn’t easily run clinical trials because marijuana was on Schedule I. For decades, researchers trying to study marijuana faced heightened DEA registration requirements, a severely limited pool of federally authorized suppliers — historically and until recently just one facility at the University of Mississippi — and protocol approval processes that meant many academic institutions and pharmaceutical companies simply didn’t bother. The result was a gap between what patients and their doctors anecdotally reported about marijuana and what peer-reviewed science substantiated. 

What Schedule III Actually Changes for Researchers

Moving marijuana to Schedule III doesn’t flip a switch and suddenly make marijuana research frictionless. DEA registration requirements still apply to anyone handling marijuana for research purposes, and the barriers of the Controlled Substances Act don’t disappear.

But the practical improvements are meaningful. Schedule III status brings marijuana into the same regulatory neighborhood as drugs like Ketamine or Tylenol with codeine — substances subject to controls but whose research is not treated with the same level of skepticism and bureaucratic friction that Schedule I imposes. We suspect researchers will find it easier to access study materials, face a less onerous approval process for their protocols, and encounter fewer institutional gatekeepers who reflexively say no to Schedule I research. Perhaps most importantly, we think that the formal federal acknowledgment that marijuana has “currently accepted medical use” — a finding embedded in rescheduling — likely starts to change the conversation in grant review committees and boardrooms across the country.

One particularly notable clarification buried in the April 22 order deserves attention: The order expands the sources of marijuana products from which clinical trials can now be conducted. The order states:

Out of an abundance of caution, the Administrator clarifies that researchers who obtain marijuana or marijuana-derived products from a state licensee for use in scientific research shall incur no civil or criminal liability under the Controlled Substances Act solely by reason of having obtained such products from a state-licensed source rather than a separately DEA-registered bulk manufacturer, provided that the researcher is registered with the Administration to conduct research with marijuana under 21 CFR 1301.13 and the state licensee from whom the researcher obtained the marijuana held a valid federal registration at the time of the transfer.

In other words, researchers can use marijuana or marijuana derived products from a state licensee so long as the researcher is properly registered and the licensee held a valid federal registration. Researchers are no longer being limited exclusively to federally grown marijuana. This is a significant practical change. The federally grown supply was notoriously limited and often criticized as unrepresentative of what patients actually use in state markets. Opening the supply pool to state-licensed products should meaningfully expand the feasibility and relevance of future clinical research. We also query whether this will create additional, meaningful demand for state-licensed growers and processors.

The Trump executive order that set this rescheduling in motion also directed HHS, FDA, CMS, and NIH to develop models for incorporating “real-world evidence” into regulatory decision-making for cannabis (marijuana and hemp) products. Is this a signal that the federal government is willing to look beyond the traditional randomized controlled trial framework that, ironically, marijuana’s Schedule I status had made it nearly impossible to satisfy? We’ll have to wait and see, but our curiosity is piqued.

Pharmaceutical Companies Are So Money — They Just Needed Someone to Tell Them It Was OK to Make the Call

So, does all this mean that pharmaceutical companies will dive into the marijuana industry in a way we haven’t seen before? I think probably, but carefully and selectively. To be sure, even under rescheduling, companies still have to clear the FDA’s drug approval process, including clinical trials demonstrating safety and efficacy. That’s a high bar — but it’s a bar pharmaceutical companies know how to clear. What they couldn’t easily navigate was the additional layer of Schedule I uncertainty. Remove that layer and the potential market share that would come with a successful marijuana-based product, and you’ve got something closer to a normal drug development risk profile — and a lucrative one at that.

For companies wondering whether the FDA drug pathway is actually navigable for a marijuana-derived product, the answer is already yes. It’s been demonstrated with Epidiolex, which is an FDA-approved cannabidiol medication for rare seizure disorders, including Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex. Jazz Pharmaceuticals’ continued investment in expanding the Epidiolex label and evidence base shows that a cannabinoid-based product can support an ongoing, multi-indication research program with the same rigor as any other pharmaceutical compound.

To be sure, companies racing to rebrand themselves as pharmaceutical players face a genuine challenge worth flagging: The FDA approval pathway is extraordinarily long and expensive, and Schedule III status doesn’t compress that timeline. MMJ International Holdings’s CEO put it bluntly recently: “You cannot shortcut the FDA. Many companies are just now deciding they want to be pharmaceutical, but the real barrier to entry is time spent inside the regulatory process.”

New Trials: The Starting Gun Has Fired, Will the Stampede Come?

As of this writing, no company has announced a brand-new clinical trial in the days since the April 22 order. But I do think what the next several months will likely bring is a significant increase in FDA pre-Investigational New Drug (IND) meeting requests and IND submissions for marijuana-derived investigational drugs, particularly in the therapeutic areas where existing anecdotal and observational evidence is strongest. A few areas stand out as most likely to attract serious investment in the near term:

  • Pain Management. Chronic pain remains one of the most commercially significant therapeutic areas in medicine. In the opioid crisis context, there is genuine public health urgency behind understanding whether cannabis can serve as a substitute or adjunct to opioid therapy. For instance, Vertanical, a European cannabis pharmaceutical company, is conducting a trial for its VER-01 compound to see if it can treat patients with chronic low back pain.  
  • Anxiety and PTSD. Given the current administration’s focus on veterans’ mental health — and its parallel embrace of psychedelic therapy research for PTSD — cannabis-based approaches to anxiety and trauma are ripe for renewed investigation. The VA’s FOCUS study on veterans with PTSD and cannabis use reflects serious institutional interest in this space.
  • Nausea, Appetite, and Oncology. Nausea, appetite, and uses associated with oncology already drive state-licensed marijuana programs. Clinical trials exploring botanical cannabis or novel cannabinoid formulations in cancer-related symptom management are a natural next step.

What This Means for Marijuana Companies and Their Counsel

For marijuana operators and investors, the message is nuanced. Rescheduling does not transform the existing marijuana industry into a pharmaceutical industry overnight — and companies that position themselves primarily as pharmaceutical players will need to reckon with the full weight of FDA drug approval requirements. That is a very different, and much more capital-intensive, business model than running a vertical segment of a state-licensed medical operation.

We predict we may see bifurcation: the existing state-licensed medical marijuana industry continuing to operate under its current model while navigating the new DEA registration requirements, and a separate pharmaceutical track where new entrants — some established pharma companies, some cannabis-native biotech firms — invest in the clinical development infrastructure needed to bring marijuana-based drugs through FDA approval. We suspect some companies and established players are betting they can straddle both worlds. Whether that’s right will depend heavily on their ability to make the cultural and operational shift from cannabis producers to regulated pharmaceutical developers — and the FDA will be the judge of that.

From a legal perspective, companies eyeing the clinical trial space should be thinking now about DEA research registration, FDA pre-IND meeting strategy, IP protection for novel cannabinoid formulations and delivery methods, and the interplay between any pending state-law marijuana business interests and a new pharmaceutical development track. There’s a lot to think about but also a lot of opportunity. The companies that position themselves wisely now, understanding both the opportunity and the remaining uncertainty, are the ones most likely to be able to capitalize.  We’re here to help.

Conclusion

And with that, it’s back to the Budding Trends lab to cook up another post in the Budding Trends Baker’s Dozen examination of all things rescheduling.

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Here at Budding Trends, we like to roll up our “Top 10 Weed Roundup” between the sacred and renowned 420 holidays. Each year, we pack a recap post with 10 highly read blog posts since the previous 420 to see what’s shakin’ on shakedown street over the last year — and we have seen a lot go down and a lot go up in smoke. So, let’s get down to business, shall we?

We’ve got everything from Alabama’s baby steps into hemp reform and kicking off their medical cannabis program to Texas going big with its medical cannabis program, proving that the Lone Star State prefers everything supersized — even their weed laws. The Trump administration’s never-ending tease of potential federal marijuana rescheduling followed by the big announcement that had us all thinking our dreams might come true just before the holidays.

We also get more down with Dr. Sunil Aggarwal’s legal tango with the DEA over psilocybin rescheduling — a seemingly sci-fi saga that brings new meaning to “tripping through red tape.” And let’s not forget how Trump’s surgeon general nominee isn’t exactly buzzing over cannabis but seems ready to blast off with psychedelic therapy.

We finish up with the intriguing tale of Maine’s Sirois case, reminding us that there’s a chilling federally patrolled intersection between state medical marijuana efforts and the Controlled Substances Act — and that’s something every cannabis entrepreneur should keep in mind, mind, mind, mind, mind, mind.

Enjoy this roundup burning with legislative drama, a dab of regulatory change, and the occasional puff of good news.

1. Is “Compromise” a Four-Letter Word? Alabama Legislature Passes Comprehensive Consumable Hemp Reform Bill

“Compromise” sometimes gets a bad rap. And history teaches us that there can be bad compromises. But as your resident glass-is-half-full contributor who has also been closely following debate over access to consumable hemp products in Alabama, I’ve been looking at some quotes about compromising and it turns out there’s some pretty good stuff from some pretty interesting folks.

2. What You Need to Know: Texas Substantially Expands Medical Cannabis Program

Everything’s bigger in Texas, unless you’re talking about the medical cannabis program. It’s no secret that Texas has the potential to be a behemoth in the space, but for years, Texas’ medical cannabis program has lagged behind other states. At the same time, Texas’ booming hemp industry is fighting for survival.

3. Crank the Party Up: Is the DEA About to Get It On with Psilocybin?

On August 11, 2025, the U.S. Drug Enforcement Administration officially transmitted a request to the Department of Health and Human Services to loosen the federal restriction on psilocybin, seeking to move one of the better-known psychedelics from Schedule I to Schedule II under the Controlled Substances Act. The petition was submitted by a familiar face to Budding Trends readers, Dr. Sunil Aggarwal. This marks a big step in Aggarwal’s years-long legal battle, which I’ve found myself keeping close tabs on.

4. What Means Means for Mushrooms and Marijuana: How Might Trump’s Surgeon General Nominee Shift the Conversation for Cannabis and Psychedelics?

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. 

5. Let’s Get to It: Will the Trump Administration Reschedule Marijuana?

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. 

6. Trump Orders Marijuana Rescheduled, Broader CBD Access in Major Announcement: What Does It Mean?

Are you not entertained? In a much-anticipated ceremony in the Oval Office, President Trump signed an executive order that (1) directs the attorney general to expeditiously reschedule marijuana to Schedule III and (2) instructs senior White House staff to work with Congress to revise the statutory definition of final hemp-derived cannabinoid products.

7. Was Rescheduling a Pipe Dream? DEA Questions Reliability of State-Run Programs and Impact on Transnational Crime

Often wrong, never in doubt. That’s our promise here at Budding Trends. A little over a year ago, we wrote these words: “DEA will reschedule marijuana from Schedule 1 to Schedule III.” We later acknowledged we (may have) jumped the gun on that and modified our prediction to be that rescheduling won’t happen in 2025. To be fair, that prediction is almost going to prove true but not exactly the way we meant it.

8. Reefer Madness: Congressional Proposal Would Keep Marijuana Schedule I, Prevent Most Prosecutions of Marijuana Use

What. Are. We. Doing. Here? The latest from Capitol Hill is a doozy: A congressional committee has approved a spending bill that contains provisions to block the Justice Department from rescheduling marijuana. The legislation would also maintain a separate long-standing rider protecting state medical cannabis programs from federal interference — though with new language authorizing enhanced penalties for sales near schools and parks. It next heads to full committee and then, potentially, to the floor.  

9. Medical Cannabis Finally Rolling in Alabama

In a monumental decision almost five years in the making, the Alabama Medical Cannabis Commission on Thursday issued medical cannabis dispensary licenses to three applicants: GP6 Wellness LLC, RJK Holdings LLC and CCS of Alabama LLC. Yellowhammer Medical Dispensaries LLC is in line to receive a license as soon as January 26, 2026, absent a court order or other action by the AMCC.

10. Hashing It Out: What the Final Chapter of the Sirois Case Teaches Us

On November 18, 2025, United States v. Sirois finally came to an end when Lucas Sirois and his father, Robert Sirois, were found guilty in the District of Maine on multiple charges related to a conspiracy to cultivate and distribute thousands of kilograms of marijuana on the black market.

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You’re fired. Last Thursday, in a move that had been the subject of widespread speculation but perhaps earlier than some predicted, President Trump announced that Pam Bondi had been removed from her post as attorney general. Deputy Attorney General Todd Blanche will take over on an acting basis.

What Happened?

Our friends at Marijuana Moment summed up the situation nicely:

President Donald Trump announced on Thursday that Attorney General Pam Bondi will be transitioning out of the role. He is reportedly considering replacing her with Environmental Protection Agency Administrator Lee Zeldin—a move that could have major implications for marijuana reform as a proposal to federally reschedule cannabis remains pending at the Department of Justice.

…

On Wednesday, The New York Times had reported that Trump has grown “frustrated” with Bondi’s leadership at DOJ, in particular her handling of the release of files related to Jeffrey Epstein.

…

While The Times did not mention marijuana as a reason for Trump’s reported dissatisfaction with Bondi, it has been more than three months since he issued an executive order directing her to complete the process of moving cannabis from Schedule I of the Controlled Substances Act to Schedule III “in the most expeditious manner,” and that has not happened.

Why Does This Matter?

One thing is clear from Trump’s extensive and storied history with attorneys general: If they don’t do what he asks, they won’t be long for the task. Trump has expressed publicly that he wants his attorney general to reschedule marijuana. Bondi didn’t do so, and she is currently looking for work. 

But does that mean that she lost her position because she did not announce the rescheduling of marijuana? It is hard to believe that is true. There are many more high-profile instances where the former attorney general drew the attention of the president (the handling of the records of a certain NYC financier comes to mind). 

That raises the questions of (1) whether the to-be-nominated attorney general’s position on marijuana will have any, and if so, how much, impact on the nomination decision and (2) whether a new attorney general will feel compelled to reschedule marijuana considering the president’s December order. Let’s take a look at some of the names that have been mentioned in the past few days as successors to Bondi.

How Do the Perceived Replacements View Marijuana?

The acting attorney general will, at least initially, be Blanche – formerly the president’s personal attorney and most recently the deputy attorney general. He will stay in that role until a new attorney general is sworn in (which could be Blanche, as discussed below) or he is replaced by Trump, whichever happens first.

There are those at the Department of Justice who want to see Blanche get the top job. So, what does he think about marijuana? Again from Marijuana Moment:

During his Senate Judiciary Committee confirmation process, Blanche said in response to a written question about marijuana rescheduling from Sen. Peter Welch (D-VT) that he would “give the matter careful consideration after conferring with all relevant stakeholders, including [Drug Enforcement Administration] personnel.”

When asked about aligning federal and state marijuana laws, he said that “coordination between federal and state authorities is critically important” but that he had “not had the opportunity to study this particular issue.”

“If confirmed, I will consult with the necessary stakeholders and give this matter careful consideration,” he said.

When asked about Obama-era enforcement guidance that directed prosecutors to generally not interfere with state cannabis laws, which was rescinded during the first Trump administration Blanche replied: “I have not had occasion to study this particular issue,”  “If confirmed…I think it is important to empower our U.S. Attorneys, who we trust to follow the law and to follow Department rules.”

The most mentioned name in Washington circles seems to be current EPA Administrator and former N.Y. Congressman Lee Zeldin. What is his relationship to marijuana?

As a member of the U.S. House of Representatives, he voted against a bill to federally legalize and tax marijuana in 2020 and was absent for a vote on a version of the legislation in 2022.

He voted in favor of 2015 amendments to protect state medical cannabis programs and CBD policies from federal interference but opposed amendments that year and in 2019 and 2020 to extend the protections to state recreational marijuana laws.

In 2015 and 2016, Zeldin voted for amendments to allow Department of Veterans Affairs doctors to issue medical cannabis recommendations.

In 2022, Zeldin voted against an amendment to require federal agencies to review security clearance denials going back to 1971 and retroactively make it so cannabis could not be used “as a reason to deny or rescind a security clearance.”

In 2019, he voted in favor of a bill to increase marijuana businesses’ access to banking services but missed a vote on a later version of the legislation in 2021.

In 2019 and 2021, Zeldin voted against amendments aimed at removing restrictions on psychedelics research.

In 2021, he voted for an anti-reform amendment to remove protections for universities that study marijuana.

As a state senator in New York, he voted against the bill that legalized medical cannabis in 2014.

In a 2022 gubernatorial debate with New York Gov. Kathy Hochul (D), Zeldin complained about smelling cannabis in public and said he is opposed to opening drug overdose prevention centers.

Also that year, he criticized state regulators’ move to give priority access to marijuana dispensary licenses for people with prior convictions in an interview with Tucker Carlson in which he also questioned New York City’s move to allow safe consumption sites for illegal drugs to operate.

In a now-deleted tweet, Zeldin said that “the Criminals for Kathy coalition is growing.”

“Cannabis dispensary licenses are going to start getting distributed in NY, & the Hochul admin will be giving FIRST PRIORITY to people previously convicted for marijuana offenses,” he said. “Hochul’s criminal first agenda is so wrong for NY.”

NORML gave Zeldin a C- grade in its “Smoke the Vote” guide.

Zeldin does not appear to have publicly weighed in on the idea of rescheduling marijuana, and his mixed record on legislation related to medical cannabis, easing the process of research on controlled substances and broader marijuana reform raises questions about where he personally stands on the issue.

A local paper in Salt Lake City mentioned Utah Sen. Mike Lee as a potential nominee. While certainly an intelligent lawyer and lawmaker, he would not be a friend to the marijuana industry.

And of course, I checked Kalshi to see what the predictive markets have to say about the AG sweepstakes. You can catch current Texas AG Ken Paxton with a 6% chance to nab the nomination. Now that would be an elegant solution to the Texas Senate Republican primary. As a betting man, I wouldn’t take those odds. 

Conclusion

So, what’s going to happen? Obviously it’s difficult to predict if, how, and when marijuana will be rescheduled when we don’t know who the chief law enforcement officer in the land will be and what the law enforcement priorities will look like at that time in this rapidly evolving national security landscape and era of heightened partisanship. 

My lean is that marijuana, while an important issue to me and anyone who finds themselves reading this, is largely a question of inside baseball. I suspect a future nominee’s position on marijuana rescheduling will be, at most, incidental to his or her nomination. And I suspect the decision of whether to reschedule marijuana will remain a question of if that decision is deemed of sufficient importance in the midst of other seemingly more pressing issues and if it is one that will advance the future attorney general’s standing with the president.