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President Trump has announced he will nominate Todd Blanche — his former personal attorney, who has been running the Department of Justice in an acting capacity — to serve as permanent attorney general. I wrote back in April about the personnel shuffle that put Blanche in the acting AG chair and what it might mean for cannabis. This post sets that speculation aside and looks at the practical question now in front of us: Assuming Blanche is confirmed — which is not guaranteed — what does his tenure mean for marijuana and for psychedelics?

The Marijuana Picture: Entrenchment, Not Suspense

The central question of a year ago — whether medical marijuana would be rescheduled — is settled. On April 22, 2026, with Blanche serving as acting attorney general, DOJ issued the final order moving DEA-approved medications and state-licensed medical marijuana from Schedule I to Schedule III. We’ve unpacked that order across our Budding Trends “Baker’s Dozen” series — what it does for 280E, banking, intellectual property, employment, and the still-open adult-use question.

So, for marijuana, a Blanche confirmation is not about whether rescheduling happens. It already did. It’s about durability.

On that front, Blanche signed the April 22 order. Consider the alternative: a brand-new attorney general arriving with no ownership of that order and every incentive to take a fresh look — to revisit the reasoning, reweigh the politics, or slow-walk implementation at the margins. A final order is far more durable than a press release, but a new chief law enforcement officer with different priorities is exactly the kind of variable that can reopen what looked settled.

Blanche is not that variable. It seems exceedingly unlikely that a confirmed attorney general would spend his tenure unwinding the order he issued as acting AG. If confirmed, the practical effect is to entrench the medical rescheduling rather than reopen it. For state-licensed medical operators already reorganizing around the end of 280E and the new registration pathway, that continuity matters — the worst outcome for them would be a rescheduling second-guessed by the next person in the chair, and Blanche’s nomination makes that considerably less likely.

That said, confirmation isn’t certain, and even a confirmed Blanche faces real work ahead. The rescheduling order is already being challenged, including in litigation from state attorneys general, and the adult-use piece remains unresolved through a separate administrative process. Whoever holds the job permanently will shape how that litigation is defended, how adult-use is handled, and what federal enforcement priorities look like. So the AG’s identity matters less for whether medical rescheduling happened than for how well it holds and what comes next.

The Psychedelics Picture: Easier to Imagine, Not Inevitable

Psychedelics — psilocybin, MDMA, ibogaine, and the rest — were not touched by the rescheduling order. Their Schedule I classification stands. But the order proved something concrete: This DOJ is willing to use its existing authority to move a substance out of Schedule I when the evidence and politics line up. For an industry long accustomed to federal foot-dragging, a working example of the machinery turning is not nothing. We covered this in our Budding Trends piece on what the order means for psychedelics.

And the attorney general sits squarely in that machinery. The clearest live example is Dr. Sunil Aggarwal’s petition to move psilocybin out of Schedule I, which the DEA transmitted to HHS for a medical and scientific evaluation in 2025. Under the statutory process, HHS makes a scientific recommendation that binds the DEA on scientific questions, but the decision whether to issue a proposed rescheduling rule rests with the DEA — an agency that answers up the chain to the attorney general. Separately, the president’s April 18 executive order directed federal agencies to reduce barriers to psychedelic research, and the FDA followed within days by granting priority vouchers to several psychedelic drug programs.

So, what does a permanent Blanche tenure portend here? The same cautious read. On the encouraging side: An administration that just rescheduled medical marijuana, issued a psychedelics-research executive order, and watched its FDA fast-track psychedelic medications is plainly not hostile to the direction of travel. On the sobering side: Rescheduling marijuana obligates no one to reschedule psilocybin, the processes are legally distinct, and — as the Congressional Research Service has noted — DOJ retains discretion to decline to act or to restart a review. The marijuana order makes psychedelic rescheduling easier to imagine; it does not make it inevitable, and a confirmed AG’s priorities will help determine whether “imaginable” ever becomes “done.”

The Bottom Line

A Blanche confirmation doesn’t decide whether medical marijuana gets rescheduled — that’s done. It bears on whether the rescheduling holds, how the litigation and adult-use questions are handled, and whether the same machinery ever turns for psychedelics. The difference between what a law says and what a law does is where the real work lives — and on both fronts, we’ve moved firmly into the “what it does” phase.

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Dr. Marty Makary resigned as FDA commissioner last week, barely a year after his Senate confirmation. HHS Secretary Robert F. Kennedy Jr. confirmed the departure and indicated the agency is searching for a replacement. Kyle Diamantas, FDA’s deputy commissioner for Food, will serve as acting commissioner in the meantime. The vacancy arrives at an extraordinarily consequential moment: a rescheduling proceeding on adult-use marijuana is scheduled to begin June 29; an executive order directing FDA to fast-track psychedelic drug reviews is sitting on the agency’s desk; the regulatory framework for what federal Schedule III status actually means for medical marijuana is very much a work in process; and a November 2026 deadline is fast approaching that could upend the hemp and CBD market as it currently exists. The person who fills this seat will have more influence over the direction of cannabis and psychedelics law than any FDA commissioner in history. And right now, that seat is empty.

Who Is Being Considered

A handful of names have surfaced as potential nominees. Former FDA Commissioner Dr. Stephen Hahn, who served from 2019 to 2021, is reportedly under consideration, as is Dr. Brett Giroir, the former assistant secretary for Health who served as acting commissioner ahead of Hahn’s confirmation. Also being discussed are Grace Graham, FDA’s current deputy commissioner for Policy, Legislation and International Affairs, and Sara Brenner, recently appointed as senior counselor for Public Health to Kennedy. Any nominee will require Senate confirmation.

Why the FDA Commissioner Matters for Cannabis

The FDA commissioner sits at the center of every major federal policy decision affecting drugs under the Controlled Substances Act, and that includes cannabis. The April 2026 rescheduling order moved state-licensed medical marijuana and FDA-approved medications to Schedule III — an action that originated in an HHS scientific and medical evaluation and that the FDA played a central role in developing. The downstream regulatory work that rescheduling triggers is, in significant part, FDA’s work to do.

Among the most consequential open questions: How will FDA treat cannabis products under the Federal Food, Drug, and Cosmetic Act? The rescheduling order did not resolve whether THC-containing products can be marketed as foods or dietary supplements, whether they require new drug applications, or how labeling and safety standards will develop for the state-licensed industry. The order reclassified a scheduling category; it did not build the regulatory framework that a fully integrated federal-state cannabis system will eventually require. That framework will be shaped, in substantial part, by the commissioner’s priorities and the agency’s enforcement posture.

The April order also addressed only state-licensed medical marijuana and FDA-approved medications. Botanical cannabis more broadly — including adult-use products — remains Schedule I pending a separate administrative hearing process scheduled to begin June 29, 2026. How FDA engages in that proceeding, and whether the agency supports or opposes further rescheduling, will reflect the commissioner’s views. Supporters of broader rescheduling argue it would bring more of the existing cannabis market under federal oversight and provide regulatory clarity; critics contend it would normalize recreational use before the public health consequences are adequately understood. The next commissioner will inherit that debate and will have a meaningful voice in how it resolves.

Why the FDA Commissioner Matters for Hemp and CBD

If the marijuana and psychedelics questions were not enough, the new commissioner will also inherit one of the most tangled and time-sensitive regulatory problems in the agency’s portfolio: what to do about hemp-derived CBD and the looming November 2026 deadline that threatens to destabilize the hemp market entirely.

The short version of a long and complicated history: The 2018 Farm Bill legalized hemp and preserved FDA’s authority to regulate hemp-derived products under the Federal Food, Drug, and Cosmetic Act. FDA promptly concluded that CBD — the hemp-derived cannabinoid that had become a multibillion-dollar consumer market — could not lawfully be sold as a food ingredient or dietary supplement. The reason was the FD&C Act’s drug preclusion provision: Because CBD had been approved as a prescription drug (Epidiolex) before it was marketed as a food ingredient, it was excluded from the dietary supplement pathway by statute. FDA acknowledged the problem, concluded in January 2023 that a new regulatory pathway was needed, said it would work with Congress to develop one, and then — in the nearly three years since — did not issue one.

Congress, growing impatient, acted in November 2025. As part of the Continuing Appropriations Act, it narrowed the definition of lawful hemp to exclude any product with more than 0.4 milligrams of combined THC per container and any cannabinoids that are synthesized or manufactured outside the Cannabis sativa L. plant. That provision takes effect November 12, 2026 — a deadline that, if it arrives without additional regulatory clarity, will render a wide swath of currently marketed hemp-derived products unlawful overnight. The hemp industry has been lobbying hard for an extension through the Hemp Planting Predictability Act, and a separate bipartisan bill — the Hemp Enforcement, Modernization, and Protection (HEMP) Act — would direct FDA to establish CBD milligram limits through formal rulemaking, with automatic statutory limits taking effect if the agency fails to act within three years.

Into this environment, Makary made one notable move before his resignation. In April 2026, he issued a letter indicating that FDA would exercise enforcement discretion with respect to orally administered, hemp-derived CBD products provided to Medicare beneficiaries under physician direction — a narrow but meaningful acknowledgment that the existing framework was not working and that some degree of access for patients was appropriate even in the absence of a formal regulatory pathway. It was a signal, not a solution. The full solution — a durable regulatory framework that addresses product safety standards, labeling requirements, THC content limits, and the relationship between the hemp-derived CBD market and the prescription drug pathway — remains unbuilt.

The new commissioner will face two immediate hemp and CBD decisions. First, whether to support or resist an extension of the November 2026 deadline — a question that implicates hundreds of thousands of farmers, manufacturers, and retailers whose livelihoods depend on knowing whether their products will be lawful past this fall. Second, and more fundamentally, whether to finally develop the comprehensive regulatory framework for hemp-derived cannabinoids that FDA has been promising since 2023. President Trump’s December 2025 executive order on medical marijuana and CBD research explicitly directed FDA, HHS, CMS, and NIH to develop a unified federal approach to hemp-derived cannabinoid products, including guidance on THC per serving limits, per container limits, and CBD to THC ratios. That directive has been sitting, largely unimplemented, for five months. Whether it moves forward — and how — is now a question for whoever succeeds Makary.

Why the FDA Commissioner Matters for Psychedelics

Trump issued an executive order in April 2026 directing FDA to prioritize review of psychedelic compounds for medical use, with a particular focus on psilocybin, MDMA, and ibogaine as potential treatments for conditions including PTSD, depression, and addiction. That directive created an institutional mandate, but mandates require leadership to execute. The pace, rigor, and outcome of expedited psychedelic reviews will depend heavily on how the new commissioner interprets and implements the president’s directive.

FDA’s track record with psychedelic drug applications has been mixed. The agency granted breakthrough therapy designation to psilocybin for treatment-resistant depression and to MDMA for PTSD, but subsequently declined to approve MDMA-assisted therapy based on concerns about trial design and data integrity. The agency’s scientific and evidentiary standards have not been publicly revised, and the question of whether an expedited review process will involve different standards — or simply a faster application of existing ones — remains open. Where the new commissioner lands on that question has significant implications for the psychedelic therapy industry and for the patients and physicians who have been following the Right to Try and compassionate use arguments we have covered on this blog.

Opinions within the medical and scientific community on psychedelic drug approval vary considerably. Proponents argue that the existing evidence base is strong enough to support approval for specific conditions and populations, and that FDA’s existing standards can accommodate approval. Critics, including some within FDA’s own scientific staff, have raised questions about trial methodology, the challenges of blinding in psychedelic studies, and long-term safety data. The commissioner will need to navigate those competing views and establish a coherent standard that the agency can apply consistently.

The Confirmation Process and What to Watch

Given the FDA’s central role in both cannabis rescheduling proceedings and psychedelic drug review, the confirmation hearing for the next commissioner nominee is likely to include pointed questions about both topics. Senators on both sides of those debates will want to understand where the nominee stands. For practitioners and operators tracking these areas, the nominee’s public statements, prior positions, and confirmation testimony will be the most direct available signal about the agency’s direction under new leadership.

We will be watching the nomination and confirmation process closely and will provide updates here as they develop. In the meantime, the acting commissioner and the career FDA staff who have been managing these proceedings will continue the agency’s work. Major regulatory actions — including FDA’s participation in the June 29 broader rescheduling hearing and any decision on the November 2026 hemp deadline — are unlikely to wait for a permanent commissioner to be confirmed.

Conclusion

There is a version of the next FDA commissioner who accelerates the regulatory framework for Schedule III medical marijuana, engages constructively in the June 29 rescheduling hearing on adult-use marijuana, implements the psychedelics executive order with rigor and scientific integrity, and finally builds the durable hemp and CBD framework that FDA has been promising since 2023. There is also a version who treats all of these matters as secondary to the agency’s more traditional portfolio of food safety, pharmaceutical approvals, and device regulation — and who presides over a November 2026 hemp deadline that arrives without a solution. And there are many points in between.

We will be there when the nomination is announced. Stay mellow out there.

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“What a long, strange trip it’s been.”

When we launched Budding Trends years ago as a modest little blog focused on cannabis law, the idea that we’d one day spend serious time tracking potential widespread access to psychedelics was, to put it mildly, not part of the original pitch deck. And yet, here we are.

Many of our award-winning readers have come along for the ride, and our numbers show that many of you (dozens!) want more. So today, we’re making it official: Budding Trends is doubling down on our coverage of the legal and policy issues surrounding psychedelic healthcare. We’ll be bringing you more frequent, more in-depth analysis of the regulatory frameworks, litigation, state legislative developments, and healthcare policy questions that are shaping whether — and how — psychedelics become part of mainstream medical treatment.

We’ve Been Building to This

We didn’t arrive at this decision overnight. If you’ve followed our psychedelic coverage, you know the story has been unspooling for several years now, and it’s been anything but boring.

We started connecting the dots back in the fall of 2023, when we wrote about the diverging federal approaches to cannabis and psychedelics — noting the FDA had issued first-ever draft guidance providing considerations for developing psychedelic drugs as medical treatments. That same season, we reported on the Ninth Circuit’s decision in Aggarwal v. U.S. DEA, which directed the DEA to reconsider its denial of a petition to reschedule psilocybin and explained what that decision meant — and, just as importantly, what it didn’t mean — for the path ahead.

Around the same time, we wrote about the moves by California and Hawaii to liberalize access to psychedelics, noting that Oregon had already opened the first licensed psilocybin service centers in the country and suggesting that we fully expected the momentum to continue. For what it’s worth, we stand by that prediction, but likely would not have been able to predict the momentum we’ve seen in Mississippi. And that momentum is only building.

In our year-in-review post covering 2023, we called that year “momentous” for psychedelics — citing the FDA guidance, the first-ever congressional hearing on psychedelic therapy, state-level legalization in Oregon and Colorado, and a wave of clinical research showing therapeutic promise. It was a good year.

And then, as they almost always do in this space, things got more complicated.

In August 2024, we wrote about the FDA’s decision not to approve Lykos Therapeutics’ MDMA-assisted PTSD therapy. We titled the post “The Bright Side of the Road” because even in that setback there were signs that the door wasn’t closed. The lesson? The legal and regulatory path for psychedelic medicine is long (and winding).

In March 2025, we returned to the Aggarwal saga one more time, after a federal appeals court ruled against the doctor who had spent years fighting to legally obtain psilocybin for his terminally ill patients. We’d been tracking that case since we first wrote about it in 2023. As we wrote in that post, we weren’t just interested in Dr. Aggarwal’s outcome — we were interested in what courts and agencies would do “when faced with a medicinal demand for psychedelics outside of the research context.” That question hasn’t been answered. And it sits right in the middle of every legal and policy challenge still to come.

On the federal administration side, we’ve watched with curiosity as members of the Trump administration have offered surprisingly sympathetic public statements about psychedelic therapy and bipartisan support has continued to develop. In May 2025, we wrote about how then-surgeon general nominee Casey Means had expressed support for psychedelic therapy in her public writings. A couple of weeks later, we covered FDA Administrator Matt Makary’s comments suggesting psychedelics were a “top priority” for the administration. And in August 2025, we reported that the DEA had formally transmitted a request to HHS to move psilocybin from Schedule I to Schedule II — a direct result of Dr. Aggarwal’s years-long litigation — and what that may mean for the industry more broadly.

And Then, in the Last Month, Things Got Interesting

We had this post largely drafted when the news dropped that, on April 18, 2026, President Trump signed an executive order that is intended to “accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.”

But we didn’t have long to noodle on that news. On April 22, 2026, the DEA issued its order on marijuana rescheduling. We talked yesterday about what rescheduling certain classes of marijuana means for psychedelics.

All of which is to say, if you were wondering whether this was a good time to start paying closer attention to psychedelic law and policy, the universe appears to have weighed in.

Why the Legal and Policy Questions Are About to Get Much Bigger

All of that coverage has convinced us of something important: The most consequential questions in the psychedelic space right now aren’t purely scientific or medical — they’re legal, regulatory and, for better or worse, political.

Clinical research has been building a compelling case for the therapeutic potential of psilocybin, MDMA, ibogaine, and other psychedelics for conditions including treatment-resistant depression, PTSD, addiction, and anxiety. Federal agencies and policymakers are paying attention in ways they weren’t even five years ago. And states are moving — sometimes cautiously, sometimes boldly — to create regulatory frameworks of their own.

But here’s the thing: The path from promising clinical results to accessible medical treatment is paved almost entirely with legal and policy decisions. What scheduling framework applies? How do state regulatory structures interact with federal law? What liability questions arise for healthcare providers who want to offer psychedelic-assisted therapy? What does informed consent look like in this context? How do healthcare licensing boards treat practitioners who are operating in this space? Who pays for it, and what does coverage look like?

These aren’t abstract questions. As the number of licensed psilocybin service centers grows, as researchers continue pushing for drug approvals, and as patients and physicians increasingly explore what’s possible, these questions are landing on real people’s desks. Including the desks of lawyers.

What You Can Expect from Us

We’re going to bring you the same mix of legal analysis, regulatory tracking, and — yes — occasional pop culture references that you’ve come to expect from Budding Trends, applied more regularly and more deeply to the psychedelic space. That means:

  • More attention to the federal regulatory process — the rescheduling proceedings, the DEA’s evolving position, FDA drug approvals and the like.
  • Closer tracking of state-level legislative and regulatory developments, as states like Oregon, Colorado, and others work through the early years of their novel psilocybin frameworks, and as other states consider their own approaches.
  • A sharper focus on the healthcare law questions, such as licensing, liability, insurance coverage, and what it means in practice to incorporate psychedelic therapy into a medical practice.
  • And when the litigation is interesting — and it usually is — we’ll be there for that, too.

And as always, we’re going to do our best to deliver the message in plain English so that you don’t feel like you’re reading a legal textbook. For Budding Trends to make any sense at all, it has to remain something that all stakeholders can understand and apply to their approaches to the product.

A Word on Why This Feels Right

We’ve said before, with only a small measure of self-deprecation, that Budding Trends started as a cannabis blog.  The psychedelic space crept into our coverage the same way a lot of things do: because the law and policy questions were genuinely interesting and because the stakes — for patients, for healthcare providers, for the regulatory system — were real.

We’ve spent the last few years trying to be fair, thorough, and at least occasionally funny on these topics. We’re going to keep doing that. We just plan to do more of it.

So, welcome to the next chapter of Budding Trends’ psychedelic coverage. We’re glad you’re here. And as always, we’ll stay on top of it so you don’t have to. Thanks for stopping by.

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This is the last 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 has addressed how rescheduling affects various areas of the law and our daily lives. We hope you’ve enjoyed the run.

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.

We don’t think there is any confusion that the DEA’s April 2026 final order does not cover psilocybin, MDMA, ibogaine, or any other psychedelic substances. Those substances are not marijuana. Their Schedule I classification remains unchanged.  But — and this is the same significant “but” we identified in our discussion of what the order means for hemp — it matters a great deal for the psychedelic industry anyway. The rescheduling order demonstrates, in a concrete and legally operative way, that the federal government is capable of moving substances out of Schedule I when the evidence, as well as political and public opinion, support the decision. The DEA’s willingness to use its existing authority to reschedule marijuana-derived medications and state-licensed medical marijuana programs is a proof of concept. The mechanism exists. The political will to use it appears to be materializing.

A Tale of Two Treaties

We wrote at the end of last week about how the manner in which Acting Attorney General Todd Blanche achieved rescheduling could dictate what comes next for other Schedule I substances like adult-use/recreational cannabis.  A quick summary for our purposes here may be helpful (although, I’d encourage you to read the entirety of the post):

  • “DOJ acted under 21 U.S.C. § 811(d)(1) — which authorizes the attorney general to control a substance under the schedule deemed most appropriate to satisfy U.S. obligations under international treaties in effect on October 27, 1970, including the Single Convention on Narcotic Drugs”
  • “This provision permits the attorney general to issue a scheduling order ‘without regard to’ the findings and notice-and-comment rulemaking procedures that ordinarily apply under the CSA”
  • In other words, Blanche bypassed the Administrative Procedure Act’s notice-and-comment requirements and the Controlled Substances Act’s ordinary scientific-findings prerequisites by invoking his authority under 21 U.S.C. § 811(D)(1) vis-à-vis the Single Convention on Narcotic Drugs.

This is where the path for psychedelics may diverge from marijuana. The Single Convention does not apply to psychedelics. The Single Convention was deliberately scoped to drugs with cannabis-, coca-, and opium-like effects. Later, as psychedelic drugs emerged and gained popularity, an entirely separate treaty was negotiated and signed in Vienna in 1971 to cover them: the Convention on Psychotropic Substances. Psilocybin, MDMA, LSD, mescaline, and most other psychedelics are scheduled under that 1971 Convention, not the Single Convention.

Why does this matter for potential rescheduling of psychedelics? The legal shortcut Blanche used to fast-track marijuana rescheduling — 21 U.S.C. § 811(d)(1) — specifically authorizes the attorney general to act without normal notice-and-comment rulemaking requirements in order to satisfy U.S. obligations under international treaties “in effect on October 27, 1970.” The 1971 Convention on Psychotropic Substances — the one governing most psychedelics — was signed in February 1971 and didn’t enter into force until 1976. It almost certainly does not qualify as a basis under Section 811(d)(1) because it was not an international treaty in effect on October 27, 1970. So what? The treaty-authority fast track that allowed Blanche to bypass the Administrative Procedure Act and issue the marijuana order immediately is very likely not available for psychedelic rescheduling.

At first glance, that sounds like bad news. It isn’t — or at least, it isn’t only bad news. It just means that psychedelic rescheduling has to find a different avenue. Rescheduling could certainly proceed under the ordinary Section 811(a)/(b) process — standard APA notice-and-comment rulemaking grounded in HHS scientific and medical findings, not treaty obligations. That process is slower and requires more procedural steps. But it also isn’t constrained by the treaty language that may ultimately limit what the marijuana rescheduling order can accomplish. A psychedelic rescheduling order built on HHS scientific findings and the APA record would rest on a broader and arguably more durable legal foundation.

Even If Not a Roadmap, Could Marijuana Rescheduling Still Be a Guide?

The rescheduling order also matters because of the record it creates. The arguments developed in the marijuana rescheduling process — about therapeutic benefit, about appropriate scheduling criteria, about the inadequacy of Schedule I for substances with accepted medical applications — are directly applicable to any future psychedelic rescheduling debate.

When HHS evaluated marijuana for rescheduling in 2023, one of the questions it had to answer was whether the substance had an “accepted medical use in treatment in the United States.” The answer — built partly on decades of research conducted despite Schedule I restrictions, and partly on real-world evidence from state medical programs — was that it does. For psychedelics, the same question will eventually need to be answered. The clinical research currently underway, often at significant cost and logistical difficulty imposed by Schedule I, is how that answer gets built. The rescheduling of marijuana-derived medications proves the loop can be broken.

HHS’s 2023 scientific and medical evaluation — which concluded that state-licensed medical marijuana and FDA-approved marijuana medications have accepted medical use and a lower potential for abuse than Schedule I substances — laid the groundwork for rescheduling, even if the final order ultimately proceeded under the treaty-authority shortcut rather than the standard eight-factor rulemaking process. For a future psychedelic rescheduling proceeding, which we think would most likely go through the ordinary Section 811(a)/(b) path, that eight-factor HHS analysis would be the critical foundation. For psychedelics, that record is being built right now. The FDA’s Breakthrough Therapy designations for psilocybin and MDMA — which require a threshold finding of preliminary clinical evidence of substantial improvement over existing therapies — are an early but meaningful marker that the evidence is moving in the right direction. They are not an “accepted medical use” finding under the CSA. But they are the kind of scientific foundation that a future HHS evaluation would build on, in the same way that decades of state medical program data and clinical research built the foundation for the marijuana finding in 2023.

The difference, of course, is that marijuana rescheduling covered substances already in FDA-approved medications (Epidiolex, Marinol) and operating under established state medical programs. Most psychedelics don’t yet have a completed FDA approval — although psilocybin and MDMA are arguably not far from that threshold. The directive of Section 5 of Trump’s April executive order is clearly designed to create institutional pressure to move quickly once Phase 3 data is in hand. 

State medical marijuana programs were a meaningful component of the HHS evaluation that supported the 2026 rescheduling order. Real-world evidence — safety outcomes, regulatory compliance data, patient access records — gave HHS something concrete to point to. While we have yet to see the broad based acceptance of state legal psychedelic programs like we have in the cannabis industry, psychedelic programs seem to have big mo on their side. Oregon and Colorado have already enacted state-legal psilocybin programs — regulated service center models where trained facilitators administer psilocybin to adults in supervised settings. Oregon’s and Colorado’s programs could generate comparable evidence about psilocybin’s safety profile and therapeutic outcomes in supervised settings. Other states are actively developing frameworks. On its face, this looks a lot like the early days of state medical marijuana: state-level access outpacing federal law, operating in an enforcement gray zone, and building regulatory infrastructure that eventually contributes to federal reform.

There’s also a broader framing point worth making. For years, the federal government’s differing treatment of marijuana and psychedelics felt inconsistent — we wrote about that divide in 2023. The federal government now appears to be converging those tracks. Approved medications and state-licensed medical marijuana have a rescheduling pathway. Psychedelics have a Right to Try pathway, a presumptive rescheduling trigger when clinical trials are complete, and $50 million in federal support for state programs. The logic of the policy is becoming coherent in a way it wasn’t before.

The Stumbling Blocks

I’m optimistic, but I’m also a cynical litigator. And the cannabis analogy has real limits. Marijuana’s path from state-legal medical program to federal rescheduling took the better part of three decades and ultimately required FDA-approved medications — not just state programs — to clear the “accepted medical use” bar. And even then, rescheduling seemed to drag along even amidst clear direction from the president about what he wanted to see happen. The phrase fits and starts comes to mind.   

Additionally, psychedelics don’t have the same broad-based support among the American public that cannabis now enjoys. According to a 2025 Gallup survey, 64% of Americans support legal marijuana. Psychedelics don’t measure up. According to a 2025 RAND survey only 23% of American adults support the legal use of psilocybin mushrooms, and support for MDMA and LSD was closer to 10%.  Patience is a virtue though, and the public support for marijuana was built over decades of state-level reform and cultural normalization. According to RAND, the level of public backing for psilocybin resembles where marijuana stood in Gallup surveys from the late 1970s through the mid-1990s — right before California legalized medical marijuana in 1996 and public support began accelerating rapidly. Whether psychedelics follow that same trajectory is an open question.

So, What Does It All Mean?

Unfortunately, I don’t have a crystal ball. But the flurry of movement at the federal level — including rescheduling and the president’s April 18 executive order directed at psychedelics — is a legitimate cause for excitement for industry advocates and stakeholders. The April 2026 rescheduling order and the April 18 executive order together represent the most coherent federal policy statement on psychedelics we’ve seen. Indeed, in the last month, the president has directed FDA and DEA to establish a Right to Try pathway for psychedelic drugs, allocated $50 million in federal funding to states developing psychedelic treatment programs, formalized data-sharing among HHS, FDA, and the VA, and established a conditional rescheduling pipeline when a Schedule I substance successfully completes Phase 3 trials for a serious mental health disorder. Combine this with the potential roadmap from marijuana rescheduling and there’s a lot to look forward to.

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The Trump administration’s interest in psychedelics as medicine has continued to come into focus over the past several weeks, with two developments suggesting that momentum at the federal level continues to grow. Both President Trump and Secretary of Health and Human Services Robert F. Kennedy Jr. continue to take actions signaling their support for the movement, even amid what could, to date, be called most charitably, um, measured efforts to move marijuana from Schedule I to Schedule III.

First, Trump signed an executive order Saturday encouraging more research into ibogaine — a psychedelic we’ve talked about before and that continues to be of particular interest to proponents of psychedelics as medicine.  According to its supporters, ibogaine has shown promise in treating opioid withdrawal symptoms and may also be used to address depression, anxiety, and PTSD. Conservative lawmakers have taken a particular interest in its ability to treat these symptoms in veterans. The executive order directs (1) “the federal government to study ibogaine, a potent psychedelic compound derived from an African shrub, as a potential treatment for post-traumatic stress disorder, traumatic brain injury and opioid dependence in veterans;”  and (2) “the FDA and DEA to establish a specific pathway for eligible patients to access investigational psychedelic drugs, including psilocybin and ibogaine, under the Right to Try Act.”

Second, and separately, RFK told podcast host Joe Rogan that the Trump administration is “very anxious” to allow psychedelic therapy “as quickly as possible.” According to our friends at Marijuana Moment who summarized the highlights, “Kennedy said he’s confident ‘we’re going to get it done,’ with plans to develop and finalize rules that would enable patients with conditions such as post-traumatic stress disorder (PTSD) and depression to access psychedelic substances like psilocybin and MDMA in a ‘very controlled setting.’” And we understand it’s not just HHS that’s taken notice of the potential benefits of psychedelics; the U.S. Department of Veterans Affairs (VA), Food and Drug Administration (FDA), and National Institutes of Health (NIH) have all taken an interest.

RFK’s comments combined with the executive order paint a picture of an administration that is at minimum rhetorically committed to advancing psychedelic medicine.

Not Coming Out of Nowhere

Regular Budding Trends readers will recall that we have been tracking the federal government’s gradual movement toward potential psychedelic rescheduling and almost certain more mainstream acceptance for some time. This month’s developments are consistent with that broader trend but represent a meaningful escalation. Prior signals came largely from individual agency officials or legislative supporters. An executive order signed by the president, combined with public statements from a cabinet-level official like RFK, carries considerably more institutional weight. On the other hand, RFK is not without critics, and it very well could be that his advocacy is not a net-positive — at least in the short term — for mainstream acceptance.

What the Executive Order Does — and Does Not — Do

Precision matters here and, to be clear, the executive order is limited.

The executive order touts the potential to address “serious mental illness for patients,” stating:

Psychedelic drugs, including ibogaine compounds, show potential in clinical studies to address serious mental illnesses for patients whose conditions persist after completing standard therapy. Indeed, the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to specific psychedelic drugs, and there are numerous products currently in the clinical trial pipeline for review of safety and efficacy. It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.

Section 2 directs the agency to fast-track psychedelic drugs that have already received breakthrough therapy designation through the National Priority Voucher Program and instructs FDA and DEA to carve out a Right to Try pathway for eligible patients seeking access to psychedelics, including ibogaine. You may recall the Right to Try pathway is the same angle Dr. Sunil Aggarwal pursued, which the DEA and ultimately the Ninth Circuit shut down.

Section 3 would leave a 1990s Cuba Gooding, Jr. satisfied — it puts real money on the table, directing HHS to allocate at least $50 million “from existing funds to support and partner with State governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses.” The federal-state collaboration framework is an interesting one that we have not seen in the cannabis space before.

Sections 4 and 5 are arguably the most consequential. Section 4 directs HHS, FDA, the VA and, where permitted, the private sector to work together to “increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs,” prioritizing “drugs that have received a Breakthrough Therapy designation.” Section 5 then closes the loop: Once a Schedule I substance successfully completes Phase 3 trials for a serious mental health disorder, the attorney general is directed to initiate and complete rescheduling review as quickly as practicable, if appropriate under 21 U.S.C. § 811.

To be sure, encouraging research into ibogaine is not the same as rescheduling it, approving it for medical use, or authorizing physicians to administer it. Ibogaine remains a Schedule I substance, and the legal and regulatory obstacles that have complicated efforts to expand access to psilocybin — which we’ve seen before — apply equally to ibogaine.

That said, administrative signaling has real consequences. The DEA and HHS operate within a political environment, and an administration that is visibly and publicly supportive of psychedelic research creates different conditions for petitions, rulemaking, and clinical trial approvals than one that is not. We noted in our coverage of FDA Administrator Martin Makary’s recent statements that companies supporting psychedelic research may become more aggressive in seeking trials and approvals under this administration. This week’s news reinforces that assessment (and encourages our optimism). 

What to Watch

As Outkast reminded us, you can plan a pretty picnic, but you can’t predict the weather. If we’ve learned anything from watching the potential rescheduling of marijuana, we know these types of decisions and actions can take on an unpredictable life of their own.  The distance between an executive order encouraging research and a patient receiving an FDA-approved ibogaine therapy remains significant. We think the more consequential developments to watch will be at the agency level, as well as at the private clinical trial level. We’ll be looking at whether HHS moves expeditiously on the psilocybin rescheduling petition currently before it, how the FDA approaches future applications for psychedelic-assisted therapies in light of its administrator’s stated priorities, and whether the DEA signals any willingness to revisit Schedule I designations for substances with growing clinical (and potentially public) support. We will also be keeping our eye on the private market, including whether the push and willingness for clinical trials continues (and whether the money follows).

As always, we will keep watching so you don’t have to. Stay tuned.

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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.