The New York Post recently reported on the results of a small clinical trial at the University of Auckland, published in the journal Neuropharmacology. It found that microdosing with lysergic acid diethylamide (LSD) was “well-tolerated, with no serious adverse reactions” and offered “preliminary evidence supporting the safety and feasibility of treating moderate depression with microdosed LSD.” Montgomery-Åsberg Depression Rating Scale (MADRS) Scores decreased by nearly 60 percent and remained lower for up to six months.
The Evidence Is No Longer Fringe
Clinical trials involving psychedelics to treat various mental health and substance use disorders are not new. Currently, several trials are exploring psilocybin (and its active metabolite, psilocin), LSD, dimethlyltryptamine (DMT), and ibogaine for conditions such as depression, PTSD, alcohol use disorder, addiction, traumatic brain injury, and other mental health issues, all showing promising results.
Despite decades of clinical research providing evidence of psychedelics’ therapeutic potential, the Drug Enforcement Administration (DEA) decided that psychedelics have “no currently accepted medical use.” It classified them as Schedule I drugs, an example of “cops practicing medicine.”
By placing psychedelics on Schedule I, the DEA erected many regulatory obstacles for researchers wishing to conduct clinical trials that could yield information regarding the efficacy, dosage, and therapeutic guidelines of plant-based or synthetic psychedelics. Additionally, plant-based psychedelics, as well as synthetics such as LSD or midomafetamine (MDMA), are off-patent. While pharmaceutical companies can still patent the processes by which they extract or synthesize psychedelics, they have little economic incentive to seek DEA approval for clinical psychedelic research.
Federal Prohibition, Bureaucratic Inertia
Since 1985, the DEA has classified MDMA (aka “ecstasy” or “molly”) as a Schedule I drug—“drugs with no currently accepted medical use and a high potential for abuse.” The agency does so despite intensive hearings on its medical use, potential for abuse, safety, and toxicity, overseen by DEA administrative law Judge Francis D. Young. Young ruled that MDMA should be classified as Schedule III—drugs with “moderate to low potential for physical and psychological dependence.”
When Agencies Play Doctor
Just as the Food and Drug Administration (FDA) can overrule its advisory panels’ recommendations, the DEA can overrule its administrative law judges’ recommendations. It did so in 1985, in another example of cops practicing medicine. Millions of people living with PTSD have been denied access to treatment with MDMA ever since.
Lykos, a public benefit corporation spun off from the Multidisciplinary Association for Psychedelic Studies (a non-profit research and educational organization), submitted data from Phase 3 clinical trials on MDMA to the FDA, hoping the agency would approve it to treat PTSD. In June 2024, an FDA advisory committee recommended, by a vote of 9–2, against the FDA approving the drug to treat PTSD. The 9–2 vote came despite a multi-site randomized double-blinded phase 3 study published in Nature in 2023 that found 86 percent of PTSD patients who received MDMA plus talk therapy had reduced severity of symptoms after 18 weeks.
The analysts contended that patients would quickly surmise they were administered a placebo if they did not experience the profound mood alterations and sensations widely known to be associated with MDMA. This isn’t unique to psychedelics; it’s a challenge across many psychoactive drug trials. The analysts argued that it may be “nearly impossible to blind” studies on such psychoactive drugs.
After the advisory committee’s vote, approximately two dozen clinicians and clinical researchers, including several holding academic positions at prestigious institutions in the US and UK, signed a “consensus statement” endorsing MDMA-assisted therapy for PTSD. The clinicians addressed the concerns FDA scientists raised about the difficulties of conducting double-blinded studies on psychoactive drugs like MDMA, stating, “Although concerns have been raised about functional unblinding and expectancy effects in the phase 3 trials, these are common issues with testing psychoactive medications. We believe that these concerns do not rise to a level that would call the main clinical trial findings into question. In our assessment, the findings provide ample evidence of the efficacy of midomafetamine-assisted therapy for PTSD.” The FDA did not approve MDMA and required Lykos to conduct further research.
Jacob Sullum reports in Reason.com that, last month, the Scottsdale Research Institute, after a long wait, secured approval from the DEA and FDA for its first-in-the-nation clinical trial using whole mushroom psilocybin to treat PTSD. Until now, psilocybin clinical trials have relied on synthesized psilocybin. However, since most people consume naturally occurring psilocybin, this trial has more practical implications.
While these clinical trials are promising, it is important not to become overly optimistic about patients being able to access any of these drugs for psychedelic-assisted psychotherapy in the near future. The current process requires the FDA to confirm that a psychedelic substance is safe and effective for specific therapeutic uses before allowing clinicians and patients to access it. Then, the DEA would need to remove the substance from Schedule I, assigning it to a different schedule category.
Finally, the FDA would almost certainly prevent patients from accessing the drug without a prescription from a licensed health care provider—most likely a physician or nurse practitioner. The FDA might even attach a Risk Evaluation and Mitigation Strategy (REMS) to the drug, detailing the type of clinician who can administer it and the protocols they must follow.
In other words, the federal agencies that helped suppress psychedelic therapy for decades will now claim authority over who may provide it.
Ironically, the federal process is poised to privilege the clinicians with the least psychedelic experience and exclude the practitioners who have actually developed these therapeutic modalities. Right now, psychedelic science and psychedelic-assisted therapy are not part of the core curriculum in medical schools. Most physicians finish medical school without structured education about the pharmacology, history, therapeutic use, or legal status of psychedelics, aside from brief mentions in toxicology lectures or substance-use disorder units—and these are usually focused on abuse and adverse effects. Only a handful of universities in the US have begun introducing content on psychedelic research and clinical applications—and even then, only as elective or ad hoc coursework, not as standardized core curricula.
Real World Experience, Forced Underground
Because the DEA has kept most psychedelics in Schedule I for half a century, the people with the most experience using them therapeutically have had to work outside the formal medical system. A loose network of underground guides and therapists—often psychologists, counselors, or simply people trained through hands-on practice—continued to facilitate psychedelic sessions in private homes and discreet retreats. Many apprenticed with traditional healers in places like Peru or Brazil, learning ceremonial and therapeutic techniques through direct mentorship long before US institutions showed any interest.
This is the irony: while federal policy shut legitimate researchers out, it also pushed the entire field underground, where practitioners developed decades of real-world expertise. Leo Zeff, an Oakland, CA, psychologist who pioneered MDMA-assisted psychotherapy in the 1970s, trained thousands of therapists before the DEA’s 1985 ban forced the work into the shadows. That subterranean lineage has shaped much of today’s psychedelic-assisted therapy—despite being ignored, and often criminalized, by the very regulators now claiming authority over the field.
States, by contrast, are beginning to recognize both the limits of federal policy and the reality of widespread, longstanding therapeutic use.
States Move Ahead While Washington Stalls
Over the past few decades, many states have grown impatient waiting for federal lawmakers to end cannabis prohibition and have enacted laws removing barriers for people wanting to use medicinal and recreational cannabis within their jurisdictions. Still, nearly 30 years after California and Arizona voters approved the first ballot initiatives legalizing medicinal marijuana in 1996, federal prohibition remains in place.
Legal scholar Victoria Litman, writing in Regulation, describes state-level efforts to remove barriers for people accessing certain categories of psychedelics, noting ballot initiatives approved by voters in Oregon and Colorado. Oregon legalized psilocybin consumption for psychedelic-assisted psychotherapy by state-licensed facilitators. Colorado has taken further steps by decriminalizing the personal possession of several psychedelics alongside a regulated therapeutic scheme. In April of this year, New Mexico’s governor signed into law a bill that legalizes psychedelic-assisted psychotherapy using psilocybin under a regulatory framework.
Maryland’s Task Force on Responsible Use of Natural Psychedelic Substances—created by the legislature in 2024 to study how the state should handle emerging interest in psilocybin, mescaline, and other naturally derived psychedelics—issued its final report in October 2025 after more than a year of research, hearings, and stakeholder meetings. The task force makes two things clear. First, the evidence is no longer easy to dismiss: natural psychedelics show real promise in treating mental-health conditions, substance-use disorders, and even chronic pain. Second, Maryland shouldn’t sit on its hands waiting for Washington. The task force explicitly recommends moving ahead with a regulated access framework now, rather than delaying action until the FDA or federal government decides what to do.
Litman contends:
We are in a moment of federal institutional retreat, not just in drug policy but across regulatory domains. For psychedelic access, states already possess broad authority under the Tenth Amendment to design innovative policies. Rather than lament federal inaction, policymakers should embrace this moment to create localized, responsive, and equitable frameworks for psychedelic access.
To be clear, Litman is no defender of federal prohibition; she is a strong proponent of ending it. Her observation is that states, confronted with federal paralysis, have become the real laboratories of psychedelic reform.
Even if states take matters into their own hands, expect progress to be slow and uneven, as state reforms will continue to collide with federal prohibition.
The Licensing Trap
Furthermore, whether legalization happens at the state or federal level, the outcome is likely to impose a twentieth-century licensing or regulatory system that restricts people to using psychedelics solely for therapeutic purposes and only under the supervision of licensed practitioners who, in most cases, lack formal training or experience in psychedelic-assisted psychotherapy, and excluding many experienced facilitators who are not state-licensed health care practitioners.
But even bold state experiments remain constrained by federal prohibition—unless Congress chooses a different path.
Rethinking The Framework
Another approach to consider is one modeled after the Dietary Supplements and Education Act of 1994 (DSHEA).
Under the DSHEA, a “dietary supplement” covers vitamins, minerals, herbs, amino acids, and similar ingredients sold as pills, capsules, powders, and the like. Importantly, DSHEA puts the onus on manufacturers—not the FDA—to ensure their products are safe and properly labeled before they reach the market. The agency doesn’t pre-approve supplements for safety or effectiveness, but it can intervene if a product turns out to be adulterated or misbranded.
DSHEA also sets basic labeling rules: products must be identified as supplements, list every ingredient and its amount, and carry the familiar disclaimer that they’re not intended to diagnose, treat, cure, or prevent disease. The law allows health claims so long as they’re truthful and not misleading, and it instructs the FDA to develop Good Manufacturing Practices (GMP) to help maintain product quality.
DSHEA has worked because it trusts adults to make their own choices and trusts producers to stand behind their products. Psychedelic policy needs the same shift—from paternalism to autonomy.
Neither naturally occurring nor synthetic psychedelics are dietary supplements. Yet psychedelics don’t neatly fit into the pharmaceutical model—most aren’t taken regularly, many are off-patent, and their therapeutic value relies as much on preparation and context as on molecular action.
Still, Congress should consider applying the same approach used to reform the FDA’s regulation of dietary supplements to psychedelics and also work to eliminate DEA oversight during that process.
From Paternalism to Autonomy
A DSHEA-style reform wouldn’t solve everything, but it would finally shift policy toward adult autonomy and away from bureaucratic paternalism.
Ideally, Congress should end psychedelic prohibition and legalize and regulate psychedelics similar to alcohol. A reform modeled after the DSHEA would only be incremental. But it would go a long way toward respecting adult autonomy and removing barriers to psychedelic-assisted therapy from experienced facilitators.
(Look for an article by me and two other authors that explores this issue in greater depth in a forthcoming issue of Regulation.)
