FOR IMMEDIATE RELEASE

Contact:

Kat Murti

Executive Director

Students for Sensible Drug Policy

kat@ssdp.org

DEA SCHEDULE I PROPOSAL WOULD CRIMINALIZE COMPOUND WITH BREAKTHROUGH THERAPY STATUS FOR POSTPARTUM DEPRESSION

September 30, 2026 – WASHINGTON, D.C. — A psychedelic drug granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for postpartum depression could soon be swept into Schedule I under a new Drug Enforcement Administration (DEA) proposal — even as the administration, FDA, and bipartisan leaders in Congress push to accelerate psychedelic research and access to new mental health treatments.

On September 23, the Drug Enforcement Administration (DEA) published a scheduling notice to place 5 tryptamines (4-Hydroxy-N,N-Diisopropyltryptamine (4-OH-DiPT), 5-Methoxy-alpha-Methyltryptamine (5-MeO-AMT), 5-Methoxy-N-Methyl-N-Isopropyltryptamine (5-MeO-MiPT), 5-Methoxy-N,N-Diethyltryptamine (5-MeO-DET), and N,N-Diisopropyltryptamine (DiPT)) into Schedule I of the Controlled Substances Act (CSA), potentially disrupting crucial scientific research and restricting access to compounds that researchers say warrant further study — not prohibition. 

One of those compounds, 4-OH-DiPT, is already at the center of promising drug development: Reunion Neuroscience’s lead drug candidate, luvesilocin (RE104), is a patented, shorter-acting prodrug of 4-OH-DiPT that the FDA granted Breakthrough Therapy designation for postpartum depression earlier this year. The DEA’s proposal to place 4-OH-DiPT and its “salts, isomers, and salts of isomers” in Schedule I could sweep this promising drug into the nation’s most restrictive drug schedule just as it advances toward Phase 3 clinical trials.

This proposed scheduling also runs directly against the direction of Executive Order 14401, which directs federal government agencies to fast-track the research, regulatory review, and patient access to psychedelic drugs for severe mental health conditions. 

Across the federal government, agencies are now acting on that directive. The FDA says it is supporting psychedelic drug development and this month convened a public hearing on the potential future therapeutic use of psychedelic drugs. The Department of Veterans Affairs is helping lead the federal research effort: VA is involved in 20 active clinical trials focused on psychedelic therapies, has launched new trials of psilocybin and MDMA-assisted therapy, and signed an agreement with the Department of Health and Human Services to increase psychedelic clinical-trial participation and help successful treatments move toward FDA evaluation. Bipartisan leaders in Congress have likewise called for expanded research and access to novel psychedelic treatments.

Against that backdrop, the DEA is moving in the opposite direction — proposing new Schedule I restrictions on compounds researchers are actively working to understand.

“At a moment when the country is confronting the devastating consequences of failing to adequately recognize and treat postpartum mental illness, the DEA is threatening to criminalize a drug the FDA itself has designated a Breakthrough Therapy for postpartum depression,” said SSDP Executive Director Kat Murti. “Women and families urgently need more options, not another failed prohibitionist policy standing between patients and potentially lifesaving treatments. We should not allow outdated drug-war policies to become another barrier to developing treatments women urgently need.”

“The DEA isn’t just working against the scientists developing these treatments. It is moving in direct contradiction to the direction being set across the federal government,” continued Murti. “The President has ordered agencies to accelerate psychedelic research and access. The FDA is actively building pathways for psychedelic medicines. The VA is leading federal psychedelic research. Bipartisan leaders in Congress are pushing for research and access. Yet the DEA is reaching for Schedule I. Federal agencies should be working together to advance science and save lives — not working at cross-purposes.

The Impact of Schedule I

Schedule I is not simply a regulatory designation. It has real consequences for scientists, drug developers, and patients who urgently need new treatment options.

Placement of these substances in Schedule I will continue to promote criminalization and unregulated markets. As decades of a failed War on Drugs show, prohibition does not eradicate use. Instead, it pushes markets underground and incentivizes synthesis of novel analogs with completely unknown safety profiles. This puts people directly at risk.

“Why move forward to ban 5 obscure compounds with almost no illicit use? Why spend taxpayer dollars – and lots of tax payer dollars – to ban substances that will only harm scientific research and provide no public health benefit?,” said Robert Rush, founder of the Rights and Reason Project and a member of SSDP’s Advisory Council. “Because the DEA can. The DEA has been allowed so much discretion with no real oversight that they have become emboldened to take whatever actions they wish. Proportionality and balancing costs and benefits are not even remote considerations.” 

“The DEA has been very open that they consider harm to research to be irrelevant in scheduling decisions. The DEA’s actions to once again act to ban these five tryptamines will only hinder critical research to address this nation’s mental health crisis, including a promising drug for post-partum depressio,” Rush continued. “These compounds are used for scientific research and are not party drugs. As the medical value of psychedelics continues to become undeniable, the DEA is attacking the ability to conduct research – research often funded by the government. The real threat to public health here is the DEA – not these five obscure research compounds. People need to start asking:   Why does this one agency have so much power?”

The implications also extend well beyond a single drug candidate. Psychedelics have shown promise for treating a variety of psychiatric and other disorders, including migraine disorders. Some of these substances, like 4-OH-DiPT and 5-MeO-DET, are shorter acting and may be more clinically manageable, offering novel treatment options. The immense legal and regulatory friction of Schedule I creates a hostile environment for biotech investment and the development of

 novel treatments. 

“The harms this would cause to research extend across the entire drug development pipeline,” said Dr. Alaina M. Jaster, neuropharmacologist and Chair of SSDP’s Science Policy Committee. “When a substance is placed in Schedule I, several limitations become imposed on a variety of activities that are likely underway before the drug is ever approved. Scheduling will disrupt everything from discovery science and screening, to manufacturing and safety determination, as well as clinical trial registrations and access.”

Pharmacology Matters

The DEA cites the similarity of these substances to other psychedelics including LSD and psilocybin. But similarity is not sameness. 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT all have unique pharmacological profiles that can produce different effects. Therefore, these compounds should all be evaluated separately, not through broad scheduling actions. 

“I’ve spent the last five years leveraging several of these substituted tryptamines and their related analogues in researching psychedelic functional selectivity,” said Dr. Ben Cummins, SSDP Ambassador and member of the Science Policy Committee. “Compounds in this family are demonstrating unprecedented efficacy in the treatment of a wide range of mental health disorders for which we don’t currently have good pharmacological answers. My work aims to untangle the hallucinogenic properties of these compounds, which limit their potential as therapeutics, from the beneficial outcomes that patients desperately need. We won’t be able to develop this next generation of treatments without the tools needed to understand the underlying mechanisms. Schedule 1 designation increases barriers to research, harming in-need patient populations by preventing care, and in some cases outright preventing science that would reduce harm.”

The very research needed to understand these pharmacological differences is the research that Schedule I would make more difficult to conduct.

A History of Research Harm

SSDP has seen these harms firsthand. Beginning in 2022, when the DEA attempted to place the psychedelic research compounds 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) into Schedule I, SSDP’s Science Policy Committee organized scientists, secured legal representation, and challenged the agency. The case ultimately became the first DEA administrative scheduling hearing of its kind since MDMA was criminalized in 1986.

The challenge also established an important precedent for “research harm.” The DEA sought to exclude evidence about how Schedule I would affect scientists and ongoing research; SSDP fought to put that evidence into the record. For the first time in a DEA scheduling proceeding, harms to scientific research were recognized as relevant to the agency’s scheduling decision — establishing a precedent that the consequences of scheduling for science cannot simply be ignored.

Those harms are not theoretical. Schedule I creates unnecessary regulatory barriers that can lead to institutional pushback, frozen research protocols, and lost funding for university and independent laboratories studying fundamental neuroscience, including the serotonin 2A receptor.

Now, as the DEA moves to schedule another group of psychedelic research compounds, the same threat to science is emerging again. And SSDP is fighting back again.

Submit a Public Comment and Take Action Before October 23, 2026

The DEA is currently accepting written public comments through October 23, 2026, at 11:59 p.m. ET. That means there is still time to tell the DEA: federal drug policy should advance science, not stand in its way.

SSDP encourages researchers, clinicians, patients, advocates, students, people with lived experience, and members of the public to make their voices heard on the impacts of strict drug scheduling on the future of psychedelic medicine. Members of the public can submit comments through SSDP’s easy-to-use federal comment tool. 

The people who research these substances, care for patients, use drugs, and live with the consequences of federal drug policy belong in the rooms where that policy is made.

“SSDP has challenged the DEA before. We are prepared to do it again — and we are asking the public to fight alongside us,” said SSDP Elected Director and Policy Committee Chair Naomi Shifman.

SUBMIT A PUBLIC COMMENT TO THE DEA

With chapters on campuses and in communities across the country, Students for Sensible Drug Policy (SSDP) is the largest youth-led grassroots network dedicated to replacing War on Drug policies with those rooted in evidence, compassion, and human rights.

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For more information, please visit ssdp.org.