DEA Renews Push to Ban Five Psychedelic Compounds Despite FDA Research Progress

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DEA Renews Push to Ban Five Psychedelic Compounds Despite FDA Research Progress

Renewed scheduling effort following historic FDA hearing elicits outcry from advocates

By Jack Gorsline

FDA Headquarters, Silver Spring, MD. Source: hapabapa / Getty Images

WASHINGTON, D.C. — Just one week after a historic public hearing on the future utility of psychedelic drugs at the Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, the Drug Enforcement Administration (DEA) is moving in the opposite direction. On September 23, 2026, the DEA formally published a scheduling order to classify five obscure psychedelic tryptamine compounds as Schedule I substances under the Controlled Substances Act (CSA), sparking immediate backlash from legal experts, researchers, and mental health advocates.

The scheduling order marks the DEA's second attempt to criminalize these specific compounds, following a heavily criticized effort that the agency was forced to withdraw in 2022. The renewed push highlights a potential fracture between federal agencies regarding the therapeutic viability of psychedelic substances, with the DEA aggressively pursuing prohibition while the FDA increasingly supports clinical exploration.

The compounds targeted in the DEA’s latest filing are 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). Currently unscheduled under U.S. federal law, these tryptamines belong to a class of psychedelics known for their hallucinogenic properties, though they remain relatively obscure outside of specialized clinical research settings.

Historically, according to the U.S. Department of Justice, at least some of these compounds were previously classified as Schedule I drugs under the CSA. In 2022, the DEA sought to broadly schedule all five substances, but a fierce public and legal pushback forced the agency to retreat and cancel a highly anticipated administrative hearing on the matter, giving scientists a temporary reprieve to continue their work.

That 2022 resistance was spearheaded in part by prominent attorney Matt Zorn, who challenged the DEA’s rationale and procedural maneuvers. In a notable shift of federal personnel, Zorn now serves as the Deputy General Counsel for the Department of Health and Human Services (HHS), having taken the role under Secretary Robert F. Kennedy Jr. in 2024.

The DEA’s justification for the ban relies on statistics that critics argue fail to demonstrate a significant public health threat. According to the agency’s own filing, there have been “a cumulative total of 518 encounters of these tryptamines by United States law enforcement in several states and the District of Columbia.” Notably, the DEA omitted any specific timeframe for when this cumulative total was gathered, leaving it unclear whether these encounters span recent months or several decades.

To bolster its case, the DEA cited data from the America’s Poison Centers’ National Poison Data System (NPDS). The data revealed 65 exposure cases involving one or more of the five tryptamines over an 18-year period, from January 1, 2003, to December 31, 2021. Yet, the filing simultaneously acknowledges a critical caveat: “no single-substance exposure cases involving the five tryptamines resulted in death.”

Furthermore, the DEA acknowledged that per the HHS's own report on the five substances, "HHS noted that the FDA is not aware of any diversion from research or legitimate manufacturing activities." This admission effectively undercuts the narrative that these compounds are bleeding out of legitimate laboratories and into the illicit market.

A Clash with Medical Innovation

The DEA’s pursuit of a Schedule I classification is particularly jarring given the recent clinical momentum surrounding one of the targeted compounds. Earlier this year, Reunion Neurosciences received a highly coveted "breakthrough therapy" designation from the FDA for its 4-OH-DiPT drug candidate. The company is actively developing the compound as a targeted treatment for postpartum depression, a debilitating condition that affects millions of new mothers worldwide.

For legal advocates and researchers, the DEA’s timing feels like an intentional attempt to chill scientific progress. Robert Rush, Esq., a prominent psychedelic attorney and the founder of the Rights and Reason Project, did not mince words when evaluating the DEA’s motivations.

“Schedule I has become the default for the DEA for any substance that is not FDA-approved and has any sort of psychoactive qualities,” Rush stated. “Many people mistakenly believe that the DEA has a different attitude regarding psychedelics versus other drugs. The actions of the DEA to once again move to schedule these five tryptamines, which have important research potential and are involved in active research, reflect the true position of the agency.”

Rush pointed to the DEA’s historical legal strategies as evidence of their disregard for scientific inquiry. “The DEA has been very explicit, though they do not consider research harm in decision-making. During our DOI/DOC scheduling challenge in 2024, they argued that harm to the research is irrelevant.”

He further highlighted the glaring contradiction between the FDA’s supportive stance and the DEA’s prohibitive one regarding clinical research. “This is particularly poignant with this example now because one of the compounds, 4-OH-DiPT, the prodrug, is currently in development for postpartum depression and has been granted breakthrough status from the FDA. We have the FDA attempting to move forward a promising new treatment while the DEA is doing everything they can to obstruct its development. One foot steps on the gas while the other steps on the brake, and the taxpayers are left to pay for this whole mess.”

Rush views the DEA's maneuver as symptomatic of a broader ideological crusade within the agency. “It is also interesting that after four years, the DEA decided to drop its previous scheduling attempt then decided to revisit it less than two weeks after a very positive FDA hearing on psychedelics,” he noted. “The DEA believes in the prohibition of all drugs unless they're coming from a pharmaceutical company, and even then, they are willing to put roadblocks in the way of promising compounds to address the mental health needs of Americans.”

“We still have a crisis of mental health issues and deaths of despair in this country, yet the DEA seems to think that research to address these issues is irrelevant and not a public health issue," Rush concluded. "The Rights and Reason Project thinks this use of taxpayer-funded resources harms public health and scientific research, and we will be fighting this to the greatest extent possible.”