DEA Calls For Increased DMT Production In 2025 To Support Development Of FDA-Approved Psychedelic Drug

The Drug Enforcement Administration (DEA) is increasing the 2025 quota for the legal production of DMT in the U.S., saying it agrees with requests for the adjustment to “support legitimate research and scientific efforts” to develop a Food and Drug Administration- (FDA) approved drug based on the psychedelic.

In a notice set to be published in the Federal Register on Tuesday, DEA cited “additional quota applications and comments from DEA-registered manufacturers,” justifying the increase for the psychedelic compound.

DEA released initial quotas for the production of Schedule I and Schedule II controlled substances for research purposes in September. At the time, it called for an increase in the manufacturing of the psychedelics ibogaine, psilocybin and psilocyn, while continuing to maintain stable quotas for other substances such as marijuana, THC and MDMA.

But following a public comment period, it raised the production goal for DMT from 11,000 grams to 20,000 grams.

It’s not clear how close researchers are to developing a DMT-based drug, but several companies have indicated their intent to bring the psychedelic to market, pending regulatory approval.

For example, one neuroscience company announced promising results with minimal adverse effects after completing a phase one clinical trial in 2022, exploring the use of the psychedelic to treat major depression.

This year, another company said it will be moving forward with plans to create an intravenous version of the drug to assist with the treatment of brain injuries resulting from strokes. And in 2021, another biotech company started trials investigating the “safety, pharmacokinetics and pharmacodynamics.”

Over recent years, DEA has generally ramped up production goals for marijuana and certain psychedelics as interest in their therapeutic potential has grown within the public and scientific community.

This comes as recent studies and anecdotal evidence—including from a sitting member of Congress, Rep. Morgan Luttrell (R-TX)—indicate the powerful psychedelic holds significant potential in the treatment of serious mental health conditions.

Meanwhile, DEA is also actively involved in an administrative hearing process to further consider a proposal to move marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). Advocates have expressed concern that the agency hasn’t made its position on the proposed rule clear, even as it serves as the primary “proponent” of the reform.

The CSA requires the attorney general to set APQs for Schedule I and Schedule II drugs each year. In theory that means that if marijuana is ultimately placed in Schedule III, DEA would cease to include it in these annual quotas because researchers would go through a different process to request access for study purposes.

That said, the Congressional Research Service (CRS) said in a report this month that while Schedule III drugs are generally subject to fewer research barriers, “medical researchers and drug sponsors of marijuana or CBD containing drugs would not benefit from these looser restrictions associated with rescheduling without congressional action.” In part, that’s because President Joe Biden signed a bill into law in late 2022 that was specifically meant to streamline cannabis-specific studies.

Separately, FDA earlier this year declined to approve a new drug application for MDMA-assisted therapy, a setback for advocates and researchers that’s generated pushback from bipartisan lawmakers.

Top Marijuana Industry Group Asks DEA Judge Whether It Can Question Agency In Rescheduling Hearings