The Drug Enforcement Administration (DEA) has announced new quotas for the production of Schedule I and Schedule II controlled substances for research purposes, calling for increased production of the hallucinogens ibogaine, psilocybin, and psilocin while maintaining stable quotas for other substances such as marijuana, THC, and MDMA.
As the DEA prepares to hold an administrative hearing in December to hear additional input on the Biden Administration’s proposal to move cannabis to Schedule III of the Controlled Substances Act (CSA), the agency posted two notices scheduled for publication in the Federal Register on Wednesday outlining the total production quotas (APQs) for various drugs that may be used in approved research.
In recent years, the DEA has generally increased its production targets in response to growing public and scientific interest in the therapeutic benefits of marijuana and certain hallucinogens, but the revised 2024 and new proposed figures for 2025 seem to indicate that, at least for now, the quotas are leveling out for most substances.
This is especially true for cannabis, with the DEA not seeking to increase the APQ for marijuana from 6,675,000 grams after 2023. Also, the 2025 quotas will remain the same compared to this year, for example for DMT (11,000 grams), MDMA (12,000 grams), LSD (1,200 grams), and mescaline (1,200 grams).
However, the agency’s revised quotas for 2024 call for increased production of psilocybin and psilocin, from 20,000 to 30,000 grams and from 24,000 to 36,000 grams, respectively. These high production levels are scheduled to continue in 2025.
“These proposed increases are intended to support research and clinical trials by Schedule I investigators registered with the DEA,” the notice of new amendments states for 2024. “These proposed increases demonstrate DEA’s support for research on Schedule I controlled substances. The proposed increases reflect research and development needs as part of the process of seeking FDA approval of new drugs.”
In a separate new notice, the DEA also called for an increase in ibogaine production from 150 grams to 210 grams for 2025.
That’s because recent studies and anecdotal evidence — including from current U.S. Congressman Morgan Luttrell (R-Texas) — suggest this powerful psychedelic drug has great potential for treating serious mental illness.
“DEA is proposing a higher APQ for ibogaine than DEA granted in 2024 to support manufacturing activities associated with increased levels of research and clinical trials on Schedule I controlled substances,” the 2025 notice states.
The CSA requires the Attorney General to set APQs annually for Schedule I and Schedule II drugs. In theory, if marijuana were eventually classified as Schedule III, the DEA would no longer include it in these annual allocations, since researchers would have to go through a separate process to request access for research purposes.
That said, the Congressional Research Service (CRS) said in a report this month that while Schedule III drugs generally face fewer research barriers, “without Congressional action, medical researchers and sponsors of drugs containing marijuana and CBD will not benefit from these looser regulations that come with the rescheduling.” This comes in part because President Joe Biden signed a bill later in 2022 specifically aimed at streamlining cannabis-specific research.
Meanwhile, a DEA administrative law judge (ALJ) recently scheduled a 10-day hearing on the agency’s proposal to ban two types of psychedelic drugs, amid backlash from researchers and advocates.
The hearing was scheduled about two months after a federal judge dismissed a lawsuit challenging the constitutionality of the DEA’s scheduling procedures as it sought to ban two hallucinogens.
Prior to the ruling, the DEA had formally canceled a scheduled administrative hearing after the agency’s administrative law judge blocked it in light of a now-dismissed lawsuit.
Separately, last month an advisory committee to the Food and Drug Administration (FDA) did not approve a new drug application for MDMA-assisted therapy, a setback for advocates and researchers and drawing backlash from lawmakers on both sides of the aisle.
White House again touts Biden-Harris marijuana plan, but with less lofty rhetoric in light of delayed vote
Image courtesy of Kristie Gianopulos.
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