Source: The Microdose, UC Berkeley Center for the Science of Psychedelics (December 5, 2025) · Federal Register proposed rule (November 28, 2025)

In the United States, 5-MeO-DMT has been a Schedule I controlled substance since 2011. Schedule I drugs can't be prescribed, and they can only be manufactured for approved purposes such as research and clinical trials.

Each year, the Drug Enforcement Administration (DEA) sets an aggregate production quota for every Schedule I and II substance. This is the maximum amount that registered manufacturers can produce in the US that year. Quotas are first published as a proposal in the Federal Register, open for public comment, and then finalized.

What was announced

When: the proposed 2026 quotas were published in the Federal Register on November 28, 2025.
5-MeO-DMT: the quota rose from 11,000 grams in 2025 to 30,000 grams for 2026, close to a threefold increase.
Other psychedelics: psilocybin was set at 40,000 grams, five times the 8,000 grams initially set in 2023. Psilocin, the active form of psilocybin in the body, was set at 48,000 grams. Quotas for MDMA and methylone also rose.
The stated reason: the DEA linked the increases to clinical trials studying these substances, particularly for depression and PTSD.

The same week, a US health research agency (ARPA-H) announced a separate $100 million program to fund rapid research on mental health treatments, including psychedelics such as psilocybin, LSD and DMT. That program doesn't name 5-MeO-DMT specifically.

What this means, and doesn't

A production quota isn't funding, approval, or a change in legal status. 5-MeO-DMT remains Schedule I in the US, and the 2026 numbers were a proposal at this stage.

What a higher quota does signal is demand. Companies and research groups need much more of the molecule because more, and larger, clinical trials are underway or planned, including the Phase 3 trials being prepared for 2026. For a molecule that was barely studied a decade ago, it's a clear sign of how far the science has moved.

None of this affects Canadian law, where 5-MeO-DMT is treated very differently.

Research summaries are for education, not medical advice. Considering 5-MeO-DMT yourself?
Start with Safety & Screening.