Finally, any person from within or outside the government can petition the DEA to reschedule substances, which may trigger FDA review of available evidence. Alternatively, the president or the federal attorney general could command the DEA to reschedule a substance. The US Congress can amend the Controlled Substances Act, changing the categorization of any controlled substance 9. Rescheduling can occur through several means. On the basis of clinical-trial data, the US Food and Drug Administration (FDA) designated psilocybin a breakthrough therapy for major depressive disorder and treatment-resistant depression 8. Psilocybin use is not criminalized in several countries, including Portugal and the Netherlands, and a study commissioned by the Dutch Ministry of Health found that over-the-counter sales posed minimal risk to individual people and the public 7.Īcknowledging its therapeutic benefits, the Canadian government made psilocybin available to people with life-threatening illness through compassionate-use regulation. Unlike other schedule I substances such as heroin, and schedule II compounds, including cocaine and fentanyl, psilocybin exhibits a low risk of toxicity and a very low potential for dependence or addiction 6. The evidence in support of rescheduling is strong, particularly for psilocybin, which is derived from fungi 5. The schedule I status of most psychedelics imposes a ceiling on many policy recommendations.

Clinical trials have now been conducted at leading universities, and a growing body of evidence supports the use of psychedelics, such as psilocybin and MDMA, in the treatment of depression 2, post-traumatic stress disorder 3 and anxiety toward the end of life 4. In the late 1990s, the US Drug Enforcement Administration (DEA) permitted some researchers to study limited amounts of psychedelics, which allowed research to resume. However, in the 1970s they were categorized as schedule I controlled substances, which are said to have “no currently accepted medical use and a high potential for abuse” this blocked mainstream research on these compounds for decades. By the middle of the 20th century, clinicians used psychedelics as adjuncts to psychotherapy, reporting a variety of benefits. Others were first synthesized in the early 20th century.

Some psychedelics have been used by Indigenous communities for hundreds or thousands of years. Psychedelics are a class of natural and synthetic compounds that includes psilocybin, MDMA (3,4-methylenedioxymethamphetamine), ibogaine and DMT (dimethyltryptamine).

Phase ten therapyuse