Psilocybin, currently a Schedule I controlled substance with no accepted medical use and high abuse potential, is actually among the safest psychoactive compounds by comparative-harm metrics—far safer than alcohol and tobacco, which are exempt from the Controlled Substances Act and regulated as adult-use commodities. This essay argues that psilocybin should be regulated under food law, specifically the dietary-supplement framework of the Dietary Supplement Health and Education Act of 1994, rather than drug law.
The Drug Enforcement Administration (DEA) classifies MDMA as a Schedule I controlled substance, the most restrictive category under the Controlled Substances Act. However, Lykos Therapeutics (formerly MAPS PBC) has submitted a New Drug Application for MDMA-assisted therapy for PTSD. If the FDA approves this drug, it would provide the 'accepted medical use' that Schedule I drugs are statutorily denied, triggering a rescheduling process. Based on precedents like XYWAV and cannabis-derived medications, the DEA would likely reschedule only the specific FDA-approved drug product—likely to be marketed as RENSANSE—to Schedule II or III, while raw MDMA remains on Schedule I. This mechanism offers a model for incrementally relaxing federal restrictions on psychedelic substances and expanding research access.