The title of this post is the title of this short paper authored by Vincent Joralemon now available via SSRN. Here is its abstract:
President Trump’s January 2026 executive order directing federal agencies to finalize the rescheduling of cannabis from Schedule I to Schedule III marks a watershed moment in American drug policy-and one whose lessons reach well beyond cannabis. This essay argues that the cannabis story exposes a misconception that has guided much of the psychedelics field: that the surest route to federal drugpolicy reform runs through the FDA’s approval pipeline. Drug rescheduling can follow two distinct paths: the “FDA backdoor,” under which agency approval of a specific formulation triggers rescheduling of that product alone (as with Marinol, XYWAV, and Epidiolex), and a federalist track in which state-level deregulation generates the political and empirical evidence base that eventually moves federal law. Cannabis ultimately moved on the federalist track, not the medicalized onedespite Marinol’s FDA approval nearly forty years ago. Drawing on the early data from Oregon’s, Colorado’s, and New Mexico’s state psilocybin programs, and on the FDA advisory committee’s 2024 rejection of MDMA-assisted therapy, the essay argues that psychedelic-policy reformers should treat state experimentationnot FDA approval-as the primary lever for substantive drug-policy change, with the medicalized pathway serving as a complementary rather than a leading strategy.