Abstract
Interest in psilocybin has accelerated, with public access in the United States expanding through a rapidly evolving landscape of decriminalization, increased availability of psilocybin-containing products, and state-regulated facilitated service models (Hutchison et al., 2025). However, uptake may be advancing faster than the evidence base. Regulatory oversight is needed to inform population-level risk. Most supervised psilocybin safety data derive from clinical trials that enroll carefully screened participants and deliver interventions in tightly controlled settings. This limits the generalizability of safety data to the broader populations likely to seek services if psilocybin products are authorized for medical use in the United States (Tan et al., 2022).