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Why regulators may toss cold water on buzz over psychedelics

Harvard Psychedelics News · Jan 24, 2024 · Alvin Powell
Open on news.harvard.edu
TL;DR

Psychedelics are drawing fast growing public interest, but federal regulators could intervene as states move to commercial or adult use models before FDA approval. The article explains how Oregon is operating a state program to produce and sell psilocybin and provide supervised administration, while Colorado is planning a similar model. Mason Marks, a Harvard Law School visiting professor, highlights the core legal risk: psychedelics remain schedule I under federal law, and federal agencies have discretion to crack down when state programs cross certain thresholds. A key flashpoint is how state rules blend psychedelics with conventional healthcare. Programs that involve clinicians sitting with clients for hours during dosing could be more likely to trigger federal action than models that create clearer separation, like certain state cannabis frameworks. The piece also notes possible consumer confusion and regulatory exposure if programs are framed as therapeutics, and it argues for regulation models that reduce cost, misunderstanding, and state versus federal conflict.

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Published Jan 24, 2024 · Added Mar 6, 2026