State-Regulated Psychedelics 'On A Collision Course' With FDA, Says Harvard Law Expert

A new article authored by renowned regulatory specialist Dr. Mason Marks, of the Project on Psychedelics Law and Regulation at Harvard Law School, highlights growing concern about the chasm between state-level regulations and the FDA’s stance on psychedelics.

Published in the Journal of the American Medical Association (JAMA Network,) the article notes that while the FDA "may soon approve psychedelics" for certain conditions as U.S. states effectively reform drug laws. 

Most noticeably, Oregon approved Measure 109, which created “a program for supervised nontherapeutic use of psilocybin” that officially opened to clients in 2023. Colorado, where 2022’s approved ballot measure Prop. 122 led to psychedelic businesses’ opening in 2025 for therapies with psilocybin, and potentially other psychedelics like mescaline, ibogaine and DMT.

Other states like Texas, Connecticut and Washington have taken what Marks calls a “conservative” reform approach, “dovetailing” with DEA and FDA regulations rather than conflicting with them by solely funding federally sanctioned psychedelics clinical trials.

See Also: Psychedelics Update: Kentucky, Arizona, Wisconsin, California, Washington, Massachusetts & Alaska

State Vs. Federal Law 

The problem with approving psychedelic programs at a state level, points out Marks, is overlooking shortcomings of an approach that is not only “expensive, redundant, and potentially misleading,” but also very likely “on a collision course” with federal law that classifies all psychedelics as Schedule I controlled substances. 

Excluding exceptions for research, production, possession and sale of psychedelics are federal felonies, says Marks. “Consequently, state-licensed psychedelic businesses violate federal law when producing or dispensing psilocybin.”

The situation shares similarities with state marijuana industries, where producers and dispensaries have for years “benefitted from an uneasy peace with federal agencies.” Supporters say they're hoping federal regulators will “extend the same courtesy” to psychedelic businesses and practitioners.

As much as state regulations conflict with federal drug laws “up to a point,” states’ psychedelic programs are, according to Marks, “blurring the lines” between psychedelics and healthcare services more than marijuana programs. He foresees this could “exceed the scope of permissible conflict,” and “pose a higher risk of federal intervention.”

Oregon’s psychedelic program -where Marks serves as a Psilocybin Advisory Board member- conflicts with federal law, yet the state draws “clear boundaries” between healthcare and the program, effectively providing psilocybin for non-therapeutic adult use. 

This would partially preserve the program from federal intervention, otherwise seen in FDA’s numerous warning letters to marijuana and kratom companies marketing products as therapeutic. The FDA also warns on off-label ketamine prescriptions for mental health treatment.

Considering this scenario, Marks says psychedelic businesses and regulators in Oregon, Colorado and states pursuing similar laws should be concerned with FDA and DEA’s intervention.

Even when the much-anticipated FDA approval of psychedelic formulations takes place, state-manufactured psychedelics will still “remain federally illegal,” as only FDA-approved formulations will move to a lower schedule and thus be marketed and prescribed. A “bifurcation” for psilocybin scheduling.

For Marks, state regulators can still change the course of events and avoid a federal collision by enforcing the prohibition on making medical claims for psychedelic therapies. This will in turn “protect consumers and health care practitioners” while “keeping the FDA and FTC at bay.”

Read the full article here.

Photo: Benzinga edit with photo by Serrgey75 and fizkes on Shutterstock.