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A new article in the JAMA (Journal of the American Medical Association) written by Dr. Mason Marks of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School suggests that state-regulated psychedelics are on a collision course with the FDA (Food and Drug Administration).
The FDA is currently reviewing psychedelic compounds like psilocybin and MDMA for various bio-tech companies, but some states aren’t waiting for drug approvals. Oregon kicked off state approvals in 2020 when voters approved Measure 109 to create a program for supervised nontherapeutic use of psilocybin. Colorado followed those voters when its residents passed Proposition 122 with psychedelic businesses expected to open in 2025.
Other states like New York, Massachusetts, Vermont, Illinois, and California are considering passing similar legislation in 2024.
Federally Illegal
Not unlike cannabis, most psychedelic drugs are considered to be Schedule 1 drugs making them federally illegal. That means these state legal programs are committing felonies when treating patients with psilocybin. Of course that hasn’t stopped the cannabis industry from becoming a billion-dollar industry while also federally illegal.
The author of the article points out the similarities between psychedelics and cannabis when it comes to the FDA and suggests that the FDA may react accordingly. While Oregon law states that psychedelics can’t be used to treat health conditions, that hasn’t stopped many businesses from advertising the use of psilocybin for depression and addiction treatments.
Dr. Marks believes that the FDA will begin to target those companies and issue cease and desist letters not unlike those issued to CBD companies that touted various remedies online.
FDA Response
In 2022, the FDA sent out over a dozen letters to companies alleging illegal marketing of cannabis products. In October 2023, the FDA issued a warning about off-label prescribing of ketamine. The FDA has also issued warnings about Kratom products which are often sold next to other grey market cannabis products.
Dr. Marks believes that the FDA is likely to approve of synthetic versions of psychedelic drugs sending the compounds to a lower level scheduling. However, he thinks that fungal-derived psilocybin could remain illegal.
This phenomenon has been observed with Δ9-THC, also called dronabinol.8 Different formulations occupy 3 different schedules. Purified dronabinol, or marijuana plants containing it, remain in Schedule I, whereas FDA-approved formulations marketed as Syndros and Marinol were moved to Schedules II and III, respectively. Consequently, dronabinol scheduling is trifurcated.
FTC Too?
The JAMA article also notes that the FTC (Federal Trade Commission) could enter the picture as well as it also cracks down on medical claims. Over the past 10 years, the FTC has filed more than 120 cases challenging claims made by supplement manufacturers. The FDA and the FTC treat medical claims the same whether it’s cannabis, psychedelics, or just over-the-counter supplements.
Confusion
Dr. Marks highlights the confusion that consumers face. For example, he writes, “Although the Oregon Health Authority acknowledges its psilocybin program is nonmedical, it declines to enforce its own restrictions on making medical claims.” The article continues saying, “The Natural Medicine Advisory Board, which helps regulators draft rules for Colorado’s program, interprets Colorado’s law to require state health insurance, funded by federal Medicaid, to cover health services offered in conjunction with unapproved psychedelic medicines. But Medicaid prohibits using its funds to support the use of Schedule I drugs such as marijuana and psychedelics, and requiring state insurance to cover related services could violate that prohibition and impermissibly involve the state in breaking federal law.”
He believes states should err on the side of conservatism when crafting these psychedelic laws so that consumers aren’t confused over what is and isn’t approved.
Bifurcated Market
Ultimately the article believes that psychedelics will end up as a bifurcated market similar to cannabis. Some of it, like synthetic products, could become legal, while other more natural versions remain illegal.
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