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JAMA Article Suggests Psychedelics Industry Likely to Clash with FDA

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Several states in the United States have already approved the use of psychedelics, even before the U.S. Food and Drug Administration (FDA) has concluded trials and drug approvals. For instance, the state of Oregon legalized the nontherapeutic use of psilocybin and established a program for supervised use following approval of Measure 109 by voters.

Soon after this, voters in the state of Colorado approved Proposition 122, which will allow psychedelic businesses to launch come 2025. Other states planning to approve similar measures in 2024 include California, New York, Illinois, Vermont and Massachusetts.

At the moment, the FDA is reviewing psychedelics such as MDMA and psilocybin applications from a range of biotechnology firms.

A recent paper published in “Journal of the American Medical Association” suggests that psychedelics regulated at the state level may clash with this federal agency soon. This is primarily because most psychedelics are still classified under Schedule I of the Controlled Substances Act, which makes them illegal at the federal level. This also means that these state programs administering psychedelics to patients are committing felonies.

The paper’s author, Dr. Mason Marks, believes the FDA may soon start targeting companies involved in this industry and present them with cease-and-desist letters. Marks is the project lead and senior fellow of the Project on Psychedelics Law and Regulation at Harvard Law School’s Petrie-Flom Center.

This is similar to what happened in the cannabis industry in 2022, when the FDA presented more than a dozen letters to companies that were marketing marijuana products illegally. This was based on the fact that cannabis is still classified as a Schedule I substance. Substances under this classification are said to have no accepted medical use and a high potential for abuse.

Earlier this year, the federal agency also issued warnings about the off-label prescription of ketamine. In addition to this, it gave warnings on kratom products, which are often sold with other gray market marijuana products.

Marks is of the opinion that the FDA will likely approve the use of synthetic versions of psychedelics and reclassify the substances to a lower schedule in the Controlled Substances Act. However, he argued, fungal-derived psychedelics may remain illegal.  He gives the example of dronabinol, which is also known as 9-THC. This compound’s formulations are classified in different schedules, with FDA-approved Syndros and Marinol formulations occupying Schedules II and III. Purified dronabinol, however, remains under Schedule I.

The article also highlighted that the Federal Trade Commission could join the bandwagon, given that it’s currently focused on cracking down on unsupported medical claims.

For enterprises that are following the clinical drug-development procedure, such as Seelos Therapeutics Inc. (NASDAQ: SEEL), no issues with the FDA may arise since they are following the established regulatory processes.

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