State-regulated psychedelics on a collision course with FDA
Outside narrow exceptions for research, the production, possession, and sale of psychedelics are federal felonies. Consequently, state-licensed psychedelic businesses violate federal law when producing or dispensing psilocybin… In Oregon… some businesses ignore these restrictions and advertise their services as treatments for depression or addiction… In October 2023, the FDA issued a warning about off-label prescribing of ketamine, an FDA-approved anesthetic with psychedelic properties, which has become popular for treating mental health conditions.
In addition to violating Oregon law, this practice conflicts with federal laws such as the Federal Food, Drug, and Cosmetic Act, which governs the FDA. As a public health agency that protects consumers against health misinformation, the FDA may be obliged to intervene… to the FDA and FTC, state psilocybin producers and dispensers making medical claims are no different from supplement or marijuana companies. Nevertheless, state psychedelic regulators have largely ignored the risks. Although the Oregon Health Authority acknowledges its psilocybin program is nonmedical, it declines to enforce its own restrictions on making medical claims. In addition to potentially misleading clients and health care professionals… Those familiar with state marijuana industries might not be alarmed. For years, marijuana producers and dispensaries have benefitted from an uneasy peace with federal agencies such as the Drug Enforcement Administration (DEA). Some who support state-regulated psychedelics think federal regulators will extend the same courtesy to psychedelic businesses and practitioners. State regulations can conflict with federal drug laws up to a point. However, state psychedelic programs are blurring the lines between psychedelics and health care services, far more than their marijuana programs do, which may exceed the scope of permissible conflict and pose a higher risk of federal intervention… Oregon’s program recently went over budget, requiring a $3 million public bailout. Owing to high operating costs and financial risk, aspiring businesses went bankrupt or decided not to enter Oregon’s market. Because the program runs on license fees, their exit worsened the budget shortfall and may drive fees and operating costs higher.
Original Article (JAMA Network):
State-regulated psychedelics on a collision course with FDA
Artwork Fair Use: Achile
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