Viewpoint December 8, 2023: State-Regulated Psychedelics on a Collision Course With FDA

JAMA Network

Interest in researching and commercializing psychedelic medicines is growing. Substances such as psilocybin and 3,4-methylenedioxymethamphetamine show potential for treating conditions including depression and posttraumatic stress disorder.1 The Food and Drug Administration (FDA) may soon approve psychedelics for these and other indications.

Meanwhile, amid increasing enthusiasm for psychedelic research, states are reforming drug laws to increase access to these controversial substances. In 2020, Oregon voters approved Measure 109 to create a program for supervised nontherapeutic use of psilocybin, a psychedelic compound produced by fungi.2 The program opened to clients this summer. Last November, voters passed Proposition 122 in Colorado,2 where psychedelic businesses will open in 2025. In addition to psilocybin, Colorado’s program may offer other psychedelics such as mescaline, ibogaine, and dimethyltryptamine.2

Other states, including New York, Massachusetts, Vermont, Illinois, and California, will consider similar legislation in 2024. However, state lawmakers often overlook the shortcomings of this approach. In addition to being expensive, redundant, and potentially misleading, many state-regulated psychedelic programs are on a collision course with FDA law.

State-Regulated Psychedelic Therapies Violate FDA Law

Congress, courts, and federal agencies consider psychedelics Schedule I controlled substances with no currently accepted medical use and a high potential for abuse.1 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.

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.3

Some states, such as Texas, Connecticut, and Washington, have taken a conservative approach to psychedelic legal reform. Their laws dovetail with DEA and FDA regulations rather than conflicting with them.2 They merely fund federally sanctioned clinical trials of psychedelics.

In contrast, Oregon’s psychedelic program conflicts with federal law. But the state draws clear boundaries between health care and its psychedelic program, which effectively provides psilocybin for nontherapeutic adult use.2 Specifically, Oregon prohibits psilocybin businesses from making medical claims or operating within health care facilities.4 Individuals who monitor clients who consume psilocybin, called facilitators, cannot diagnose or treat medical conditions.4 If they hold health care licenses, facilitators cannot exercise the privileges of those licenses while monitoring psilocybin clients except in emergencies.4

These boundaries protect consumers and health care professionals by clarifying that Oregon psilocybin businesses do not treat health conditions. However, some businesses ignore these restrictions and advertise their services as treatments for depression or addiction. 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.1

Potential FDA Intervention

The FDA frequently sends warning letters to marijuana companies marketing products as therapeutic. In 2022, it sent more than 2 dozen letters regarding products containing Δ9-tetrahydrocannabinol (Δ9-THC), cannabidiol, or Δ8-THC.5 In such instances, the FDA alleges illegal marketing of “unapproved treatments for various medical conditions or for other therapeutic uses.” It sends similar warnings regarding illegal marketing of kratom,1 a federally legal herbal product, and unapproved stem cell therapies.6 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.7

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https://jamanetwork.com/journals/jama/fullarticle/2812934

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