Understanding the Current Legal Status of Psychedelics in the United States

Understanding the Current Legal Status of Psychedelics in the United States

WRITTEN BY: Vicente Sederberg LLP Charles Alovisetti Josh Kappel Genevieve Meehan     In a previous article, we explored one potential current opportunity for entrepreneurs interested in psychedelics and mycelium—producing non-psychoactive mushroom supplements. But are there any current commercial opportunities that involve psychedelics? The short answer is: that current legal options (i.e. legal at the state level or the state and federal level) are limited. There are four different paths under which psychedelic operations may exist in the United States. Two approaches apply to commercial operations—the traditional medical path and the emerging non-medical state-regulated path, while the other two paths are better seen as non-commercial—underground therapy and religious use. There are also illicit sales of psychedelic drugs separate from any therapeutic or ceremonial use. However, as might be expected, individuals engaged in such activities typically do not utilize the services of corporate attorneys. Commercial Operations Traditionally Regulated Medical Practice The first path, that of traditional medicine, currently offers patients limited options. The only psychedelic drug that is approved (outside of clinical trials) for psychiatric use—as opposed to anesthesia—through the traditional medical system is Ketamine. On March 5, 2019, the U.S. Food and Drug Administration (FDA) approved esketamine (a component of Ketamine and sold under the brand name Spravato) for treatment-resistant depression. As a Schedule III drug, it is also possible for a physician to proscribe Ketamine for non-FDA-approved indications—so-called off-label use. As noted on the chart on the following page, other than Ketamine, all major psychedelic drugs are categorized as Schedule I drugs under the Controlled Substances Act (CSA). Being categorized as Schedule I means these drugs have no accepted medical use, are considered at elevated risk for abuse, and, with limited exceptions (like an approved clinical trial as discussed below), are illegal to possess, sell, or consume under federal law. The only opportunity…

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