Lexology April 1, 2024
McGuireWoods LLP

Interest in the potential for psilocybin to be developed as a mental health treatment has continued to grow in recent months, due in part to recent activity by the U.S. Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA).

Present FDA and DEA Positions

As discussed in McGuireWoods’ July 6, 2023, alert, growing evidence of psilocybin’s significant mental health benefits has spurred states to push for and enact legislation that decriminalizes or legalizes recreational psychedelic mushroom usage. At the federal level, the FDA announced its draft guidance on June 23, 2023, indicating that it will approve clinical trials that investigate psilocybin’s potential to treat anxiety, depression, post-traumatic stress disorder and other health issues, while the DEA has confirmed that...

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