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Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal
Source, February 21, 2006

Gonzales v. O Centro

Chief Justice Roberts holds the federal government failed to show a compelling interest justifying its ban on the Uniao do Vegetal church's sacramental use of hoasca (ayahuasca tea with DMT) under the Religious Freedom Restoration Act. The Court rejects the UN Convention argument and upholds the peyote precedent for religious exemptions to the Controlled Substances Act.

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Church of the Holy Light of the Queen v. Mukasey
Source, March 18, 2009

Church of the Holy Light of the Queen v. Mukasey

A federal court ruling applying Gonzales v. O Centro to the Santo Daime church in Oregon, granting the right to import and drink ayahuasca under RFRA. Judge Panner's findings describe the religion's origins, ritual, physiological effects, and the government's health and diversion evidence.

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Oregon Psilocybin Services Act (Ballot Measure 109)
Source, Approved by voters November 3, 2020; codified as Oregon Laws 2021, chapter 1

Oregon Measure 109

Oregon's 2020 ballot measure created the first US state-licensed psilocybin services program. The findings cite FDA's breakthrough-therapy designation for depression, and the statute establishes licensed service centers and facilitators rather than unsupervised legalization.

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Psychopharmacologic Drugs Advisory Committee Meeting on Midomafetamine (MDMA) for PTSD: Discussion and Votes
Testimony, June 4, 2024

FDA advisory committee on MDMA, 2024

The transcript of the FDA advisory committee that reviewed Lykos Therapeutics' application for MDMA-assisted therapy for post-traumatic stress disorder. Hosted here are the chair's opening of the committee questions and the two votes: 2 to 9 against finding the drug effective, and 1 to 10 against finding that its benefits outweighed its risks, with each member's stated reasons. Members cited functional unblinding, expectation bias, the many trial participants who had used MDMA before, and reports of misconduct. The FDA declined to approve the application in August 2024.

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Psychedelic Drugs: Considerations for Clinical Investigations (Guidance for Industry)
Source, July 2026 (finalizing a June 2023 draft)

FDA Psychedelic Drugs Guidance

Considerations for Clinical Investigations (Guidance for Industry)

FDA guidance (July 2026) for sponsors developing psychedelics—5-HT2A agonists including psilocybin and LSD, plus MDMA—as approved medicines. It addresses the regulatory pathway for Schedule I drugs in clinical trials and identifies methodological challenges: perceptual effects complicate blinding ('functional unblinding'), and the independent contribution of psychotherapy paired with dosing remains uncharacterized.

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