Regulatory ambiguity and governance challenges for psilocybin mushrooms in Brazil

Abstract

The legal status of psilocybin mushrooms in Brazil remains ambiguous, despite increasing global scientific and public interest in their therapeutic and ceremonial use. This commentary examines the regulatory uncertainty surrounding psilocybin mushrooms in Brazil and situates the debate within broader legal, drug policy, public health, and Indigenous rights discussions. Building on academic literature, media reports, jurisprudence, and insights drawn from the regulatory experience surrounding ayahuasca, our commentary argues that any future coherent approach to psilocybin regulation would need to integrate scientific evidence, Indigenous knowledge, and ethical governance. We underscore the importance of regulatory mechanisms that ensure Indigenous leadership in decision-making and protect traditional knowledge, consistent with international frameworks such as the World Health Organization's Global Traditional Medicine Strategy and the United Nations Declaration on the Rights of Indigenous Peoples. Despite the growing international momentum toward psychedelic reform, the absence of a coherent framework in Brazil continues to generate legal uncertainty and arbitrary enforcement. Accordingly, our reflection points to the need to open formal deliberative spaces by regulatory bodies, particularly the Brazilian Health Regulatory Agency (ANVISA) and the National Drug Policy Council (CONAD), to develop evidence-based, culturally sensitive, and constitutionally consistent policies for psilocybin regulation in Brazil.