Sanitary regulation of Cannabis-derived products authorized for importation in Brazil: Characteristics and regulatory trajectory

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Abstract
The regulation of Cannabis-derived products for medicinal purposes in Brazil is currently a topic of great importance, but faces challenges related to importation, safety, and efficacy of these products. The aim of this study was to analyze the regulatory framework of Cannabis-derived products authorized for importation in Brazil. This is a descriptive study, based on the analysis of lists published by Anvisa, between 2015 and 2024, concerning Cannabis-derived products authorized for importation. The products included in the most recent 2023 list were also analyzed against the parameters established by current regulations. The analysis revealed a continuous increase in the number of products, with 577 additional items since 2015. It was observed that 69.2% of the products did not specify CBD and THC concentrations, and 13.2% presented inaccurate information on labels. Of the 542 products analyzed, 347 originated from the United States, and 17 (5%) had irregularities reported by the Food and Drug Administration (FDA). The current regulatory gap regarding Cannabis-derived products authorized for importation allows their entry into the country without ensuring sanitary compliance. The urgent implementation of adequate regulation is required, defining legal and technical aspects to guarantee safe and high-quality products for the population.
Funding Information
  • Ministério da Saúde/Fiocruz (1.2022)

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