Sanitary regulation of Cannabis-derived products authorized for importation in Brazil
Characteristics and regulatory trajectory
Bibliographic Data
| ID | 11128404 |
|---|---|
| Authors | Gabriel Gouveia Clemente (0009-0001-7620-1808, Universidade Federal Fluminense), Cátia Verônica Dos Santos Oliveira (0000-0002-0464-1476, Fundação Oswaldo Cruz), Marina Fajardo Villela Martins Pompílio da Hora (0009-0005-9907-0619, Universidade do Estado do Rio de Janeiro), Elaine Silva Miranda (0000-0002-6204-5023, Universidade Federal Fluminense), Claudia Garcia Serpa Osorio-De-Castro (0000-0003-4875-7216, Fundação Oswaldo Cruz), Ângela Esher (0000-0002-7473-8636, Fundação Oswaldo Cruz), Cláudia Du Bocage Santos Pinto (0000-0002-5478-4977, Universidade Federal de Mato Grosso do Sul) |
| Year | 2025 |
| Volume | 49 |
| Issue | 147 |
| Publication date | 2025-01-01 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Saúde em Debate (JOURNAL) |
| Journal identifiers | ISSN: 0103-1104 • E-ISSN: 2358-2898 |
| Publisher | FapUNIFESP (SciELO) (PUBLISHER) |
| DOI | 10.1590/2358-2898202514710408i |
| OpenAlex | W4417330408 |
| Language | EN |
| References cited | 18 |
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
Food and drug administration · Food products · Government (linguistics) · Legislation · Product (mathematics) · Regulatory authority · Cannabis and Cannabinoid Research · Forensic Toxicology and Drug Analysis · Psychedelics and Drug Studies
| Highly cited | No |
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