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

Abstract

The regulation of cannabis products for medicinal purposes in Brazil is a highly relevant topic today but faces many challenges, especially regarding imported products. The current regulatory gaps raise concerns related to their efficacy, safety, and public health. The objective of this study was to analyze the regulatory landscape of cannabis-containing products authorized for importation into Brazil. This is an exploratory study, based on a qualitative and quantitative analysis of the lists published by Anvisa between 2015 and 2024 regarding cannabis-containing products authorized for import. The products included in the most recent list from 2023 were also analyzed in light of the parameters established by current regulations. The analysis of these lists 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 the concentration of CBD and THC, and 13.2% presented incorrect labeling information. In 90% of the cases, no certificate of analysis was found. Of the 542 products analyzed, 347 were from the United States, and 17 (5%) had irregularities recorded by the FDA. The study found that the current regulatory gap concerning cannabis products authorized for import allows their entry into the country without assurance of sanitary compliance. There is an urgent need for Anvisa to implement adequate regulation for these products, defining legal and technical requirements to ensure the quality, safety, and effectiveness of products intended for the population.