The National Health Surveillance Agency (ANVISA in Portuguese) has published the Partial Impact Analysis Report on Regulation for Medical Food Use 2026.

Regulatory issue
The Brazilian regulatory framework applicable to special dietary foods creates barriers to the regulation and access to certain products indicated for the dietary management of specific metabolic, physiological, or pathological conditions.

Objectives
Reduce regulatory barriers for the supply of products indicated for the dietary management of metabolic, physiological, or pathological conditions that are suitable for their intended use and safe. To achieve this, the aim is to improve labeling and communication standards; increase regulatory flexibility for the incorporation of new formulations, presentations, and innovations; define requirements that differentiate these products from other special dietary foods and medications; optimize ANVISA’s performance in the analysis of these foods; and expand the dissemination of information about these products.