Brazil Moves Forward With Review of Rules for Foods for Medical Purposes

As part of its 2026-2027 Regulatory Agenda, Brazil’s National Agency for Sanitary Surveillance (ANVISA) is reviewing the regulatory framework for foods for medical purposes. The initiative aims to modernise existing requirements in response to scientific and technological developments, changes in clinical practice, and the growing diversity of products available internationally.

The review covers potential changes to labelling and communication requirements, micronutrient and macronutrient limits, overage rules, and requirements for innovative formulations and product formats. ANVISA is also assessing how these products should be defined and categorised to distinguish them more clearly from other foods for special purposes and medicines.

As part of the regulatory process, the food industry has provided comments and technical input on the alternatives under consideration. Industry contributions highlighted the importance of greater regulatory predictability, clear scientific evidence requirements and closer alignment with international references. The industry also raised potential implications for implementation, including the need to reformulate products, revise labelling and regulatory dossiers, conduct additional studies and adapt existing portfolios.

ANVISA will use these contributions to inform the next stage of its Regulatory Impact Analysis, including the assessment of the costs, benefits and risks of the different regulatory alternatives.

Although the review forms part of the 2026–2027 Regulatory Agenda, ANVISA has not specified an exact date for finalising the new regulatory framework.