Brazil dominates the marketplace for dietary supplements in Latin America (LATAM). It has well-defined legislation for functional and health claims for either nutrient or non-nutrient components and also for the demonstration of safety and efficacy. The Brazilian Regulatory framework for functional and health claims, novel foods, foods for infants and children, and other nutritional products has been developed by the National Health Surveillance Agency (ANVISA-Agência Nacional de Vigilância Sanitária) based on the safety and efficacy of the products and defines functional foods as foods and not drugs.
The food supplement category was created in 2018 to guarantee the population's access to safe and quality products. ANVISA has approved claims on a case-by-case basis with the scientific advice of the Technical and Scientific Committee on Functional Food and Novel Ingredients (CTCAF). Brazil’s dietary supplement market is further categorized into vitamins and minerals, proteins and amino acids, probiotics, prebiotics, and others.
A crucial aspect of launching and strategizing food/dietary supplement products in Brazil is to assess the Regulatory challenges and find the right Regulatory solutioning partner. Freyr’s Subject Matter Experts (SMEs) assist in food product classification, formulation/ingredient assessment, label and claims review, technical dossier compilation, submission, pre-market approvals, and follow-ups with the ANVISA.
- Food Product Classification
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Claims Consultation
- Product Registration
- Compilation, Gap Analysis, and Submission of Dossier
- Interaction with the ANVISA
- Legal Representation Services
- Regulatory Intelligence Report
End-to-end Regulatory consultation
Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
Support for region-specific Regulatory activities
Extensive partner network across the globe
Strong relationship with different Health Authorities