ANVISA
Agência Nacional de Vigilância Sanitária (Brazil) · agencia nacional de vigilancia sanitaria · brazilian health surveillance agency · rdc 243
Brazil's health surveillance agency — regulates food supplements under RDC 243/2018 as a notification-based food category with strict ingredient and claim positive lists.
ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil's federal regulator for food safety, medicines, medical devices, cosmetics and tobacco. For dietary supplements, ANVISA operates the food supplement category established by RDC 243/2018 (Resolução da Diretoria Colegiada) and the technical Normative Instruction IN 28/2018 — together they consolidated fragments previously scattered across bromatology, novel food and functional food rules into a coherent suplementos alimentares regime.
The regime is notification-based, not pre-market registration. The company submits a notification through Peticionamento Eletrônico (electronic petitioning), the product appears in the public ANVISA database, and the company is responsible for compliance. ANVISA does not pre-approve — it post-market inspects. The technical heart is IN 28's three positive lists: authorised ingredients (vitamins, minerals, amino acids, fatty acids, carbohydrates, probiotics, enzymes, prebiotics, plant bioactives) with specifications and source restrictions; maximum and minimum daily doses per ingredient per target population; authorised claims (nutrient claims plus a closed list of functional claims tied to specific ingredients at specific doses). An ingredient outside the positive list triggers the novel food path under RDC 16/1999 — a multi-year scientific assessment. Disease-treatment claims immediately reclassify the product as a medicine requiring full ANVISA medicine registration.
Labels must be in Brazilian Portuguese with the mandatory 'Este produto não é um medicamento' disclaimer, the Tabela Nutricional per single dose and daily dose, the RDC 727/2022 front-of-pack high-fat/sugar/sodium magnifying-glass warnings where thresholds are exceeded, the importer with CNPJ and the AFE (Authorisation for Operation). In V5 the ANVISA notification, the RDC 243 category, the AFE, the positive-list compliance check and the Portuguese label live on one SKU spine, so an ANVISA inspection or Notivisa adverse-event query opens to compiled evidence.
- ANVISA RDC 243/2018
- ANVISA IN 28/2018
- ANVISA RDC 727/2022
- ANVISA RDC 665/2022
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