Brazil ANVISA Supplements Readiness: RDC 243/2018, IN 28/2018 and the Notification-Based Food Supplement Regime
Brazil's food supplement category did not legally exist as a distinct regulatory class until 2018.
In Short
- RDC 243/2018 (Resolução da Diretoria Colegiada) defines suplementos alimentares as foods in measured-dose presentations (capsule, tablet, sachet, liquid dose, gummy)…
- Normative Instruction IN 28/2018 (regularly updated by subsequent INs) is the technical heart of the regime.
- Brazilian supplement labels are governed by RDC 243, the general food labelling rules RDC 429/2020 and RDC 727/2022 (front-of-pack nutritional labelling).
RDC 243/2018 created suplementos alimentares as a notification-based food category under ANVISA (the Agência Nacional de Vigilância Sanitária), consolidating fragments that previously sat across the bromatology, novel food and functional food rules. The companion Normative Instruction IN 28/2018 set the permitted ingredient list, dose limits and the claim universe. The result: a workable, notification-based pathway for international supplements into the largest Latin American market — but with strict adherence to the ANVISA positive lists, Portuguese-language labelling and Mercosul-aligned GMP.
RDC 243/2018 — the food supplement category and the notification regime
RDC 243/2018 (Resolução da Diretoria Colegiada) defines suplementos alimentares as foods in measured-dose presentations (capsule, tablet, sachet, liquid dose, gummy) intended to complement the diet of healthy individuals over four years old, providing nutrients, bioactive substances, enzymes or probiotics. Critically, supplements are not medicines — disease-treatment, cure or prevention claims are prohibited and immediately reclassify the product as a medicine requiring full ANVISA medicine registration.
More on rDC 243/2018 — the food supplement category and the notification regime
RDC 243 operates by notification rather than registration: the company submits the notification through the Sistema de Peticionamento Eletrônico, the product appears in the public ANVISA database, and the company is responsible for compliance. ANVISA does not pre-approve — it post-market inspects.
IN 28/2018 — the positive lists for ingredients, dose and claims
Normative Instruction IN 28/2018 (regularly updated by subsequent INs) is the technical heart of the regime. Three positive lists: (1) authorised ingredients (vitamins, minerals, amino acids, fatty acids, carbohydrates, probiotics, enzymes, prebiotics, plant-derived bioactive substances) with specifications and source restrictions; (2) maximum and minimum daily doses per ingredient per target population; (3) authorised claims (nutrient claims and a closed list of functional claims for specific ingredients at specific doses).
More on iN 28/2018 — the positive lists for ingredients, dose and claims
An ingredient outside the positive list triggers the novel food path under RDC 16/1999 — a separate, much longer ANVISA assessment. A claim outside the IN 28 list is simply not allowed on a RDC 243 notification.
Labelling — Portuguese, the Tabela Nutricional and the mandatory disclaimer
Brazilian supplement labels are governed by RDC 243, the general food labelling rules RDC 429/2020 and RDC 727/2022 (front-of-pack nutritional labelling). Mandatory in Brazilian Portuguese: product name with the category 'suplemento alimentar', net content in legal metric units, ingredient list, nutritional information table (Tabela Nutricional) per single dose and per daily dose, daily dose and number of doses per pack, target population, storage conditions, manufacturer or importer with CNPJ, batch number and expiry.
More on labelling — Portuguese, the Tabela Nutricional and the mandatory disclaimer
The mandatory disclaimer 'Este produto não é um medicamento' ('This product is not a medicine') and 'Não exceder a recomendação de consumo diária indicada' ('Do not exceed the recommended daily intake') must appear. Front-of-pack high-in-sugar / saturated fat / sodium magnifying-glass warnings apply if thresholds are exceeded.
GMP — RDC 665/2022 and Mercosul alignment
Manufacturing GMP for Brazilian food supplements is governed by RDC 665/2022 (replacing RDC 240/2018), aligned with the Mercosul Common Market food GMP framework. Domestic manufacturers need a Licença Sanitária from the local health authority and an ANVISA Authorisation for Operation (AFE) when applicable.
More on gMP — RDC 665/2022 and Mercosul alignment
Imported supplements must be supported by GMP evidence from the manufacturing country — typically a US FDA inspection record, an EU GMP certificate or a national equivalent — accepted at ANVISA's discretion. Importers must hold an AFE as importers of food supplements and route shipments through a licensed customs warehouse.
A 150-Day Brazil Entry Path
- Days 1–20
positive-list gate — confirm every ingredient is on IN 28 at the proposed dose, every claim is on the IN 28 allowed claim list, the format is supplement-allowed.
- Days 21–45
Portuguese label and Tabela Nutricional build, front-of-pack threshold check, mandatory disclaimers.
- Days 46–70
importer AFE setup, GMP evidence packaging for the foreign manufacturing site.
- Days 71–100
notification submission through Peticionamento Eletrônico, ANVISA technical clarifications.
- Days 101–130
customs clearance pilot shipment, first-arrival ANVISA documentary check.
- Days 131–150
distributor onboarding, post-market vigilance setup (consumer complaint handling, adverse-event reporting to ANVISA Notivisa).
Questions
Do I need ANVISA pre-approval to sell a supplement in Brazil?
No — RDC 243/2018 is a notification regime, not pre-market registration. The company files a notification through ANVISA's electronic petitioning system and can market once the notification is acknowledged. ANVISA controls compliance through post-market inspection and database surveillance. The product, however, must comply with every IN 28 positive list before notification — non-compliance at notification is a hold.
What if my ingredient is not on the IN 28 positive list?
The supplement cannot use the RDC 243 notification path. The ingredient must first be assessed and authorised through the ANVISA novel food path under RDC 16/1999 — a multi-year scientific assessment — before any product containing it can be notified as a food supplement. In practice this routes most cutting-edge ingredients to the medicine path or out of Brazil until the positive list catches up.
Can I use a US FDA cGMP certificate as proof of GMP for ANVISA?
Generally yes — ANVISA accepts foreign GMP evidence from recognised regulators (US FDA, EU competent authorities, PIC/S inspectorates) for imported supplements, supplementing the importer's own AFE. Acceptance is at ANVISA's discretion, and high-risk dosage forms (sterile, novel) attract closer scrutiny. The GMP evidence must be current and cover the supplement dosage form.
Are health claims allowed on Brazilian supplements?
Only the closed list of nutrient claims and functional claims published under IN 28 — and only when the product meets the minimum effective dose for the specific ingredient tied to that claim. Disease-treatment, cure or prevention claims are prohibited and reclassify the product as a medicine requiring full ANVISA medicine registration. The mandatory 'Este produto não é um medicamento' disclaimer reinforces the boundary on the label.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
The Dietary Supplement Operations Guide
What the label says. What the batch proves.
- The rules and who decides
- Specification to finished batch
- Test, review, investigate
- Labels, samples and recall
Plus Evidence map and four worksheets.
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The Dietary Supplement Operations Guide
What the label says. What the batch proves.
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