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Selling food supplements in Brazil

In Brazil, food supplements (suplementos alimentares) follow ANVISA's RDC 243/2018. Ingredients, limits and claims come from the lists in IN 28/2018, the product is notified to ANVISA before sale, and the label carries the name "Suplemento Alimentar", set warnings in Portuguese and a nutrition table.

Updated · Each section links to the official source it comes from

Regulator
ANVISA
Main rule
RDC 243/2018 (Suplementos alimentares)
Permitted lists
IN 28/2018: constituents, limits and claims
Before sale
Notification to ANVISA (IN 281/2024, Annex II)
Name on the label
"Suplemento Alimentar" plus the form
Therapeutic claims
Not allowed

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is the product a food supplement under RDC 243/2018? Read more
  2. 2Is each constituent on the IN 28/2018 lists, and within the limits? Read more
  3. 3Has the product been notified to ANVISA? Read more
  4. 4Does the label carry the name, warnings and nutrition table? Read more
  5. 5Are the claims taken word for word from IN 28/2018? Read more
  6. 6If a lot is unsafe, how is it recalled? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

What counts as a supplement

The definition in RDC 243/2018 and what may not go into a supplement at all.

  • A food supplement is a product for oral intake, presented in pharmaceutical forms, meant to supplement the diet of healthy people with nutrients, bioactive substances, enzymes or probiotics, alone or combined.
  • Substances on the World Anti-Doping Agency's prohibited list, substances controlled under Portaria 344/1998, certain plant species and partially hydrogenated oils are banned (Article 7).

How we help: Compliant Always keeps the evidence for how each product was classified with the product, so the answer is on record when a retailer asks. Ask about this

Constituents and limits

Only listed constituents may be used, within listed minimum and maximum amounts.

  • Constituents are limited to those in Annexes I and II of IN 28/2018 (RDC 243/2018, Article 4).
  • Minimum and maximum amounts, by population group, are in Annexes III and IV of IN 28/2018 (Article 9).
  • A new constituent needs a petition to ANVISA with evidence of safety and efficacy, and the product can be regularised only after that decision (Articles 20 and 21).

How we help: Compliant Always reads your formulation against the IN 28 lists and limits, and keeps the supplier specifications behind each constituent. Ask about this

Notification and recall

How a supplement is put on record with ANVISA before sale, and what happens when a lot is unsafe.

  • Supplements are in Annex II of IN 281/2024, so they are notified to ANVISA under RDC 843/2024.
  • Notification is automatic, without prior assessment; sale can start once it is filed, and the label carries "Alimento notificado na Anvisa:" with the process number (RDC 843/2024, Article 21).
  • Notifications are maintained every 5 years, filed between October and December (Article 23).
  • Recalls follow RDC 655/2022: ANVISA is notified immediately and a report follows within 48 hours.

How we help: Compliant Always keeps the notification and its process number with the product, and shows when the 5-year maintenance window comes round. Ask about this

Name, warnings and nutrition table

What a supplement label has to show, in Portuguese.

  • The product is named "Suplemento Alimentar" followed by the pharmaceutical form, in capitals and bold, in a contrasting colour, at least one third the size of the largest brand lettering (Articles 12 and 13).
  • The label carries "Este produto não é um medicamento" (this product is not a medicine), "Não exceder a recomendação diária de consumo indicada na embalagem" (do not exceed the recommended daily intake on the pack) and "Mantenha fora do alcance de crianças" (keep out of the reach of children) (Article 14).
  • It also states the population groups, the quantity and frequency of use, and storage conditions (Article 14).
  • Nutrition labelling follows RDC 429/2020 and IN 75/2020 (Article 15).

How we help: Compliant Always reads your label against the name, warning and nutrition rules, and shows which line is missing or worded differently. Ask about this

Claims

Which functional and health claims a supplement may make.

  • Claims may be made only as listed in Annex V of IN 28/2018, with no textual variations (RDC 243/2018, Article 16).
  • Claims are mandatory for probiotics and enzymes (Article 16).
  • Claims that the product treats, cures or prevents disease are prohibited (Article 17).

How we help: Compliant Always sets each claim on your pack beside the listed wording in IN 28/2018, so differences are visible. Ask about this

Who answers for what

WhoWhat they answer forHow we help
ManufacturerThe formulation, the notification and the label.Formulation, specifications and filing kept with each product.
ImporterNotifying imported supplements and their Portuguese labels.The foreign supplier's documents read against the lists before the goods arrive.
Brand ownerThe claims and what the label says.Claims compared word for word with the permitted list.
Ingredient supplierSpecifications that show the constituent and its purity.Specifications collected once and shown to each customer that asks.

States and municipalities

Under the Consumer Defence Code, the federal government, the states and the Federal District make concurrent rules on production, distribution and consumption, and together with the municipalities they oversee and control production, distribution and advertising (Article 55).

Health surveillance is shared: state, Federal District and municipal health authorities license food establishments and receive the communication of start of manufacture for many foods, and INMETRO's delegated state bodies (IPEMs) inspect regulated and pre-packaged products on the market.

Questions businesses ask

Do I need to register food supplements in Brazil?
Supplements are notified to ANVISA, not registered. They are in Annex II of IN 281/2024, and notification under RDC 843/2024 is automatic, without prior assessment; sale can start once it is filed.
Which ingredients can go into a supplement in Brazil?
Only constituents listed in Annexes I and II of IN 28/2018, within the minimum and maximum amounts in Annexes III and IV (RDC 243/2018, Articles 4 and 9).
How do I add a new ingredient to the Brazilian supplement lists?
By petition to ANVISA with evidence of safety and efficacy. A product using it can be regularised only after ANVISA's decision (RDC 243/2018, Articles 20 and 21).
What must a supplement be called on the label?
"Suplemento Alimentar" followed by its form, in capitals, bold and a contrasting colour, at least one third the size of the largest brand lettering (RDC 243/2018, Articles 12 and 13).
Which warnings must a supplement label carry in Brazil?
"Este produto não é um medicamento", "Não exceder a recomendação diária de consumo indicada na embalagem" and "Mantenha fora do alcance de crianças", plus population groups, dose and storage (Article 14).
Can a supplement make health claims in Brazil?
Only the claims listed in Annex V of IN 28/2018, with no change to the wording. Therapeutic claims are prohibited (RDC 243/2018, Articles 16 and 17).
Do probiotics need a claim on the label?
Yes. Claims are mandatory for probiotics and enzymes (RDC 243/2018, Article 16).
Are any substances banned in supplements?
Yes: substances on the WADA prohibited list, substances controlled under Portaria 344/1998, certain plant species and partially hydrogenated oils (RDC 243/2018, Article 7).
Does a supplement need a nutrition table?
Yes. Nutrition labelling follows RDC 429/2020 and IN 75/2020 (RDC 243/2018, Article 15).
How often is a supplement notification renewed?
Notifications are maintained every 5 years, filed between October and December (RDC 843/2024, Article 23).
How does Compliant Always help with selling in Brazil?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

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