How to get a dietary supplement approved in Brazil: the full path

A foreign manufacturer arrives in Brazil with a finished product, a dossier built for another country, and one question: how long does it take? The honest answer is that nobody can say before answering a different question, which is almost never asked at the start — what will the label say?

That is the sentence that decides the whole path. Not the formulation, not the origin, not the volume. The sentence.

What counts as a dietary supplement

RDC 243/2018 is Brazil's regulatory framework for dietary supplements. It sets requirements for composition, quality, safety and labelling — and, more importantly for anyone entering, it separated dietary supplements from conventional foods.

That separation is not bureaucratic. It created a category that captures two kinds of product foreign manufacturers tend to think of as simple:

• foods with no history of use in the country — ingredients and compounds with no documented consumption in Brazil;
• foods carrying a functional or health property claim on the label.

The second case catches almost everyone. A tea is a food. The same tea, with “supports digestion” on the label, may stop being one.

The line on the label does not describe the product. It reclassifies it.

The positive list: why being true is not enough

Here is the point that surprises newcomers most. A term or brand suggesting a functional property may only be used if two conditions are met at the same time:

• the property is proven; and
• the claim appears on the positive list of IN 28/2018.

The second condition is what kills projects. Off the list, the line does not go on the label — clinical study in hand or not, and regardless of whether the claim is accepted in Europe or the United States. The Brazilian list is the Brazilian list.

In practice, the decision about what the label will say has to be made before assembling the dossier, not after. A dossier built to support a claim that does not exist on the list is work thrown away.

A label is not a translation

Even with the claim settled, a label is a regulatory document, not translated copy. Three requirements that tend to be discovered late:

• Mandatory information must be in Portuguese. When the original label is not, a complementary label applies — with adequate size, prominence and visibility, not any sticker slapped on top (RDC 259/2002).
• For cosmetics and personal care, the chemical composition must use the official translation. ANVISA publishes a list of translated ingredients, and that is the one that counts — not the manufacturer's own (RDC 646/2022, in force since November 2023).
• Part of that information may move to digital format, reachable by QR code, under the same rule. That eases the physical label — it does not waive anything.

The cost of finding this out late is not the label itself. It is the batch sitting still, already printed with the wrong artwork, waiting for a reprint — after approval has already come through.

Who can hold the registration

ANVISA does not accept registration in the name of a foreign company. Approval is held by a Brazilian company with an Operating Authorisation (AFE), which carries sanitary liability for the product in the country.

That has a contractual consequence worth more than it seems: whoever holds the registration controls market access. When the registration sits with the distributor and the partnership stops working, switching partners can mean redoing the entire approval.

This is why ownership and transfer conditions are clauses to settle before any filing. It is the decision that determines your negotiating position two years later.

Timelines: what belongs to the agency and what belongs to you

For medicines, Law 13,411/2016 set ANVISA's maximum decision deadlines: 365 days for ordinary registration and 120 days for priority, extendable by up to one third, once only. Food and supplements follow their own routes, generally shorter.

But notice what that number is and what it is not. It is the legal ceiling on the agency's decision. It is not your project's timeline — the clock only starts at filing.

And before filing there is the dossier, which is where most projects slip, because it depends on the manufacturer and not on the agency. When someone asks “how long does it take?”, the honest answer has two parts: the agency's deadline, which is in the law, and the time to filing, which is on you. The second is the only one you can shorten.

The three mistakes that cost the most time

• Deciding the label last. The claim decides the category, the category decides the route, the route decides the timeline. Starting from the label inverts the usual order — and the usual order is wrong.
• Reusing another country's dossier without reclassifying. A dossier built for the FDA or EFSA answers different questions. What is missing is rarely data; it is data organised against the Brazilian rule.
• Leaving ownership to the commercial negotiation. By the time it reaches the table, the registration is already being filed — and the balance of power has already shifted.

Where we come in

Guardian Pharma is a business originator based in Brasília. We run the study that decides whether and how your product enters Brazil and clear the obstacles standing in the way, regulatory classification among them. The Entry Route, with pricing, channel and targets, is written before the first shipment.

We do not execute the commercial operation: we do not import, distribute or sell. Execution stays with the manufacturer or with the distributor they choose, and we support that choice.

If you have a product and do not yet know which regime it falls under, that is the first conversation — and it happens before any commercial commitment.

Regulatory basis: RDC 243/2018 and IN 28/2018 (dietary supplements); RDC 259/2002 (labelling); RDC 646/2022 (composition in Portuguese); Law 13,411/2016 (decision deadlines). This text explains the regulatory mechanism and does not replace analysis of a specific case.