[Brazil] New rules for dietary supplements

/ Brazil - ANVISA / MAPA, Regulatory updates / By

Date: February 22nd, 2024

The regulatory landscape for dietary supplements (suplementos alimentares) in Brazil has officially shifted. Under Instrução Normativa – IN N 281, enacted by the National Health Surveillance Agency (Anvisa), the Brazilian government has established an updated, uniform framework governing how food categories and packaging are commercialized in the country.

For international manufacturers, this regulation completely changes the compliance requirements for existing and new products in the Brazilian market.

What has changed?

Previously, certain categories of dietary supplements enjoyed exemptions from specific notification procedures before entering the Brazilian market. This is no longer the case.

According to Annex II of the new normative instruction, Dietary Supplements (Suplementos alimentares) have been explicitly categorized under products subject to mandatory notification (obrigatoriedade de notificação) directly with Anvisa.

Consequently, any dietary supplement that previously operated under an exemption must now strictly undergo the official notification process to maintain or achieve compliance.

Key requirements for manufacturers

To successfully transition or launch a dietary supplement under the updated rules, manufacturers must submit specific technical data through Anvisa’s system. The core documentation package includes:

  • A completed notification form: Tailored specifically to the product category within Anvisa’s portal.
  • Valid sanitary licensing: A copy of a valid sanitary license (licenciamento sanitário) of the manufacturer(s) responsible for production, quality control, and storage.
  • Stability study reports: Comprehensive data ensuring that the nutritional properties of the supplement are fully maintained throughout its entire declared shelf life (including post-reconstitution studies for products requiring dilution).

The operational challenge: Local hosting requirements

Beyond compiling the technical dossier, the major operational hurdle for foreign manufacturers is that regulatory filings and product licenses must be hosted by a legally established local entity in Brazil.

International brands cannot hold these licenses directly from abroad. To maintain market access without the heavy overhead of setting up a physical subsidiary, manufacturers must partner with a trusted local host.

How Mandala International can help?

As a specialized partner in Latin American healthcare compliance, Mandala International provides a seamless pathway through our established local entity, Mandala Brazil.

We can act as your legal regulatory host in the country: holding your product notifications safely, managing your compliance portfolio, and ensuring your existing or upcoming supplement lines fully align with the current Anvisa mandates without any distribution disruptions.

Contact us for more information

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