Brazil stands out as one of the most dynamic yet highly regulated markets for dietary supplements. To help companies better understand the challenges and successfully access this strategic market, ProductLife Group participated in a webinar organised by SYNADIET - the French National Union of Dietary Supplements .
During the session, our experts Silvia Fontes (Regulatory Affairs Project Expert) and Léa Trichelot (Regulatory Affairs Expert) provided an in-depth overview of the Brazilian regulatory framework and the key steps required for compliant market entry.

Understanding the Role of Brazilian Authorities

Two main institutions shape the regulatory landscape for dietary supplements in Brazil:
  • ANVISA (Agência Nacional de Vigilância Sanitária)
  • MAPA (Ministério da Agricultura, Pecuária e Abastecimento)
The speakers explained how these authorities oversee classification, control, and regulatory requirements, outlining the obligations that manufacturers and exporters must consider from early development to market notification.

The Post-2018 Regulatory Framework

Since the regulatory update in 2018, dietary supplements are governed primarily by:
  • RDC 243/2018, which defines product categories and general criteria
  • IN 28/2018, which details authorised ingredients, limits, conditions of use, and technical specifications
The session also covered recent regulatory updates, illustrating how the framework continues to evolve in response to scientific advances and market needs.

Critical Steps Before Market Entry

To enter the Brazilian market successfully, companies must follow a structured process that includes:
  • Developing formulations aligned with authorised ingredient lists and limits
  • Assessing allowed claims
  • Ensuring product stability
  • Completing the mandatory notification prior to market launch
Common regulatory pitfalls were also discussed-issues that often lead to delays or rejection by authorities, and which companies can proactively avoid through proper preparation.

Why This Topic Matters

Brazil offers significant commercial potential, but its regulatory landscape demands precise compliance. Understanding the rules is not only essential for meeting legal requirements but also a decisive factor for accelerating access and ensuring successful export operations.

Access the Full Presentation

Download the complete slide deck shared during the SYNADIET webinar

Download the presentation

Need regulatory support for Brazil or other markets?

Contact our Regulatory Affairs experts at ProductLife Group

Contact us
← Back to all