Breaking into Brazil’s Dietary Supplement Market: Navigating a Complex Regulatory Landscape

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. 

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. 

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. 

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. 

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. 

Download the complete slide deck shared during the SYNADIET webinar

Contact our Regulatory Affairs experts at ProductLife Group