ANVISA Nutraceutical & Dietary Supplement Regulation Brazil – Advanced Compliance Handbook For “Dietary Supplements” Market Entry

Brazil has rapidly emerged as one of the fastest-growing global markets for nutraceuticals,functional foods, probiotics, bioactive compounds, and dietary supplements. As consumer demand for preventive healthcare and wellness products continues to rise, the Brazilian regulatory landscape under Agência Nacional de Vigilância Sanitária (ANVISA) has evolved into a highly structured and science-driven framework.

For international manufacturers, importers, and nutraceutical brands, successful entry into Brazil now requires a deep understanding of ANVISA dietary supplement regulations, ingredient authorization requirements, health claims compliance, notification pathways, and post-market surveillance obligations.

This advanced 2025 handbook explores the latest regulatory updates, including RDC 243/2018, IN 28/2018, RDC 843/2024, and the recently published Normative Instruction No. 373/2025, helping companies achieve compliant and efficient market access in Latin America’s largest healthcare economy.

Why Brazil’s Nutraceutical Market Matters in 2025

Brazil’s supplement and functional food industry is experiencing substantial expansion due to:

• Rising demand for preventive healthcare
• Growth of sports nutrition and wellness sectors
• Increased consumer awareness of probiotics and bioactive
• Government focus on food safety and transparency
• Strong import demand for innovative nutraceutical ingredients

As a result, Brazil is becoming a strategic regulatory target for global nutraceutical companies.

Understanding ANVISA’s Regulatory Framework for Dietary Supplements

What is a Dietary Supplement Under ANVISA?

Under RDC 243/2018, dietary supplements (“Suplementos Alimentares”) are defined as:

Products intended for oral administration are designed to supplement the diet of healthy individuals using nutrients, probiotics, enzymes, bioactive substances, amino acids, or other approved constituents.

Products are typically presented in pharmaceutical dosage forms such as:

• Capsules 
• Tablets 
• Powders 
• Gummies 
• Sachets 
• Liquids 

Core ANVISA Regulations Governing Supplements

Key Changes Introduced Under IN 373/2025

The 2025 update significantly expands ANVISA’s regulatory oversight.

Include Newly Updated Areas:

• Revised approved ingredient lists
• Updated maximum daily intake limits
• New mandatory warning statements
• Enhanced probiotic strain governance
• Expanded bioactive constituent approvals
• Stricter health claim controls

Newly Approved Ingredients Under ANVISA 2025 Updates

Several innovative nutraceutical ingredients have now been added to ANVISA’s approved constituent lists.

These additions reflect Brazil’s growing openness toward advanced nutraceutical innovation.

Brazil Supplement Classification: Food vs Medicine

One of the most critical regulatory considerations is proper product classification.

Products May Be Classified As:

Therapeutic Claims: A Major Compliance Risk

ANVISA strictly prohibits dietary supplements from making:

• Disease treatment claims
• Cure or prevention claims
• Pharmaceutical-like therapeutic statements

Improper claims can trigger:

• Product reclassification as medicine 
• Registration delays 
• Market suspension 
• Administrative penalties 

Ingredient Authorization & Novel Ingredient Approval

Approved Ingredients

Only constituents listed below:

• IN 28/2018 
• IN 76/2020 
• IN 373/2025 

may be used without additional authorization.

Novel Ingredient Petition Requirements

For non-listed ingredients, manufacturers must submit a full technical dossier including:

• Toxicological studies
• Safety assessments
• Bioavailability data
• Daily exposure calculations
• Human-use evidence
• Interaction analysis
• Stability studies

ANVISA Market Access Pathways (2025)

Risk-Based Regulatory Framework

Under RDC 843/2024, Brazil now applies tiered regulatory oversight.

Notification vs Registration

Notification Pathway

Used for:

• Standard dietary supplements
• Approved ingredients
• Low-risk formulations

Benefits

• Faster market access 
• Simplified review 
• Lower regulatory burden 

Registration Pathway

Required for:

• High-risk products
• Novel ingredients
• Certain functional foods
• Infant nutrition products

Timeline

Approximately 12–18 months depending on complexity.

ANVISA Dossier Structure For Supplements

Module I – Administrative Documents

Includes:

• Brazilian legal representative 
• Company licenses 
• Fee payment proof 
• Import authorization documentation 

Module II – Technical Documentation

Includes:

• Product formulation
• Manufacturing process flowchart
• Stability studies
• Packaging specifications
• GMP evidence
• Shelf-life validation

Module III – Safety & Efficacy

Includes:

• Toxicology data
• Scientific substantiation
• Literature reviews
• Clinical evidence (if applicable)

GMP Requirements for Nutraceutical Manufacturing

Manufacturers must comply with:

RDC 275/2002 GMP Standards

This includes:

• Hygiene controls
• Process validation
• Documentation systems
• Traceability programs
• Storage controls
• Quality assurance oversight

Labeling Requirements Under ANVISA

Mandatory Label Elements

All supplements must display:

• “SUPLEMENTO ALIMENTAR” prominently
• Recommended intake
• Population restrictions
• Ingredient declaration
• Storage conditions
• Nutrition table

Mandatory Warning Statements

Brazilian supplement labels must include:

“Este produto não é um medicamento”
(“This product is not a medicine”)

Additional mandatory statements include:

• Do not exceed recommended intake 
• Keep out of reach of children 

Health Claims Compliance

Only approved claims listed by ANVISA may be used.

Claims Must:

• Match approved ingredient functions
• Stay within permitted wording
• Reflect approved dosage conditions

Post-Market Surveillance (PMS) Requirements

After commercialization, companies must maintain ongoing vigilance systems.

PMS Obligations Include:

• Adverse event monitoring
• Product complaint management
• Stability deviation review
• Traceability maintenance
• Recall readiness

Penalties For Non-Compliance

Failure to comply with ANVISA regulations may result in:

Important ANVISA Compliance Deadlines

Key Compliance Strategies for Brazil Market Entry

Companies Should:

• Conduct ingredient gap analysis early
• Validate all claims before launch
• Ensure GMP alignment
• Prepare bilingual compliant labels
• Appoint experienced Brazilian representation
• Build robust post-market surveillance systems

Emerging Nutraceutical Trends in Brazil (2025)

The Brazilian market is increasingly focused on:

• Probiotics & microbiome products
• Sports nutrition supplements
• Cognitive health ingredients
• Bioactive plant compounds
• Functional fibers
• Sustainable and clean-label nutraceuticals

How Maven Regulatory Solutions Supports ANVISA Compliance

At Maven Regulatory Solutions, we support global nutraceutical and dietary supplement companies through:

Our Services Include:

• ANVISA regulatory strategy development 
• Ingredient compliance assessment 
• Novel ingredient dossier preparation 
• Brazil supplement notification & registration 
• Labeling and health claims review 
• GMP and quality compliance support 
• Post-market surveillance systems 
• Import authorization support 
• Regulatory intelligence monitoring 

Our team helps brands simplify complex Brazilian regulations while accelerating compliant market access.

Conclusion

Brazil’s nutraceutical and dietary supplement market presents enormous commercial opportunity but regulatory compliance under ANVISA has become increasingly sophisticated.

The latest updates under:

• RDC 243/2018
• IN 28/2018
• RDC 843/2024
• IN 373/2025

demonstrate Brazil’s shift toward a more science-based, risk-driven, and globally harmonized regulatory system.

Companies that proactively align formulation strategy, ingredient authorization, claims compliance, GMP systems, and post-market vigilance will gain a major competitive advantage in Latin America’s fastest-growing supplement market.

At Maven Regulatory Solutions, we help organizations navigate Brazil’s evolving nutraceutical regulations with confidence ensuring compliant, efficient, and future-ready market entry.

FAQs – ANVISA Dietary Supplement Regulation Brazil

1. Does Brazil require ANVISA registration for dietary supplements?

Most standard dietary supplements follow the notification pathway, while high-risk or novel products may require full registration.

2. What is RDC 243/2018?

RDC 243/2018 is ANVISA’s primary regulation establishing sanitary, safety, composition, and labeling requirements for dietary supplements in Brazil.

3. Can supplements make therapeutic claims in Brazil?

No. Supplements cannot claim to treat, cure, or prevent diseases. Such claims may trigger pharmaceutical classification.

4. What is IN 373/2025?

Normative Instruction No. 373/2025 updates approved ingredient lists, intake limits, warning labels, and health claim requirements for supplements.

5. Are probiotics regulated separately in Brazil?

Yes. Probiotic strains must comply with ANVISA-approved strain lists, dosage requirements, and substantiated health claims.