ANVISA: Regulatory Requirements For Nutraceuticals And Food Supplements In Brazil (2025)

Brazil’s nutraceutical and dietary supplement market is rapidly expanding, driven by increasing demand for preventive healthcare, immunity support, and functional nutrition. To ensure product safety, transparency, and quality, ANVISA (Agência Nacional de Vigilância Sanitária) has implemented updated 2025 regulatory frameworks, making compliance essential for successful market entry.

ANVISA Nutraceutical Regulations 

ANVISA regulates nutraceuticals in Brazil as food products, not drugs. Under RDC 373/2025, companies must use approved ingredients, follow dosage limits, comply with labeling rules, and notify ANVISA before selling. Products with novel ingredients or claims require additional approval, and foreign companies must appoint a Brazilian regulatory representative.

Key Compliance Highlights (2025)

• Nutraceuticals classified as food, not pharmaceuticals 
• Only ANVISA-approved ingredients allowed 
• RDC 373/2025 defines ingredient limits and claims 
• Pre-market notification mandatory 
• Strict labeling and safety requirements 
• No disease treatment claims permitted 
• Mandatory local Brazilian partner for foreign companies 

Brazil Nutraceutical Compliance Checklist

• Ingredient compliance with RDC 373/2025 
• Labeling aligned with ANVISA regulations 
• Safety and stability testing completed 
• ANVISA notification submitted 
• Local representative appointed 
• Claims validated and compliant 

Regulatory Classification of Nutraceuticals

Under ANVISA, nutraceuticals are regulated as food supplements, which significantly impacts regulatory pathways and marketing claims.

Key Principle

• Cannot claim to treat, cure, or prevent diseases 
• Only functional or health-support claims allowed 

Product Classification Framework

RDC 373/2025: Ingredients, Limits, and Claims

The cornerstone of Brazil’s 2025 nutraceutical regulation is RDC 373/2025, which defines:

• Approved ingredient lists 
• Minimum and maximum dosage limits 
• Permitted health claims 
• Restrictions on bioactive substances 

Approved Categories

• Vitamins and minerals 
• Probiotics and prebiotics 
• Enzymes 
• Herbal and botanical extracts 

Compliance Focus

• Strict adherence to approved lists 
• Scientific validation of claims 
• Controlled dosage limits 

Labeling Requirements for Nutraceuticals

Labeling compliance is one of the most critical enforcement areas under ANVISA.

Mandatory Label Information

• Full ingredient list 
• Recommended dosage 
• Usage instructions 
• Safety warnings 
• Allergen information 
• Approved health claims only 

 Labeling Compliance Checklist

Registration and Notification Process

ANVISA follows a notification-based regulatory system for most supplements.

Standard Pathway

• Online notification before commercialization 
• Faster market entry compared to pharmaceuticals 

Special Approval Required If

• Novel ingredients are used 
• New claims are introduced 
• Ingredients are not on approved lists 

Safety, Quality, and Stability Requirements

To ensure consumer safety, ANVISA enforces strict quality and safety standards.

Core Requirements

• Microbiological testing 
• Contaminant analysis 
• Stability testing 
• GMP compliance 

Safety and Quality Standards

Local Representation Requirement

Foreign companies must appoint a Brazil-based regulatory representative to:

• Handle ANVISA submissions 
• Ensure compliance 
• Act as liaison with authorities 

Key Regulatory Updates in 2025

RDC 373/2025

• Updated ingredient lists 
• Revised dosage limits 
• Enhanced labeling requirements 

Public Consultation 1.324/2025

• Expanding ingredient approvals 
• Industry-driven regulatory updates 

Acceptance of Global Regulatory Data

ANVISA now considers international approvals to:

• Accelerate market entry 
• Reduce regulatory duplication 
• Support global compliance alignment 

Compliance Strategy for Brazil Market Entry

To ensure success in Brazil’s nutraceutical market:

• Conduct ingredient compliance checks 
• Align labeling with ANVISA rules 
• Validate safety and stability data 
• Partner with local regulatory experts 
• Monitor ongoing regulatory updates 

Emerging Trends in Nutraceutical Regulations

• Growth in plant-based and clean-label supplements 
• Increased focus on label transparency 
• Expansion of functional nutrition products 
• Digital transformation in regulatory submissions 
• Global harmonization of compliance frameworks 

Regulatory Expertise That Drives Compliance

Maven Regulatory Solutions delivers scientifically grounded, regulation-driven strategies tailored to ANVISA’s evolving requirements.

Proven Experience in Global Markets

Our expertise spans:

• Brazil and Latin America 
• United States and Europe 
• Global nutraceutical regulatory frameworks 

Scientific Authority

Our multidisciplinary team includes:

• Regulatory affairs specialists 
• Toxicologists and safety experts 
• Labeling and compliance professionals 

Trust Through Transparency

We assure you:

• Accurate labeling compliance 
• Clear ingredient disclosure 
• Continuous regulatory monitoring 
• Long-term compliance sustainability 

Why ANVISA Compliance Matters

Non-compliance can lead to:

• Product recalls 
• Import restrictions 
• Regulatory penalties 
• Market delays 

Compliance ensures:

• Faster approvals 
• Consumer safety 
• Market credibility 
• Sustainable growth 

How Maven Regulatory Solutions Supports You

Our Services

• ANVISA regulatory strategy 
• Nutraceutical compliance assessment 
• Labeling review and optimization 
• Product notification and approval 
• Local partner coordination 
• Post-market compliance 

Why Choose Maven

• Deep expertise in ANVISA regulations 
• End-to-end compliance solutions 
• Strong Latin America market experience 
• Advanced regulatory and safety capabilities 

Conclusion

Brazil’s nutraceutical market presents significant opportunities, but success depends on navigating ANVISA’s 2025 regulatory framework with precision.

By aligning with:

• RDC 373/2025 requirements 
• Labeling and safety standards 
• Notification and compliance pathways 

Companies can achieve efficient market entry and long-term success.

FAQs

1. What is RDC 373/2025?

It defines approved ingredients, dosage limits, and labeling rules for nutraceuticals in Brazil.

2. Are nutraceuticals drugs in Brazil?

No, they are regulated as food products.

3. Is ANVISA approval mandatory?

Most products require notification; some need approval.

4. Can supplements claim disease treatment?

No, only functional claims are allowed.

5. Is a local partner required?

Yes, for regulatory compliance in Brazil.

6. What testing is required?

Microbial, stability, and safety testing.

7. How can Maven help?

Through complete regulatory and compliance support.