July 08, 2025

Brazil’s market for supplements and nutraceuticals is growing fast. To keep products safe, ANVISA (Brazil’s health agency) has set clear rules for 2025.

Main Rules

1. Product Type

  • Supplements are treated as food, not medicine.
  • They can only say they support health, not that they cure diseases.

2. Ingredients and Limits

  • Only ANVISA-approved ingredients can be used.
  • Rule 373/2025 lists:
    • Allowed ingredients
    • Min and max amounts (vitamins, probiotics, enzymes, etc.)
    • Approved health claims

3. Labels

  • Labels must show:
    • Ingredients
    • How to use it and warnings
    • Only approved claims
  • Some products need extra label info.

4. Registration

  • Most products must be notified online to ANVISA before selling.
  • If a product has a new ingredient or claim, it needs special approval.

5. Safety and Quality

  • Products must pass safety and germ tests.
  • Some need stability tests to prove they stay safe over time.

6. Local Partner

  • Foreign companies need a Brazilian partner to handle paperwork and compliance.

7. Regular Updates

  • ANVISA keeps updating lists and rules based on science and global standards.

New in 2025

  • Rule 373/2025: Updated ingredient lists, limits, and labeling rules.
  • Public Consultation 1.324/2025: Collecting feedback on new ingredient rules.
  • Foreign Documents Accepted: ANVISA now accepts some approvals from agencies like FDA/EMA to speed things up.

Final Word

To sell supplements in Brazil in 2025, companies must:

  • Use only approved ingredients
  • Follow new label and limit rules
  • Notify ANVISA online before selling
  • Have a local partner in Brazil

Staying updated is important because the rules change often.