Expert Regulatory Support for Successful Food Approval in ANVISA
Brazil’s nutraceutical and dietary supplement market is among the fastest growing in Latin America. With rising consumer demand for health, wellness, and preventive nutrition, the market presents tremendous opportunity. However, ANVISA’s (Agência Nacional de Vigilância Sanitária) complex regulatory framework requires expertise in classification, ingredient compliance, and dossier submission.
At DDReg, we provide end-to-end Food Supplements Regulatory Services in Brazil, from formulation review to registration, notification, and post-market compliance, to help you achieve faster, compliant market access.
Our Food Supplement Regulatory Services in Brazil
As a trusted Brazilian food supplement consultant, DDReg offers full-scope regulatory support tailored to your product category and business goals.
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Product Classification
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Ingredient and Formula Compliance
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Label & Claims Review
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Dossier Preparation and Submission
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Local Representation & Liaison
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Post-Market Regulatory Compliance
Understanding ANVISA Requirements for Dietary Supplement Registration
ANVISA regulates food supplements under RDC 243/2018 and related Normative Instructions (e.g., IN 28/2018, IN 361/2025).
Supplements are considered intermediate-risk foods and are subject to notification or registration, depending on formulation and intended use.
Notification vs. Registration| Category | When It Applies | Process |
|---|---|---|
| Notification | Standard ingredients, no functional or health claims | Online notification, quicker time-to-market |
| Registration | Novel ingredients, probiotics, enzymes, or functional claims | Full dossier review by ANVISA before marketing |
All food supplements must comply with ANVISA labeling norms, including:
- Product category and serving size
- Nutrient content and usage instructions
- Mandatory statements: “This product is not a medicine” and “Do not exceed daily intake”
- Claims must be pre-approved or scientifically substantiated
Why Choose DDReg for Food Supplements Regulatory Services in Brazil?
- 16+ years of global regulatory expertise with local presence and partnerships
- Deep understanding of ANVISA regulatory consulting for supplements
- Proven success in dossier preparation and communication with ANVISA
- Strategic guidance for Nutraceutical registration in Brazil and beyond
- End-to-end support: registration, import licensing, and post-approval compliance
Whether you’re launching a new dietary supplement in Brazil or expanding your existing nutraceutical portfolio, DDReg ensures compliance, speed, and market confidence.
Your Path to Market Entry in Brazil
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Step 1: Product & Ingredient Assessment
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Step 2: Regulatory Strategy & Documentation Plan
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Step 3: Dossier Preparation & Local Representation
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Step 4: ANVISA Submission (Registration or Notification)
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Step 5: Approval, Import Licensing, & Post-Market Support