Food supplement
A food category intended to complement the diet. Composition, constituents, limits, permitted claims and labeling must comply with rules applicable to the final product and target audience.
This does not authorize therapeutic claims.
Brazil / scoped readingThe route follows
DK / REGULATORY CONTEXT
The route follows
the product.
A platform can inform multiple programs. Each product has its own intended use, composition, claims and requirements. This is scoped information; final classification requires specialist review.
— 01Three natures, three decisions
The same scientific vocabulary does not create the same category.
Medicine
A product with therapeutic intent subject to development, demonstration of quality, safety and efficacy and its own regulatory pathway. A molecular mechanism does not by itself change the category of a supplement.
The route depends on indication, formulation and jurisdiction.
Experimental product
A research or development object whose preclinical and/or clinical assessment requires protocols, oversight and relevant permissions before use or communication of results.
Research is not an approved product.
— 02Regulatory framework and applicability
Supplements: the current framework matters.
The following rules guide Brazilian diligence but do not replace checking current amendments, actual classification and product-specific acts.
RDC 243/2018
General health requirements for food supplements. Replaced the isolated food-for-athletes framework of RDC 18/2010, which was revoked.
IN 28/2018
Lists of constituents, use limits, claims and complementary labeling, considered with subsequent amendments.
RDC 843/2024
Part of the current food regularization framework. The applicable route and concrete requirements must be confirmed for the product category.
IN 281/2024
Complements food regularization rules and categories. Its application to a particular case depends on documented classification.
Reading correction
Former RDC 18/2010 must not be presented on its own as a current “food for athletes” classification. Historical references need reconciliation with RDC 243/2018, amended IN 28/2018 and current regularization rules.
— 03From architecture to responsibility
Five checks before any claim.
The process involves brand, manufacturer and technical parties according to their actual obligations. A list of permitted ingredients does not, by itself, authorize any claim about the combination.
- 01
Classify
Determine intended use, category, market, audience and final presentation.
- 02
Review composition
Verify each constituent, specification, per-serving limit and condition of use against current lists.
- 03
Scope claims
Compare commercial and professional wording and evidence against permitted claims; do not import ingredient results to the product.
- 04
Document
Review labeling, traceability, quality, responsible manufacturer and applicable regularization pathway.
- 05
Update
Record regulatory version, legal-regulatory advice and changes before launch or geographic expansion.
— 04Documentsry status
Product-specific regulatory status.
Each product's classification depends on intended use, composition, jurisdiction and applicable documentation. Specific regulatory questions are addressed directly in institutional discussions.
This overview does not establish product approval. Each formulation's regulatory status is verified through its own documentation.