The National Health Surveillance Agency ( ANVISA in Portuguese) has published Public Consultation no. 1,325, dated 04/17/2025 on the proposed amendment of the Resolution of the Collegiate Council – RDC that amends RDC no. 243, dated July 26, 2018, which provides for the sanitary requirements for food supplements, RDC no. No. 839, of December 14, 2023, which provides for safety testing and authorization of use of novel foods and novel ingredients and Normative Instruction – IN No. 28, of July 26, 2018, which establishes the lists of constituents, limits of use, declarations and supplementary labeling of food supplements.

The National Health Surveillance Agency (ANVISA in Portuguese) has published amendment the Regulatory Instruction – IN No. 28, of July 26, 2018, which establishes the lists of constituents, limits of use, declarations and complementary labeling of food supplements.

The National Health Surveillance Agency (ANVISA in Portugues) has published Normative Instruction – IN No. 284/2028 updating Normative Instruction – IN No. 28/2018, which establishes the lists of constituents, limits of use, declarations and complementary labeling of food supplements.

The National Agency for Regulation, Control and Sanitary Surveillance (ARCSA in Spanish), has published in public consultation the External Instructions on Hygienic Sanitary Conditions – Food Processing Plants, Food for Special Dietary Uses, Food Supplements and Tobacco Products V 2.0″.

Closing date of the consultation: 19/10/2023.

Last July 27 was the deadline for companies to adapt their products to the new regulations for foods categorized as dietary supplements. Collegiate Council Resolution (RDC) N° 243, published in 2018, created the category “food supplement” and granted a five-year adaptation period for products already on the market.

Within that period, these products could be manufactured, imported and marketed in accordance with the standards applied in their regularization, with no changes in formulation or labeling.

With the end of the deadline, 3,179 products that were exempted from Anvisa registration by the new regulation had their registrations cancelled. From now on, these products can only be manufactured and imported if they fully comply with the requirements established by the new regulation. They must also be regularized before the local health surveillance agency, by means of a notice of commencement of manufacture or importation.

The standard also allows the marketing until the end of the validity period established on the label of ineligible products that were manufactured and imported before July 27, 2023.