Brazil Updates Dietary Supplement Rules Adds New Ingredients and Labeling Warnings

June 9, 2025 – Brazil’s National Health Surveillance Agency (ANVISA) issued Directive INNo 373, amending the 2018 Dietary Supplement Regulation (Directive No. 28). The updates, effective immediately with a 24-month transition period, introduce significant changes to the regulation of dietary supplements.

Key amendments include:

• Expanded Ingredient List: New substances approved for dietary supplements (excluding products for infants aged 0–3) include citrus fiber, 2'-fucosyllactose derived from E. coli K12, and γ-aminobutyric acid (GABA).
• Maximum Daily Intake Limits: For supplements designed for individuals aged 19 and older, GABA intake is capped at 50 mg per day, while for those aged 4 and older, 2'-fucosyllactose is limited to 3 mg per day.
• Health Claims: Bifidobacterium animalis subsp. HN019 (ATCC SD5674) is now permitted to carry the claim “helps maintain gum health”, provided the product meets the required dosage.
• Labeling Requirements: Products containing citrus fiber must include a warning label stating: “Not suitable for pregnant women, breastfeeding mothers, or children under 4 years old.”

These updates aim to align Brazil’s regulations with global standards while addressing safety and efficacy concerns. Stakeholders have until 2027 to fully comply with the new rules.