Brazil Enforces 24 Month Transition for New Supplement Rules Affecting Over 4 Key Ingredients

On May 15, 2025, Brazil’s health regulator ANVISA published Instruction No. 361, marking a significant revision to its 2018 dietary supplement framework. The new directive introduces changes that impact formulation, labeling, and permitted health claims, with a 24-month transition period already in effect.

One of the most notable updates is the addition of calcitriol derived from yeast to the list of allowed nutrients, but with restrictions: products containing it must not be consumed by children under 11, and the warning must be clearly displayed on the label.

Cactus fruit extract and xylo-oligosaccharides, now listed with specific intake limits for adults over 19, are also regulated under Annex 3. The daily maximum for cactus fruit extract is set at 54.6 mg, and just 2 mg for xylo-oligosaccharides, signaling tighter dosage control for certain bioactive ingredients.

ANVISA has also expanded the list of approved health claims. Supplements with astaxanthin may now use claims such as “helps protect the body from free radical damage” and “supports eye health and relieves eye fatigue” — but only if the active amount meets the prescribed threshold.

Labeling regulations were updated as well. Any supplement containing cactus extract or xylo-oligosaccharides must include warnings against consumption by pregnant or breastfeeding women and children.

This regulatory overhaul aims to ensure safety, improve transparency, and bring Brazil’s supplement standards closer to global benchmarks, while giving manufacturers two years to comply.