Brazil Revises Food Supplement Regulations, New Limits on Potassium and Sodium Content, Prohibits New Ingredients for Pregnant Women

On December 2, 2024, the Brazilian National Health Surveillance Agency (ANVISA) issued official document number INNo336, revising the regulations for food supplements, effective immediately upon publication. The main revisions include:

1. In Annex I, the list of permitted ingredients for food supplements, the active substance "anthocyanin" is renamed to "Moro Orange Anthocyanin";
2. In liquid electrolyte supplements, the allowable potassium content must not exceed 700 mg/l, and sodium content must not exceed 1150 mg/l. These supplements are restricted to adults aged 19 and older, excluding pregnant and breastfeeding women. Additionally, the maximum daily intake of cranberry proanthocyanidins is set at 39 mg;
3. The product label for hydrolyzed beef protein must clearly state: "Not suitable for pregnant women, breastfeeding women, and children," while the label for Lactobacillus rhamnosus should include: "Not suitable for pregnant women, breastfeeding women, infants, children, immunocompromised individuals, or people with serious illnesses."