Brazil’s National Health Surveillance Agency (ANVISA) has amended Normative Instruction No. 28/2018 to revise constituent authorizations, usage limits, and labeling requirements for food supplements, with significant updates focused on curcumin and tetrahydrocurcuminoids derived from Curcuma longa.
Key changes
1.The amendment adds tetrahydrocurcuminoids as an authorized bioactive constituent for adult food supplements and introduces a new restriction prohibiting its combined use with turmeric rhizome extract in the same product.
2.It also updates Annexes governing minimum and maximum permitted levels, setting a minimum daily intake of 80 mg and a maximum of 130 mg for curcumin in adults, while tetrahydrocurcuminoids are capped at 120 mg.
3.In addition, ANVISA has introduced mandatory supplementary labeling requirements for products containing these constituents, requiring warnings against use by pregnant or breastfeeding women, children, individuals with liver or biliary diseases, or gastric ulcers, and advising consumers using medication or with illnesses to seek medical advice.
The measure provides a six-month transition period for manufacturers and importers to align products with the revised requirements, including temporary allowance for warnings to be communicated through company websites and customer service channels during the adaptation phase. The changes took effect upon publication and further strengthen Brazil’s regulatory controls over food supplement safety and consumer information.