The National Health Surveillance Agency (ANVISA in Portuguese) has updated Normative Instruction IN 28/2018 to include new limits and detail the changes in the labeling of dietary supplements that contain turmeric (also known as açafrão) in their composition.

The update was motivated by the identification—within the context of post-marketing surveillance—of a potential risk of liver damage associated with the use of supplements and medications containing turmeric (Curcuma longa) or curcuminoids. In March, Anvisa issued a pharmacovigilance alert to warn users of these products about the associated risks.

The three main points of the regulatory update:

• Mandatory inclusion of the following warning on supplement labels: “This product should not be consumed by pregnant women, breastfeeding women, children, people with liver or biliary diseases, or gastric ulcers.” People with illnesses or who are taking medications should consult their doctor.

• The limits for curcumin consumption should be calculated by adding its three main components (total curcuminoids).

• Inclusion of tetrahydrocurcuminoids in the list of permitted ingredients, with restrictions on mixing this new component with the natural extract of the plant in the same product to avoid overloading the body with this substance.