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Regulatory framework for dietary supplements and the public health challenge

Brazil

Oct 31, 2019

In Brazil, until 2018 dietary supplements had no legal definitions. According to the Brazilian Health Regulatory Agency (ANVISA ), most products used as dietary supplements were classified into different regulatory categories: (I) Food for athletes; (II) Vitamin and/or mineral supplements; (III) New foods and/or new ingredients; (IV) Food of functional and/or health property; (V) Specific medications; and (VI) Herbal medicines. The large number of products on the market makes inspection difficult, and the lack of safety for consumer health is the biggest risk associated with this outlook. This scenario favors the commercialization of dietary supplements containing proscribed substances in Brazil, such as ephedrine and 1,3-dimethylamylamine. Cases of dietary supplements deliberately adulterated to intensify the pharmacological effect and promote a false image that the product works are widely described in literature3,5,1315. In addition, the lack of official methodologies in Brazil for this type of analysis makes the quality and safety of these products questionable. Consumer fraud was also connected to dietary supplements commercialized in Brazil due to divergences between the amount of carbohydrate and protein declared on labels and the actual values found after analysis by ANVISA.

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