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Vitamin Dietary Supplement: Changes and Challenges with the New ANVISA Regulations


Jun 29, 2021

In July 2018, the Brazilian National Health Surveillance Agency (Agncia Nacional de Vigilncia Sanitria, ANVISA, in Portuguese) published new regulations for food supplements, leading to changes both in the sales denomination and labeling statements, and in the composition of these products. Among dietary supplements, those containing vitamins are the most consumed by the population. The objective of the present work is to discuss the changes in the parameters established for the products containing vitamins, mainly in relation to the required and allowed concentrations of micronutrients, and to verify the impact of these changes for the population since the publication of the new standards. Until July 2018, vitamin-based products containing between 15% and 100% of the recommended daily intake (RDI) of these micronutrients were classified as vitamin supplements; above this dosage, they were considered medicines. The new legislation changed the minimum and maximum limits allowed for vitamin food supplements. Taking into account the maximum vitamin limits established for adults, the most relevant differences were the increase in these limits in a proportion of 100, 76 and 43 times in regarding vitamins E, B6 and C respectively, when compared to those previously established. For the required minimum limits, the major difference was observed for vitamin D, with a four-fold increase in its concentration. In conclusion, changes in legislation can influence the health of the population, so the ideal amounts of vitamin in supplements and the recommendation to consume these products require extensive discussion and reflection.

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