Labeling of vitamin and mineral supplements: a revision of the federal normative regulations

In Brazil, there is a steadily increasing offer and demand for products on the basis of vitamins and minerals. According to Brazilian law, the differences in the dosages offered to the consumer in each product are the parameter for its classification as alimentary supplement or medicament. The limit between these two concepts, however, is confusing and lacks clearness. Considering the risk posed by imprudent consumption of such products and seeking to facilitate the interpretation and consolidation of the norms dealing with vitamin and mineral products as well as to create the basis for a master's degree dissertation, a bibliographical survey and evaluation of the entire juridical basis regarding the labeling of these products was conducted. It was concluded that the normative regulations are extensive, complex and of difficult understanding, with a great number of norms dealing with the same subject issued by different authorities. These norms are not consolidated leading to difficult interpretation by retailers, health professionals and consumers and even to failures in the application of these norms by the control authorities. Suggestions are made for helping to correct the failures identified in the study.