Resumen
In this study, we investigate whether the regulatory power of the Brazilian Health Regulatory Agency (Anvisa) has violated the law and the Federal Constitution. We demonstrate this with the (in)decision of the Plenary of the Federal Supreme Court concerning the (in)validity of the sanitary regulation which has prohibited the tobacco industry in the country from adding essences of flavor and aroma to tobacco smoke products. As a problem, we see the limited regulatory function of Anvisa, which, by taking into account the conflicting interests of the market, includes the identification of problems with regulatory elements involving technical and legal requirements as well as political regulation. We will use the deductive method with a qualitative approach of the case study referent to the (un)constitutionality of the Resolution of the Board of Directors, RDC No. 14, of March 15, 2012, oriented towards the discussion about Anvisa's regulatory capacity versus the limits of its competency established by primary standards issued by the National Congress. We conclude that Anvisa has issued Resolution RDC No. 14, of 2012, which contains sufficient legal characteristics to authorize its impugnation before the Constitution.