Dietary supplements: International legal framework and adulteration profiles, and characteristics of products on the Brazilian clandestine market

Abstract

The objectives of this work were to evaluate current legislation on dietary supplements in the United States, the European Union and Brazil, and the profile of adulterated and/or irregular products on these markets. Due to a less restrictive legal framework, a supplement product that is freely available in the US may be considered a drug or even be proscribed in the EU and Brazil, thus giving rise to a clandestine market based on smuggling. From 2007 to 2014, the United States Food and Drug Administration reported 572 cases of supplement adulterations in the country, mainly products for sexual enhancement (41.6%). Data from the European Union Rapid Alert System for Food and Feed showed 929 adulterations during the same period, over 40% due to unauthorized ingredients or undeclared medicines. From 2007 to 2013, the Brazilian Federal Police Department seized 5470 supplement products, 92.2% with an American-declared origin. Qualitative chemical analyses performed on 2898 products found 180 adulterations, 41.1% due to undeclared drugs, mainly anabolic steroids, anorectics and products for erectile dysfunction, all considered medicines in Brazil. Educating the public regarding the potential risks they are taking when consuming adulterated or irregular products is necessary to protect the health of consumers.

Keywords: Adulteration; Brazil; Dietary supplements; European Union; Fat-burners; Hormones; Irregular products; Legislation; United States.