Title:Dietary Supplements: Foods, Medicines, or Both? A Controversial Designation with Unspecific Legislation
Volume: 23
Issue: 19
Author(s): Carla Pereira, Lillian Barros*Isabel C.F.R. Ferreira*
Affiliation:
- Centro de Investigação de Montanha (CIMO), ESA, Instituto Politécnico de Bragança, Campus de Santa Apolónia, 1172, 5301-855 Braganca,Portugal
- Centro de Investigação de Montanha (CIMO), ESA, Instituto Politécnico de Bragança, Campus de Santa Apolónia, 1172, 5301-855 Braganca,Portugal
Keywords:
Dietary supplements, USA legislation, EU legislation, medicinal products, Food Supplements Directive, Food and Drugs
Administration.
Abstract: Background: Dietary supplements have been widely used among the United States of America (USA)
and the European Union (EU) population not only as a form of nutrition but also for medicinal purposes. Still, the
legislation regulating these supplements remains unclear due to the fact that they can be considered as foodstuffs
and/or medicinal products depending on various factors.
Methods: The present review article intends to provide information concerning the variations on the definition of
dietary supplements, the allowable substances on it, as well as the marketing and labelling requirements among
the USA and the EU legislation.
Results/Conclusions: In fact, several discrepancies can be found between regulations in the USA (mainly
regulated by the Food and Drugs Administration) and in the EU (principally regulated by the Food Supplements
Directive or by the Directive 2001/83/EC), and even between the different Member States of the EU, with the
main differences observed in new products marketing requirements.
