Dietary Supplements Questioned in the Polish Notification Procedure upon the Basis of Data from the National Register of Functional Foods and the European System of the RASFF

Int J Environ Res Public Health. 2022 Jul 3;19(13):8161. doi: 10.3390/ijerph19138161.

Abstract

Dietary supplements (DS) in the countries of the European Union falls within the scope of the food law. DS may, however, contain substances that are simultaneously applied in medicinal products as defined in the pharmaceutical law. The presence of such ingredients may cause problems with the product qualification. The phenomenon of applying such borderline ingredients in dietary supplements may require additional regulations, and ensuring them may be problematic. We conducted an analysis aiming to identify dishonest market practices resorted to by the producers and distributors of non-conforming dietary supplements. We examined mostly questioned DS and compared them with data from the RASFF system and registers of medicinal substances and pharmaceutical entities. The results show that some operators tend to re-notify the same products in response to the initiation of official control procedures. Products in the form of capsules or powders were the most common re-notifications within the 50-100 days. Based on the data obtained, it can be concluded that some entities are obliged to document the safety of the product or its compliance with the regulations, use the imperfection of the notification procedure, and re-notify the questioned product in order to keep it on the market despite potential non-compliance.

Keywords: GIS; RASFF; dietary supplements; notification.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Consumer Product Safety*
  • Dietary Supplements
  • Functional Food*
  • Pharmaceutical Preparations
  • Poland

Substances

  • Pharmaceutical Preparations

Grants and funding

This research was supported by the project “InterDoktorMen—Building new quality and effectiveness of education in the formula of doctorate studies for healthcare managers at the Health Sciences Faculty at the Medical University in Łódź” (POWR.03.02.00-00-1027/16-00) and co-financed from European Union resources from the European Social Fund as a part of the Operational Programme Knowledge Education Development.