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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

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...

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Autores principales: Wróbel, Kacper, Milewska, Anna Justyna, Marczak, Michał, Kozłowski, Remigiusz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9266288/
https://www.ncbi.nlm.nih.gov/pubmed/35805820
http://dx.doi.org/10.3390/ijerph19138161
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author Wróbel, Kacper
Milewska, Anna Justyna
Marczak, Michał
Kozłowski, Remigiusz
author_facet Wróbel, Kacper
Milewska, Anna Justyna
Marczak, Michał
Kozłowski, Remigiusz
author_sort Wróbel, Kacper
collection PubMed
description 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.
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spelling pubmed-92662882022-07-09 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 Wróbel, Kacper Milewska, Anna Justyna Marczak, Michał Kozłowski, Remigiusz Int J Environ Res Public Health Article 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. MDPI 2022-07-03 /pmc/articles/PMC9266288/ /pubmed/35805820 http://dx.doi.org/10.3390/ijerph19138161 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Wróbel, Kacper
Milewska, Anna Justyna
Marczak, Michał
Kozłowski, Remigiusz
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9266288/
https://www.ncbi.nlm.nih.gov/pubmed/35805820
http://dx.doi.org/10.3390/ijerph19138161
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