Comparison between the American and the European Systems of Monitoring Adverse Effects of Dietary Supplements and Their Usefulness on the Polish Market

Abstract

Many Polish patients do not inform physicians about supplements they use in addition to prescribed medicines. This may be because they consider dietary supplements as being rather natural products that cannot cause health problems. Although dietary supplements may produce side effects, Poland’s food safety system and medical statistics do not recognise the necessity of reporting such cases. However, a different approach is observed in France and the United States where adverse effects of food supplements as well as drugs are reported. The aim of this study was to determine the need for creating in Poland a general model of a register monitoring dietary supplements and their adverse effects. In order to achieve this goal, a detailed comparison between the American and European monitoring systems was made. It showed the relationship between negative symptoms caused by specific components in supplements and t profiles of patients who reported side effects. Additionally, it was found that there is a real risk associated with side effects caused by dietary supplements. Therefore, it necessary to establish in Poland a special system for recording such cases as it should be beneficial to patients, including polypragmatic patients.

Frequency of Vitamins and Nutritional Supplements Use among Iraqi People in Baghdad City

“…Even though using dietary supplements is generally believed to be safe, there is no guarantee that there won't be any unintended consequences. Incorrect use can have serious repercussions, including an increased risk of bleeding due to an overdose of vitamin E, as well as hepatotoxicity and teratogenicity due to a chronic overdose of vitamin A. Additionally, the dangers of drug-drug interactions are significant, particularly with certain drug classes, which can predispose subjects to dangerous adverse effects such as those that occur between vitamin K and oral anticoagulants [35,36]. In addition, taking an excessive amount of multivitamins is associated with a number of negative health impacts, including photosensitivity and neurotoxicity in the case of an overdose of pyridoxine, as well as congenital defects in the case of an excessive use of vitamin A in pregnant women [37].…”

Nutrivigilance: the road less traveled

“…In other words, where some individual nations may have mechanisms of supplement evaluation and pre-market consumer notification, the overall European Union does not provide such legislation or regulation as a broad umbrella of protection. The collection of EU data and harmonization of nutrivigilance practice is needed from the public health perspective ( Vo Van Regnault et al, 2021 ; de Boer et al, 2022 ; Wróbel et al, 2023 ).…”