The toxicological analysis and assessment of essential elements (Cu, Fe, Mn, Zn) in Food for Special Medical Purposes (FSMP) dedicated to oncological patients available in Polish pharmacies

Abstract

Foods for Special Medical Purposes (FSMP) for oncology patients, available in pharmacies, play a crucial role in providing nutrition and supplementation. However, the scientific literature lacks comprehensive research on the safety of essential trace elements in these products. This study aimed to assess Cu, Fe, Mn and Zn levels in commonly prescribed FSMPs (n = 23) from Polish pharmacies. Using ICP-MS after microwave-induced digestion (using concentrated nitric acid and hydrogen peroxide), we evaluated element levels. Our research used three approaches: the raw score for Cu, Fe, Mn, and Zn; single intake per serving; and the daily ration, compared with the reference values of the European Food Safety Authority. Discrepancies were found between the actual and declared product compositions, influenced by the route of administration and the recommended intake. Despite variations, all products were considered safe for oncological patients based on current evidence. However, it is recommended to have clear guidelines for FSMPs in cancer care. This pioneering study evaluates the safety and quality of prescription FSMPs for cancer patients from toxicological and nutritional perspectives, highlighting the need for standardised protocols in pharmacy-dispensed FSMPs.