The toxicological analysis and safety assessment of heavy metals (Hg, Pb, Cd, and As) in food for special medical purposes (FSMP) available in Polish pharmacies for oncological patients

Abstract

The presence of heavy metals in food products may seem an archaic concern; however, our study reveals that the risk is significant, unexpectedly in Food for Special Medical Purposes (FSMP) for oncology patients available in Polish pharmacies. This investigation fills that gap through a detailed toxicological analysis and health risk assessment of these heavy metals in FSMP products (n = 23) using inductively coupled plasma mass spectrometry (ICP-MS). Our comprehensive risk assessment involved evaluating (1) the concentrations of As, Cd, Hg, and Pb in both liquid and powdered FSMP formulations, (2) the amount of heavy metals ingested per serving as specified by the manufacturer, and (3) the cumulative daily and weekly intake adjusted for body weight, benchmarked against the provisional tolerable weekly intake (PTWI). While most samples were below PTWI limits, Cd levels raised concerns due to potential cumulative exposure risks, particularly for oncology patients consuming these products regularly. This study underscores the hidden dangers of heavy metal contamination in FSMP, emphasizing the need for vigilant monitoring and stringent regulatory frameworks to ensure patient safety. By uncovering these latent risks through meticulous toxicological assessment, our research provides crucial insights that could safeguard vulnerable populations. This study is significant due to concerns related to the complex risk assessment of FSMP for cancer patients, considering the complexity of oncological diseases and other comorbid factors, as well as the verification of available legal and regulatory acts of FSMP at the European Community level.