Articles

The classification of sodium butyrate hinges on its intended physiological application, as regulatory bodies must determine whether it functions as a general dietary supplement or as a food for special medical purposes designed for patients with specific metabolic requirements (Kaźmierczak-Siedlecka et al., 2022). While food supplements are defined by their role as concentrated nutrient sources meant to augment a healthy diet (Chopra et al., 2021), FSMPs are restricted to the dietary management of individuals whose nutrient intake is compromised by a clinically diagnosed disease or medical condition (Spacova et al., 2023). Consequently, sodium butyrate’s status as an FSMP is contingent upon demonstrated efficacy in managing gastrointestinal dysfunction and inflammatory responses, where it serves as a key metabolite influencing host physiology (Sun et al., 2024). This distinction necessitates a rigorous assessment of the product’s intended mechanism, as FSMPs must provide specific nutritional support to patients suffering from conditions where the gut barrier or systemic immune response is impaired (Kalkan et al., 2025; Vinderola et al., 2023). Furthermore, regulatory challenges persist due to the fragmented nature of postbiotic classification, which often lacks the standardization required to distinguish between general wellness products and those intended for therapeutic management (Guglielmetti et al., 2025). Europe: