Consideration of Issues Related to the Registration of Foods for Special Medical Purposes for Preterm or Low-Birth-Weight Infants

Several guidelines and expert consensuses issued by the World Health Organization (WTO), the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), the American Academy of Pediatrics (AAP) and relevant Chinese associations provide recommendations and corresponding evidence-based medical evidence for the enteral nutritional requirements of preterm or low-birth-weight infants. Relevant clinical nutrition research has greatly progressed. Foods for special medical purposes (FSMPs) designed to meet the nutritional requirements of preterm or low-birth-weight infants provide an option for enteral nutrition support when necessary. This review article summarizes progress in research on the nutritional requirements of preterm or low-birth-weight infants and the clinical application of the major categories of FSMP products, and analyzes the existing problems. Based on the current consensus, this article discusses science and safety issues that need adequate consideration when FSMPs for preterm or low-birth-weight infants are registered for sale, so as to provide a reference for the development and registration of relevant products.