Objective To provide a scientific basis for optimizing the registration and regulation， disease/medical states with a high clinical need for specific whole-nutrient foods for special medical purposes （FSMP-S） were identified.Methods A core outcome set construction method was used in this study. A systematic review was conducted to determine the list of diseases/medical states that could be supported by FSMP-S. Then， a list of diseases/medical states with high clinical demand for FSMP-S was selected through the Delphi method and face-to-face consensus meetings， and optimization suggestions for classifying the FSMP-S were proposed.Results A total of 27 studies were identified， and 103 diseases/medical states with FSMP-S intervention were obtained from 5，984 papers in Chinese and English. Forty-seven physicians and dietitians from 3A hospitals participated in two rounds of Delphi surveys， after which 23 diseases/medical states were recognized as having high clinical demand for FSMP-S. The consensus meeting narrowed the scope of the FSMP-S to a high clinical need of 11 diseases/medical states. Finally， a “1+1” optimization strategy was proposed to add nutritional metabolic characteristics to the classification method for FSMP-S.Conclusion The “1+1” strategy could optimize the classification of FSMP-S from the perspective of clinical application requirements； however， its feasibility remains undemonstrated.