INFORM January 2024

14 • inform January 2024, Vol. 35 (1)

TABLE 2. Regulatory framework for different stages of FSMP products. Stage Regulatory Approach Development Standards for food additives and nutrient fortification during the research and development process are clearly defined in “General Guidelines for Special Medical Purpose Infant Formula Foods” (GB 25596-2010) and “General Guidelines for FSMP” (GB 29922-2013). Clinical According to “General Guidelines for FSMP” (GB 29922-2013), specific full-nutrient formula foods require clini cal trials. Applicants must engage accredited clinical trial institutions to produce clinical trial reports, which must encompass comprehensive statistical analysis and data. Registration The materials supplementation period spans six months, with the typical registration process for a newly devel oped FSMP product taking around a year. The registration procedures and eligibility criteria are more rigorous compared to conventional food or health products. For specific full-nutrient formula foods, the inclusion of clini cal trial reports may extend the timeline to as long as three years. Production To standardize the production of FSMP, the State Administration for Market Regulation introduced the “Detailed Review Regulations for Production Permits of FSMP” in 2016. These regulations cover production facilities, equipment, layout, processes, personnel management, and corporate governance for FSMP manufacturers. Distribution The “Interim Measures for Reviewing and Administering Advertisements for Drugs, Medical Devices, Health Foods, and FSMP” (2019) stipulate that advertisements for FSMP must prominently specify their target audi ence, explicitly state that they are unsuitable for non-target audiences, recommend usage under the guidance of a physician or clinical nutritionist, and restrict the advertising of specific full-nutrient formula foods to medi cal and pharmaceutical professional publications jointly designated by the State Council’s health administration department and the State Council’s drug supervision and management department. Additionally, Article 19 of the “Measures for Investigating and Dealing with Illegal Acts in Food Safety on the Internet” (2017) specifies that specific full-nutrient formula foods for specialized medical purposes cannot be sold online.

ids. The findings laid a strong theoretical foundation for diabe tes-specific medical foods. Gestational Diabetes Mellitus (GDM), a condition caused by prolonged high blood sugar levels during pregnancy, poses substantial risks to both mother and fetus. Jin-feng Ji, deputy chief physician at Xiaolan Hospital, affiliated with Southern Medical University, conducted a study involving 103 GDM patients. The study integrated dietary management, edu cation, and diabetic nutritional supplements. The results suggested that this comprehensive approach effectively man aged and controlled GDM, consequently reducing pregnancy complications. Respiratory disorders, such as chronic obstructive pul monary disease (COPD), acute respiratory distress syndrome (ARDS), and acute lung injury (ALI), have received significant attention. FSMP for COPD often include high-fat, low-carbo hydrate formulations containing medium-chain triglycerides (MCTs) and omega-3 unsaturated fatty acids to preserve lung function and alleviate inflammation. Yan-li An, chief physician at Zhengzhou People’s Hospital, conducted research show casing the benefits of enteral nutritional support in reducing clinical symptoms and markers in ARDS patients. The results underscored the positive impact of early nutritional support for ARDS patients after mechanical ventilation, leading to bet ter patient conditions and reduced mortality rates. Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease, have also been a target of research. FSMP for IBD aims to mitigate inflammatory lesions by adjust ing dietary composition, often using easily digestible proteins and low fiber content. Lactose intolerance is common among

enteritis patients, necessitating lactose-free products. Xiu-fang Wang, chief physician at Xinhua Hospital of Hubei Provinces, conducted a study involving 131 ulcerative colitis patients, which emphasized the advantages of enteral nutrition in improving body weight, albumin, and total protein levels. In summary, the development of disease-specific FSMP in China, particularly for diabetes, respiratory disorders, and inflammatory bowel diseases, has shown promise in improving patient outcomes and addressing unique dietary needs associ ated with these conditions. HISTORY OF FSMP IN CHINA The first phase in the evolution of China’s FSMP policy began between 1970 and 2000. During this period, as clinical nutri tion advanced, the potential societal value of FSMP emerged. Reports of their clinical application first appeared in Beijing as early as 1974. In the 1980s, the Chinese healthcare system started recognizing the specialization of nutrition disciplines. Formal policies to regulate the use of clinical nutrition took hold in the early 2000s. In 2002, the Chinese Medical Association classified FSMP as a category, while government bodies indicated their relevance by including them on medical insurance policies. In 2006, the China Nutrition Improvement Action Plan emphasized proper nutrition for sustaining health. Comprehensive guidelines were established for enteral and parenteral nutrition to assist physicians in devising suitable nutritional support regimens and outline operational proto cols. This era established China’s specific technical and func tional requirements for FSMP. It also identified issues arising