Analysis of formulations of nutritionally complete foods for special medical purposes and enteral nutrition products in China

Background: In China, enteral nutrition (EN) products have been used clinically since 1974 and were regulated as pharmaceuticals, limiting product availability due to strict registration requirements. To better address unmet clinical needs, foods for special medical purposes (FSMPs) were introduced and regulated as special foods. Although the number and diversity of approved products grew rapidly, it remained unknown whether this expansion has translated into a product landscape that can sufficiently meet clinical needs. The objective of this study is to systematically evaluate the formulation landscape of approved nutritionally complete FSMPs and EN products in China, assess their alignment with specific clinical nutrition requirements, and identify potential unmet needs. Methods: A complete list of approved nutritionally complete FSMPs and EN products was obtained from official regulatory websites. Products were categorized by protein source, presence of medium-chain triglycerides (MCT), and dietary fiber content. Macronutrient energy distributions and specific nutrient levels were calculated to analyze compositional patterns. We consulted two clinical dietitians from Huashan Hospital, a Tertiary Grade-A Hospital, to identify patient groups with unmet nutritional needs. Specific nutrition requirements of clinical conditions were extracted from national and international guidelines. Nutrient composition and ingredient lists were then systematically compared against these criteria to assess alignment with clinical nutritional needs. Results: Eighty-seven nutritionally complete products were included and categorized into 12 formula groups, with the majority ( n = 78, 89.7%) concentrated in five groups: 1) standard intact-protein formulations with dietary fiber but no MCT ( n = 31, 35.6%); 2) standard intact-protein formulations with dietary fiber and MCT ( n = 17,19.5%); 3) extensively hydrolyzed formulations with MCT but no dietary fiber ( n = 11, 12.6%); 4) standard intact-protein formulations with MCT but no dietary fiber ( n = 10, 11.5%); and 5) standard intact-protein formulations without MCT or dietary fiber ( n = 9, 10.3%). Formulations showed substantial homogeneity, with macronutrient energy distributions clustered within similar narrow ranges. When compared with condition-specific requirements, only a small proportion of products met the detailed criteria. Conclusions: Most FSMPs and EN products in China are concentrated in a few dominant categories with similar macronutrient distributions. Significant gaps persisted in addressing the diverse clinical needs, highlighting the urgent need for more formulations tailored for specific clinical conditions.