Recently, the National Health Commission and the State Administration for Market Regulation jointly issued the national food safety standards General Principles for Food for Special Medical Purpose and Complete Nutritional Formula for Tumors, which will come into effect on September 2, 2026.
Food for special medical purpose (hereinafter referred to as FSMP) refers to food specially processed and prepared to meet the special requirements of nutrition or meals for people with restricted eating: disorder of digestion and absorption, metabolic disorder or special disease status. The release of two national food safety standards will have a significant impact on the innovative research and development, registration supervision and industrial development of FSMP.
The national food safety standard General Principles for Food for Special Medical Purpose issued in December 2013 provides a basis for the production and management of FSMP, and has played an important role in ensuring food safety, meeting clinical nutritional needs and regulating the market of FSMP. The newly amended General Principles for Food for Special Medical Purpose revised product classifications and technical requirements, etc. For instance, it newly added product categories such as partially modified nutrient complete formula and non-complete nutritional formula for specific disease, detailed the specific categories of amino acid components, adjusted the nutrient limits of complete nutritional formula, newly added optional components, etc., which are conducive to better meeting the nutritional needs of patients in different disease states.
The Complete Nutritional Formula for Tumors is the first national standard for specific complete nutritional formula in China. At present, there are over 4.5 million new cases of tumors in China every year. Cancer patients usually have a series of characteristic changes in metabolic patterns and nutritional requirements, such as abnormal carbohydrate and fat metabolism, increased demand for energy and high-quality protein, and altered requirements for some micronutrients and nutrients with immunomodulatory effects. Due to the influence of the disease itself and anti-tumor treatment, the incidence of malnutrition is as high as 80%, seriously affecting the treatment effect and quality of life of patients. Based on the General Principles for Food for Special Medical Purpose, the Complete Nutritional Formula for Tumors clearly stipulates the requirements for raw materials, sensory property, nutritional components, as well as labels and instructions for use of complete nutritional formula for tumors, taking into account the metabolic characteristics of tumors and nutritional needs, which can better meet the nutritional needs of tumor patients.
The State Administration for Market Regulation is actively promoting the registration of FSMP in accordance with the new national food safety standards, formulating guiding documents such as the Guidelines for the Registration of Complete Nutritional Formula Tumors, and proactively providing more targeted technical guidance and services for enterprises to ensure a smooth market transition and high-quality industrial development, and better meet the clinical nutritional needs of a large number of patients.
Source: SAMR
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