INFORM January 2024

12 • inform January 2024, Vol. 35 (1)

TABLE 1. Primary technical requirements for common Non-Full-Nutrient Formula foods. Product Category Formula’s Key Technical Requirements

Protein (Amino Acid) Components: • Comprised of proteins and/or amino acids • Protein sources may include one or more amino acids, protein hydrolysates, peptides, or high-quality whole proteins Fat (Fatty Acid) Components: • Comprised of fats and/or fatty acids • Options include long-chain triglycerides (LCT), medium-chain triglycerides (MCT), or other legally approved fat (acid) sources

Nutrient Components

Carbohydrate Components: • Based on carbohydrates

• Carbohydrate sources may include monosaccharides, disaccharides, oligosaccha rides, polysaccharides, maltodextrin, glucose polymers, or other legally approved raw materials

Thickening Components

• Based on carbohydrates • Incorporates one or more thickening agents • May include dietary fiber • Primarily based on carbohydrates and proteins • Can include various vitamins and minerals • May contain dietary fiber

Liquid Formulation

Electrolyte Formulation

• Primarily based on carbohydrates • Contains appropriate electrolytes

Amino Acid Metabolic Disorder Formulation

• Mainly composed of amino acids but lacks or contains minimal amounts of amino acids related to metabolic disorders • Contains adequate fats, carbohydrates, vitamins, minerals, and/or other components • Meets partial protein (amino acid) requirements while addressing the patient’s need for certain vitamins and minerals

The General Guidelines for FSMP outlines 13 full-nutrient formula foods intended for patients with diverse medical con ditions. These include: • diabetes • chronic obstructive pulmonary disease (COPD) • kidney disease, malignant tumors (cachexia) • inflammatory bowel disease • food protein allergies • refractory epilepsy • obesity • weight-loss surgery • liver disease • muscle wasting syndrome • stress-related conditions (trauma, infection, surgery, and others) • fatty acid metabolism disorders • gastrointestinal absorption disorders In addition, there are non-full-nutrient formula foods designed for individuals requiring specific or partial nutrient supplementation (Table 1), those with metabolic disorders, or those with distinct dietary needs. Whether they are full-nutri ent or non-full-nutrient formulas, the key distinction in FSMP lies in the composition and content of the product.

potassium, copper, magnesium, iron, and others. In addition to essential nutrients, the standard permits the addition of optional nutrients to full-nutrient formula foods. While these nutrients are not mandatory, they contribute to human growth and development. Currently, in China, six optional nutrients have been added to registered products, including chromium, molybdenum, choline, taurine, L-carnitine, and dietary fiber. However, fluo ride, inositol, and nucleotides have not yet been incorporated. This opens new avenues for future research and development of FSMP. MEDICAL CONDITIONS AND DISTINCTIONS Foods for Special Medical Purposes are categorized into two main groups: Infant FSMP and Non-Infant FSMP. Infant FSMP in China are designed for patients aged 0-12 months and encom pass a variety of formulations. Examples include lactose-free or low-lactose options, partially hydrolyzed protein formula tions, premature or low birth weight infant formulas, breast milk supplements, and formula for amino acid metabolic disor der. On the other hand, Non-Infant FSMP are tailored for indi viduals over one year with specific nutritional requirements, digestive absorption disorders, metabolic disorders, or other medical conditions.