Technical Analysis of Five Approved Special Medical Liquid Formulas: Insights into Raw Materials and Nutrient Design

Currently, China has officially approved five special medical-purpose liquid formula foods designed for individuals aged ten and above who require fat intake restriction or have digestive and absorption disorders. The approved products are listed in Table 1.

Key highlights

• All five products are domestically produced in China, with approvals granted to five different companies (one approved product each): Hebei Aisheng, Jilin Maifu Nutrition, Tibet Duoxin Health, Jiangsu Fresenius Kabi SSPC, and Jiangsu Wuxi Everlasting Health;
• The lineup consists of four powdered products and one liquid product;
• Most powdered products come in stick-pack formats for convenience and ease of use; and
• The shelf life ranges between 12 to 24 months.

Table 1. Five approved special medical-purpose liquid formula foods

Liquid formula foods, being fat-free, are suitable for patients that need to restrict fat intake, those with anorexia nervosa, swallowing difficulties, intestinal dysfunction, or those in the perioperative period. The formulations are primarily based on carbohydrates and proteins, with the optional addition of various vitamins, minerals, and dietary fibers. Additionally, product labels should indicate the osmolarity of the ready-to-eat state.

The sources of raw materials, nutrient content, and osmolarity parameters of the five liquid formulas are summarized in Table 2 and Table 3. Statistical analysis reveals that all five products incorporate multiple vitamins, with key differences primarily in the selective addition of minerals and dietary fibers. Fresenius Kabi stands out in the inclusion of trace elements such as chromium and molybdenum, while Aisheng demonstrates an advantage in dietary fiber enrichment, particularly with resistant dextrin.

Osmolarity data in Table 3 shows significant differences among the five special medical-purpose liquid formulas, ranging from 260 milliosmoles per kilogram (mOsmol/kg) to 985 mOsmol/kg. Low-osmolarity products are suitable for patients sensitive to osmotic pressure, particularly those with weak intestinal function or those requiring low-osmolarity nutritional support. High-osmolarity products may be more appropriate for patients who can tolerate higher osmotic pressure or for medical scenarios requiring rapid replenishment of electrolytes or specific nutrients. However, caution is needed regarding potential gastrointestinal burdens associated with high osmolarity. Overall, these variations in osmolarity reflect different formulation strategies, allowing manufacturers to tailor products based on the needs of their target patient groups.

Table 2. Nutrient ingredient sources of the five liquid formulas

Table 3. Nutrient content of the five liquid formulas

CIRS Group recommends that companies conduct thorough preliminary preparations before applying for the registration of special medical-purpose foods. This includes market analysis to understand demand, literature research to validate the scientific basis of the formulation, and factory audits to ensure compliance during the trial production process. 

About CIRS Group

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 domestic and international food companies achieve one-stop compliance solutions. CIRS offers a full range of regulatory services covering novel food applications, synthetic biology-derived foods, U.S. GRAS notification, EU novel food application, health food registration, and food for special medical purposes (FSMP).

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