When the nutritional need of certain people cannot be met through ordinary meals or daily meals, FSMP can be used as an effective way of nutritional supplementation and play a role in nutritional support. The following is a brief description of the relevant knowledge on FSMP.

Definition of FSMP

FSMP means food that are 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 products should be used individually or with other supplementary foods as recommended by doctor or clinical dietitian, including FSMP for infants from 0 months to 12 months and FSMP for people over 1 year old.

Classification of FSMP and its Approval Situation in China

In China, FSMP has undergone a transition from “drug” to “food”. FSMP was initially supervised in the form of enteral nutrition preparations following by drug. After the two national food safety standards, the General Principles of Food for Special Medical Purpose for Infants in 2010 and the General Principles of Food for Special Medical Purpose in 2013, the FSMP has a clearer definition and classification. The specific classification can be seen in the table below.As of the end of December 2020, a total of 55 formula foods have passed the registration and approval of FSMP. Among them, there are 31 FSMP for infants, accounting for 56% of the total. In 2020, a total of 12 FSMP, 2 FSMP for infants (partially hydrolyzed milk protein formula, amino acid formula), 7 full nutritional formulas for special medical purpose, and 1 electrolyte formula for special medical purpose which was first approved, 1 protein components formula for special medical purpose which was first approved, 1 carbohydrate components formula for special medical purpose which was first approved.

Specific Suitable Group and Identification Method of FSMP

FSMP mainly take protein, fat, carbohydrates, vitamins and minerals as nutritional indicators; the physical and chemical indicators mainly include carbon-nitrogen supply ratio, energy density, osmotic pressure, etc. Due to the different physiological characteristics and nutritional needs of various special patients, the raw materials and nutrient contents of each type of FSMP are also different to a certain extent.

Among FSMP for people over 1 year old, the full nutritional formulas are suitable for people who need a comprehensive supplement of nutrients and have no special requirements for specific nutrients, such as patients with frailty, chronic malnutrition, and long-term bed rest; specific full nutritional formulas are suitable for people who need a comprehensive supplement of nutrients under specific diseases or medical conditions, and the special needs of people for some nutrients can be met; Non-full nutritional formulas are suitable for people who need to supplement single or partial nutrients, according to the medical condition of individual patient or special needs, such as patients with diarrhea or fasting before surgery who need to supplement water and electrolytes.

In terms of product form, most FSMP approved for marketing are powder, and a small part are liquid, which can easily be confused with other types of products such as solid beverage or sports beverage in general food. General food only has SC food production license number, while the registration number “National Food Zhuzi TY”, the corresponding suitable people and consumption method should be marked on the label of FSMP. The special food information query platform on the website of the SAMR will record the information about FSMP.