According to the regulation “Administrative Measures for Registration of Foods for Special Medical Purpose (2015)” and GB 13432-2013 “National Food Safety Standard Label of Prepackaged Foods for Special Dietary Uses”, the foods for special dietary uses (FSDU) are divided into the following four categories:
a. Infant formula food
b. Infant auxiliary food
c. Food for special medical purpose (FSMP)
d. Others (Including auxiliary food supplements, sports nutrition foods, and other special dietary foods with corresponding national standards)
The infant formula food for special medical purpose is an infant formula food, but also belongs to FSMP.
Therefore, FSMP fall into the category of FSDU.
2. The Difference
1) Whether the Doctor Guidance is Needed?
The consumption of FSMP shall be used alone or in combination with other food under the guidance of doctors or clinical dietitians, while the other FSDU such as sports nutrition products can be consumed according to the product label.
2) Whether the Registration of Filling are Needed?
The new "Food Safety Law" stipulates that FSMP and infant formula powder (hereinafter referred to as "infant formula") to be registered with the CFDA. only products that have obtained the approval certificate can launch production. Other FSDU are not required to be registered or registered before the production launch.
3) Different Targeting Group
FSMP are known as “patient meal”. FSMP is targeting to eating restriction, digestion and absorption difficulty, metabolic disorder or other special dysfunctional illness groups. For example, infant formula food for special medical purpose is designed for premature babies, food protein allergy baby, lactose intolerance baby, etc.. other FSDU is targeting to patients with diabetes, cancer, kidney disease, etc.
4) Different Channel of Distribution
The channel of distribution for FSMP is limited to the hospitals and the doctors. Doctors’ prescriptions and recommendations are the main distribution channels of the products, and only a handful of FSMP enterprises have distribution channels covering pharmacies, supermarkets, and e-commerce. The other FSDU distributes through are chain supermarkets, and e-commerce.
3. Similarities:
Neither Foods for FSMP and FSDU can claim functions
Whether it is FSMP or other FSDU, they are the food that provide nutrition for the specific group of people. The national regulations prohibit such products declare functions.