Definition and Classification of FSMP:
1. Definition
As especially formulated foods that are produced to meet the special requirements for nutrient or meals of people who suffer from eating limitation, disorder of digestion and absorption, metabolic disorders or special disease state, these products shall be eaten individually or with other foods under the guidance of doctors or clinical dietitians.
2. Classification
2. Classification
The Difference and Relationship Between FSMP and FSDU:
The Relationship
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. Formula foods for infants and young children
b. Complementary foods for infants and young children
c. Food for special medical purpose (FSMP)
d. Others (Including complementary nutritional supplements, sports nutritional foods and other foods for special dietary uese 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.
Therefore, FSMP fall into the category of FSDU.
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 or filing 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.
The Similarity
Neither 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.
The Current Market for FSMP:
During last 7 years, FSMP product has increased by 4 times from sales volume perspective and with 30% annual average growth rate in China
The List of the FSMP Approved in China:
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No.
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Enterprise name
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Product name
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Registration certification No.
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Expiration date
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Publication date
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Category
|
|
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1
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SHS International Ltd
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Amino acid formula of Neocate infant formula milk powder for special medical
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State Food Registration No. TY20175001
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2022/11/19
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0-12 months
|
Lacto protein deep hydrolysis formula or amino acid formula
|
|
|
2
|
ABBOTT LABORATORIES S.A.
|
Lacto protein partial hydrolysis formula of Similac Qinhu infant formula milk powder for special medical use
|
State Food Registration No.TY20175002
|
2022/11/19
|
0-12 months
|
Lacto protein partial hydrolysis formula
|
|
|
3
|
ABBOTT LABORATORIES S.A.
|
Lacto protein partial hydrolysis formula of Eleva Hehu infant formula milk powder for special medical use
|
State Food Registration No.TY20175003
|
2022/11/19
|
0-12 months
|
Lacto protein partial hydrolysis formula
|
|
|
4
|
Hangzhou Beingmate Maternal and Infant Nutrition Co., Ltd.
|
Lactose free formula of Beingmate infant formula food for special medical use
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State Food Registration No.TY20180001
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2023/2/12
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0-12 months
|
Lactose free formula or low lactose formula
|
|
|
5
|
SHS International Ltd
|
Phenylketonuria formula of Newbery infant formula milk powder for special medical use
|
State Food Registration TY20185001
|
2023/2/26
|
0-12 months
|
Amino acid metabolism disorder formula
|
|
|
6
|
Mead Johnson (Holland) Co., Ltd
|
Lacto protein partial hydrolysis formula of Qinshu infant formula milk powder for special medical use
|
State Food Registration No.TY20185002
|
2023/3/19
|
0-12 months
|
Lacto protein partial hydrolysis formula
|
|
Please note: Original article of Global Foodmate of Information Service and Business Department, please indicate the source from the Global Foodmate if reprint.