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The Registration Status of Protein Formulas for Special Medical Purposes in China

from CIRS by

Currently, China has officially approved 24 protein formulas for special medical purposes designed for individuals over the age of one who require protein supplementation due to specific diseases or medical conditions.

All 24 products are domestically produced, involving 21 companies. Among them, Daisy FSMP has 3 products, Shandong Ruoyao has 2, and other companies such as Haizheng Sulikang, Guangzhou EnterNutr, and Jilin Mifu each have 1 product.

The products include 22 powdered formulas and 2 liquid formulas. Notably, Daisy FSMP’s Dongze Li Liang protein formula for special medical purposes - is the first liquid product of its kind in China.

China,Registration,Food,FSMP,Protein,Formula

The product details are as follows:

24 approved protein formulas for special medical purposes

S.N.

Applicant

Product name

Dosage form

Registration No.

1

Haizheng Sulikang

Yi Neng Jia (伊能佳)

Powder

国食注字TY20200009

2

Guangzhou EnterNutr

Pu Rou Ting (普柔汀)

Powder

国食注字TY20200012

3

Maifu Nutrition

Pu Suo (浦索)

Powder

国食注字TY20200013

4

Hebei Aisheng

Nuo Bao Ping (诺葆平)

Powder

国食注字TY20210014

5

Hunan Jiudian Pharmaceutical

Dong Ze Ding (冬泽定)

Powder

国食注字TY20220002

6

YABAO

Wei Yuan Tai (唯源泰)

Powder

国食注字TY20230008

7

AusNuotore

AusNuotore You Da Li (爱优诺优达力)

Powder

国食注字TY20230018

8

XI'AN LI BANG

Li Ru Jing (立如箐)

Powder

国食注字TY20230019

9

Jiangzhong Pharmaceutical

Chu Yuan An Ben (初元安本)

Powder

国食注字TY20230027

10

KWINS HEALTH

Jia Shan Neng (嘉膳能)

Powder

国食注字TY20230033

11

Shandong Ruoyao

Ruo Yi (若益)

Powder

国食注字TY20230039

Ruo Su (若速)

Powder

国食注字TY20230064

12

Wuxi Hengyi

Hengyi Qingyuan (恒益清元)

Powder

国食注字TY20230042

13

DAISY FSMP

Dong Ze Li An (冬泽力安)

Powder

国食注字TY20230045

Dong Ze Li Tai (冬泽力太)

Powder

国食注字TY20230062

Dong Ze Li Liang (冬泽力亮)

Liquid

国食注字TY20240019

14

Harbin Ballansat

Wei Ka Su (唯卡素)

Powder

国食注字TY20230056

15

Hangzhou Niuquxing

Hai Neng Bo (海能博)

Powder

国食注字TY20230057

16

Nanjing Yuheming

Ke Hui Yan (科惠研)

Powder

国食注字TY20230060

17

Nantong Richen

Li You Yi (力优宜)

Powder

国食注字TY20230065

18

Shandong Lihao

Mi Su (咪素)

Powder

国食注字TY20240007

19

GUANGDONG JUNJOY

Jun Bei Qing (君蓓清)

Powder

国食注字TY20240016

20

Shandong Tecompharma Ltd.

Feng Bai (丰白)

Powder

国食注字TY20240028

21

Jiangsu Zhengda Fenghai

Yi Li Jia (益立佳)

Liquid

国食注字TY20240030

The protein sources in the currently approved protein formulas mainly include milk proteins, plant proteins, and hydrolyzed proteins, with a protein content of approximately 80%.

  • Milk proteins: These include whey protein powder, concentrated whey protein powder, whey protein isolate, casein, calcium caseinate, and concentrated milk protein.
  • Plant proteins: Mainly soybean isolate protein.
  • Hydrolyzed proteins: These include hydrolyzed whey protein powder and soy peptides powder.
  • Dual protein sources: Combining two or more types of proteins can provide a complementary amino acid profile, thereby improving the nutritional value of the protein. 70% of the protein formulas products use a combination of milk protein and soybean isolate protein as their protein sources.

The ingredient composition is as follows:

Ingredient composition results

S.N.

Applicant

Product name

Ingredient composition

1

Haizheng Sulikang

Yi Neng Jia (伊能佳)

Whey protein powder, soybean isolate protein

2

Guangzhou EnterNutr

Pu Rou Ting (普柔汀)

Concentrated whey protein powder, soybean isolate protein, guar gum, mogroside

3

Maifu Nutrition

Pu Suo (浦索)

Whey protein isolate, calcium caseinate, edible essence, phospholipids, sucralose

4

Hebei Aisheng

Nuo Bao Ping (诺葆平)

Whey protein powder, soybean isolate protein, modified soybean phospholipids, silicon dioxide

5

Hunan Jiudian Pharmaceutical

Dong Ze Ding (冬泽定)

Hydrolyzed whey protein powder, soy peptides powder, edible essence, steviol glycoside, sucralose

6

YABAO

Wei Yuan Tai (唯源泰)

Calcium caseinate, concentrated whey protein powder, soybean isolate protein, silicon dioxide

7

AusNuotore

AusNuotore You Da Li (爱优诺优达力)

Concentrated milk protein, whey protein isolate, edible essence, silicon dioxide, sucralose

8

XI'AN LI BANG

Li Ru Jing (立如箐)

Concentrated whey protein powder, whey protein isolate, edible essence

9

Jiangzhong Pharmaceutical

Chu Yuan An Ben (初元安本)

Whey protein isolate, soybean isolate protein, sucralose

10

KWINS HEALTH

Jia Shan Neng (嘉膳能)

Hydrolyzed whey protein powder, soybean isolate protein, whey protein isolate, sucralose

11

Shandong Ruoyao

Ruo Yi (若益)

Concentrated whey protein powder, soybean isolate protein, guar gum, silicon dioxide

Ruo Su (若速)

Hydrolyzed whey protein powder, soy peptides powder, citric acid, sucralose

12

Wuxi Hengyi

Hengyi Qingyuan (恒益清元)

Whey protein isolate, hydrolyzed whey protein powder

13

DAISY FSMP

Dong Ze Li An (冬泽力安)

Soybean isolate protein, whey protein isolate

Dong Ze Li Tai (冬泽力太)

Soy peptides powder, hydrolyzed whey protein powder, food flavoring, steviol glycoside

Dong Ze Li Liang (冬泽力亮)

Water, soy peptides powder, hydrolyzed whey protein powder, food flavoring, mogroside, steviol glycoside

14

Harbin Ballansat

Wei Ka Su (唯卡素)

Concentrated whey protein powder, soybean isolate protein, food flavoring

15

Hangzhou Niuquxing

Hai Neng Bo (海能博)

Concentrated whey protein powder, soybean isolate protein

16

Nanjing Yuheming

Ke Hui Yan (科惠研)

Concentrated whey protein powder, casein, phospholipids, mogroside, food flavoring

17

Nantong Richen

Li You Yi (力优宜)

Whey protein isolate, concentrated whey protein powder

18

Shandong Lihao

Mi Su (咪素)

Concentrated whey protein powder, soy protein isolate, Xanthan gum, Vanillin, silicon dioxide, sucralose

19

GUANGDONG JUNJOY

Jun Bei Qing (君蓓清)

Concentrated whey protein powder, soy protein isolate, silicon dioxide, food flavoring

20

Shandong Tecompharma Ltd.

Feng Bai (丰白)

21

Jiangsu Zhengda Fenghai

Yi Li Jia (益立佳)

Note: The two protein formulas approved this month (Feng Bai and Yi Li Jia) are not included in the above statistics because their label sample information is not available in the Special Food Information Query Platform.

Nutrient content statistics are as follows:

Nutrient content results

Nutrient

Unit

Content range

Energy

kJ/100g

1380~1664

Protein

g/100g

75~88

Fat

g/100g

0~6.1

Carbohydrate

g/100g

0.1~9

Sodium

mg/100g

100~1110

Potassium

mg/100g

471-486

When designing protein formulas, companies must comply with national food safety standards and thoroughly validate protein sources and other components. This ensures that the product design is well-founded and meets clinical needs.

For more information about the registration of FSMP in China, please click here to learn about our FSMP registration service.

If you need any assistance or have any questions, please get in touch with us via service@hfoushi.com.

Further information

The Registration Status of Formulas for Fat Supplementation in China

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