[FSMP] Overview of 22 Approved Carbohydrate Component Formulas Approved in China

Currently, China has officially approved 22 special medical-use carbohydrate component formulas designed for people over one year who suffer from specific diseases or need carbohydrate supplementation.

The 22 carbohydrate component formulas are all domestic products made by 20 companies, among which, DAISY FSMP and Tibet DUOXIN HEALTH had two approved products, and the other 18 companies had one product. Jiangsu Province has the highest number of approved products, totaling 7.

The first carbohydrate component formula 泉克 was registered by Tibet DUOXIN HEALTH and approved in 2020, other carbohydrate component formulas were approved mostly in 2021, 2023, and 2024.

China,Food,FSMP,Registration,Special,Medical,Purpose

Details of 22 carbohydrate component products

S.N.	Company	Product Name	Province	Register N.
1	Tibet DUOXIN HEALTH	泉克 (Quanke)	Tibet	国食注字TY20200010
2	GUANGDONG JUNJOY	君蓓安 (Junbeian)	Guangdong	国食注字TY20210007
3	Hainan Donglian	富安 (Fuan)	Hainan	国食注字TY20210010
4	Jiangsu Zhengda Fenghai	素乾® (Suqian)	Jiangsu	国食注字TY20210011
5	DAISY FSMP	冬泽速棠 (Dongze Sutang)	Jiangsu	国食注字TY20210013
6	CSPC Zhongnuo Pharmaceutical (Taizhou) Co. LTD	葆棠华 (Baotanghua)	Jiangsu	国食注字TY20210017
7	Zhejiang Yiyuansu	益安喜® (Yianxi)	Zhejiang	国食注字TY20210020
8	Jiangsu Xihong	西沁® (Xiqin)	Jiangsu	国食注字TY20210024
9	Hebei Aisheng	诺葆安® (Nuobaoan)	Hebei	国食注字TY20230001
10	Shandong Ruoyao	若和® (Ruohe)	Shandong	国食注字TY20230004
11	Chenxin Pharmaceutical	欣饴元 (Xinyiyuan)	Shandong	国食注字TY20230016
12	DAISY FSMP	冬泽予棠 (Dongze Yutang)	Jiangsu	国食注字TY20230047
13	AusNuotore Nutritional Products	爱优诺赋力素(AusNuotore Fulisu)	Jiangxi	国食注字TY20230048
14	Guangdong Yue Microbiology	采衡® (Caiheng)	Guangdong	国食注字TY20230067
15	Zhejiang Hisun Sulikang	伊畅佳® (Yinchangjia)	Zhejiang	国食注字TY20230068
16	Wuxi Hengyi	恒益舒棠 (Hengyi Shutang)	Jiangsu	国食注字TY20240006
17	Tibet DUOXIN HEALTH	艾诺佳 (Ainuojia)	Tibet	国食注字TY20240009
18	Jilin Maifu Nutrition	麦孚卡能®(Maifu Kaneng)	Jilin	国食注字TY20240010
19	Guizhou Jinjiu Biotech	玖康益® (Jiukangyi)	Guizhou	国食注字TY20240027
20	Tecang Pharmaceutical	速劲 (Sujing)	Shandong	国食注字TY20240029
21	Kwins Health Pharmaceutical	拜全术韦 (Baiquan Shuwei)	Jiangsu	国食注字TY20240043
22	Tianjin Hezhi Guangping Pharmaceutical	维特膳棠 (Weite Shantang)	Tianjin	国食注字TY20240044

Formula Content

S.N.	Company	Product Name	Formula ingredients
1	Tibet DUOXIN HEALTH	泉克 (Quanke)	Water, maltodextrin, crystalline fructose
2	GUANGDONG JUNJOY	君蓓安 (Junbeian)	Water, maltodextrin, crystalline fructose, citric acid monohydrate, sodium citrate, potassium citrate, sucralose
3	Hainan Donglian	富安 (Fuan)	Water, maltodextrin, crystalline fructose, potassium citrate, citric acid, sodium citrate, stevioside, food flavor
4	Jiangsu Zhengda Fenghai	素乾® (Suqian)	Water, maltodextrin, crystalline fructose, sodium citrate, potassium citrate, citric acid, food flavoring, sucralose
5	DAISY FSMP	冬泽速棠 (Dongze Sutang)	Maltodextrin, table dextrose, crystalline fructose
6	CSPC Zhongnuo Pharmaceutical (Taizhou) Co. LTD	葆棠华 (Baotanghua)	Water, maltodextrin, dextrose, crystalline fructose, sodium citrate, potassium citrate, citric acid, DL-malic acid, sucralose, food flavors
7	Zhejiang Yiyuansu	益安喜® (Yianxi)	Water, maltodextrin, crystalline fructose, anhydrous dextrose, sodium citrate, citric acid, food flavoring
8	Jiangsu Xihong	西沁® (Xiqin)	Water, maltodextrin, crystalline fructose, food flavoring, sucralose, citric acid
9	Hebei Aisheng	诺葆安® (Nuobaoan)	Maltodextrin, crystalline fructose
10	Shandong Ruoyao	若和® (Ruohe)	Water, maltodextrin, crystalline fructose, citric acid
11	Chenxin Pharmaceutical	欣饴元 (Xinyiyuan)	Water, maltodextrin, crystalline fructose
12	DAISY FSMP	冬泽予棠 (Dongze Yutang)	Water, maltodextrin, table dextrose, crystalline fructose
13	AusNuotore Nutritional Products	爱优诺赋力素 (AusNuotore Fulisu)	Maltodextrin, crystalline fructose
14	Guangdong Yue Microbiology	采衡® (Caiheng)	Water, maltodextrin, crystalline fructose, DL-malic acid, food flavoring, citric acid, sucralose
15	Zhejiang Hisun Sulikang	伊畅佳® (Yinchangjia)	Water, Maltodextrin, crystalline fructose, food flavoring
16	Wuxi Hengyi	恒益舒棠 (Hengyi Shutang)	Maltodextrin, crystalline fructose, sodium citrate, citric acid, flavor for food
17	Tibet DUOXIN HEALTH	艾诺佳 (Ainuojia)	Maltodextrin, crystalline fructose
18	Jilin Maifu Nutrition	麦孚卡能® (Maifu Kaneng)	Water, Maltodextrin, crystalline fructose, citric acid, sodium citrate
19	Guizhou Jinjiu Biotech	玖康益® (Jiukangyi)	Water, Maltodextrin, crystalline fructose, citric acid
20	Tecang Pharmaceutical	速劲 (Sujin)	Maltodextrin, dextrose, crystalline fructose
21	Kwins Health Pharmaceutical	拜全术韦 (Baiquan Shuwei)	Water, Maltodextrin, crystalline fructose, citric acid
22	Tianjin Hezhi Guangping Pharmaceutical	维特膳棠 (Weite Shantang)	Maltodextrin, dextrose

Nutrient content

Nutrient	Unit	Content level
Energy	kJ/100mL	203~223
Protein	g/100mL	0
Fat	g/100mL	0
Carbohydrates	g/100mL	12.5~13.1
Sodium	mg/100mL	0~74

The 22 carbohydrate component products share a similar formula design – these products consist of two or more carbohydrates and aim to supply energy and carbohydrates. These products have simple formulas, no other nutrients, only carbohydrates. Companies can add as many food additives as needed during the production process, but the use method and application level must conform to the technique and necessity of application, and stay in line with the requirements of relevant national standards such as GB 29922 and GB 2760.

According to GB 29922-2013, the raw materials of the carbohydrate component products can be monosaccharides, disaccharides, oligosaccharides, polysaccharides, maltodextrins, glucose polymers, or other raw materials approved by laws and regulations. Maltodextrins, as a kind of raw material of polysaccharides, can be easily digested, has excellent solubility and stability, and is cost-effective. Thus this ingredient is widely used in various products, including beverages, candies, and milk products. However, as maltodextrin has a neutral flavor and is less sweet, it can be used in combination with crystalline fructose to enhance the taste of the product.

At present, the main source of carbohydrates in the 22 approved carbohydrate component products are maltodextrins and crystalline fructose. Glucose is also applied in some other products. The content of carbohydrates is approximately 12.5%.

There are also significant differences among the formulation characteristics. The following is a detailed comparison in terms of age, nutrient content, osmotic pressure, dosage form, net content and specifications, and shelf-life, to provide a reference basis for companies in the selection or product development.

Applicable population

Six products are suitable for people over the age of one year, 12 products are suitable for people over the age of ten years, and four products are suitable for people over the age of eighteen.

Age	Quantity	Product Name
Over 1 year	6	冬泽速棠 (Dongze Sutang), 欣饴元 (Xinyiyuan), 冬泽予棠 (Dongze Yutang), 麦孚卡能® (Maifu Kaneng), 玖康益® (Jiukangyi), 拜全术韦 (Baiquan Shuwei)
Over 10 years	12	泉克 (Quanke), 葆棠华 (Baotanghua), 益安喜® (Yianxi), 西沁® (Xiqin), 诺葆安® (Nuobaoan), 爱优诺赋力素 (AusNuotore Fulisu), 采衡® (Caiheng), 伊畅佳® (Yinchangjia), 恒益舒棠 (Hengyi Shutang), 艾诺佳 (Ainuojia), 速劲 (Sujin), 维特膳棠 (Weite Shantang)
Over eighteen	4	君蓓安 (Junbeian), 富安 (Fuan), 素乾® (Suqian), 若和®(Ruohe)

Nutrient content

The basic nutrient content is 12.5% pure carbohydrates and some products contain electrolytes (sodium).

Nutrient content	Quantity	Product Name
12.5% carbohydrate	12	冬泽速棠 (Dongze Sutang), 西沁®(Xiqin), 诺葆安®(Nuobaoan), 若和®(Ruohe), 欣饴元 (Xinyiyuan), 冬泽予棠 (Dongze Yutang), 爱优诺赋力素 (AusNuotore Fulisu), 采衡® (Caiheng), 伊畅佳® (Yinchangjia), 麦孚卡能® (Maifu Kaneng), 玖康益® (Jiukangyi), 拜全术韦 (Baiquan Shuwei)
12.5% carbohydrate+sodium	10	泉克 (Quanke), 君蓓安 (Junbeian), 富安 (Fuan), 素乾®(Suqian), 葆棠华(Baotanghua), 益安喜®(Yianxi), 恒益舒棠 (Hengyi Shutang), 艾诺佳 (Ainuojia), 速劲 (Sujin), 维特膳棠 (Weite Shantang)

Osmotic pressure

The osmotic pressure of the products' ready-to-eat state is different, and the osmotic pressure distribution range is 180 ~310 mOsmol/kg, and is mainly concentrated in 200~300 mOsmol/kg, and the low osmotic pressure is relatively well tolerated.

The Guidelines for Registration of Formulas with Carbohydrate Components for Special Medical Purposes issued on July 1, 2024, stipulate that the products contain 12.5g of carbohydrates per 100mL in the ready-to-eat state, and the osmotic pressure of the products should not be higher than 320 mOsmol/kg.

Scope of the osmotic pressure	Quantity	Product Name
100-200mOsmol/kg	3	爱优诺赋力素 (AusNuotore Fulisu), 采衡® (Caiheng),玖康益® (Jiukangyi)
200-300mOsmol/kg	17	泉克 (Quanke), 君蓓安 (Junbeian), 富安 (Fuan), 素乾® (Suqian), 葆棠华 (Baotanghua), 西沁® (Xiqin), 诺葆安® (Nuobaoan), 若和® (Ruohe), 欣饴元 (Xinyiyuan), 冬泽予棠 (Dongze Yutang), 伊畅佳® (Yinchangjia), 恒益舒棠 (Hengyi Shutang), 艾诺佳 (Ainuojia), 麦孚卡能® (Maifu Kaneng), 速劲 (Sujin), 拜全术韦 (Baiquan Shuwei), 维特膳棠 (Weite Shantang)
300mOsmol/kg以上	2	冬泽速棠 (Dongze Sutang), 益安喜® (Yianxi)

Dosage form

The main dosage form is liquid, including 15 liquid products and seven powdered products.

Dosage	Quantity	Product Name
Liquid	15	泉克 (Quanke), 君蓓安 (Junbeian), 富安 (Fuan), 素乾® (Suqian), 葆棠华 (Baotanghua), 益安喜® (Yianxi), 西沁® (Xiqin), 若和® (Ruohe), 欣饴元 (Xinyiyuan), 冬泽予棠 (Dongze Yutang), 采衡® (Caiheng), 伊畅佳® (Yinchangjia), 麦孚卡能 (Maifu Kaneng)®, 玖康益® (Jiukangyi), 拜全术韦 (Baiquan Shuwei)
powder	7	冬泽速棠 (Dongze Sutang), 诺葆安® (Nuobaoan), 爱优诺赋力素 (AusNuotore Fulisu), 恒益舒棠 (Hengyi Shutang), 艾诺佳 (Ainuojia), 速劲 (Sujin), 维特膳棠 (Weite Shantang)

Net content and specifications

Currently 200mL/ bottle is the mainstream specification.

Net content and specifications	Quantity	Product Name
200mL	13	泉克 (Quanke), 君蓓安 (Junbeian), 富安 (Fuan), 素乾® (Suqian), 西沁® (Xiqin), 若和® (Ruohe), 欣饴元 (Xinyiyuan), 冬泽予棠 (Dongze Yutang), 采衡® (Caiheng), 伊畅佳® (Yinchangjia), 麦孚卡能® (Maifu Kaneng), 玖康益 (Jiukangyi)®, 拜全术韦 (Baiquan Shuwei)
400mL	1	葆棠华 (Baotanghua)
260mL	1	益安喜® (Yianxi)
Other (Powder)	7	冬泽速棠 (Dongze Sutang), 诺葆安® (Nuobaoan), 爱优诺赋力素 (AusNuotore Fulisu), 恒益舒棠 (Hengyi Shutang), 艾诺佳 (Ainuojia), 速劲 (Sujin), 维特膳棠 (Weite Shantang)

Shelf-life

The shelf-life is between 12 to 24 months.

Shelf-life	Quantity	Product Name
12M	5	君蓓安 (Junbeian), 冬泽速棠 (Dongze Sutang), 益安喜® (Yianxi), 速劲 (Sujin), 拜全术韦 (Baiquan Shuwei)
18M	5	素乾® (Suqian), 葆棠华 (Baotanghua), 西沁® (Xiqin), 爱优诺赋力素 (AusNuotore Fulisu), 麦孚卡能® (Maifu Kaneng)
24M	12	泉克 (Quanke), 富安 (Fuan), 诺葆安® (Nuobaoan), 若和® (Ruohe), 欣饴元 (Xinyiyuan), 冬泽予棠 (Dongze Yutang), 采衡® (Caiheng), 伊畅佳® (Yinchangjia), 恒益舒棠 (Hengyi Shutang), 艾诺佳 (Ainuojia), 玖康益® (Jiukangyi), 维特膳棠 (Weite Shantang)

The newly released “Guidelines for Registration of Carbohydrate Component Formulas for Special Medical Purposes” points out that for products that meet the requirements in the guidelines, the submission of application materials can be optimized. Related applicants should pay attention to the following points:

1. The source of carbohydrates must meet the requirements of GB 29922 and the registration guidelines, and the use of food additives needs to have the necessity of process or use conform to the provisions of GB 29922, GB 2760;

2. The carbohydrate content in the ready-to-eat product should be 12.5g/100mL, the osmotic pressure shall not be higher than 320 mOsmol/kg, and the formulas that do not meet the requirements still need to submit the basis of product formula design;

3. If the same applicant registers products in the same category, then the products must have differences in the characteristics of product formulations, clinical use scenarios or product formulations. Corresponding materials must be provided;

4. Applicants may not submit the stability study report when applying for registration, but are still required to organize and carry out the stability study according to the requirements of “Requirements for Stability Study of Food Formulas for Special Medical Purposes (Trial) (Revised Edition 2017)”, and keep the records so they can be checked if required.

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