As of now, China has officially approved four thickening component formulas for special medical purposes designed for individuals over 10 years old with swallowing difficulties and/or aspiration risks, all of which were approved in the past two years.
All four products are domestically produced and are in powdered form. Each of the following companies – Jilin Maifu, Hebei Aisheng, Shandong Ruoyao, and Jiangsu Daisy FSMP – has had one formula approved.
Table 1. List of four approved thickening components
S.N. |
Applicant |
Product name |
Dosage form |
Registration number |
Ingredient list |
---|---|---|---|---|---|
1 |
Jilin Maifu |
Maifu Shun Bao (麦孚顺宝®) |
Powder |
TY20230026 |
Maltodextrin, Xanthan gum, Erythritol, Guar gum, Sodium alginate |
2 |
Hebei Aisheng |
Nuo Bao Chang (诺葆畅®) |
Powder |
TY20240012 |
Maltodextrin, Xanthan gum |
3 |
Shandong Ruoyao |
Ruo Ning (若宁) |
Powder |
TY20240021 |
Maltodextrin, Guar gum, Gellan gum, Carrageenan, Xanthan gum |
4 |
Jiangsu Daisy FSMP |
Dong Ze Li Shun (冬泽力顺) |
Powder |
TY20240031 |
Xanthan gum, Maltodextrin |
The thickening components are based on carbohydrates and incorporate one or more thickeners, with dietary fiber optionally added. Among the four approved products, all use maltodextrin as the carbohydrate source, combined with one or more thickeners to enhance thickening performance and expand their applicability. Only one product includes dietary fiber in its formula.
Maltodextrin is widely used in thickening components for special medical purposes due to its recognized safety and stability. Its excellent properties, such as rapid dissolution, low moisture absorption, resistance to clumping, and good taste, make it a preferred choice. Additionally, its relatively low cost offers significant cost-effectiveness for large-scale applications.
Table 2. Dysphagia food levels corresponding to the product after preparation with water
Product name |
Maifu Shun Bao (麦孚顺宝®) |
Nuo Bao Chang (诺葆畅®) |
Ruo Ning (若宁) |
Dong Ze Li Shun (冬泽力顺) |
||||||||||
Water amount |
200mL |
200mL |
400mL |
100mL |
||||||||||
Use level |
1g |
2.5g |
5g |
10g |
2g |
4g |
6g |
1.5g |
3.0g |
6.0g |
0.2g |
0.4g |
0.8g |
3g |
Type |
Slightly thick |
Mildly thick |
Moderately thick |
Extremely thick |
Mildly thick |
Moderately thick |
Extremely thick |
Slightly thick |
Moderately thick |
Extremely thick |
Slightly thick |
Mildly thick |
Moderately thick |
Extremely thick |
IDDSI level* |
1 |
2 |
3 |
4 |
0+1 |
2 |
3 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
* The International Dysphagia Diet Standardisation Initiative (IDDSI)
Table 3. IDDSI levels
Level |
Description/characteristics |
Physiological rationale for this level of thickness |
IDDSI Flow Test/Others |
---|---|---|---|
0: Thin |
|
Functional ability to safely manage liquids of all types. |
Less than 1 mL remaining in the 10 mL slip tip syringe after 10 seconds of flow |
1: Slightly thick |
|
|
Test liquid flows through a 10 mL slip tip syringe leaving 1-4 mL in the syringe after 10 seconds |
2: Mildly thick |
|
|
Test liquid flows through a 10 mL slip tip syringe leaving 4 to 8 ml in the syringe after 10 seconds |
3: Moderately thick/ liquidised |
|
|
Test liquid flows through a 10 ml slip tip syringe leaving > 8 ml in the syringe after 10 seconds |
4: Extremely thick/ pureed |
|
|
n/a. The IDDSI Flow test is not applicable |
5: Minced & moist |
|
|
Use chopstick test, finger test, and spoon tilt test. |
6: Soft & Bite-sized |
|
|
Fork pressure, chopstick, and finger test |
7: Easy to chew |
|
|
/ |
The four approved formulas are classified according to the international IDDSI standards. This makes it easier for doctors and nutritionists to guide the usage based on the patient’s age, weight, and medical condition, in order to to thicken foods, reducing the risk of leftover residue and aspiration during swallowing. In China, there are also relevant standards, such as the Chinese Expert Consensus on Nutritional Management of Dysphagia Diets (2019 Edition). It classifies liquid foods into three levels: Level 1 (mildly thick), Level 2 (moderately thick), and Level 3 (extremely thick). Solid foods are classified into three levels as well: Level 4 (pureed), Level 5 (minced and moist), and Level 6 (soft and bite-sized).
The nutrient content of the four approved formulas is as follows:
Table 4. Nutrient content results
Nutrient |
Unit |
Content |
---|---|---|
Energy |
kJ/100g |
1186~1539 |
Protein |
g/100g |
0.3~2.5 |
Fat |
g/100g |
0 |
Carbohydrate |
g/100g |
53.7~90 |
Sodium |
mg/100g |
180~465 |
Dietary fiber |
g/100g |
31.5 |
When designing the thickening components, companies must follow the national food safety standards, choose appropriate ingredients, and thoroughly evaluate the thickening effects, consumption methods, and the resulting consistency after preparation.
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