Currently, China has officially approved 22 special medical use carbohydrate component formulas designed for people over one year who suffered from specific diseases or needs carbohydrate supplementation. 22 carbohydrate component formulas are domestically made by 20 companies, among which, DAISY FSMP and Tibet DUOXIN HEALTH were approved for 2 products each, and the other 18 companies were approved for 1 product. The largest number of approved companies is in Jiangsu Province, with a total of 7 products. The first carbohydrate component formula 泉克 was registered and approved by Tibet DUOXIN HEALTH in 2020, other carbohydrate component formulas were approved mostly in 2021, 2023 and 2024.

According to the information released by the Department of Special Food of the State Administration of Market Supervision, as of September 30, 2024, the number of domestic and foreign special medical foods that have been successfully registered in China has reached 206. 14 new special medical foods were added in the third quarter of 2024, all of which are domestically manufactured products, including 6 full nutritional products, 6 non-full nutritional products, and 2 special medical infant products

Detailed information on 206 registered FSMPs (as of September 26, 2024)

Founded in 2009, Asiaceutical Expo&Summit (AAES) is one of the most influential technology-oriented exhibitions in the nutrition and health industry in the Asia-Pacific. AAES gathers the global industrial development trends, domestic and overseas industry technology forces, global innovative ingredients and innovative products, providing enterprises with inspiration for product differentiation development, helping enterprises grasp industrial development opportunities, and building market competition barriers.

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on food for special medical purpose (FSMP) to help you gain a clearer understanding of the current requirements in China.

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.

As of now, China has officially approved 15 lactose-free/low-lactose infant formulas for special medical purposes. These are designed for infants aged 0 to 12 months with lactose intolerance. The 15 products consist of 12 domestic formulas and three imported ones from 14 companies. Among these, Wissun International has had two formulas approved, while the other 13 companies each have had one. All 15 products are in powdered form. Notably, only one low-lactose formula for special medical purposes has been approved, which is Neng Dun by Wissun International.

Analysis of 19 Approved Preterm/Low Birth Weight Infant Formulas for Special Medical Purposes

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.

Currently, China has officially approved two formulas for special medical purposes designed for individuals requiring fat supplementation due to specific diseases or medical conditions. Both products are domestically produced: one by Qingdao Languo and the other by Daisy FSMP. Notably, Qingdao Languo’s “Lanpei fat formula for special medical purposes” is the first of its kind in China. Both are in powder form and contain medium-chain triglycerides (MCT) as their fat source, with about 70% fat content.