According to the information recently released by the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) products approved in China has reached 140. Companies must register FSMP products with the SAMR, and it is applicable to both foreign and domestic products sold in China. As of September 20, 46 new FSMP Products have been approved for use in 2023, covering 23 nutritionally complete foods, 18 nutritionally incomplete foods, and five infant formulas for special medical purposes.

On August 18, 2023, we hosted a free webinar in Chinese and Japanese on the promotional barriers and key compliance points for functional food and food with medical properties. A lot of questions were raised during the webinar. We have collected questions and made a Q&A summary.

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on foods for special medical purposes (FSMP) applications to help you understand the current requirements in China.

China offers a wide range of food categories in addition to complex food regulations and standards. It is crucial to precisely determine whether the raw materials and additives used in a food product comply with Chinese regulatory standards before it is imported or launched on the market. How do you verify the compliance of food raw materials? What is the scope of use and amount of food additives permitted? Typically, these types of queries call for food enterprises to carry out multiple inquiries and research.

According to the recent consulting situation from CIRS, we found that enterprises have asked more valuable questions related to FSMP, indicating that they are gradually comprehensive on this kind of products. In order to help consumers and enterprises to have a better understanding of FSMP registration-related affairs and its clinical trial requirements, CIRS Group will hold a webinar in June 14.

From years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on foods for special medical purposes (FSMP) applications to help you understand the current requirements in China.

On February 10, 2023, China National Center for Food Safety Risk Assessment (CFSA) issued a draft for public consultation on several new food additives, which contains the latest development in the review of 2’-fucosyllactose. In 2022, trending topics such as “2’-fucosyllactose (2’-FL)”, “Lacto-N-neotetraose (LNnT)”, and “collecting public comments” have arisen many discussions, which also made public wonder about the application progress of these substances.

On February 13, 2023, the Department of Food Safety Standards, Monitoring and Evaluation issued a public consultation on the draft of the General Rules on Infant Formula for Special Medical Purposes. The deadline for public comments is March 20, 2023. If approved it will replace the General Rules of Infant Formula Food for Special Medical Purposes (GB 25596-2010). We have highlighted seven major changes laid out in the draft.

Since the 1990s, the aging of China’s population has accelerated. According to the data of the seventh national population census, the proportion of Chinese aged 65 and over has reached 13.5%, which is higher than the global average of 9.3%. The aging population has promoted the development of the “silver economy” and expanded the consumption of the products and services aimed at older consumers. This article lays out the new opportunities and challenges for the "geriatric food industry".

On November 7, 2022, the State Administration for Market Regulation (SAMR) released a public consultation on the Draft of the Labeling Guidelines on Foods for Special Medical Purposes (FSMP). The deadline for the feedback is November 25, 2022.