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ChemLinked joined the 6th China Special Food Conference this week, which was held from Oct. 15 to 18 in Jiangsu Province. To help enterprises keep up with the latest changes, this article will focus on the regulatory and supervision trend in foods for special medical purpose (FSMP) sector. Stay tuned with ChemLinked for more reports related to special food market, complementary baby food, etc.
Regulatory Trend: Revision to "GB 29922 General Rules for Foods for Special Medical Purpose"
Yang Xiaoguang, the major drafter of “General Rules for Foods for Special Medical Purpose (GB 29922)” brought the newest revision progress of this GB standard. Yang indicated that the consultation draft would be released for public feedback at the end of this month. He also predicted China would likely approve the amendment in 2022.
Major revisions are summarized as followed.
First, a piece of great news to enterprises, especially to overseas enterprises. At present, only the product type listed in GB 29922-2013 is eligible to apply for or obtain FSMP product registration approval. However, once the revision comes into effect, as long as enterprises provide sufficient evidence like medical research, the effect of clinical practice, etc., the official will accept the application.
Second, nutritionally complete foods will have more optional ingredient choices. For nutritionally complete foods that are designed for people from 1 to 10 years old, it is expected to add four optional ingredients. They are 1,3-Dioleoyl-2-palmitoylglycerol (OPO), lutein, lactoferrin and CaseinPhosphopeptides (CPP). For nutritionally complete foods that are targeting at people over 10 years old, the proposed new optional ingredients include vitamin K2, EPA+DHA, CaHMB. During the Special Food Conference, Yang also received the suggestion of adding lactoferrin into this category.
Third, the indicators for nutritionally incomplete foods will be revised, including the newly added content requirements for each component. For example, the protein content of protein component should be over 80%. Besides, a new component “dietary fiber component” is added into the category of nutritionally incomplete food.
Finally, the labeling requirements are revised. For example, products like liquid formula, electrolyte formula, amino acid metabolism disorder formula food, etc., should label the osmotic pressure.
During his speech, Yang also implied the regulatory trend of FSMP. Experts are now evaluating the necessity of conducting clinical trials for certain products like nutritionally complete food for intractable epilepsy, which is actually a nutritionally complete ketogenic formula food. The idea here is to require clinical trial for products which are for specific diseases, and do not require clinical trial for products which aim to mainly supplement nutrition.
Yang Xiaoguang, the major drafter of “General Rules for Foods for Special Medical Purpose (GB 29922)”
Supervision Trend
Yu Wei, an official from Special Food Safety Supervision and Management Division of SAMR (State Administration for Market Regulation) disclosed following supervision trends of FSMP industry.
First, FSMP products will be subject to regular sampling inspections from next year. Currently, SAMR only carry out specialized inspection for FSMP products annually due to its limited quantity. The implementation of the new measure next year means FSMP products will face greater supervision intensity with higher inspection frequency.
Second, SAMR will keep supervising the use of FSMP products in hospitals together with National Health Commission. Up until now, provinces and municipalities like Jiangsu, Shanghai, Hubei, Zhejiang, etc. have released their rules of using FSMP in hospitals.
Third, to rectify the industry chaos of selling solid beverage as FSMP, SAMR will further regulate solid beverage products. For example, a consultation draft of “State Administration for Market Regulation’s Notice on Strengthening Solid Beverage Quality and Safety Supervision” was released this year. Yu also implied the recommended GB standard for solid beverage may be adjusted in future.
Fourth, according to China’s cross border e-commerce (CBEC) policy, it is forbidden to purchase CBEC products online for subsequent pickup offline because CBEC products are supervised as products for personal use. But such behaviors have been found during the offline sales of FSMP products. Yu claimed that a further stringent supervision will be carried out.
Fifth, the official believes consumers’ need for FSMP is huge but consumers know little about such products and also don’t know where to get such products. In the future, SAMR will keep enhancing public’s perception of FSMP products, especially people in small cities and rural areas.
Yu Wei, Special Food Safety Supervision and Management Division of SAMR
During Yu’s speech, she regarded FSMP sector as a very promising industry and encouraged enterprises to be optimistic. ChemLinked also believes it is about time to consider entering China’s FSMP sector. First, FSMP products are in a great demand. According to statistics, among the 140 million inpatients in China, 40% to 50% of them are lack of clinical nutrition diagnose and treatment. Second, the industry is developing fast with an average growth rate of 37%. Third, hospitals and doctors are expected to further help patients finding appropriate FSMP products. In July 2021, China released “Expert Consensus on Clinical Management of Food for Special Medical Purposes (FSMP) (2021 Edition),” which is a guideline to help standardize the use of FSMP products in hospitals. In August 2021, China also recognized FSMP products as a charge item in hospitals. Such development will greatly accelerate the industry development.
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