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As of December 31, 2025, a total of 59 Foods for Special Medical Purposes (FSMPs) were approved in 2025 (registration number: 國食注字TY2025XXXX), bringing the cumulative number of approved FSMPs in China to 290.
To continuously optimize the port business environment and support the development of import trade in substances with both food and medicinal uses, the General Administration of Customs (GAC), the National Health Commission (NHC), the State Administration for Market Regulation (SAMR), and the National Medical Products Administration (NMPA) have decided to pilot the implementation of classified import management for certain food–medicinal substances.
According to the information released by the Center for Food Evaluation, State Administration for Market Regulation and the Special Food Information Query Platform, in 2025, State Administration for Market Regulation issued a total of 2130 health food (dietary supplement) registration approvals. Among them, 200 approvals were for new health food products, including 194 domestic products and 6 imported products.
Recently, China's National Health Commission (NHC) issued notifications regarding the approval and review of “Three new foods” (new food raw materials, new food additives, and new food-related products).
On December 17, 2025, the Official Journal of the European Union published the European Commission's guidance document for the implementation of Commission Regulation (EU) 2024/3190.
Nicotinamide Mononucleotide (NMN) is currently undergoing regulatory authorization processes in multiple major global markets. To help companies clearly understand the international compliance status of NMN, CIRS has summarized recent regulatory developments in the United States, Australia, and the European Union for reference.
Rhodiola is a traditional Chinese medicinal herb included in the Pharmacopoeia of the People’s Republic of China and is also listed in the Catalogue of Substances Permitted for Use in Health Foods. It is a commonly used raw material for health foods, primarily containing saponin compounds such as rhodioloside, which are associated with health functions including alleviating physical fatigue and improving tolerance to hypoxia. According to searches on official platforms, more than 500 registered health food products using Rhodiola or Rhodiola-derived products as raw materials have been approved to date.
On 3 November 2025, EFSA released its safety evaluation report on synthetic cannabidiol (CBD) as a novel food. According to the assessment conducted by EFSA’s expert panel, the safety of the NF synthetic CBD cannot be established.
On December 8, 2025, Tianjin Hesheng Biotechnology Co., Ltd. (HS SynBio) (Tianjin) received “FDA has no questions” letter. This marks the official recognition of its HMO 2'-Fucosyllactose (2'-FL) as GRAS.
In Japan, foods with functional claims refer to products for which the seller files a notification with the Consumer Affairs Agency (CAA) before marketing. The seller must submit scientific evidence supporting the safety and functional effectiveness of the product and may display the related functional claims. Unlike foods for specified health purpose, foods with functional claims are primarily the responsibility of the seller, and the filing process is comparatively less complex.
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