Blue Hat / SAMR

China supplement market entry operates under a binary regulatory framework. Blue Hat health food (保健食品) status is required for domestic sale of products carrying health-function claims, administered by SAMR, the State Administration for Market Regulation (before the 2018 reform, CFDA), under the Food Safety Law and the Administrative Measures for the Registration and Filing of Health Food. Two pathways: Registration (注册, 2-5 years, full toxicology/animal/human functional evidence) for novel formulations or ingredients outside the catalogue; Filing (备案, 6-12 months) for vitamins/minerals from the published Health Food Ingredient Catalogue at catalogue doses. Both result in the distinctive blue health-food mark plus the registration/filing number (国食健字 for registered) on label and entry in the Public Health Food Database. The Health Food Function Claim Catalogue lists 24 approved health-function claims with NMPA-specified verbatim wording — claims outside the catalogue are prohibited regardless of evidence. Manufacturing under GB 31621 and GB 16740 with NMPA facility approval; labelling under GB 7718, GB 28050 and GB 16740 with full Chinese language label. Cross-Border E-Commerce (CBEC) is the alternative channel — Tmall Global, JD Worldwide, Kaola, Pinduoduo Global, Xiaohongshu, Vipshop Global and platforms in the Hainan free trade port — treating products as personal-import bypassing Blue Hat requirement provided the category is on the CBEC Positive List and the product has documented home-jurisdiction regulatory clearance. CBEC requires Chinese overlabel sticker, bonded warehouse fulfilment, and respects per-consumer purchase limits (CNY 26,000 single, CNY 50,000 annual). CBEC offers materially faster market entry (weeks vs months/years) and dominates international supplement brand China entry, with Blue Hat reserved for hero SKUs warranting registration investment.