Health Supplement Regulations in China

Blue Hat registration is administered by the State Administration for Market Regulation (SAMR) through the National Medical Products Administration (NMPA). Products that complete registration receive approval to display the distinctive blue hat logo on their packaging — a trust signal for Chinese consumers that indicates government review and approval.

Without Blue Hat registration, supplements cannot be sold through any domestic channel in China. Not retail stores, not pharmacies, not domestic e-commerce platforms like Tmall Classic or JD.com. There are no exceptions and no shortcuts.

The registration process requires a comprehensive product dossier including: complete formulation with all ingredients and quantities, raw material specifications, manufacturing process documentation, quality control procedures, stability testing data, safety assessment documentation, and efficacy evidence for any health claims. All documentation must be in Chinese, prepared according to Chinese regulatory formats.

Products must undergo testing at Chinese-accredited laboratories only. Foreign lab results — even from highly respected institutions — are not accepted. Testing includes safety evaluation (toxicology, heavy metals, microbiology), functional testing for claimed benefits, stability testing under Chinese conditions, and component verification.

For foreign manufacturers, Chinese authorities may also require facility inspections. Inspectors verify that manufacturing conditions meet Chinese standards and that the facility can consistently produce the registered formulation.

China's health food regulatory system has two tracks for market access: registration (注册) and filing (备案). The distinction is based on product type and ingredients.

Filing (simplified path) applies to products that only supplement vitamins, minerals, and other nutrients listed in the Health Food Raw Material Directory. As of 2023, this directory includes 85 approved ingredient combinations. Filing also covers products using any of the 10 functional raw materials approved for notification (including coenzyme Q10, melatonin, spirulina, fish oil, whey protein, and ginseng). The filing process is faster — typically 6-12 months — and does not require clinical trials.

Registration (full path) applies to products that make specific functional health claims (27 approved health function categories, such as immune support, memory improvement, or fatigue reduction) or that contain ingredients outside the approved catalogue. Registration requires the complete process described above: Chinese lab testing, potentially clinical trials, and full SAMR review. Timeline: 2-5 years.

For imported health food, both filing and registration must be submitted to SAMR at the national level. Domestic products file at the provincial level. In both cases, the applicant must be either a manufacturer or a legally authorized representative in China.

The filing path has become significantly more accessible since 2023 with the expansion of the raw material directory. But for foreign brands with functional products — which is most premium supplement brands — the full registration path remains the only domestic option.

Cross-border e-commerce (CBEC) allows foreign brands to sell directly to Chinese consumers through platforms like Tmall Global without a Chinese business entity and without domestic product registration. The legal basis: products sold via CBEC are classified as personal imports, purchased by individual Chinese consumers for personal use.

This classification means CBEC products are exempt from Blue Hat registration, exempt from Chinese labelling requirements (you can sell in your original international packaging), and subject to a different, lower tax regime. Instead of standard import duties plus 13%+ VAT, CBEC products pay a 9.1% comprehensive tax (calculated as 70% of the standard VAT rate, with import duties waived).

For health supplements, CBEC exemption is particularly significant because it bypasses not just the registration paperwork, but the clinical trial requirement entirely. Your existing home-market certifications — EU food supplement notification, FDA registration, Australian TGA listing, or Health Canada NPN — are sufficient for Tmall Global.

The mechanics: products are shipped from your home country to a bonded warehouse in a Chinese Free Trade Zone. Goods remain legally outside China's regulatory regime until a consumer purchase triggers instant customs clearance. Delivery to the customer takes 1-3 days. About 70% of CBEC supplement sales use this model; the remaining 30% use direct international shipping (7-15 days delivery).

CBEC is not, however, completely unregulated. Products must be legally sold in their home market, must comply with Chinese advertising law (you cannot make health claims even via cross-border), and must appear on the CBEC Positive List.

China's Advertising Law applies to all supplements sold in China — including cross-border products. The rules are stricter than most foreign brands expect, and violations carry real penalties including fines, product delisting, and store suspension.

You cannot claim that supplements treat, cure, or prevent diseases. This includes indirect claims, implied claims, and testimonials that suggest therapeutic effects. Phrases like "boosts immunity," "prevents cancer," or "treats insomnia" are prohibited in marketing materials, product pages, and customer communications.

Only Blue Hat-registered products can display approved health function claims — and only the specific claims approved during registration. Cross-border products cannot make functional health claims at all, even if those claims are legal in their home market.

What you can do: describe ingredients and their general nutritional properties, reference scientific research (carefully), explain manufacturing processes, highlight certifications and quality standards, and share customer reviews (as long as they don't make health claims). The emphasis should be on ingredient quality, sourcing, manufacturing standards, and brand heritage rather than health outcomes.

This is an area where many foreign brands make costly mistakes. Marketing copy that's perfectly legal in the US or EU can trigger violations in China. Have all Chinese-facing content reviewed for advertising law compliance before publication.