Registration and Compliance of Food Supplements in China

1. The Chinese market for dietary supplements

2. Regulatory classification in China: one product = multiple options

Dietary supplements are regulated mainly by the State Administration for Market Regulation (SAMR) and its delegated agency, the National Medical Products Administration (NMPA), formerly the CFDA. Customs code classification and import controls are the responsibility of the Customs (GACC).

The Chinese authorities distinguish several categories:

• Food supplements and foods for special dietary use. These are often enriched with vitamins, minerals or other essential nutrients. Intended to support specific physiological functions such as digestion or immunity.

• Health foods (保健食品). They are nutraceutical products with validated functional claims. For example, boosting immunity or improving sleep. They are subject to mandatory registration with the NMPA.

• Foods with a nutritional purpose, including standard food products without specific claims. However, they may contain ingredients beneficial to health (fiber, omega-3, antioxidants, etc).

• Products for external use or “wellness” products. These are sometimes associated with functional cosmetics (slimming patches, joint care products). Although they may contain ingredients similar to dietary supplements, their method of administration and classification under the Food and Drug Regulations are different.

 

• An ordinary food product
• A dietary supplement
• A cosmetic product (if external application and beauty claims)
• Or a drug (if therapeutic claim or active medicinal ingredient).

Consequently, the choice of regulatory framework influences the level of requirements in terms of testing, registration, duration and associated costs. It is therefore essential to determine the precise category applicable, right from the start of the project.

2.1. Preliminary classification, an essential step

Before any action is taken, it is essential to determine which regulatory category a product is likely to fall into. A vitamin-based supplement, for example, may be classified as an ordinary food, a functional food or, if high dosage and therapeutic claims are involved, as a medicine.

Classification depends on several factors: composition, active ingredients, functional claims, galenic form (capsule, liquid, powder) and consumption methods.

Before exporting to China, it is also essential to verify the regulatory conformity of ingredients. The Chinese authorities distinguish between substances authorized in functional foods and those reserved for standard foods. Several official lists are regularly updated: catalogs of authorized ingredients, lists of prohibited substances, and lists of materials with dual status (food and medicine).

Some substances are also subject to daily dosage restrictions. Other criteria, such as the origin of an ingredient, the manufacturing process and the conformity of the claimed uses, may also come into play.

Naturally, products distributed in China must comply with Chinese GB standards. These vary according to the applicable regulatory category.

We strongly advise you to call on a specialized firm, familiar with Chinese regulations and in close contact with the relevant authorities, to carry out a preliminary classification of the product.

2.2. Two approval systems: notification or registration

• A declaration system for health food type products based on authorized ingredients. They are subject to a simplified declaration if the ingredients are pre-approved by the NMPA.

• An approval logic for innovative products or products with a claimed functional effect. They are subject to a full registration procedure, which must include (local) clinical trials, toxicological tests and inspection of the production site (for imported supplements).

Some brands initially opt for the cross-border e-commerce sales model to test the Chinese market without going through regulatory registration. However, this channel is subject to a restricted list of authorized products and quantity limits per consumer. Feedback from exporters remains mixed: high marketing costs, poor control over distribution and promotional consistency, risks of parallel imports... all factors that weigh on the profitability and continuity over time of export sales.

2.3. Registration procedures for imported supplements

Products imported into China must comply with several stages:

a. Translation and certification of technical documents (composition sheets, certificates, proof of overseas marketing, etc)

b. Conformity testing in a local laboratory accredited in China

c. NMPA registration for products classified as “health food”

d. Obtaining specific import licenses through Chinese customs

e. Customs declarations complying with the requirements of the China Import Food Safety Law.

 

Note: the time required for the complete registration process can vary from 6 to 24 months, depending on the complexity of the formula and the status of the manufacturer.

2.4. Marketing and labelling requirements

Labeling rules are strict and must include:

• Product name and recognized functions
• Detailed composition in Chinese
• Chinese approval or declaration number
• Official brand logo (for health food)
• Cautionary statements (use for specific populations, children, pregnant women).

Please note: marketing claims must strictly comply with the list of functions authorized by the health authorities. They must not make comparisons with drugs or suggest therapeutic effects. In China, an Advertising Law formally prohibits any misleading or exaggerated communication in the health field. This includes the abusive use of testimonials, medical formulations or guarantees of results. Tighter controls apply to e-commerce channels and social networks, which are currently being monitored by the authorities. The risks of denunciation by competitors or consumers are very real.

2.5. The specific segment of pet supplements

The market for supplements for pets (dogs, cats) or livestock is regulated separately by the Ministry of Agriculture and Rural Affairs (MARA).

All products must be registered as additives or functional feeds, and authorization from MARA is required prior to import.

Registration dossiers must include the complete formula, certificates of analysis, safety reports and, if required, local tests.

Imported supplements must be properly labeled in Chinese. The customs in China systematically carry out checks on entry. Some substances authorized in the West may be prohibited.

3. Specificities and requirements for local production in China

For foreign companies wishing to manufacture (or outsource) their dietary supplements in China, the regulatory framework offers certain advantages. It also imposes strict compliance requirements. Here is the logic that applies to the production of so-called sensitive products:

3.1 Site registration and required licences

Before any activity is launched, the company must officially register its manufacturing site with the local supervisory authority. This registration attests to the legality of the operation, and is a prerequisite for any license application or inspection.

Two types of license are generally required:

• A food production license (for humans or animals, as the case may be)

• A sanitary license, which confirms that the production facilities comply with the hygienic conditions required for the manufacture of food or health products.

If production is subcontracted to a manufacturer already established in China, he should have these licenses in good and due form. Finally, in the case of supplements considered as “health food”, an additional registration authorization with the NMPA may be required, depending on the targeted functional claims. See also our page dedicated to special licenses in China.

3.2 Compliance with local standards

Production must comply with strict safety, hygiene, quality control and traceability standards:

• Application of Chinese national standards for ingredients, additives, processes and packaging

• Implementation of a traceability system for raw materials and finished products

• Establishment of an HACCP or equivalent health risk management plan.
  
  

3.3 Ccomparative advantages over imported products

Unlike imported products, locally manufactured products can benefit from streamlined registration procedures:

• Lower logistics costs (and fewer customs steps if ingredients are imported).

• Shorter registration times for certain product categories, notably supplements declared as standard foods.

• Fewer checks on foreign documentation (certificates of origin, translations).

• The possibility of adapting products to Chinese tastes and consumption habits.
  
  
• And probably lower production costs and a competitive selling price.

When subcontracting production to a local manufacturer for an international brand, pay particular attention to the terms and conditions governing the granting or transfer of intellectual property rights (trademark, logo, patents, etc.). The contract should also include strict confidentiality clauses concerning the processes, formulas or know-how transferred, as well as non-competition and non-infringement undertakings. These measures are designed to prevent misuse or misappropriation of intangible assets by the subcontractor. It should be noted that the Chinese authorities are paying increasing attention to compliance with these contractual commitments.

4. Penalties and heightened controls in case of non-compliance

In the event of non-compliance with approval procedures or illegal importation, the penalties incurred will be:

• Confiscation of products in stock and immediate withdrawal from distribution
• Very high financial penalties
• And possibly blacklisting, as China's social credit system plays an increasingly important role in sustainable market access.

CONCLUSION The classification and registration of dietary supplements in China requires rigorous preparation and a well-adapted regulatory strategy. Support from a local partner or specialized firm is strongly recommended to anticipate bottlenecks, limit delays and avoid classification errors. By choosing a methodical approach that complies with established rules, companies can gain access to this fast-growing strategic market, under increasingly clear, but still demanding, conditions. [ Contact us to discuss your project in China ]