Regulations Impacting Natural Products in China

Understanding China's regulatory environment for natural products

Although these agencies have specific roles, there is also interplay between them. For example, many imported health foods or dietary supplements are registered as foods in China as it is cheaper ($28,000 per year) and more expedient than registering dietary supplements or functional foods (up to $42,000 per year) via SFDA. Additionally, the examination for a dietary supplement license is very strict, with the need for animal testing on any final products. However, importers of finished goods would not go through SFDA for function product claims but rather AQSIQ for Food Labeling Authentication, and then the MOH for Food Sanitation License prior to any marketing throughout China. AQSIQ would continue to enforce Food Labeling Authentication via Regulation on Food Labeling Administration.

Raw ingredient producers generally register their businesses as pharmaceutical companies in China. SFDA controls the issue of pharmaceutical production license via the Pharmaceutical Production Administration Act, which means most companies first register their business at SFDA before SAIC. SFDA also regulates all food, drugs and cosmetics. Although SFDA plays an important role, it does not regulate the whole supply chain from start to end. Agencies such as AQSIQ, SAIC, MOH and the Ministry of Commerce (MOC) also participate in the administration and take control of the regulations they are charged to enforce. SAIC also governs the marketing activities of any end-products within the market, and helps combat fake and illegal products in a bid to protect consumers. Interestingly, the MOC is an entity that controls the issue of direct selling of nutritional products. Its remit is different from those granted through Pharmaceutical Production Licenses from SFDA as licenses granted from the MOC are for direct sale only and not through natural health stores or other traditional retail outlets.

Inside Tradition

There is no real working definition for dietary supplements from the Chinese market. However, there has been a definition for health foods encompassing dietary supplements and functional foods fortified with such nutrients as vitamin, minerals, coenzyme Q10 (CoQ10), herbs and Traditional Chinese Medicine (TCM).

The TCM market is well regulated and defined; however, as with many countries, it is more of an issue of enforcement. The TCM decree, or “regulations on the protection of types of traditional medicine,” was brought into effect within the People’s Republic of China on Jan. 1, 1993. The decree outlines 27 individual articles split over five chapters covering issues related to TCMs produced and manufactured within China. The articles provide direction on the registration of TCM and the protection the Chinese administrative department of Public Health under the State Council can grant. In brief, if an application on a TCM is approved, the State Council can issue a “Certificate of Protection of Types of Traditional Chinese Medicine”. The decision of approval is made by appointed experts in the medical service, scientific research, inspection, trading and management of TCM. This certificate can provide two types/classes of protections—first and second class—dependent on six conditions.

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