Regulations Impacting Natural Products in China : Understanding China's regulatory environment for n

Understanding China's regulatory environment for natural products

Mark J. Tallon, Ph.D.
04/17/2008

The Chinese economy is a true behemoth with an estimated $7.5 billion generated annually on dietary supplements and ingredients. The past five years have seen a dichotomy of favor develop around Chinese goods and services. A huge acceleration in economic demand for Chinese manufacturing was apparent; however, recent issues have raised concerns about safety and standards. Understanding the Chinese dietary supplement and food regulatory system can help companies navigate the country’s evolving natural products market.

The Chinese system of regulatory control in relation to foods, beverages, supplements and ingredients (FBSI) is no doubt complex. At present there are three main agencies that regulate the sale, manufacture and advertising of FBSI: the State Food and Drug Administration (SFDA), the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), and the Ministry of Health (MOH).

The SFDA regulates structure/function and health claims on dietary supplements and, in co-operation with the State Administration for Industry and Commerce (SAIC), oversees and governs the approval of advertising. This agency also handles GMP (good manufacturing practice) authentication of dietary supplement and raw ingredient facilities. SFDA and its branches examine dietary supplement advertisements before they are released. According to the Provisional Regulation on Health Food Advertising Examination, SFDA can stop any exaggerated dietary supplement advertising and punish those infringing the law through fines. According to the Regulation on Nutritional Supplement Claim and Examination, this agency can also kill any misleading claims that are not substantiated, claims to cure or treat disease, or are not within the 27 health functions/claims (i.e., “lower blood pressure”). The MOH classified the “health functions” of nutritional health products via the Food Hygiene Law of the People’s Republic of China and Health Food Administration Act. In 2005, SFDA took over the business of health food claim examination from MOH; however, the functions have not changed.

The second main agency is the AQSIQ, which controls the quality, safety, import and export of dietary supplements and raw ingredients. AQSIQ played a key role in cooperation with the U.S. FDA and U.S. Congressional delegation in addressing the food safety issues facing the country in 2007. By enforcing the Food Hygiene Law and Quality Law of the People’s Republic of China, this agency can inspect any manufacturer’s facility of dietary supplements or raw ingredients. According to the Standardization Law of the People’s Republic of China, trade associations such as the China Health Care Association or the China Chamber of Commerce for Import & Export of Medicines & Health Products have the responsibility to develop manufacturing and quality standards for dietary supplements or raw ingredients. Following their development, the standards are submitted to AQSIQ as a guideline for enforcement. According to Law of the People’s Republic of China on Import and Export Commodity, AQSIQ can also inspect and quarantine any dietary supplement or raw ingredient for import and export purpose.

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