Regulations Impacting Natural Products in China

Understanding China's regulatory environment for natural products

Second class protection is applicable for products that meet the following criteria: conform to the provisions of Article 6 in these regulations, or having once listed under first class protection but now being cancelled; having outstanding curative effects for a certain disease; or effective substances and special preparations extracted from natural medicinal materials.

The period of first class protection is for 30, 20 or 10 years and second class is for seven years. The protection granted provides the prescription and pharmaceutical techniques shall be kept secret and not published. These regulations are in some ways like the article 13.5 claims available through the EU system, although the protection period extends beyond the five years of 13.5 claim approvals. There are some caveats to the granting of a certificate of protection, such as where a TCM may be required in a clinical (hospital) environment. If a TCM used for the treatment and cure of disease is in short supply, under article 19 (Chapter 4) of the regulation, the province with the shortfall may utilize a similar TCM including its pharmaceutical techniques and manufacturing, even if it has first class protection certificate.

Today’s Market

Over the past year, the biggest issues for Chinese health food industry have been combating corruption, reinforcing government administration, and ensuring quality and safety. Many SFDA high officials faced charges in 2007 due to corruption related to GMP authentication, drugs and health foods claim examination. The Chinese government reformed and re-structured SFDA, and many drugs and health foods were required to resubmit health/product claims. Many facilities were also required to resubmit evidence for GMP authentication. Following recent government reform talks, it appears likely the Chinese government will merge the MOH and SFDA.

For a long time, food, drug, dietary supplement and cosmetic administration has been a complicated issue in China. Several agencies were involved; however, poor administrative efficiency led to significant consumer unrest and mistrust, which has required restructuring and reform by the Chinese government.

The government evidently reinforced the administration on health food (including dietary supplement, functional food and cosmetic) advertising through the MOH and SFDA. The situation that functional food advertising can be released without any authority examination has significantly changed. Any health food advertising that want to be released should pass the provincial-level SFDA examination.

The examination scope includes: 1) words or expressions in the advertising that could cause consumers to mistake it for a drug or pharmaceutical; 2) words or artistic expressions in the advertising that directly or indirectly claim therapeutic functions; 3) words or expressions in the advertising that cite medical institutes, hospitals, doctors as substantiation; and/or 4) advertising content exceeding the functions and scope that MOH and SFDA had defined.

Andrew Liu, founder and chief consultant, Flacious Consulting Ltd. (China), noted, “Already these changes have reduced a significant number of legal advertisements as well as the re-writing of brochures and product labels. ... This change in stance by the Chinese government will help win back the consumer confidence and trust on health food and to ensure this industry to development towards the right direction.”

The Chinese market, already estimated at more than $30 trillion, is an exciting opportunity for both importers and exporters. As 2008 plays out, the Western market will refocus on the East and, in particular, a renewed China with tighter GMPs, HACCP and strong affiliations with U.S. and European standards organizations. While there is some continued thought that issues of quality are a Chinese problem, it is important to realize in an expanding global marketplace with tighter margins, attainment of high quality materials from China is a global issue that will require shared insights if the market is to thrive

Mark J. Tallon, Ph.D., is chief science officer of NutriSciences Inc., a London-based consultancy firm specializing in global health claim substantiation, product development and technical writing. For more information, visit NutriSciences.net.

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