The draft, which was approved by the National People’s Congress, covers overall food safety in China, including regulations that oversee the country’s burgeoning supplement and nutrition industry.
At its current rate of growth, China has the potential to become the world’s largest market for dietary supplements and nutritional food ingredients, especially as it has the largest consumer base in the world.
According to Jeff Crowther, executive director of the US-China Health Products Association, China’s Ministry of Health has been positioning the healthcare system towards a more preventative system, with supplements gaining greater prominence.
“The authorities have also been encouraging the move from an export-driven economy to a consumption-based one. Dietary supplements are consumer goods and fit nicely with increasing domestic consumption,” Crowther said.
“The Chinese are among the most health conscious people in the world. With centuries of natural based therapies, with traditional Chinese medicine, massage, and herbal and food therapy ingrained in their culture.
“Unfortunately, the regulations [until now] have been keeping the industry at bay and have essentially been stalling the explosive growth of the industry that one would expect.”
Less time and cost
Crowther, whose association has been urging Chinese authorities to allow consumers the same access to dietary supplements that the US and other countries offer, says the draft reform shows that China’s National People’s Congress has been listening to the many pleas for change from industry groups, companies and consumers.
Among the most important changes in the draft are articles 65 and 66, which refer to the status of health food products in China.
According to Article 65: “For health foods imported to China for the first time, these products should be approved by the administrative sections in the exported country (or region).”
Labels will also be required to state clearly that “this product does not have the functions of disease prevention and treatment”.
Article 66, meanwhile, suggests that importers of certain supplements will be allowed to record their products with China’s Food and Drug Administration—a significant improvement on the existing law, which requires all so-called “health food” importers to apply for “blue hat” certification, with in turn takes time and great expense.
However, the proposed changes will only affect a small percentage of the products attempting to enter the market. For example single ingredient vitamin and minerals products will not have to go through testing and their manufacturers will simply have to notify China FDA. Products containing more than two ingredients, though, will most likely have to go through the current blue hat registration system.
“This is a great move in the right direction,” said Crowther. “But they will have limited effect on many of the companies and products that are attempting to be sold in China. For example most American and other imported products have more than one ingredient in the formula. They are also at potency levels that are too high for China FDA standards.
"What these reforms are doing is creating a notification system which is what we have been advocating for since 2010. Once the notification system is in place the industry can continue to share information with China FTA to encourage the expansion of any ingredient approval list as well as formulas and potency levels. So basically there's a crack in the door and we the industry should firmly plant our foot in it."
Companies and the public can comment on the draft until July 31.