The first of the documents comes under the banner of “Administrative regulations for nutritional supplements”, while the second covers the “Information requirement for nutritional supplements”. Both are under the remit of the China Food and Drug Administration.
First step in modernising system
The draft documents deal with the implementation of a notification or recording-type system for nutritional supplements, which are defined as vitamins and minerals.
“This is China’s first step towards modernising its health food industry and is the result of consistent engagement and information sharing from groups like US-China Health Products Association,” said the USCHPA’s executive director, Jeff Crowther.
Since 2010, the association has been publishing annual dietary supplement industry position papers, which it has shared with the CFDA and State Council, as well as the National People’s Congress Legislative Office.
“This is a new category called ‘nutritional supplements’, which at this point only includes vitamins and minerals. All other supplements will still have to go through the current very strict ‘blue hat’ registration system, which takes two to three years to complete, and costs close to US$100,000 per SKU,” said Crowther
He believes that it will take until next year before this new category of nutritional supplements is implemented.
“It is a step in the right direction and there will be further development in the years to come. China is taking this industry very serious and is conservative in its approach,” said Crowther, adding that the USCHPA is in the process of reviewing the documents before making a formal comment on their contents.
Regulatory overhaul
The new draft is part of a wider-reaching exercise by food authorities to reorganise their notoriously Byzantine regulations on product approvals across the health foods segment, the results of which are expected before the end of this year in a final regulatory document.
The process has witnessed Chinese officials engaging with overseas regulators for the first time, an indication that they understand the need for reform to promote the wider importation of high-quality products that are proven in other markets, Crowther believes.
However, although the overall draft regulations, released earlier this year, look like an improvement over the current system, industry watchers suggest they could go further as the CFDA’s position on risk assessment would require products with multiple ingredients to go through registration. As a result, they would not be eligible to proceed through this new draft notification system.
These regulations are also forcing Chinese ingredient suppliers to rely heavily on export-orientated business strategies due to the lack of domestically produced dietary supplements, said Crowther.
“If the regulations become more open and transparent moving towards 100% notification, there would be many more opportunities for both foreign and domestic ingredient suppliers to sell to Chinese manufacturers of dietary supplements.”