Health foods filing in China: Only 40 out of 1,800 approved products were from international brands in 2020
This means that local China products made up the overwhelming majority (97%) of the approved products.
This is according to statistics compiled by China regulatory consultancy CIRS using information from the Center for Food Evaluation, State Administration for Market Regulation (SAMR), Special Food Information Query Platform.
Publicly available information from the market regulator of different provinces and cities was also considered.
Out of the 1,817 health foods approved via the filing track, only 40 were imported products, while the bulk of them (1,777) were domestic products.
The filing track requires companies to use raw materials listed in the Health Food Raw Materials Directory, which is made up of mainly minerals and vitamins.
This is a faster go-to-market strategy, where the product approval process usually takes months, whereas the alternative – the health foods registration track could take years to complete.
Out of the 40 imported products, most were multi vitamins and mineral supplements, followed by vitamin D, vitamin D plus calcium and B-vitamins supplements.
Geography wise, 26 were from the US, followed by six from Australia, four from Canada, two from Germany, one from Finland and Hong Kong.
Mega Health International from the US had 10 products approved, becoming the company with the highest number of approved products.
Vitamin World USA Corporation took the second place with six products, while Nature’s Bounty and Jamieson Laboratories each had four products approved.
Past records have shown that the number of imported health foods approved via the filing track has always been in small numbers.
CIRS pointed out that between 2017 and 2020, only 104 out of 5,000 over health foods approved via filing were from overseas companies.
This means that over 99% of the approved products were from China.
This is despite the fact that the filing track has less stringent requirements as compared to the registration track and is thus a popular method amongst local companies when introducing new products.
“CIRS believes that the main reason seen in the low rates of approval amongst imported health foods is because these [overseas] companies lacked understanding of China’s health foods regulations.
“[Thus], the documents [that they have submitted] did not satisfy the regulatory requirements and are thus unable to be filed successfully,” the consultancy explained.
Citing an article written by the SAMR, it added that documents that prove the imported products have been legally manufactured and sold overseas would be crucial when the regulatory assess the filling application.
“CIRS suggests overseas health foods enterprises to follow the regulatory requirements of China strictly, present the relevant documents as a proof, to avoid the risk of the such documentations not meeting the requirements.”
On the other hand, the consultancy said that new regulations, including the expansion of the Health Food Raw Material Directory from March 1 will allow firms a wider range of options when developing health foods. Products applied via the filing track will also come in more varieties.
Local China firm Biohigh took the top spot with 156 health foods approved via filing last year.
Wuhan Mai Xin Li was placed second with 45 products approved and Jiangxi HaoYu Biological Science and Technology was third with 42 products approved.
Region wise, health foods enterprises from the Shandong and Jiangxi province topped the list of health foods filing approval.
There were 399 and 266 products from the Shandong and Jiangxi approved via filing.
Most of the approved health foods from both local and overseas firms came in the form of tablets.
For local firms, two-thirds (1,068) of the approved health foods came in the form of tablets, which is further categorised into chewable (474), effervescence (100), swallow type tablets (426), and lozenges (68).
For overseas firms, 70% of the health foods were in the tablet form.
Out of the remaining 12 approved products, 10 were capsules and two were liquid.
In contrast to local products, no imported products came in the form of granules while 124 local Chinese products were in this particular format.
We will be shining the spotlight on China's 2020 health foods registration data tomorrow.