Imported Health Food Filing in China: The Best is Yet to Come

As a burgeoning and thriving health food market, China witnessed a lot of new overseas health food brands grow and develop. Since China introduced dual-track system for imported health food in 2017, qualified imported products are allowed to enter the market by product filing, a channel with the lower access barrier comparing product registration, and  every year dozens of products gained the filing approval to enter the market. Nevertheless, compared with domestic health food brands, obviously, there's more can be expected for overseas health food brands.

1. Imported Health Food Filing in 2021 

In 2021 alone, 23 imported health food products obtained filing approvals, adding the total number of products with filing approvals to 159. Check China Imported Health Food Filing Directory for more information.

The 23 imported health food products come from five countries. Among them, the all 12 Canadian products are from two brands, Jamieson and Nutricorp. Japan’s FANCL and I.B obtained 2 and 6 filing approvals, respectively. Besides, AusNatures from Australia, Good Health from New Zealand, and NutrioneLife from South Korea each successfully obtained 1 filing approval. 

Among the 23 products, 2 are capsules and the rest are all tablets. Vitamin B was the most used nutrient, being added in 7 products, followed by vitamin C, iron, calcium and vitamin D.

Note: The data is from Center for Food Evaluation, State Administration for Market Regulation. Due to the lag of information release by the competent authority, the current number of filing approvals may be inconsistent with the data above.

2. More to be Expected

Despite every year witnessed dozens of imported health food products passed the filing application, the number is still tiny especially comparing to Chinese domestic products. Actually, with more favorable regulatory polices keep emerging, overseas brands are able to find more opportunities to get their products filed, thereby seizing a much broader offline market in China. 

For example, SAMR published "Dosage Forms and Technical Requirements for Health Food Filing (2021 Edition)" and "List of Auxiliary Materials for Health Food Filing and Terms of Use (2021 Edition)" in early 2021, making it possible for imported health food in the form of gelatinized confection or powder to obtain filing approval. At present, most imported health food products with filing approval are either tablets or capsules. With more dosage forms permitted for filing, diverse imported products can enter the Chinese market easily. Gummy supplement is considered as a perfect example, check here to learn why gummy supplement is the next promising sector for overseas manufacturers.

Furthermore, at the end of 2021, SAMR released the draft of "Health Food Raw Materials Directory - Nutrient Supplement (2022)" and "Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplement (2022)". China plans to add four food ingredients into the raw material directory for nutrient supplement, including new sources of calcium, folic acid and DHA. Since DHA was listed in this directory, "supplement n-3 polyunsaturated fatty acids" was added as a new health function for nutrient supplement correspondingly. Once the two drafts are approved, it means imported products can use these four ingredients and the new claim for health food filing. With the regulatory efforts on reducing barriers to market access, enterprises are given greater space on the production of health food products, and more products become qualified for filing, which are bound to help enterprises obtain more filing approvals in the future.

3. Benefits and Challenges for Imported Products Filing 

To be sure, Cross Border E-Commerce (CBEC) is a good platform and opportunity for overseas health food brands. However, the implementation of the filing system leads a path for these brands to a broader market and thus to achieve greater influence. Industry experts pointed out¹ that overseas health food brands should try to develop both CBEC and the general trade (filing) channels in a balanced way. In the long run, the two channels should be integrated and complementary. CBEC may be more suitable to be used as a channel for new product to enter the market, especially some high-end niche products, while general trade is more welcomed by mature and popular health food products. 

As per the filing data, a huge gap exists between the filing number of domestic and imported products, which can be attributed to the difference of application numbers, review period, etc. However, in terms of application requirements, actually there is no essential difference between domestic and imported products in the application process and required tests of the same product. Though product filing is definitely a route for overseas brands to conquer a larger market, they also have to face the challenges and obstacles in the filing process:

• Thorough understanding of laws and regulations: there are many complex laws and regulations related to the filing of health food. Only specialists who are very familiar with the laws and regulations can fully understand, plan reasonably and avoid detours as much as possible.

• Rich experience and communication skill: when it comes to detailed requirements in the regulations, some unwritten requirements may not be stated or explained clearly in the regulations. Only specialists who have relevant filing experience and strong communication with both applicants and competent authorities can cope with those details.

• Close tracking of regulatory dynamics: the regulatory climate keeps changing and improving in China. The regulations are adjusted and updated from time to time. Any lag may waste the previous efforts.

To overcome the above, overseas health food enterprises must spend a lot of efforts, and thereby the vast majority of them choose to entrust domestic agencies to handle the filing matters. ChemLinked and its founder, Reach24H, have jointly launched the health food filing service. With professional expertise and reliable service, we expect to help overseas health food & supplement brands to grow in China. Reach out to us at contact@chemlinked.com.