Analysis on the Filing Status of Chinese Health Foods (Dietary Supplements) in the First Half of 2023

In order to help enterprises better understand the filing status of health food (dietary supplements) in China, CIRS gathered statistics on the health food approved in 2023 (as of June 30) and analyzed them from multiple perspectives.

Related Links

Statistics of health food registrations in the first half of 2023

China health food registraion and filing

Filing Status of Health Food in China

According to the information released by the Special Food Information Query Platform, in 2023 (as of June 30), a total of 1,969 health food obtained filing certificates, of which 1,953 are domestic health foods and 16 are imported health foods (detailed information is shown in Table 1).

Table 1. Filing Information of Imported Health Food

S.N.	Product Name	Applicant	Filing Number	Country
1	澳琳达牌叶酸胶囊	TAS MANIA PTY LTD	食健备J202300000001	Australia
2	澳琳达牌B族维生素片	TAS MANIA PTY LTD	食健备J202300000002	Australia
3	NZN®多种维生素片	ALPHA LABORATORIES (NZ) LIMITED	食健备J202300000003	New Zealand
4	古德海兹牌铁叶酸咀嚼片	Good Health Products Limited	食健备J202300000004	New Zealand
5	古德海兹牌钙维生素D软胶囊	Good Health Products Limited	食健备J202300000005	New Zealand
6	爱司盟牌叶酸片	ESMOND NATURAL, INC.	食健备J202300000006	America
7	爱司盟牌多种矿物质片	ESMOND NATURAL, INC.	食健备J202300000007	America
8	康麦斯®维生素C咀嚼片(甜橙味)	Kang Long Group Corporation	食健备J202300000009	America
9	康麦斯®钙咀嚼片(柠檬味)	Kang Long Group Corporation	食健备J202300000010	America
10	康麦斯®钙维生素D咀嚼片	Kang Long Group Corporation	食健备J202300000011	America
11	澳健莱®锌维生素C片	AUSNATURES PHARMACEUTICALS PTY LTD	食健备J202300000012	Australia
12	澳健莱®钙维生素D维生素K片	AUSNATURES PHARMACEUTICALS PTY LTD	食健备J202300000013	Australia
13	澳健莱®镁片	AUSNATURES PHARMACEUTICALS PTY LTD	食健备J202300000014	Australia
14	安菲斯尔牌钙镁维生素D胶囊	APEXEL CO., LTD	食健备J202300000015	Korea
15	澳世康牌B族维生素片	Nature's Care Manufacture Pty Limited	食健备J202300000016	Australia
16	澳世康牌镁锰多种维生素胶囊	Nature's Care Manufacture Pty Limited	食健备J202300000017	Australia

Filing Status of Health Food in Different Regions

The number of approved domestic filing health food is varied in different regions in China. Shandong has the largest number of filings and a total of 557 products obtained filing certificates. Anhui and Guangdong rank second and third place with 336 and 177 respectively.

Filing Status of Health Food in Different Enterprises

403 domestic health food manufacturers have obtained health food filing certificates. Weihai Baihe Biotechnology Co., Ltd. has the largest number of approvals with a total of 80 filed products, followed by Weihai Unisplendour Biotechnology Development Co., Ltd. and Hubei Kangencui Pharmaceutical Co., Ltd., with 62 and 61, respectively.

Filing Status of Health Food in Different Dosage Forms

At present, the permitted dosage forms for filing include tablets, capsules (hard/soft), oral liquids, granules, powders, and gelatin candy (gummies).

The main dosage form for domestic health food filing is tablets with 841, accounting for 43.1% of the total. The capsules include soft and hard capsules, accounting for 752 filings. The quantity of soft capsule products is far higher than that of hard capsule products, which are 562 and 190 respectively. In addition, the number of oral liquids (including drops) and granule products are 73 and 50 respectively. Among oral liquid products, there are only two drop products. The quantity of powder and gelatin candy (gummies) products are 150 and 87 respectively.

Filing Status of Health Food in Different Functional Ingredients

Among the filed domestic health foods in 2023, there are 1,252 nutrition supplements, accounting for 64.1% of the total. The rest are 701 functional health foods with broken ganoderma lucidum spore powder, coenzyme Q10, melatonin, fish oil or spirulina as single raw material. Among the nutrition supplements, products with the function of supplementing a single nutrient are greater in quantity, accounting for 523, followed by products supplementing multi-vitamins & minerals (411 products filed) and two nutrients (318 products filed).

Among the domestic filed products, the most popular nutrition supplements are Vitamin C supplements, Calcium & Vitamin D supplements, and Multi-vitamins & minerals supplements, which are 221, 132, and 238 respectively.

The functional health food with broken ganoderma lucidum spore powder, coenzyme Q10, fish oil, melatonin, or spirulina as the single raw material has been transferred to filing supervision on June 1, 2021. Their filing numbers are 221, 202, 128, 121, and 29 in 2023 (as of June 30).

Note: Nutrition supplements with less than three products are classified as “Others”.

CIRS Comments

On June 14, 2023, State Administration for Market Regulation (SAMR) issued four new regulations, including:

• Health Food Raw Materials Directory of Nutrition Supplements (2023 Version);
• Health Function Directory of Allowing Nutrition Supplement Claims (2023 Version);
• Health Food Raw Materials Directory – Soy Protein Isolate; and
• Health Food Raw Materials Directory – Whey Protein.

These four regulations will take effect from October 1, 2023. Compared with the current Raw Materials Directory, “DHA” is added to the Raw Materials Directory (2023 Version). As the function of this nutrient (“supplying n-3 polyunsaturated fatty acids”) is within the scope of “supply nutrients”, CIRS believes that overseas enterprises can also apply for the filing of DHA products. In addition, soy protein isolates and whey protein have become newly available raw materials for health food filing, whose filing scope of health food made of the two raw materials is expected to be applicable for domestic products only.

We believe that in the future, with the continuous expansion of the directory of health food raw materials and improvement of the dual-track system of health food, there will be more health food categories into the public view, injecting vitality into the Chinese market.

Note:

I. The data in this article is from the Special Food Information Query Platform.

II. There may be some omissions in the data of the Special Food Information Query Platform, thus the data in this article is for reference only, and please refer to the information published by the government.

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