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.

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

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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