Analysis on the Filing Status of Health Food (Dietary Supplement) in 2022 in China

In order to help enterprises better understand the filing status of health food (dietary supplements) in China, we have gathered statistics on the health food approved in 2022 and analyzed the data from multiple perspectives.

Filing Status of Health Food in China

According to the information released by the Special Food Information Query Platform, in 2022 (as of December 31), a total of 3,343 health foods obtained the filing certificates, of which 3,336 were domestic health foods and the remaining seven were imported health foods (detailed information is shown in Table 1).

Table 1. Filing Information of Imported Health Foods

Filing Status of Health Foods in Different Regions

The number of approved domestic filings for health food is varied in different regions in China. Shandong has the largest number with a total of 772 products obtaining filing certificates. Guangdong and Anhui rank second and third place with 482 and 354 respectively.

Filing Status of Health Foods at Different Enterprises

There are 589 domestic health food manufacturers that have obtained health food filing certificates. Weihai Baihe Biotechnology Co., Ltd. has the largest number of approvals, with a total of 136 filed products, followed by Hubei Kangencui Pharmaceutical Co., Ltd. and China Resources Shenghai Health Technology Co., Ltd., with 86 and 71 filed products, respectively.

Filing Status of Health Foods 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 1,564 – accounting for 46.9% of the total. Soft and hard capsule filings total 1,127, with soft capsule products (781) outnumbering hard capsule products (346). In addition, the quantity of oral liquid (including drops) and granule products are 148 and 140 respectively. Among oral liquid products, there are only 12 drop products.

Powder and gelatin candy (gummies) are new dosage forms that have only been available for filing since June 1, 2021, and 239 and 118 products respectively received the filing certificates in these two dosage forms in 2022.

Filing Status of Health Foods in Different Functional Ingredients

Among the filed domestic health foods in 2022, there are 2,131 nutrition supplements, accounting for 63.9% of the total. The remaining 1,205 functional health food use broken ganoderma lucidum spore powder, coenzyme Q10, melatonin, fish oil, or spirulina as single raw material. Among the nutrition supplements, the products with the function of supplementing a single nutrient and supplementing multi-vitamins & minerals are greater in quantity, 808 and 800 respectively, followed by products supplementing two nutrients (523 products are filed).

Among the domestic filed products, the most popular nutrition supplements are Vitamin C supplements, Calcium & Vitamin D supplements, and Multi-vitamins & minerals supplements, at 355, 207, and 509 respectively.

The functional health food with broken ganoderma lucidum spore powder, coenzyme Q10, melatonin, fish oil, or spirulina as the single raw material have been transferred to filing supervision on June 1, 2021. Their filing numbers are 411, 311, 244, 192, and 47 in 2022 (as of December 31).

Note: Nutrition supplements with less than 5 products are classified as “Others”.

CIRS Comments

Starting from June 1, 2021, domestic health foods that use broken ganoderma lucidum spore powder, coenzyme Q10, melatonin, fish oil or spirulina as the single raw material can apply for filing in China (domestic products only). At the same time, gelatin candy and powder have been added to the approved dosage forms for filing products. The implementation of these regulations enables companies to make better choices of raw materials, function claims and dosage forms for filing products.

On December, 20 2021, SAMR issued three drafts, including Health Food Raw Materials Directory of Nutrition Supplement (2022 version) (Draft). This means that more raw materials, including DHA, soy protein isolate, and whey protein, will be added to the list of health food raw materials.

On October 25, 2022, SAMR issued the draft on Health Food Raw Material Directory of 3 active ingredients (Panax ginseng C.A. Meyer, Panax quinquefolium L., and Ganoderma) and related Technical Requirements. As one of the raw materials mentioned above, “DHA” was added into the “Directory of Nutrition Supplements” since its function ("supply n-3 polyunsaturated fatty acids") is within the scope of “supply nutrients”, based on which, we expect that overseas enterprises will also be able to apply for the filing of DHA products in the future.

As for the health food made of soybean protein isolate, whey protein, Panax ginseng C.A. Meyer, Panax quinquefolium L. and Ganoderma, we expect that the filing scope may be similar to the filing of coenzyme Q10, which means only domestic products have access to filing while the overseas need to apply for health food registration.

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 in the public view, and inject 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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Further Information

Analysis on China Health Food (Dietary Supplement) Filing Products from 2017 to 2021