Immune support, alleviating physical fatigue dominated China’s health foods registration approvals last year

Out of the 421 new health foods approved via the registration route, over half of them (52 per cent) made the single claim of enhancing the immune system.

In China, health foods or dietary supplements containing ingredients not listed in the Health Foods Raw Materials Directory will need to be registered with the State Administration for Market Regulation (SAMR).

The registration process takes up a longer time and a higher cost as compared to the alternative – the filing process. The latter is applicable to products containing ingredients listed inside the raw materials directory.

Latest data compiled by Hangzhou-based regulatory consulting firm CIRS showed that a total of 1,445 health foods registrations were approved by the SAMR last year.

Of which, 421 are approvals for new products, while the remaining 1,024 are renewals of registration or changes in registration information for existing products. 

Out of the new products, 397 made only a single health claim, and 208 products, which is 52.4 per cent of them, had made claims related to immune health.

The second most common health claim is “assisting blood lipids reduction” –​​ a claim made by 64 products, followed by “antioxidative” – ​a claim made by 29 products, and “alleviating physical fatigue” – made by 28 products.

Twenty-three products made two health claims, with “enhancing immunity”, and “alleviating physical fatigue” ​the two most common claims.

Only one product made the claim of “supplying calcium, magnesium, vitamin D, and vitamin K”. ​

The total number of newly approved health foods in 2022 is higher than that of 2021, ​the report noted.

The consultancy believes that with the Detailed Rules for Technical Evaluation of New Functions of Health Food pilot trial​ announced last August, there would be more opportunities for product innovation in the future, as it provides a more detailed guidance and specifications for companies to register for new health foods functions.

Dosage formats​

Capsule, soft capsule, and tablet were the three most common dosage formats for new health foods approved via the registration route last year.

A total of 115 new products came in the capsule form, 108 in soft capsule, 81 in tablets, and 30 in oral liquid.

Others, including 27 of them came in granules form, 20 in powder, 14 are tea products, and seven were alcohol.

Companies ​

Contract manufacturer Sirio Pharma dominated the health foods registration approvals last year, having received eight registration certificates.

Beijing Wanshengtang Pharmaceutical Technology, Weihai Kangboer Biopharmaceutical, Nutryfarm (Chengdu) Biomedicine, and Qingdao Haizhisheng Biotechnology received five registration certificates each.