The State Administration for Market Regulation made the announcement on December 31 last year.
With the approval, they are added to Health Food Raw Material Directory. Raw materials in the directory could be made into health foods that come with health claims pre-specified by the authorities.
In this case, both ginseng and American ginseng products could claim to either “aid the strengthening of immunity” or “alleviating physical fatigue” or make both claims concurrently.
Products containing ganoderma could only claim the former.
The permitted daily dosage for ginseng is between one to three grams, 1.5 to three grams for American ginseng, and four to six grams for ganoderma.
Based on the announcement, the three ingredients could only be used to make single raw material formulation and could not be formulated with other raw materials.
Companies should also specify the breed of the raw materials used when submitting a health food filing. In this case, companies should ensure that the scientific name and breed of the raw materials used are in line with the Chinese Pharmacopeia.
The authorities also pointed out that products containing these raw materials are not suitable for children, adolescents, pregnant, and breastfeeding women.
The last time the Chinese authorities expanded the Directory was last October, where it officially allowed the use of soy protein isolate, whey protein, and DHA for health foods filing.
In China, health foods or health supplements need to undergo either the filing or registration process before they could be retailed in the country.
The filing process is faster and less costly, but companies could only choose raw materials that are listed in the Directory and make health claims pre-specified by the authorities.
Out the three raw materials mentioned, ginseng was the most used in health foods approved via the registration route in China, said the SAMR.
The authority added that the topic of “ginseng growth age restriction” has been a topic of concern to the industry. Some products in the market, such as South Korean brand Cheong Kwan Jang from Korea Ginseng Corporation, claim that ginseng is best grown for six years.
Based on consultations with research institutions, including The Institute of Medicinal Plant Development (IMPLAD), the industry, and regulatory departments, the SAMR said that the age requirement of ginseng used for health foods filing should be the same as that of health foods registration.
Moving forward, it plans to regulate the use of ginseng in health foods filings based on Traditional Chinese Medicine (TCM) standards.
Over 3,500 health foods filings approved in 2023
According to Hangzhou-based regulatory consultancy CIRS, a total of 3,632 health foods were approved in China via the filing route.
Of which, 36 of them were imported products, with 14 from the US, eight from Australia, seven from New Zealand, five from England, and one each from South Korea and Taiwan.
The remaining 3,596 were locally produced in Mainland China.
Most of the products were multivitamins and minerals products, while cracked ganoderma spores powder and co-enzyme Q10 were the more popular functional raw materials used in these products.