Recently, the State Administration for Market Regulation(SAMR), in conjunction with the National Health Commission and the State Administration of Traditional Chinese Medicine, issued the "Health Food Raw Material Catalog Ginseng", "Health Food Raw Material Catalog American Ginseng", "Health Food Raw Material Catalog Ganoderma" (hereinafter referred to as the three catalogs), and the accompanying explanatory documents, which will come into force on May 1, 2024 .
The names and sources of ginseng, American ginseng and Ganoderma lucidum, which are included in the catalog of raw materials for health food filing, are consistent with the contents under the same varieties in the current Chinese Pharmacopoeia.
According to the provisions of the three catalogs, the raw materials included in the catalog of raw materials for health food products for the record can only be used as a single raw material, and cannot be used in combination with other raw materials; for raw materials with multiple varieties of sources, the varieties to be used should be clearly defined for the record of the products.
The existing registered health food products with ginseng as raw material are relatively more, and the relevant regulations on the growth period of ginseng have been the hotspot of industry concern. The SAMR has commissioned the Institute of Medicinal Plants of the Chinese Academy of Medical Sciences and other scientific research institutions to carry out research on the inclusion of ginseng in the directory of raw materials for the record of health food products, and has organized various regulatory authorities to study and judge the issues of ginseng's life span that the industry has focused on in the draft, and has ultimately determined that the life span of ginseng for the record of the product is in line with that of the currently registered product. The SAMR summarized the technical review of registered products using ginseng as raw material in the past, and through the organization of technical and management experts in the traditional Chinese medicine industry, determined the source of raw material and safety indexes, and put forward the idea of the future regulation of filed products made of traditional Chinese herbal medicines as raw material.
The inclusion of the three raw materials of American ginseng, ginseng and ganoderma in the catalog of raw materials for health food filing will bring affects in the following aspects:
1. It helps to standardize the relevant health food market and ensure the safety and effectiveness of health food. By stipulating the names and dosages of the raw materials and their corresponding efficacy, the catalog of health food ingredients for record can protect the rights and health of consumers.
2. It will prompt health food manufacturers to pay more attention to product quality in the production process. Manufacturers need to follow the prescribed dosage and efficacy of the production, otherwise it will not pass the record.
3.Consumers can learn about the raw materials, dosage and corresponding efficacy of the products according to the catalog of raw materials for health food filing, so that they can better choose the health food that suits them. This helps to protect consumers' right to know and choose.
4. It provides regulatory basis and guidance for the regulatory authorities, which helps to standardize the market order of ginseng, American ginseng and ganoderma health food products, and improves the efficiency and effectiveness of the regulatory work.
5.Provides guidance and support for relevant enterprises, which is conducive to promoting the healthy and orderly development of the whole industrial chain from cultivation to plant extracts to end products. Enterprises can choose suitable raw materials for production according to the catalog and improve the market competitiveness of their products.