Recently, the State Administration for Market Regulation, together with the National Health Commission and the State Administration of Traditional Chinese Medicine, released the “Health Food Raw Material Catalog Ginseng”, “Health Food Raw Material Catalog American Ginseng”, “Health Food Raw Material Catalog Ganoderma” and supporting interpretation documents, classifying ginseng, American ginseng, Ganoderma lucidum is included in the health food registration raw material catalog (hereinafter referred to as the raw material catalog), and the name and variety source of its raw materials are stipulated to be consistent with the contents of the same species in the current “Pharmacopoeia of the People’s Republic of China”.
As a traditional Chinese medicinal material, ginseng takes a long time to be planted, has a low survival rate and has high nutritional value. It has always been known as the “King of Herbs”. American ginseng and Ganoderma lucidum are also two commonly used Chinese medicinal materials. With the development of social economy and the improvement of people’s health awareness, people’s demand for traditional tonics such as ginseng is increasing, and the number of health food products using ginseng and other raw materials is increasing. What does it mean when relevant departments publish three raw material catalogs? What impact will it have on the traditional Chinese medicine industry? Are there any changes in the regulatory approach to registered products using traditional Chinese medicinal materials as raw materials?
Accelerate the launch of health food raw materials of traditional Chinese medicine
Traditional Chinese medicinal materials are the source of the traditional Chinese medicine industry chain. Through different forms of intensive processing, the forms of products using Chinese medicinal materials as raw materials are becoming more and more diverse. In addition to traditional Chinese patent medicines and Chinese herbal pieces, in recent years, Chinese herbal medicines have become more and more widely used in health foods, special medical formula products, and ordinary foods with the same origin as medicine and food.
“This time, three varieties of Chinese medicinal materials have been included in the catalog of health food registered raw materials, setting a precedent that traditional Chinese medicinal materials can be used unilaterally in registered products as health food raw materials. This will greatly increase the speed of research and development of health food products with Chinese medicinal raw materials. It means that traditional Chinese medicine, as the most distinctive and advantageous ‘Chinese solution’ in the field of health food in China, is accelerating.” Dong Zhengqi, a researcher at the Institute of Medicinal Plants, Chinese Academy of Medical Sciences, said in an interview with a reporter from Science and Technology Daily that Chinese medicinal materials have entered the health food raw material catalog for the first time. , indicating that the country’s approval policy for health food is more relaxed and the market is more tolerant of health food. It is a powerful measure to promote the “dual-track” management of health food registration and filing.
Ginseng, American ginseng and Ganoderma lucidum are common traditional Chinese medicinal materials used in health foods. Previously, the production of health foods containing such Chinese medicinal materials required registration with the State Food and Drug Administration, which took a long time and the registration was only valid for 5 years. After being officially included in the raw material catalog, health foods using ginseng, American ginseng, and Ganoderma lucidum as raw materials can adopt the registration system, that is, companies only need to submit materials to the provincial food and drug supervision and administration department for registration. This will reduce costs for enterprises and save money and time for new product development.
Xiao Wei, a researcher at Guangdong Pharmaceutical University, said that the current food safety law stipulates that health foods implement a “dual-track system” of filing and registration approval. Health food raw materials and health functions are subject to catalog management. The raw material catalog defines the registration and filing channels. Those included in the raw material catalog can be filed directly. This means that products using these three types of Chinese medicinal materials as raw materials can be directly registered as health products, speeding up the launch of high-quality products and better meeting the needs of consumers.
However, the regulations for using Chinese herbal medicines in health foods and medicines are different in many aspects. Xiao Wei introduced that, for example, Chinese medicinal materials have different definitions in health foods and drugs. In health foods, Chinese medicinal ingredients are usually regarded as having functional activity, while in drugs, they are regarded as having pharmacodynamic activity. The approval procedures and application scope of the two are also different. The labeling requirements for Chinese herbal medicines used in health foods cannot involve functions such as disease prevention and treatment, while Chinese herbal medicines used in medicines can claim to have therapeutic effects on specific diseases.
“In general, there are certain differences in the regulations for the use of Chinese herbal medicines in health foods and drugs. Health foods emphasize regulating body functions, while drugs have the purpose of treating diseases. Whether they are health foods or drugs, they need to comply with relevant regulations. laws and regulations to ensure its quality and safety.” Xiao Wei emphasized.
Need to pay attention to the authenticity of raw materials of Chinese medicinal materials
Currently, there are many registered health food products using ginseng as raw materials. The relevant regulations on the growth period of ginseng have always been a hot topic in the industry. The catalog released this time shows that the ginseng used in health foods is artificially grown and is 5 years old or less. This is consistent with current requirements for registered products.
“The advantage of using Chinese medicinal materials as raw materials for health food is that Chinese medicinal materials have strong traditional Chinese medicine effects. Therefore, we must pay close attention to the authenticity of the raw materials of Chinese medicinal materials.” Dong Zhengqi said that compared with medicines, health foods have low-dose and long-term effects. Taking characteristics. When Chinese herbal medicines are used as health food raw materials, more attention needs to be paid to the safety indicators of exogenous pollutants such as pesticide residues, heavy metals, and mycotoxins.
In this regard, the raw material catalog clearly stipulates that the raw material names and variety sources of the Chinese medicinal materials included in the raw material catalog shall be consistent with the content under the same species in the current 2020 version of the “Pharmacopoeia of the People’s Republic of China”. The raw materials listed in the raw material catalog this time can only be used as single raw materials during product registration and cannot be used in combination with other raw materials. For raw materials that come from multiple sources, the varieties used should be clearly stated during product registration.
In terms of quality, ginseng, American ginseng and Ganoderma lucidum must be genuine, and inferior products or counterfeit products are not allowed; Chinese medicinal materials must be dry, free of impurities, insect-eaten and non-deteriorated and meet the pharmacopoeia quality standards. The raw material catalog also limits the active ingredients of ginseng, American ginseng and Ganoderma lucidum to ensure that their content reaches a certain standard, and stipulates the maximum dosage of ginseng, American ginseng and Ganoderma lucidum in health foods to prevent adverse reactions caused by excessive use.
Xiao Wei believes that ginseng, American ginseng, and Ganoderma lucidum are valuable Chinese medicinal materials. After being included in the raw material catalog, the name and variety source of raw materials will be stipulated to limit the use of informal and inferior raw materials in the health food market, which will help reduce false propaganda and low-quality products. . At the same time, by clarifying health function claims and raw material usage regulations, market transparency can be increased, which will help enhance the credibility and image of the health food industry and guide consumers to make reasonable choices.
Strengthening quality supervision is particularly important
As the Chinese herbal medicine market continues to expand, some non-standard Chinese herbal medicine raw material products have also begun to circulate, bringing potential risks to consumers’ health. Experts said that the inclusion of traditional Chinese medicinal materials in the catalog of health food raw materials is of great significance to standardizing the development of the Chinese medicinal materials industry. At the same time, it is particularly important to strengthen quality supervision.
In Xiao Wei’s view, currently, the supervision of registered products using traditional Chinese medicinal materials as raw materials still faces some challenges, such as inconsistent quality standards, inaccurate labels, and difficulty in tracing the origin. He suggested that verification of the source and quality of raw materials for Chinese medicinal materials should be strengthened. Regulatory authorities should review and file production companies that provide raw materials for traditional Chinese medicine to ensure that they comply with relevant laws and standards. At the same time, supervision of the planting, harvesting, processing, and circulation of traditional Chinese medicinal materials should be strengthened. It is also necessary to formulate regulatory standards and specifications, establish quality standards for traditional Chinese medicinal health food raw materials that are different from medicinal material standards, clarify the plant base and planting age of the raw materials, and set limits on index ingredients, pesticide residues and heavy metal residues.
“All parties must form a joint force to give full play to the main responsibilities of production enterprises and the supervisory responsibilities of relevant local departments to build a high-quality supervision system. Enterprises should strictly control the purchase of goods, strengthen the management of raw material procurement, be responsible for the quality of purchased raw materials, and actively establish Raw material traceability system. Regulatory authorities should also strengthen the qualification inspection of raw material suppliers during and after the supervision of production licenses, system inspections, etc., and gradually build a supervision system based on the inspection of ‘certificates’.” Dong Zhengqi added.
As a consumer, how should you choose health foods that use Chinese medicinal materials as raw materials? Experts suggest that you can pay attention to and give priority to companies whose raw materials of Chinese medicinal materials come from authentic areas, whose breeding and breeding meet the requirements of the “Good Manufacturing Practice for Chinese Medicinal Materials”, and whose raw material bases have passed green and organic certification or use green and organic planting technologies. product.