NMN Included! National Health And Medical Commission Accepts New Varieties Of Food Additives!
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Recently, the National Health and Medical Commission issued an announcement that it has accepted the application for NMN (β-nicotinamide mononucleotide) as a new food additive.
NMN (β-nicotinamide mononucleotide) is a naturally occurring biologically active nucleotide that exists in various organisms and can also be used as a cosmetic raw material.
Previously, Hu Jiqiang, chairman of Conba Group, as a representative of the National People's Congress, put forward the "Suggestions on Strengthening the Research and Development of New Anti-aging Food (Drug) Products to Support the Healthy Development of Related Industries", and the State Administration for Market Regulation responded to this suggestion. For details, see Down.
Reply to Recommendation No. 1067 of the Fourth Session of the Thirteenth National People's Congress
Representative Hu Jiqiang:
Your "Suggestion on Strengthening the Research and Development of New Anti-aging Food (Drug) Products and Supporting the Healthy Development of Related Industries" has been received, and the reply is as follows:
Your suggestion introduces in detail the mechanism of action, industrial distribution, and development status of new anti-aging related products using NMN (β-nicotinamide mononucleotide) as raw material, and proposes to accelerate the use of NMN and its anti-aging effect Suggestions such as mechanism research, guiding enterprises to include NMN in the catalog of new food raw materials and health food raw materials, and encouraging scientific research institutions to develop new anti-aging products reflect your extensive attention to the frontier fields of life sciences, which will be of great help in promoting new anti-aging products. The development of products and related industries is of constructive significance.
After literature and data inquiries, the NMN products sold on cross-border e-commerce in my country mainly come from the United States, Canada, Japan, Germany, Australia, Switzerland, Hong Kong, China and other countries and regions. my country is currently in the research stage. The China National Institute of Standardization and the China Academy of Inspection and Quarantine have the ability to carry out NMN-related research, including the use history, safety, functionality and function claims of NMN at home and abroad. The China National Institute of Standardization developed a method for the detection of NMN in food raw materials based on hydrophilic interaction chromatography (HILIC), and prepared a high-purity NMN product with a purity of 97%. The Chinese Academy of Inspection and Quarantine can carry out the research and establishment of NMN composition and content detection methods, as well as raw material and product stability tests, toxicological safety evaluation tests, health function evaluation animal tests, etc.
1. About health food function evaluation and health function catalog management
According to the "Food Safety Law of the People's Republic of China" and "Health Food Registration and Record Management Measures" and other laws and regulations, health food claims of health functions should have scientific basis. For health food registration, the health function demonstration report of the product should be submitted, mainly including: the main ingredients of the formula have functions, the principle of product composition, the compatibility of product formula and the dosage have the basis of domestic and foreign experimental scientific literature. Focus on clarifying the functional components and content of the raw materials used, product health function tests and crowd use evaluation materials, etc.
According to the "Administrative Measures for the Catalog of Health Food Raw Materials and the Catalog of Health Functions", for NMN that has corresponding health functions after research, relevant units or individuals are allowed to put forward suggestions to be included in the catalog of health functions. It is suggested that the name, explanation, mechanism, basis and research report of the health function should be provided, specifically including: analysis of the health needs of the population of the health function, analysis and review of the health function and the health effect of the body; research materials such as the principle basis and scope of application of the health function test ;Health care function evaluation methods and judgment standards, corresponding sample animal experiments or human food test and other functional test reports; relevant scientific literature basis and other materials for the research and application of the same or similar functions at home and abroad. The review agency conducts technical evaluation on the proposed materials to be included in the health function catalog and makes a technical evaluation conclusion. The State Administration for Market Regulation shall review the materials submitted by the review agency to be included in the health function catalog. The Committee and the State Administration of Traditional Chinese Medicine shall publish the list of health functions included in a timely manner.
2. About the management and safety assessment of health food raw material catalog
According to the "Administrative Measures for the Catalog of Health Food Raw Materials and the Catalog of Health Functions", the inclusion of NMN in the catalog of health food raw materials should meet the following conditions: it has a history of consumption at home and abroad, the safety of the raw materials is definite, and it has been used in approved and registered health foods; the raw materials correspond to Efficacy has been included in the current health care function catalogue; product technical requirements such as raw materials and their dosage range, corresponding efficacy, production process, and testing methods can be standardized to ensure the consistency of product quality filed according to the catalogue.
At present, the positioning and safety of NMN as a food raw material are not yet clear, and there is a lack of national food safety standards. It is recommended to carry out safety assessments based on new food raw materials or clarify national food safety standards. NMN and related products have not yet been registered as health food in my country, and the conditions for NMN as a raw material for health food are not yet mature, and further monitoring and research are needed.
3. Relevant regulations on formulating NMN food safety standards
Food safety standards are an important technical support to ensure food safety, public health and life safety, and an important basis for food safety supervision. According to the "Food Safety Law of the People's Republic of China", the national food safety standards are formulated and promulgated by the health administrative department of the State Council in conjunction with the food safety supervision and management department of the State Council. National food safety standards shall be reviewed and approved by the National Food Safety Standard Review Committee organized by the health administrative department of the State Council. For local specialty foods, if there is no national food safety standard, the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government may formulate and publish a local food safety standard, and report it to the health administrative department of the State Council for the record. At the same time, the state encourages food production enterprises to formulate enterprise standards that are stricter than national food safety standards or local standards, apply to the enterprise, and report to the health administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government for the record. At present, our bureau is cooperating with the National Health and Health Commission to prepare the "Fourteenth Five-Year Plan" Food Standard System Construction Plan, taking into account food safety standards and quality standards, national standards and local standards, and at the same time clarifying the food categories and application of new food raw materials. food safety standards.
4. Relevant policies on the research and development of new drugs
NMN declared drugs should be registered and approved by the State Food and Drug Administration. In October 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices" (Tingzi [2017] No. 42), further proposing to reform clinical trial management and speed up listing review. Evaluation and approval, promoting drug innovation and generic drug development, strengthening the life cycle management of drugs and medical devices, improving technical support capabilities and reform opinions, including optimizing clinical trial approval procedures, accelerating the review and approval of urgently needed clinical drugs, supporting the clinical application of new drugs, improving technology Review system, strengthening review and inspection capacity building and other reform measures. After the release of the document, the State Food and Drug Administration, together with relevant departments, conscientiously implemented the relevant requirements of the document, and further promoted the reform of the drug review and approval system. In July 2020, the "Measures for the Administration of Drug Registration" was revised and implemented, fully absorbing the reform measures that have been proven effective through reform practice, and forming a long-term mechanism to encourage drug innovation. In December 2020, the State Food and Drug Administration issued a notice on the "Administrative Measures for Communication and Exchange of Drug R&D and Technical Review", providing applicants for drug registration with a variety of active communication channels such as face-to-face meetings, video conferences or written replies, especially Pay attention to the communication in the clinical application and marketing application stages in the process of innovative drug research and development. The State Food and Drug Administration will pay close attention to the needs of patients, and speed up the review and approval of innovative drugs on the basis of ensuring the safety, effectiveness and quality control of approved drugs.
V. Strengthening the research and supervision of NMN-related products
According to the "Food Safety Law of the People's Republic of China" and "Drug Administration Law of the People's Republic of China", NMN has not obtained new food raw materials, food additives, health food and drug licenses in my country, and cannot be used as food and medicine for production and operation. Food production and the use of new food raw materials to process food should strictly implement the "National Food Safety Standards Standards for the Use of Food Additives" (GB 2760), the "National Food Safety Standards for the Use of Food Nutritional Fortifiers" (GB 14880) and other standards and relevant new food raw materials. According to the regulations, it is strictly forbidden for production enterprises to illegally use non-food raw materials to produce food, and to strictly investigate and deal with illegal additions. At the beginning of this year, the State Administration of Market Supervision organized provincial market supervision departments to investigate the illegal operation of "elder medicine" with NMN as the main ingredient in the jurisdiction according to law, and seriously investigated and dealt with relevant illegal sales.
In the next step, the State Administration for Market Regulation will work with the National Health Commission, the State Food and Drug Administration and other relevant departments to support the basic research of NMN and related products, and guide the standardized development of NMN and related products.
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