1 definition of health food health food or functional food, in a broad sense, refers to some non-traditional foods or their ingredients that make up people's usual diet. Consumers hope to strengthen their physique, improve their physiological functions and even prevent diseases by eating these health foods. Up to now, there is no unified definition of health food in the world, and the concept of health food is not the same because of the different cultural backgrounds between East and West. Article 2 of the Measures for the Administration of Health Foods promulgated by the Ministry of Health1June 35, 1996 stipulates that "the health foods mentioned in these Measures refer to foods with specific health care functions. That is, food that is suitable for a specific group of people, has the function of regulating the body, and is not aimed at treating diseases. " However, there is no official definition of health food or functional food in the United States so far. As far as its meaning is concerned, it covers a wide range, including familiar nutrients (such as vitamins, minerals, amino acids, etc. ) and non-nutritive ingredients in herbs or other plants. Therefore, in American health food stores, people can often see some products that combine nutrients and herbs. For example, there are five different capsules in one package, namely vitamins, b- carotene, garlic oil, ginkgo biloba extract and ginseng extract. 2 American Dietary Supplement Health and Education Act (1994) The United States has not promulgated any special laws or regulations on the management of health food or functional food. All foods are subject to federal food, drug and cosmetic laws. The law stipulates that general foods and ingredients shall not claim to have special functions; Of course, after sufficient scientific evidence and the approval of the US Food and Drug Administration (FDA), some health care functions can be marked on the label. For example, folic acid can prevent neural tube defects in newborns, and calcium can prevent osteoporosis, but it is not allowed to claim the efficacy of diagnosing or treating diseases. In order to clarify the management policies for the development, production and operation of more and more functional foods, the US Congress passed the Dietary Supplement Health and Education Act on1October 25th, 1994. The main contents of this law are as follows: (1) The US Congress recognizes that improving the health status of American citizens is the primary task of the federal government; There are more and more scientific reports about the importance of nutrition and the benefits of dietary supplements in promoting health and preventing diseases. The intake of certain nutrients and dietary supplements is related to the prevention of some chronic diseases, such as cancer, heart disease and osteoporosis. To this end, the federal government of the United States believes that while strictly preventing unsafe or shoddy products from entering the market, unreasonable management measures should not be taken to create obstacles for the listing of high-quality products; The ultimate goal of this law is to protect consumers' right to obtain safe dietary supplements. ⑵ Definition of dietary supplements: including vitamins, minerals, herbs or plants, amino acids, dietary substances used by people to increase their total dietary intake, and mixtures of the above supplements in the form of concentrates, metabolites, components or extracts; Not as a traditional food, nor as the only content of a meal or meal; Marked as a dietary supplement; No food additives; Its forms can include powder, soft glue (capsule) and capsule. ⑶ Safety must be guaranteed, but there is no provision on what safety information needs to be submitted to FDA for review. (4) No health care function shall be claimed, except for some nutrients with sufficient scientific basis. 5] The name and content of the main components must be clearly marked. [6]199410 June 15 A dietary ingredient that has not been listed in the United States is called a "new dietary ingredient", and an application (including safety information and use) needs to be submitted to the US FDA, and the FDA will make an approval decision within 180 days after receiving the application. Once the production process must meet the requirements of GMP. (8) A "Dietary Supplement Labeling Committee" will be established to put forward the requirements for dietary supplement labeling to the competent government departments. (9) Establish a "Dietary Supplement Office" in the National Institutes of Health (NIH) to discuss the role of dietary supplements in health care and promote scientific research on the health care and disease prevention of dietary supplements. 3 China's Health Food Management Measures Before the promulgation of 19951October 30, People's Republic of China (PRC)'s Official Food Hygiene Law, health food was not included in the legal management, and the trial Food Hygiene Law only stipulated that "drugs should not be added to food", and the Management Measures for New Resource Foods promulgated by the Ministry of Health did not allow claims of functional functions. But in fact, there are many kinds of health foods in China's market, with various claimed functions and uneven product quality. It is difficult for consumers to choose qualified, suitable and suitable products for their physical needs. In order to reverse this out-of-control situation, the official Food Hygiene Law clearly stipulates that "the products and instructions of foods with specific health care functions must be submitted to the health administrative department of the State Council for examination and approval" and that "foods with specific health care functions must not be harmful to human health, the contents of product instructions must be true, and the functions and components of products must be consistent with the instructions, and there must be no falsehood". In order to implement these provisions of the Food Hygiene Law, the Ministry of Health promulgated the Measures for the Administration of Health Foods on1March 1996 15, and issued the Notice on Seriously Implementing the Measures for the Administration of Health Foods on April 1996. Its main contents are as follows: (1) Any food that claims to have a specific health care function must be approved by the Ministry of Health before it can be produced and sold; The import of health food should also be approved by the Ministry of Health. ⑵ The requirements for examination and approval of health food are: it has a safe, clear and stable health care function, the formula has a scientific basis, and the efficacy cannot be publicized in the label instructions and advertisements. (3) The production of health food must meet the corresponding norms and hygiene requirements, and enterprises that have not been examined and approved by the provincial health administrative department may not produce health food. (4) The Management Measures shall take effect from 1 June, 19961day. In the notice of April, the Ministry of Health pointed out that 1 96 65438+June1to 65438+February 3 1 was the declaration stage for self-examination and rectification of enterprises, during which an application for preliminary examination was made to the local provincial health administrative department, and those who passed the preliminary examination were reviewed by the Ministry of Health and issued certificates. 1 997 65438+1October1March 3 1, the Ministry of Health will conduct a comprehensive inspection of the health food market. After1March 3, 9971,it is no longer allowed to produce and operate health food without approval or application for approval. 5. In order to implement the Food Hygiene Law and the Measures for the Administration of Health Foods, the Ministry of Health will gradually identify some health function evaluation and testing institutions, and will promulgate a series of norms and standards related to the production, supervision and management of health foods. 4 How to distinguish between health food and medicine In principle, it seems not difficult to distinguish between health food and medicine. Because health food only has health care function, it can't replace drugs to treat diseases. For example, any kind of antibiotic will not be mistaken for health food, instant tea or garlic powder will not be considered as medicine. However, according to the theory of homology of Chinese medicine and food, and the fact that many health foods are mainly composed of Chinese medicine, it is not easy to distinguish the two. Some Chinese medicines, in particular, do have the function of regulating body functions and preventing diseases. If they are processed into oral liquid, it is difficult to judge whether they should be food or medicine. Therefore, from a scientific and technological point of view, it is difficult to draw a clear line between health food and medicine (especially health brand medicine mainly based on traditional Chinese medicine). However, from the perspective of government management, food and medicine must be separated. Therefore, China has promulgated the management methods of health food and medicine respectively, with different requirements. So are other countries. 5 Comparison of management methods of health food between China and the United States Although there is no official management method of health food or functional food in the United States, only the Dietary Supplement Law exists, but there are many similarities in the involved objects and management principles. For example, both countries believe that health food refers to food or ingredients that constitute people's daily diet and cannot replace daily consumption diet. For another example, both countries stipulate that it is not allowed to claim the function of treating diseases, which cannot replace the usual disease treatment measures. However, due to the differences in cultural background, production technology level, quality and knowledge level of enterprises and consumers, the policies and measures adopted by the government authorities of the two countries are quite different. The practice in the United States does not require product approval one by one, except that new food ingredients need to be sent to safety materials (there is no specific regulation), and they can be produced and listed without approval. The United States emphasizes providing detailed information on ingredients and content in product labels, and consumers can choose their own products. The practice in China is that both production enterprises and products need approval, and the requirements for application materials are also more specific, such as materials for product safety evaluation and functional evaluation. The national conditions of the two countries are different, so the management methods are different and there is no difference. It is important that when the development and production of health food are in the ascendant, excellent health food can enter the domestic and foreign markets only if the business community fully understands the different requirements of governments.