Article 1 In order to strengthen the supervision and management of health food and ensure the quality of health food, these Measures are formulated in accordance with the relevant provisions of the Food Sanitation Law of People's Republic of China (PRC) (hereinafter referred to as the Food Sanitation Law).

Article 2 The term "health food" as mentioned in these Measures refers to food with specific health care functions. That is, it is suitable for specific people to eat, has the function of regulating the body, and does not aim at treating diseases.

Article 3 The health administrative department of the State Council (hereinafter referred to as the Ministry of Health) shall implement the examination and approval system for health food and health food instructions.

Chapter II Examination and Approval of Health Food

Article 4 Health food must meet the following requirements:

(1) It has a clear and stable health care function as proved by necessary animal and/or human function tests;

(two) all kinds of raw materials and their products must meet the requirements of food hygiene and do not cause any acute, subacute or chronic harm to human body;

(3) The composition and dosage of the formula must have scientific basis and clear functional components. If the functional components cannot be clearly defined under the existing technical conditions, the names of the main raw materials related to health care functions shall be determined;

(four) labels, brochures and advertisements shall not publicize the curative effect.

Article 5 Any food that claims to have health care function must be examined and confirmed by the Ministry of Health. Developers should apply to the local provincial health administrative department. After passing the preliminary examination, it shall be reported to the Ministry of Health for approval. The Ministry of Health issued a health food approval certificate to qualified health foods, with the approval number of "Wei Shi Jian Zi ()". The food that has obtained the health food approval certificate is allowed to use the health food mark specified by the Ministry of Health (see the annex for the logo pattern).

Article 6 When applying for the health food approval certificate, the following materials must be submitted:

(a) health food application form;

(two) the formula, production technology and quality standards of health food;

(3) Toxicological safety evaluation report;

(4) Health function assessment report;

(five) the list of functional ingredients of health food, as well as the qualitative and/or quantitative inspection methods and stability test reports of functional ingredients. Because under the existing technical conditions, it is impossible to define the functional components, it is necessary to submit the list of main raw materials related to health care functions in food;

(six) product samples and their health inspection reports;

(7) Labels and instructions (samples);

(8) Relevant information at home and abroad;

(nine) other materials that should be submitted according to the relevant provisions or product characteristics.

Article 7 The Ministry of Health and the provincial health administrative department shall set up an evaluation committee to undertake technical evaluation, which shall be composed of experts in food hygiene, nutrition, toxicology, medicine and other related disciplines.

Article 8 The evaluation committee of the Ministry of Health holds four evaluation meetings every year, usually in the last month of each quarter. All materials that pass the preliminary examination must be sent to the Ministry of Health before the end of the first month of each quarter. According to the evaluation opinions, the Ministry of Health shall make a decision on whether to approve or not within 30 working days after the evaluation.

If the review committee of the Ministry of Health deems it necessary to reinspect the declared health food, the inspection agency designated by the Ministry of Health shall reinspect it. The re-inspection fee shall be borne by the health food applicant.

Article 9 When two or more partners apply for the same health food, the health food approval certificate shall be signed by the same person, but it can only be issued to the person in charge determined by all partners. When applying, in addition to the materials listed in these Measures, a letter of recommendation from the person in charge signed by all partners shall also be submitted.

Tenth "health food approval certificate" holders can use this certificate to transfer technology or cooperate with others in production. At the time of transfer, the transferee shall apply to the Ministry of Health for a copy of the health food approval certificate. When applying, you should hold a health food approval certificate and provide a valid technology transfer contract. A copy of the health food approval certificate is sent to the transferee, and the transferee has no right to transfer the technology.

Eleventh drugs that have been approved by the relevant state departments for production and sale may not apply for the "Health Food Approval Certificate".

Article 12 When importing health food, the importer or agent must apply to the Ministry of Health. At the time of application, in addition to the materials required in Article 6, the relevant standards of the producing country (region) or international organizations, and the certificates issued by the relevant health institutions of the producing country and the selling country (region) that allow production or sales shall also be provided.

Article 13 The Ministry of Health shall issue the Certificate of Approval for Imported Health Foods that have passed the examination, and the products that have obtained the Certificate of Approval for Imported Health Foods must be marked with the approval number and the health food mark specified by the Ministry of Health.

Port imported food hygiene supervision and inspection institutions shall conduct inspection with the Approval Certificate for Imported Health Food, and release them after passing the inspection.

Chapter III Production and Operation of Health Food

Article 14 Before producing health food, a food production enterprise must submit an application to the local provincial health administrative department, which will examine and approve it, and mark the permitted items of "health food" on the applicant's health permit before production.

Fifteenth when applying for the production of health food, the following materials must be submitted:

(1) A valid hygiene license for food production and operation issued by the health administrative department directly under its jurisdiction;

(2) The original or photocopy of the health food approval certificate;

(3) enterprise standards of health food, hygiene standards of production enterprises and formula instructions formulated by production enterprises;

(4) For technology transfer or cooperative production, a valid technology transfer or cooperative production contract signed with the holder of the health food approval certificate shall be submitted;

(5) Introduction of production conditions, production technicians and quality assurance system;

(six) the quality and hygiene inspection report of three batches of products.

Article 16 Food that has not been examined and approved by the Ministry of Health shall not be produced and operated in the name of health food; Enterprises that have not been examined and approved by the provincial health administrative department may not produce health food.

Seventeenth health food producers must organize production in accordance with the approved content, and may not change the product formula, production technology, product quality standards, product names, labels, instructions, etc.

Article 18 The production technology and conditions of health food must meet the corresponding hygiene standards of food production enterprises or other relevant hygiene requirements. The selected process should be able to maintain the stability of the functional components of the product. In the process of processing, functional components are not lost, destroyed or transformed, and harmful intermediates are not produced.

Article 19 stereotyped packaging shall be adopted. Packaging materials or containers that come into direct contact with health food must meet the relevant hygiene standards or hygiene requirements. Packaging materials or containers and their packaging methods should be conducive to maintaining the stability of functional components of health food.

Article 20 When purchasing health food, health food business operators must obtain a copy of the health food approval certificate and product inspection certificate issued by the Ministry of Health.

To purchase imported health food, a copy of the approval certificate of imported health food and the inspection certificate of the port imported food hygiene supervision and inspection institution shall be obtained.

Chapter IV Labels, Instructions and Advertisements of Health Food

Twenty-first health food labels and instructions must meet the relevant national standards and requirements, and indicate the following contents:

(1) It has health care function and is suitable for people;

(2) Diet and proper consumption;

(3) storage method;

(4) The name and content of the effective ingredients. Because under the existing technical conditions, it is impossible to define the functional components, and the names of raw materials related to health care functions must be marked;

(five) the approval number of health food;

(6) health food marks;

(seven) other label contents specified in the relevant standards or requirements.

Article 22 The names of health foods shall be accurate and scientific, and names of people, places, codes and exaggerated or misleading names shall not be used, and names of non-main functional ingredients in products shall not be used.

Twenty-third health food labels, instructions and advertising content must be true, in line with product quality requirements. There must be no propaganda suggesting that the disease can be cured.

Twenty-fourth it is forbidden to use feudal superstition to promote health food.

Twenty-fifth foods that have not been examined and approved by the Ministry of Health according to these Measures shall not be publicized in the name of health food.

Chapter V Supervision and Administration of Health Food

Article 26 According to the Food Hygiene Law and the relevant regulations and standards of the Ministry of Health, health administrative departments at all levels should strengthen the supervision, monitoring and management of health food. The Ministry of Health may organize supervision and spot checks on health food that has been approved for production, and announce the results of spot checks to the public.

Article 27 The Ministry of Health may decide to review the approved health food according to the following circumstances:

(a) after scientific development, the understanding of the functions of the original approved health food has changed;

(two) the formula, production technology and health care function of the product are questioned and may change;

(three) health food supervision and monitoring work needs.

Those who fail the exam or do not accept the second interview shall be revoked by the Ministry of Health. If qualified, the original certificate is still valid.

Twenty-eighth health food producers and operators of general hygiene supervision and management, in accordance with the "Food Sanitation Law" and the relevant provisions.

Chapter VI Punishment Rules

Article 29 In any of the following circumstances, the administrative department of health of the local people's government at or above the county level shall be punished according to Article 45 of the Food Sanitation Law.

(a) without the approval of the Ministry of Health in accordance with these measures, but in the name of health food production and operation;

(two) imported without approval, operating in the name of health food;

(3) The names, labels and instructions of health food are not used according to the approved contents.

Thirtieth health food advertising to promote curative effect or using feudal superstition to promote health food, in accordance with the relevant provisions of the State Administration for Industry and Commerce and the Ministry of Health "food advertising management measures" punishment.

Article 31 Anyone who violates the Food Hygiene Law or other relevant hygiene requirements shall be punished in accordance with relevant regulations.

Chapter VII Supplementary Provisions

Thirty-second health food standards and functional evaluation methods shall be formulated and approved by the Ministry of Health.

Thirty-third functional evaluation, testing and safety toxicology evaluation of health food shall be undertaken by inspection institutions recognized by the Ministry of Health.

Article 34 The Ministry of Health shall be responsible for the interpretation of these Measures.

Article 35 These Measures shall be implemented as of June 6, 1996. Other health management measures are inconsistent with these measures, and these measures shall prevail.

Interim provisions on the examination of health food advertisements

Article 1 In order to strengthen the examination of health food advertisements and standardize the examination of health food advertisements, these Provisions are formulated in accordance with the Administrative Licensing Law, the Decision of the State Council Municipal Government on Setting Administrative Licensing for Administrative Examination and Approval Items that Really Need to Be Retained (Order No.412) and other laws and regulations.

Article 2 The State Food and Drug Administration of the United States shall guide and supervise the examination of health food advertisements.

The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the examination of health food advertisements within their respective jurisdictions.

The (food) drug supervision and administration department at or above the county level shall supervise the publication of health food advertisements that have been examined and approved within its jurisdiction.

Article 3 An applicant who publishes an advertisement for health food must be the holder of the health food approval certificate or a citizen, legal person or other organization entrusted by him.

The applicant may advertise health food by himself or by entrusting other legal persons, economic organizations or citizens.

Article 4 An application for advertising domestic health food shall be submitted to the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the holder of the health food approval certificate is located.

An application for publishing an advertisement for imported health food shall be submitted by the China office of an overseas production enterprise of the product or the agency entrusted by the enterprise to the local (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government.

Article 5 To apply for publishing health food advertisements, the following documents and materials shall be submitted:

(a) health food advertising review form (schedule1);

(2) Samples (samples, tapes) and electronic documents consistent with the published contents;

(3) A photocopy of the health food approval certificate;

(four) a copy of the "health permit" of the health food production enterprise;

(five) the applicant and the advertising agent's "business license" or the copy of the main qualification certificate and identity certificate; If there is an entrustment relationship, the original power of attorney shall be submitted;

(6) Quality standards, instructions, labels and actual packaging of health food;

(seven) health food advertisements with trademarks, patents, etc., must submit a copy of the relevant documents;

(eight) other relevant documents to confirm the authenticity of the advertising content;

(9) A statement of the authenticity of the substantial contents of the application materials.

When submitting a copy of this article, it shall be signed and sealed by the applicant.

Article 6 Where the application materials for health food advertisements are incomplete or do not meet the statutory requirements, the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall inform the applicant of all the contents that need to be corrected on the spot or within five working days; Fails to inform, since the date of receipt of the application materials is accepted.

Article 7 The advertising application for health food whose production and sale are explicitly prohibited by the relevant departments in the State Council shall not be accepted. The relevant departments in the State Council have cleaned up and rectified the cancelled health care function, and no longer accept the application for product advertisement of this function.

Article 8 The publicity of health-care functions, functional ingredients/symbolic ingredients and contents of products, suitable people and consumption in health-care food advertisements shall be based on the contents of the instructions approved by the State Council, the US Food and Drug Administration, and shall not be changed at will.

Health food advertisements shall guide consumers to use health food reasonably, and the following circumstances and contents shall not appear in health food advertisements:

(1) Containing assertions or guarantees indicating the efficacy of the product;

(2) It contains a statement that health can be obtained by using the product;

(3) By exaggerating or exaggerating a certain health condition or disease, or by describing the physical harm easily caused by a certain disease, the public is worried and afraid of their own health, and mistakenly believes that health food without advertising will suffer from a certain disease or lead to the deterioration of their health;

(four) to describe the functional characteristics and mechanism of the product in a way that is difficult for the public to understand, such as specialization, mystification and language expressing scientific and technological content;

(five) the use and appearance of the names and images of state organs and their institutions, medical institutions, academic institutions and trade organizations, or the names and images of experts, medical personnel and consumers as proof of product efficacy.

(6) Containing so-called "scientific or research achievements" or "experimental or data proof" that cannot be verified;

(seven) exaggerating the efficacy of health food or expanding the range of applicable people, and explicitly or implicitly applying to all symptoms and all people;

(8) containing terms confused with drugs, directly or indirectly promoting the therapeutic effect, or explicitly or implicitly promoting the therapeutic effect of certain ingredients.

(nine) compared with other health foods or drugs, medical devices and other products, belittle other products;

(ten) the use of feudal superstition to promote health food;

(eleven) claiming that the product is a secret recipe of the family;

(twelve) contains invalid refund, insurance company underwriting and other content;

(13) containing promises such as "safety", "no toxic side effects" and "no dependence";

(fourteen) absolute terms and expressions containing the latest technology, the highest science and the most advanced law;

(fifteen) claim or imply that health food is necessary for normal life or treatment of diseases;

(sixteen) with the effective rate, cure rate, evaluation, reward and other comprehensive evaluation content;

(seventeen) directly or indirectly encourage the arbitrary and excessive use of health food.

Ninth health food advertisements shall not be published in the form of news reports.

Article 10 Health food advertisements must indicate the name of health food products, the approval number of health food, the approval number of health food advertisements, the identification of health food, and the people who are not suitable for eating health food.

Eleventh health food advertisements must explain or indicate the warning that "this product can not replace drugs"; Health food labels and suggestions must often appear in TV advertisements.

Article 12 The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, from the date of acceptance, examine the application materials and advertising contents submitted by the applicant, and make a decision on whether to issue the approval number of health food advertisements within 20 working days.

For the health food advertising application that has passed the examination, the health food advertising approval number will be issued, and the health food advertising examination form will be copied to the advertising supervision organ at the same level for the record.

For the application for health food advertisements that fail to pass the examination, the applicant shall be informed in writing of the examination opinions, explain the reasons and inform him of his right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

Article 13 The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall report the approved Examination Form of Health Food Advertisements to the State Food and Drug Administration for the record. If the State Food and Drug Administration of the United States considers that the health food advertisements examined and approved do not meet the statutory requirements, it shall order the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government to make corrections.

Fourteenth health food advertising approval number is valid for one year.

If the approval number of health food advertisements expires and the applicant needs to continue to publish advertisements, it shall re-submit an application for publication to the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government in accordance with these provisions.

Fifteenth health food advertisements that have been examined and approved need to be changed, they shall apply to the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government for re-examination.

Where the basis for advertising review of health food instructions and quality standards changes, advertisers shall immediately stop publishing and apply to the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government for re-examination.

Article 16 In any of the following circumstances, the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the health food advertisement has been examined and approved shall return it for examination:

(1) The State Food and Drug Administration of the United States considers that the contents of health food advertisements approved by the food supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government do not meet the statutory requirements;

(2) The advertising supervision and administration organ suggests a review.

Article 17 In any of the following circumstances, the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government that have examined and approved health food advertisements shall revoke the approval number of health food advertisements:

(1) The approval certificate of health food has been revoked;

(two) health food is ordered by the relevant state departments to stop production and sales;

(three) the advertisement examination is unqualified.

Eighteenth unauthorized changes or tampering with the approved health food advertising content for false publicity, by the original examination and approval of the provinces, autonomous regions and municipalities directly under the central government, the food and drug supervision and administration department shall order the applicant to make corrections and give a warning. If the circumstances are serious, the approval number of the health food advertisement shall be revoked.

Article 19 Where an applicant conceals relevant information or provides false materials to apply for publishing health food advertisements, the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall handle it in accordance with the provisions of Article 78 of the Administrative Licensing Law.

Article 20 Where an applicant obtains the approval number of health food advertisements by cheating, bribery or other improper means, the pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall handle it in accordance with the provisions of Article 79 of the Administrative Licensing Law.

Article 21 The decision made by the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government to revoke or withdraw the approval number of health food advertisements shall be reported to the State Food and Drug Administration, copied to the advertising supervision and administration organs at the same level for reference, and announced to the public at the same time.

Article 22 If the (food) drug supervision and administration department finds that there is an illegal act of publishing health food advertisements, it shall fill in the Notice of Transfer of Illegal Health Food Advertisements (Table 2) and transfer it to the advertising supervision and administration organ at the same level for investigation.

Where an advertisement for health food is published outside the place where the advertisement is examined and approved without authorization, the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government that published the advertisement shall fill in the Notice on Handling Illegal Health Food Advertisement (Table 3), and the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government that examined and approved the original advertisement shall handle it according to the relevant regulations.

Article 23 The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall establish an advertising announcement system for illegal health food, regularly publish advertising announcements for illegal health food, and report to the State Food and Drug Administration, and the State shall regularly summarize the advertising announcements for illegal health food. The advertisement announcement of illegal health food shall be copied to the advertising supervision and administration organ at the same level.

Article 24 If the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government and their staff fail to perform their duties of examination according to law, the State Food and Drug Administration or the supervisory organ shall order them to make corrections, and the directly responsible person in charge and other directly responsible personnel shall be dealt with according to relevant regulations.

Twenty-fifth provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and management departments in violation of the provisions of these measures in the process of examination of health food advertisements, resulting in damage to the legitimate rights and interests of the parties, shall be compensated in accordance with the provisions of the State Compensation Law.

Twenty-sixth health food advertising approval number is "X Shen Jianguang (X 1)". Where "X" is the abbreviation of all provinces, autonomous regions and municipalities directly under the Central Government; "X 1" stands for vision, sound and words; "X2" consists of ten digits, with the first six digits representing the review year and the last four digits representing the advertisement approval number.