Health Food Management Regulations

Article 1 is to strengthen the supervision and management of health food and ensure the quality of health food. According to the "Food Hygiene Law of the People's Republic of China" (hereinafter referred to as "Food Hygiene Law"), these measures are formulated.

Article 2 Health foods as mentioned in these Measures refer to foods that are shown to have specific health functions. That is, food that is suitable for consumption by specific groups of people, has the ability to regulate body functions, and is not intended to treat diseases.

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

Chapter 2 Approval of Health Food

Article 4 Health Food must meet the following requirements:

(1) After the necessary animal and/or human functions Tests have proven that they have clear and stable health care effects;

(2) Various raw materials and their products must meet food hygiene requirements and not cause any acute, subacute or chronic harm to the human body;

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

(4) Labels, instructions and advertisements must not promote the therapeutic effects.

Article 5: All foods claiming to have health-care functions must be reviewed and confirmed by the Ministry of Health. Developers should apply to the local provincial health administrative department. After preliminary review and approval, it will be submitted to the Ministry of Health for approval. The Ministry of Health will issue a "Health Food Approval Certificate" to health foods that pass the review, and the approval number is "Weishijianzi () No.". Foods that have obtained the "Health Food Approval Certificate" are allowed to use the health food logo stipulated by the Ministry of Health (see the attachment for the logo pattern)

Article 6 When applying for the "Health Food Approval Certificate", the following information must be submitted:

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(1) Health food application form;

(2) Formula, production process and quality standards of health food;

(3) Toxicological safety evaluation report ;

(4) Health function evaluation report;

(5) List of functional ingredients of the health food, as well as qualitative and/or quantitative testing methods and stability test reports of the functional ingredients. If the functional ingredients cannot be clarified under the existing technical conditions, a list of the main raw materials related to health functions in the food must be submitted;

(6) Product samples and their hygienic inspection reports;

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(7) Labels and instructions (samples submitted for review);

(8) Relevant domestic and foreign information;

(9) Information that should be submitted according to relevant regulations or product characteristics Other materials.

Article 7 The Ministry of Health and the provincial health administration department shall respectively establish review committees to undertake technical review work. The committees shall be composed of experts in food hygiene, nutrition, toxicology, medicine and other related professions.

Article 8 The Ministry of Health Evaluation Committee holds four evaluation meetings every year, usually in the last month of each quarter. All materials that pass the preliminary review must be sent to the Ministry of Health before the end of the first month of each quarter. Based on the review opinions, the Ministry of Health will make a decision on whether to approve it within 30 working days after the review.

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

Article 9: When two or more collaborators apply for the same health food at the same time, the "Health Food Approval Certificate" must have the same signature, but the certificate will only be issued to all collaborators* **With the identified responsible person. When applying, in addition to submitting the information listed in these measures, a letter of recommendation from the person in charge signed and sealed by all collaborators should also be submitted.

Article 10 The holder of the "Health Food Approval Certificate" can use this certificate to transfer technology or cooperate with other parties in production. When transferring, you should apply for a copy of the "Health Food Approval Certificate" from the Ministry of Health together with the transferee ***. When applying, you should hold the "Health Food Approval Certificate" and provide a valid technology transfer contract. A copy of the "Health Food Approval Certificate" is issued to the transferee, and the transferee has no right to transfer technology.

Article 11 Drugs that have been approved for production and operation by relevant national departments shall not apply for a "Health Food Approval Certificate".

Article 12 When importing health food, the importer or agent must apply to the Ministry of Health. When applying, in addition to providing the materials required in Article 6, the relevant standards of the producing country (region) or international organization, as well as the production or sales permission certificate issued by the relevant health agency of the production and selling country (region) are also required.

Article 13 The Ministry of Health will issue an "Imported Health Food Approval Certificate" to imported health foods that have passed the review. Products that have obtained the "Imported Health Food Approval Certificate" must be marked with the approval number and the Ministry of Health's approval number on the package. Prescribed health food label.

The port imported food hygiene supervision and inspection agency will conduct inspections based on the "Imported Health Food Approval Certificate" and release it after passing the test.

Chapter 3 Production and Operation of Health Food

Article 14 Before producing health food, food production enterprises must apply to the local provincial health administrative department, and obtain approval from the provincial health administrative department. Production can only be carried out after the health administrative department has reviewed and approved and added the "health food" licensing item on the applicant's health license.

Article 15 When applying for the production of health food, the following information must be submitted:

(1) A valid food production and operation health license issued by the health administrative department with direct jurisdiction;

(2) The original or copy of the "Health Food Approval Certificate";

(3) The health food enterprise standards, production enterprise hygiene specifications and formulation instructions formulated by the production enterprise;

(4) For technology transfer or cooperative production, a valid contract for technology transfer or cooperative production signed with the holder of the "Health Food Approval Certificate" should be submitted;

(5) Introduction to production conditions, production technicians, and quality assurance systems;

(6) Quality and health inspection reports for three batches of products.

Article 16 Foods that have not been reviewed and approved by the Ministry of Health shall not be produced and operated in the name of health food; enterprises that have not been reviewed and approved by the provincial health administrative department shall not produce health food.

Article 17 Health food producers must organize production in accordance with the approved content, and may not change the product formula, production process, enterprise product quality standards, product name, label, instructions, etc.

Article 18 The production process and production conditions of health food must comply with the corresponding hygiene regulations of food production enterprises or other relevant hygiene requirements. The selected process should be able to maintain the stability of the functional ingredients of the product. During the processing, the functional ingredients are not lost, destroyed, transformed and harmful intermediates are not produced.

Article 19 Shaped packaging should be used. Packaging materials or containers that are in direct contact with health food must comply with relevant hygiene standards or requirements. Packaging materials or containers and their packaging methods should be conducive to maintaining the stability of the functional ingredients of health food.

Article 20 When purchasing health food, health food operators must obtain a copy of the "Health Food Approval Certificate" issued by the Ministry of Health and the product inspection certificate.

When purchasing imported health food, you should obtain a copy of the "Imported Health Food Approval Certificate" and the inspection certificate from the port imported food hygiene supervision and inspection agency.

Chapter 4 Health Food Labels, Instructions and Advertising

Article 21 Health food labels and instructions must comply with relevant national standards and requirements, and indicate the following:

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(1) Health care effect and suitable group of people;

(2) Consumption method and appropriate consumption amount;

(3) Storage method;

< p> (4) Name and content of functional ingredients. If the functional ingredients cannot be clarified under the existing technical conditions, the names of raw materials related to health functions must be indicated;

(5) Health food approval number;

(6 ) Health food labels;

(7) Other label contents stipulated by relevant standards or requirements.

Article 22 The names of health food should be accurate and scientific. People’s names, place names, code names, exaggerated or easily misunderstood names must not be used, and names of non-main functional ingredients in the product must not be used.

Article 23 The labels, instructions and advertising content of health food must be true and meet the product quality requirements. There should be no promotions that suggest cures for illnesses.

Article 24 It is strictly prohibited to use feudal superstition to promote health food.

Article 25 Foods that have not been reviewed and approved by the Ministry of Health in accordance with these Measures shall not be promoted in the name of health food.

Chapter 5 Supervision and Management of Health Food

Article 26 In accordance with 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 and management of health food. Supervision, monitoring and management of food. The Ministry of Health can organize supervision and random inspections of health foods that have been approved for production and publish the random inspection results to the public.

Article 27 The Ministry of Health may determine to re-examine the health food that has been approved based on the following circumstances:

(1) After scientific development, the health food that was originally approved shall be reexamined. There is a change in understanding of the function;

(2) The formula, production process, and health function of the product are questioned about possible changes;

(3) The need for supervision and monitoring of health food .

For those who fail to pass the review or do not accept re-examination, the Ministry of Health will revoke their "Health Food Approval Certificate". For those who pass the test, the original certificate will still be valid.

Article 28 The general hygiene supervision and management of health food manufacturers and operators shall be implemented in accordance with the Food Hygiene Law and relevant regulations.

Chapter 6 Penalty Provisions

Article 29 If any of the following circumstances occurs, the health administrative department of the local people’s government at or above the county level shall be responsible for Articles of punishment.

(1) Producing and operating in the name of health food without being reviewed and approved by the Ministry of Health in accordance with these Measures;

(2) Importing without approval as a health food, but using the name of health food Business operations in the name of food;

(3) The names, labels and instructions of health food are not used in accordance with the approved content.

Article 30 Anyone who promotes curative effects in health food advertisements or uses feudal superstition to promote health foods shall be punished in accordance with the relevant provisions of the "Food Advertisement Management Measures" of the State Administration for Industry and Commerce and the Ministry of Health.

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

Chapter 7 Supplementary Provisions

Article 32 Health food standards and functional evaluation methods shall be formulated, approved and promulgated by the Ministry of Health.

Article 33: Functional evaluation and testing, and safety and toxicological evaluation of health foods shall be undertaken by inspection agencies recognized by the Ministry of Health.

Article 34 These measures shall be interpreted by the Ministry of Health.

Article 35 These Measures will come into effect on June 1, 1996. If other health management measures are inconsistent with these Measures, these Measures shall prevail.

Interim Provisions on the Review of Health Food Advertisements

Article 1 is to strengthen the review of health food advertisements and standardize the review behavior of health food advertisements. These regulations are formulated by laws and regulations such as "Decision on Setting Administrative Licensing for Retained Administrative Approval Items" (Order No. 412).

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

The (food) drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the review of health food advertisements within their respective jurisdictions.

The (food) and drug regulatory authorities at or above the county level should monitor the release of health food advertisements reviewed and approved within their jurisdiction.

Article 3 Applicants who publish health food advertisements must be the holders of health food approval documents or the citizens, legal persons and other organizations entrusted by them.

Applicants may themselves or entrust other legal persons, economic organizations or citizens to serve as agents for health food advertisements.

Article 4 Applications for publishing domestic health food advertisements 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 health food approval certificate holder is located.

The application for publishing advertisements for imported health foods 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 product is located by the office in China of the overseas manufacturer of the product or the agency entrusted by the enterprise. .

Article 5 To apply for the release of health food advertisements, the following documents and materials should be submitted:

(1) "Health Food Advertisement Review Form" (Attachment 1);

(2) Samples (samples, sample tapes) and electronic documents that are consistent with the published content;

(3) Copies of health food approval documents;

(4) ) A copy of the "Hygiene License" of the health food production enterprise;

(5) Copies of the "Business License" or subject qualification documents and identity documents of the applicant and advertising agent; if entrusted relationship, the relevant original power of attorney should be submitted;

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

(7) Trademarks appearing in health food advertisements , patents, etc., copies of relevant supporting documents must be submitted;

(8) Other relevant documents used to confirm the authenticity of the advertising content;

(9) Claim application materials A statement of the truthfulness of the material content.

Copies submitted as stipulated in this article must be stamped with the applicant’s signature.

Article 6 If the application materials for health food advertising release are incomplete or do not meet statutory requirements, the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall notify the applicant on the spot or within 5 working days. All content that needs to be supplemented and corrected; if no notification is made within the time limit, the application will be accepted from the date of receipt of the application materials.

Article 7: Advertising applications for health foods whose production and sale are expressly prohibited by relevant departments of the State Council will not be accepted. The relevant departments of the State Council are cleaning up and rectifying the canceled health care functions, and applications for product advertising of this function will not be accepted.

Article 8 The promotion of health functions, product functional ingredients/iconic ingredients and contents, suitable groups, consumption, etc. in health food advertisements shall be based on the instructions approved by the Food and Drug Administration Department of the State Council. It is accurate and cannot be changed arbitrarily.

Health food advertisements should guide consumers to use health foods rationally. Health food advertisements shall not contain the following situations and contents:

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

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(2) Contains statements that health can be achieved by using the product;

(3) By exaggerating or exaggerating a certain health condition or disease, or by describing the physical harm that a certain disease can easily cause , causing the public to worry and fear about their own health, and misunderstand that if they do not use the advertised health food, they will suffer from a certain disease or cause their health condition to deteriorate;

(4) Using professional terms that are difficult for the public to understand, Mysterious language, language indicating scientific and technological content, etc. are used to describe the functional characteristics and mechanisms of the product;

(5) Using and appearing in the name and name of state agencies and their public institutions, medical institutions, academic institutions, and industry organizations Image, or use the name and image of experts, medical personnel and consumers to prove the efficacy of the product.

(6) Containing unverifiable so-called "scientific or research findings", "experimental or data proof", etc.;

(7) Exaggerating the efficacy of health food or expanding its appropriateness The scope of the population is expressly or implicitly suitable for all symptoms and all groups of people;

(8) Contains terms that are confusing with drugs, directly or indirectly promotes the therapeutic effect, or expressly or implicitly promotes the effects of certain ingredients The health food has disease treatment effect.

(9) Comparing with other health foods or medicines, medical devices and other products to disparage other products;

(10) Using feudal superstition to promote health foods;

(11) Claiming that the product is an ancestral secret recipe;

(12) Containing invalid refunds, insurance company insurance, etc.;

(13) Containing " "Safe", "no toxic side effects", "no dependence", etc.;

(14) Containing absolute terms and expressions such as the latest technology, the highest science, the most advanced manufacturing methods, etc.;

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(15) Claiming or implying that health food is necessary for normal life or treating diseases;

(16) Containing comprehensive evaluation contents such as effectiveness, cure rate, competition, and awards;

(17) Directly or indirectly instigating arbitrary or excessive use of health foods.

Article 9 Health food advertisements shall not be published in the form of news reports or other forms.

Article 10 Health food advertisements must indicate the name of the health food product, the health food approval number, the health food advertising approval number, the health food label, and the groups for which the health food is not suitable.

Article 11 Health food advertisements must explain or indicate the warning that “this product cannot replace drugs”; health food labels and warnings must always appear in TV advertisements.

Article 12 The (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall review the application materials and advertising content submitted by the applicant from the date of acceptance, and make a decision within 20 working days. Decision on whether to issue an approval number for health food advertising.

For health food advertising applications that pass the review, a health food advertising approval number will be issued, and a copy of the "Health Food Advertising Review Form" will be sent to the advertising supervision agency at the same level for filing.

For health food advertising applications that fail to pass the review, the applicant shall be informed of the review opinions in writing, explain the reasons, and inform the applicant of its right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.

Article 13 The (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall submit the approved "Health Food Advertising Review Form" to the State Food and Drug Administration for record. If the State Food and Drug Administration believes that the health food advertisements reviewed and approved are inconsistent with statutory requirements, it shall order the (food) drug regulatory department of the original province, autonomous region, or municipality directly under the Central Government to make corrections.

Article 14 The health food advertising approval number is valid for one year.

If the validity period of the health food advertising approval number expires and the applicant needs to continue to publish advertisements, he shall resubmit a publication application to the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government in accordance with these regulations.

Article 15 If the content of an approved health food advertisement needs to be changed, an application should be made to the (food) drug regulatory department of the original province, autonomous region, or municipality directly under the Central Government for re-examination.

If the advertising review basis such as instructions and quality standards of health food changes, the advertiser should immediately stop publishing and apply for re-examination to the (food) drug regulatory department of the province, autonomous region, or municipality directly under the original approval.

Article 16 If a health food advertisement that has been reviewed and approved falls into any of the following circumstances, the (food) drug regulatory department of the province, autonomous region, or municipality where the original approval was made shall transfer it for review:

(1) The State Food and Drug Administration believes that the content of health food advertisements approved by the (food) drug regulatory authorities of the province, autonomous region, or municipality where the original approval was issued does not meet statutory requirements;

(2) The advertising regulatory authority recommends review.

Article 17 If an approved health food advertisement falls into any of the following circumstances, the (food) drug regulatory department of the original province, autonomous region, or municipality directly under the Central Government shall withdraw the health food advertisement approval number:

(1) The health food approval document has been revoked;

(2) The health food has been ordered to stop production and sales by the relevant state departments;

( 3) The advertisement fails to pass the review.

Article 18 If the content of an approved health food advertisement is changed or tampered with without authorization to make false propaganda, the (food) drug regulatory department of the original province, autonomous region, or municipality directly under the Central Government shall order the applicant to make corrections and give a warning. , if the circumstances are serious, the health food advertising approval number will be withdrawn.

Article 19 If the applicant conceals relevant information or provides false materials to apply for the release of health food advertisements, the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall comply with Article 78 of the "Administrative Licensing Law" be processed according to the regulations.

Article 20. If an applicant obtains a health food advertising approval number through improper means such as deception or bribery, the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government that makes the approval shall apply in accordance with the Administrative Licensing Law. 》Article 79.

Article 21 The decision made by the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government to revoke or withdraw the health food advertising approval number shall be submitted to the State Food and Drug Administration with a copy The advertising supervision and management authority at the same level shall keep it for reference and announce the decision to the public at the same time.

Article 22: If the (food) and drug regulatory department discovers any illegal health food advertisement, it shall fill out the "Illegal Health Food Advertisement Transfer Notice" (Attachment 2) and transfer the advertisement to the same level Supervision and management agencies investigate and deal with it.

If a health food advertisement that has been modified or tampered with without authorization is published outside the place where the advertisement is approved, the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the advertisement is released shall fill in the "Notice on Handling Illegal Health Food Advertisements" ” (Appendix 3), the (food) drug regulatory department of the province, autonomous region, or municipality where the original approval was issued shall handle it in accordance with relevant regulations.

Article 23 The (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall establish an announcement system for illegal health food advertising, regularly publish the "Illegal Health Food Advertising Announcement" and report it to the State Food and Drug Administration , the State Food and Drug Administration regularly summarizes the "Illegal Health Food Advertisement Announcements". A copy of the "Illegal Health Food Advertisement Announcement" shall be sent to the advertising supervision and management authority at the same level at the same time.

Article 24 If the (food) drug regulatory authorities of provinces, autonomous regions, or municipalities directly under the Central Government and their staff fail to perform their review duties in accordance with the law, they shall be ordered to make corrections by the State Food and Drug Administration or the supervisory authority, and shall be ordered to make corrections in accordance with the law. Relevant regulations deal with the directly responsible supervisor and other directly responsible personnel.

Article 25: During the review process of health food advertisements, if the (food) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government violates the provisions of these Measures and causes damage to the legitimate rights and interests of the parties, it shall comply with the national compensation law. provide compensation.

Article 26 The approval number for health food advertising is "X Shijian Guangshen (X1) No. X2". Among them, "X" is the abbreviation of each province, autonomous region, and municipality directly under the Central Government: "X1" represents video, audio, and text; "X2" consists of ten digits. The first six digits represent the year and month of review, and the last four digits represent the serial number of advertising approval.