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Interim Provisions on the Examination of Advertising for Health Food

 

Article 1 These Provisions are formulated in accordance with the Administrative Licensing Law and the Decision of the State Council on Establishing Administrative Licenses for Administrative Examination and Approval Projects that really need to be retained (Decree 412) in order to strengthen the examination of health food advertisements and standardize the examination of health food advertisements.

 

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

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

The drug supervision and administration departments at or above the county level shall monitor the publication of health food advertisements examined and approved within their jurisdictions.

 

Article 3 The applicant for publishing health food advertisements must be the holder of the health food approval certificate or the citizens, legal persons and other organizations entrusted by them.

 

Introduction

 

The applicant may, on his own or by entrusting other legal persons, economic organizations or citizens as agents of health food advertisements.

Article 4 An application for the publication of advertisements for health food made in China shall be submitted to the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government (food) where the holder of the approval certificate is located.

The application for the publication of advertisements for imported health food shall be submitted to the drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government (food) where the overseas production enterprise of the product is located in China or the agency entrusted by the enterprise.

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

(1) Health Food Advertising Review Form (Schedule 1);

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

(3) Copies of approval certificates for health food;

(4) Copies of the Hygienic License of the health food production enterprises;

(5) Copies of Business License or Subject Qualification Certificate and Identity Certificate of the applicant and the advertising agent; if there is an entrustment relationship, the original of the relevant letter of attorney shall be submitted;

(6) Quality standards, instructions, labels and packaging for practical use of health food;

(7) Where trademarks, patents and other contents appear in health food advertisements, copies of relevant certification documents must be submitted;

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

(9) A statement declaring the authenticity of the substance of the application materials.

 

The applicant's signature is required for the submission of copies of the provisions of this article.

Article 6 If the application materials for publishing health food advertisements are incomplete or do not meet the statutory requirements, the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government (food) shall inform the applicant of all the contents that need to be corrected on the spot or once within five working days; if they fail to inform the applicant within the time limit, they shall be accepted as soon as the application materials are received.

Article 7 The relevant departments of the State Council explicitly prohibit the production and sale of health food, and their advertising applications shall not be accepted. Relevant departments of the State Council have cleaned up and rectified the cancelled health function, and the application for advertisement of products with this function is not accepted.

Article 8 The propaganda of health function, product efficacy ingredient/marking ingredient and content, suitable population and consumption quantity in health food advertisements shall be based on the contents of the instructions approved by the Food and Drug Administration Department of the State Council and shall not be changed arbitrarily.

 

Prohibition

 

Advertisements for health food should guide consumers to use health food rationally. Advertisements for health food should not include the following situations and contents:

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

(2) Containing the expression that health can be obtained by using the product;

(3) By exaggerating or exaggerating a certain health condition or disease, or describing the physical hazards that a disease can easily cause, the public will be worried about their own health and fear, misunderstanding that health food without advertising will suffer from a certain disease or lead to deterioration of their health condition;

(4) Describing the function characteristics and mechanism of the product in terms of specialized terms, mysterious language and language expressing scientific and technological content that are difficult to understand by the public;

(5) Utilizing and appearing the names and images of state organs and their institutions, medical institutions, academic institutions and trade organizations, or proving the effectiveness of products in the names and images of experts, medical personnel and consumers.

(6) Including the contents of so-called "scientific or research findings" and "experimental or data proof" which can not be verified;

(7) To exaggerate the efficacy of health food or expand the scope of suitable population, indicating or implying that it is suitable for all symptoms and all groups;

(8) Containing words confused with drugs, publicizing the therapeutic effect directly or indirectly, or expressing or implying the therapeutic effect of the health food by publicizing the role of certain ingredients.

(9) Comparing with other health food products or products such as pharmaceuticals, medical devices and so on, depreciating other products;

(10) Propaganda of health food using feudal superstitions;

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

(12) Containing invalid refunds, insurance companies, etc.

(13) Containing promises of "safety", "non-toxic side effects" and "non-dependence";

(14) Including absolute terms and expressions such as the latest technology, the highest science and the most advanced legal system;

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

(16) It contains comprehensive evaluation contents such as efficiency, cure rate, evaluation and award-winning.

(17) directly or indirectly encouraging the arbitrary or excessive use of health food.

 

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 health food products, the approval number of health food, the approval number of health food advertisements, the label of health food and the unsuitable population of health food.

Article 11 Advertisements for health food must state or indicate that "this product can not replace drugs". The signs and advices for health food in TV advertisements must always appear.

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

To examine the qualified application for health food advertisement, the approval number of health food advertisement shall be issued, and the "Health Food Advertising Examination Form" shall be copied to the advertising supervision organ at the same level for the record.

When examining unqualified advertisement applications for health food, 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 administrative proceedings in accordance with the law.

Article 13 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government (food) shall submit to the State Food and Drug Administration for the record the Health Food Advertising Examination Form which has been examined and approved. If the State Food and Drug Administration considers that the health food advertisements examined and approved are not in conformity with the statutory requirements, it shall order the provincial, autonomous region and municipality directly under the Central Government (food) drug supervision and administration departments at the original examination and approval place to rectify them.

Article 14 The validity period of the approval number for health food advertisements is one year.

When the validity period of the approval number for health food advertisements expires and the applicant needs to continue to publish the advertisements, he or she shall, in accordance with these Provisions, reapply to the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government (food).

Article 15 If the contents of health food advertisements need to be changed after examination and approval, they shall apply to the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government (food) where they were originally examined and approved for re-examination.

If the basis for advertising review of health food such as instructions and quality standards has changed, 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 (food) for re-examination.

Article 16 In any of the following circumstances, the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government (food) where the advertisements for health food have been examined and approved shall call back for review:

(1) The State Food and Drug Administration considers that the contents of health food advertisements approved by the drug administration departments of provinces, autonomous regions and municipalities directly under the Central Government (food) in the original examination and approval areas do not meet the legal requirements;

(2) Advertising supervisory and administrative organs recommend review.

Article 17 In any of the following circumstances, the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the Central Government (food) where the health food advertisements have been examined and approved shall withdraw the approval number of the health food advertisements:

(1) The approval certificate for health food is revoked;

(2) Health food is ordered by the relevant state departments to stop production and marketing;

(3) Unqualified in the review of advertisements.

 

Article 18 Where the advertisement contents of health food are altered or tampered with without authorization to make false propaganda, the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government (food) in the original examination and approval area shall order the applicants to correct and give warnings. If the circumstances are serious, the approval number of the health food advertisement shall be withdrawn.

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

Article 20 Where an applicant obtains the approval number of a health food advertisement through deception, bribery or other improper means, it shall be handled by the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government (food) at the place of examination and approval in accordance with the provisions of Article 79 of the Administrative Licensing Law.

Article 21 Decisions made by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government (food) to revoke or withdraw the approval number of advertisements for health food shall be submitted to the State Food and Drug Administration and copied to the advertising regulatory authorities at the same level for reference, while announcing the decision to deal with it to the public.

Article 22 Where a drug regulatory department finds that it has unlawfully issued advertisements for health food, it shall fill in the Notice of Delivery of Illegal Health Food Advertisements (Schedule 2) and transfer it to the advertising regulatory authority at the same level for investigation and punishment.

Where an advertisement for health food is published outside the place where the advertisement is examined and approved without authorization, the drug supervision and Administration Department of the province, autonomous region or municipality directly under the Central Government (food) where the advertisement is issued shall fill in the Notice of Advertising Processing for Illegal Health Food (Schedule 3), and the drug of the province, Autonomous Region or municipality directly under the Central Government (food) where the advertisement was originally examined and approved. The quality supervision and management department shall deal with it in accordance with the relevant provisions.

Article 23 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government (food) shall establish a system of advertisement announcement of illegal health food, regularly publish the advertisement announcement of illegal health food and report it to the State Food and Drug Administration, and the State Food and Drug Administration shall regularly publish the advertisement announcement of illegal health food. Make a summary. The Advertising Announcement of Illegal Health Food shall be copied to the advertising supervisory and administrative organs at the same level.

Article 24 If the provincial, autonomous region or municipality directly under the Central Government (food) drug supervision and administration departments and their staff fail to perform their examination duties in accordance with the law, the State Food and Drug Administration or the supervisory organ shall order them to make corrections, and in accordance with the relevant provisions, the directly responsible persons in charge and other directly responsible persons shall be dealt with.

Article 25 In the process of examining advertisements for health food, the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government (food) violate the provisions of these Measures and cause damage to the legitimate rights and interests of the parties concerned, they shall pay compensation in accordance with the provisions of the State Compensation Law.

Article 26 The approval number of health food advertisement is "X2 of X1". Among them, "X" is the abbreviation of provinces, autonomous regions and municipalities directly under the Central Government; "X1" stands for sight, sound and text; "X2" consists of ten digits, the first six representatives examine the year and the last four represent the serial number of advertising approval.