Measures for the Administration of Registration of Health Food

Chapter 1: General Provisions

FirstThis Measure is formulated to ensure the safety and quality controllability of health food, standardize its registration practices, and in accordance with the "Food Safety Law of the People's Republic of China" (hereinafter referred to as the "Food Safety Law"), the "Administrative Licensing Law of the People's Republic of China," and the "Regulations on Supervision and Administration of Health Food."
SecondThis regulation defines "health food" as a type of food claimed to have specific health benefits. Specifically, it refers to foods suitable for certain populations that help regulate bodily functions, are not intended for disease treatment, and pose no acute, subacute, or chronic harm to the human body. Nutrient supplements aimed at replenishing vitamins and minerals are included under health food management.
Dietary supplements must be approved by the National Medical Products Administration and obtain product registration certificates in accordance with the law.
Nutritional supplement products must be approved or registered with the national food and drug regulatory authority in accordance with the law, and obtain the corresponding approval or registration number. Specific regulations shall be formulated separately.
    ThirdThis Measure applies to the acceptance, on-site verification, registration testing, technical review, and approval of health food within the People's Republic of China.
    Article 4Food supplement registration refers to the approval process by which the national food and drug regulatory authority reviews an applicant's submission for a food supplement in accordance with statutory procedures, conditions, and requirements. This review assesses the product's safety, functional claims, quality controllability, and labeling and instructions, ultimately determining whether to approve its registration.
Food supplement registration applications include product registration, modification, technology transfer, and renewal.
    Article 5The national food and drug regulatory authority oversees the registration of health supplements nationwide and accredits institutions responsible for testing and evaluating them.
The national food and drug regulatory authority entrusts provincial, autonomous region, and municipal-level food and drug regulatory authorities to accept domestic health food registration applications, conduct on-site inspections, sample and submit for testing, and approve certain change applications.
    Article 6Applicants are responsible for the accuracy of their submitted documents.
    Article 7The national food and drug regulatory authority periodically adjusts the scope of health claims for dietary supplements based on scientific advancements and publishes the updates.
The national food and drug regulatory department encourages research into new functions of health foods and formulates relevant policies; specific regulations will be issued separately.
    Article 8Registration and management of health food shall be strictly supervised in accordance with the Food Safety Law, following the principles of science, openness, fairness, impartiality, and convenience.

Chapter 2: Application and Approval
Section 1: General Provisions

    Article 9Applicant refers to the entity that submits a health food registration application, assumes corresponding legal responsibilities, and becomes the holder of either the "Domestic Health Food Product Registration Certificate" or the "Imported Health Food Product Registration Certificate" upon approval. In cases of joint development by multiple parties, one party shall be designated as the applicant. Domestic health food refers to health foods produced and sold within China; its applicant must be a legally registered legal person or other organization in China.
Imported health food refers to health products manufactured and sold abroad that are marketed in China. The applicant must be a legally registered health food manufacturer located outside of China. For registration of imported health food, the overseas applicant must submit the application through its office within China or via a domestic agent it has authorized.
    Article 10Applicants shall designate personnel with relevant technical expertise and familiarity with the laws, regulations, and technical requirements governing health food registration to handle health food registration applications.
    Article 11Testing facilities recognized by the national food and drug regulatory authority shall conduct safety toxicology studies, functional studies, verification of efficacy/marker component detection methods, stability studies, and hygienic studies for health food registration applications.
Registration testing for health food applications shall be conducted by testing institutions recognized by the national drug and food regulatory authority.
    Article 12The National Medical Products Administration and the food and drug administration departments of provinces, autonomous regions, and municipalities shall display on their websites for accepting health food registration applications the items of registration declaration materials and sample forms for relevant registration application documents.
    Article 13Personnel from the food and drug regulatory authorities and relevant units involved in health food registration shall keep confidential the technical materials and test data submitted by applicants.
    Article 14Applicants must submit a declaration stating that their use does not infringe on others' patents. Any patent disputes arising during registration shall be resolved in accordance with applicable patent laws and regulations.
    Article 15Applicants must submit complete and standardized application materials.

    Article 16Applicants shall be allowed to correct errors on the spot if they are readily fixable.
    Article 17If the applicant's submitted materials are incomplete or do not meet statutory requirements, the National Medical Products Administration and the provincial, autonomous region, or municipal food and drug administration shall immediately inform the applicant of all contents requiring correction within 5 days. Failure to notify within this period shall be deemed as acceptance of the application from the date of receipt.
    Article 18During the review process, if additional information is required, the food and drug regulatory authority shall provide all such requests in a single notice. The applicant must submit compliant supplementary materials within 5 month(s) of receiving the notice. Failure to submit within the specified timeframe will result in rejection of the application. If exceptional circumstances prevent submission within the deadline, the applicant must submit a written request to the food and drug regulatory authority within the specified period, explaining the reasons. The authority shall issue its decision within 20 day(s).
    Article 19For registration applications requiring supplementary materials during the health food registration process, the review timeline is extended by 30 days from the original review period. For change applications, the extension is 10 days.
    Article 20Upon legal review, if registration is approved, the National Medical Products Administration shall issue either a "Domestic Health Food Product Registration Certificate" or an "Imported Health Food Product Registration Certificate" to the applicant within the prescribed time limit and deliver it within 10 days. If registration is not approved, the applicant shall be notified in writing within the prescribed time limit, with reasons provided, and informed of their right to request a reconsideration, apply for administrative reconsideration, or file an administrative lawsuit in accordance with the law.
    Article 21The National Medical Products Administration (NMPA) and the local medical products administrations of provinces, autonomous regions, and municipalities shall notify affected third parties if, during their review of a health food registration application, they find that the matter directly involves significant interests of others. The applicant and affected third parties may submit written statements or request a hearing in accordance with the law.

    Article 22The national food and drug regulatory authority shall publish relevant information on the acceptance, technical review, rejection of applications, and administrative approval for health food registration on its government website.

Section 2: Product Registration Application and Approval

    Article 23Product registration applications include those for domestically produced health foods and imported health foods.
Domestic health food registration applications refer to registrations submitted by applicants intending to produce and sell health foods within China.
Imported health food registration applications refer to registrations for health foods already produced and sold abroad that are intended to be marketed in China.
    Article 24Applicants must complete the necessary development work before applying for registration of domestic health food.
The development process includes formula screening, process research, stability studies, quality standard establishment, safety and functionality assessments, and label and instruction manual preparation. It requires producing 3 consecutive batches of samples at a facility licensed to manufacture health supplements in the same dosage form, along with toxicological safety testing, functional efficacy testing, analysis and method validation of active/marker components, microbiological testing, and stability studies.
   Article 25Applicants may apply for health food registration only after completing the development work.
    Article 26To apply for registration of a domestic health food, the applicant shall complete the "Application Form for Registration of Domestic Health Foods" in accordance with regulations and submit the application materials and sample products to the local food and drug administration department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located.
Upon receiving the declaration materials and submitted samples, the food and drug regulatory authorities of provinces, autonomous regions, or municipalities directly under the Central Government shall conduct a formal review of the compliance and completeness of the materials within 5 days. If the materials meet the requirements, an acceptance notice shall be issued. If they do not, the applicant shall be notified to make corrections. Upon resubmission that meets the requirements, an acceptance notice shall be issued; otherwise, a notice of non-acceptance shall be issued with written reasons provided.
    Article 27The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall conduct on-site inspections within 30 days from the date of application acceptance, collect samples for testing, and submit review opinions along with the declaration materials and submitted samples to the National Food and Drug Administration. They shall also issue a notice of inspection to the designated testing institution and provide the required samples for testing.
    Article 28If the product development site is not within the same provincial administrative region as the acceptance location, the food and drug administration department of the province, autonomous region, or municipality where the application was accepted shall notify the food and drug administration department of the province, autonomous region, or municipality where the product development site is located to conduct an on-site inspection within 5 days of accepting the application. The food and drug administration department at the product development site shall return its inspection opinion to the accepting department within 15 days of receiving the notification.
    Article 29Upon receiving the review opinions, application materials, and samples submitted by provincial, autonomous region, or municipal food and drug regulatory authorities, the national food and drug regulatory authority shall organize relevant personnel to conduct technical review and administrative approval of the product's safety, functionality, quality controllability, packaging, labeling, instructions, and quality standards within 80 days if the submission meets all requirements. If registration is approved, a "Domestic Health Food Product Registration Certificate" shall be issued to the applicant; if not approved, an approval opinion notice shall be sent to the applicant. A copy shall also be forwarded to the food and drug regulatory authority of the province, autonomous region, or municipality where the application was accepted.

    Article 30Before applying for registration of imported health food, the applicant shall conduct safety toxicology studies, functional studies, verification of efficacy marker/characteristic component testing and methods, stability studies, and microbiological tests at a test institution recognized by the national food and drug regulatory authority.
    Article 31To apply for registration of imported health food, the applicant shall complete the "Application Form for Registration of Imported Health Food" in accordance with regulations and submit the application materials and samples to the National Medical Products Administration.
Upon receiving the declaration materials and submission samples, the national food and drug regulatory authority shall conduct a formal review of the materials' compliance and completeness within 5 days. If the materials meet the requirements, an acceptance notice will be issued. If they do not, the applicant will be notified to make corrections. Upon resubmission that meets the requirements, an acceptance notice will be issued; if it still does not meet the requirements, a notice of non-acceptance will be issued with written reasons provided.
    Article 32The national drug and food regulatory authority shall issue an inspection notice to the designated testing agency within 30 days of accepting an application for registration of imported health foods, along with samples from 3 consecutive production batches. Where necessary, it may conduct on-site verification of the product's development process and production conditions and collect additional samples.
    Article 33The national drug and food regulatory authority shall, within 80 days of accepting an application for registration of imported health foods, organize relevant personnel to review the product's safety, functionality, quality controllability, packaging, labeling, instructions, and quality standards. If approved, a "Certificate of Registration for Imported Health Food Products" shall be issued to the applicant; if not approved, an approval opinion notice shall be issued to the applicant.

    Article 34A single product applying for health food registration may claim no more than two health functions.

Section 3: Product Change Request and Approval

    Article 35A change application is a request submitted by the applicant to modify the content specified in the Health Food Product Registration Certificate and its attachments.
The applicant for a change must be the holder of the health food product registration certificate.
    Article 36Applicants may not submit requests to change the health function name, ingredients, method of consumption, dosage, expand the scope of suitable populations, or narrow the scope of unsuitable populations, as these changes could affect safety or efficacy.
    Article 37To apply for changes to the contents of the "Domestic Health Food Product Registration Certificate" and its attachments, the applicant shall complete the "Domestic Health Food Change Application Form" and submit relevant materials and explanations to the provincial, autonomous regional, or municipal food and drug administration department where the applicant is located.
The provincial, autonomous regional, or municipal food and drug administration departments shall conduct a formal review of the completeness and compliance of the submitted materials within 5 days of receipt. If the materials meet the requirements, an acceptance notice shall be issued. If they do not, the applicant shall be notified to correct them. Upon successful correction, an acceptance notice shall be issued; otherwise, a notice of non-acceptance shall be issued with written reasons.
    Article 38For applications involving changes to product names, addition of precautions, narrowing of the target population, or expansion of contraindicated populations, provincial, autonomous regional, and municipal food and drug regulatory authorities shall submit the declaration materials to the National Food and Drug Administration within 10 days after accepting the application.

The national food and drug regulatory authority shall, within 20 days of receiving the application materials, organize relevant personnel to review them. If approved, a "Domestic Health Food Change Approval Certificate" shall be issued to the applicant; if not approved, an approval opinion notice shall be sent to the applicant, with copies forwarded to the relevant provincial, autonomous regional, or municipal food and drug regulatory authorities.
    Article 39For applications involving additions to functional items, changes to product specifications, auxiliary materials, production processes, shelf life, or quality standards, the provincial, autonomous regional, or municipal food and drug regulatory department shall review the submitted documentation within 30 days of acceptance. If necessary, they shall conduct on-site inspections, issue a review opinion, collect samples, and submit them to an accredited testing agency for examination. The review opinion and all submission documents shall then be forwarded to the National Food and Drug Administration.
The national food and drug regulatory authority shall, within 50 days of receiving the review opinion and application materials, organize relevant personnel to conduct technical evaluation and administrative review of the submitted materials. If the change is approved, a "Domestic Health Food Change Certificate" shall be issued to the applicant; if not approved, an Approval Opinion Notice shall be sent to the applicant, with copies forwarded to the relevant provincial, autonomous region, or municipal food and drug regulatory authorities.
    Article 40For registration applications involving changes to the applicant's name or address, the food and drug administration of the province, autonomous region, or municipality shall organize relevant personnel to review the submitted materials within 20 days of receiving the application. If approved, a "Domestic Health Food Change Certificate" shall be issued to the applicant; if not approved, an Approval Opinion Notice shall be issued to the applicant, and the case shall be reported to the National Food and Drug Administration.
    Article 41To apply for changes to the contents of the "Imported Health Food Product Registration Certificate" and its attachments, applicants shall complete the "Application Form for Changes to Imported Health Food Products" and submit relevant materials to the China National Medical Products Administration.

    Article 42The National Medical Products Administration shall, within 5 days of receiving the declaration materials, conduct a formal review of their standardization and completeness, and issue an acceptance or non-acceptance notice.
    Article 43For applications to change the applicant's name or address, add precautionary notes, narrow the scope of suitable populations, or expand the scope of unsuitable populations, the National Medical Products Administration shall organize relevant personnel to review the submission materials within 20 days after receiving the review opinion and application documents. If approved, an "Imported Health Food Change Certificate" shall be issued to the applicant; if not approved, a Notice of Approval Opinion shall be issued.
    Article 44For applications involving new function claims, changes to product specifications, excipients, processes, shelf life, quality standards, or changes in production sites outside China, the National Medical Products Administration shall organize relevant personnel to conduct technical review and administrative examination of the application materials within 50 days of receiving the review opinions and submission documents. If approved, a "Certificate for Domestic Health Food Changes" shall be issued to the applicant; if not approved, an Approval Opinion Notice shall be issued.
    Article 45The validity period of the health food change certificate matches that of the original product registration certificate.
    Article 46To apply for the reissuance of a health food product registration certificate, the applicant shall submit a written application to the National Medical Products Administration, stating the reasons.
For replacement due to loss, submit the original copy of the public notice of loss published in a nationwide newspaper. For replacement due to damage, return the original product registration certificate. Upon review, if requirements are met, a new product registration certificate will be issued using the original approval number with unchanged validity period. The reissued certificate shall display the original approval date and include the notation "Reissued."

Section 4: Registration Application and Approval for Technology Transfer Products

    Article 47Technology transfer product registration application refers to the process where the holder of a "Domestic Health Food Product Registration Certificate" transfers full rights to the product's production technology and sales/production authority to a health food manufacturing enterprise, and jointly applies for a new "Domestic Health Food Product Registration Certificate" issued to the transferee.
    Article 48Products with technology transfer approvals granted during the validity period of a product registration certificate shall not be eligible for subsequent technology transfer applications. The transferee must be a manufacturer holding a Good Manufacturing Practice (GMP) certification for the same dosage form of health food products.
    Article 49The transferor shall enter into an agreement with the transferee, transfer all technical documentation to the transferee, and guide the transferee to produce 3 consecutive batches of samples that meet the product quality standards.
    Article 50To apply for the transfer of health food technology, both the transferor and the transferee must jointly complete the "Application Form for Domestic Health Food Technology Transfer Product Registration" and submit relevant materials to the provincial, autonomous regional, or municipal food and drug regulatory department where the transferee is located.
The provincial, autonomous regional, or municipal food and drug administration departments shall conduct a formal review of the completeness and compliance of the submitted materials within 5 days of receipt. If the materials meet the requirements, an acceptance notice shall be issued. If they do not, the applicant shall be notified to correct them. Upon successful correction, an acceptance notice shall be issued; otherwise, a notice of non-acceptance shall be issued with written reasons.
    Article 51Provincial, autonomous regional, and municipal food and drug administration departments shall conduct on-site inspections within 30 days of receiving the application, collect samples, and submit them to accredited testing agencies for analysis. The resulting review opinions shall be submitted to the National Food and Drug Administration along with the application materials.
    Article 52The national food and drug regulatory authority shall complete technical review and administrative review within 50 days of receiving the review opinion and declaration materials. If transfer is approved, a new "Domestic Health Food Product Registration Certificate" shall be issued to the transferee; the certificate's validity period remains unchanged, and the original "Domestic Health Food Product Registration Certificate" held by the transferor shall be cancelled. If transfer is not approved, an approval notice shall be issued to the applicant, and the original "Domestic Health Food Product Registration Certificate" shall be returned to the transferor. Copies shall also be sent to the provincial, autonomous regional, or municipal food and drug regulatory authorities where the transferor and transferee are located.

Chapter 3: Development of Health Foods

    Article 53The national food and drug regulatory authority shall establish guidelines for the development of health supplements to guide and standardize their research and development.
    Article 54Applicants shall conduct development based on scientific research and the Guidelines for Health Food Development, and accurately maintain all relevant development records.
Applicants must have personnel, facilities, equipment, instruments, and management systems appropriate for the research project. If outsourcing research to third parties, a contract must be signed with the contractor, and this arrangement must be disclosed at the time of registration application.
    Article 55Applicants shall submit product formulations, manufacturing processes, and enterprise standards to testing institutions accredited by the National Medical Products Administration.
Certified testing institutions shall conduct relevant trials in accordance with national requirements. Human consumption trials must be approved by the institution's ethics committee before implementation. Original records related to the trials shall be retained for no less than 5 years.

Chapter 4: Registration Testing of Health Food

    Article 56For applications for health food product registration, the designated testing agency shall conduct the test within 50 days of receiving the sample and submit the test report to the National Food and Drug Administration, while copying the food and drug administration that ordered the test and the applicant.
    Article 57For applications involving product registration changes or technology transfers, the designated testing agency shall conduct testing within 30 days of receiving the test samples. The testing report must be submitted to the National Medical Products Administration, with a copy sent to both the local food and drug administration that requested the testing and the applicant.
    Article 58 Applicants shall provide the inspection agency with relevant documentation and reference materials for testing.
    Article 59The accredited testing agency must issue the test report within the prescribed timeframe. If the testing agency cannot complete the registration testing work within the specified period, it shall provide a written explanation and, upon approval, may extend the deadline by 30 days.
    Article 60Certified inspection agencies must operate in accordance with the law, ensuring that inspection work and results are accurate, scientific, and standardized. They shall not issue false reports.

Chapter 5: Technical Review of Health Food

    Article 61Supplements technical review shall comply with applicable laws, regulations, food safety national standards, and relevant requirements. The review process shall be scientific, standardized, transparent, fair, and impartial.
    Article 62The national food and drug regulatory authority shall establish technical review procedures for health foods and conduct reviews strictly in accordance with these procedures.
    Article 63The national food and drug regulatory authority shall establish and update technical review guidelines based on current scientific and technological needs, publish them, and use them to guide and standardize technical review activities.
Technical review of health food should strengthen assessment of product safety for consumption, scientific formulation, functional efficacy, reasonable manufacturing processes, and quality controllability.
    Article 64The National Medical Products Administration establishes an expert pool for health food evaluation, comprising experts in food science, nutrition, medicine, pharmacy, and related fields.
Review experts shall be selected by specialty according to random principles.
Review experts shall conduct technical reviews based on the technical review criteria and relevant national regulations, provide independent and objective review opinions, and take responsibility for those opinions.
Review experts shall proactively recuse themselves from products they helped develop.

Chapter 6: Raw Materials and Excipients

    Article 65The raw materials and excipients used in health supplements must be safe for human consumption and comply with national food safety standards or relevant requirements. In the absence of national food safety standards, a self-defined quality standard must be provided along with supporting documentation related to these raw materials and excipients.
    Article 66Raw materials and auxiliaries approved by the National Medical Products Administration for health foods, as well as those published or approved by the Ministry of Health for consumption and used in food production, may be used as raw materials and auxiliaries in health foods.
    Article 67If the raw materials and auxiliary substances used for registering a health food fall outside the scope of these Measures, relevant safety toxicology evaluation test reports and supporting data on edible safety for such materials must be provided in accordance with applicable regulations.
    Article 68Imported health food products must use raw materials and auxiliary ingredients that comply with all applicable Chinese regulations for health food raw materials and auxiliaries.

Chapter 7: Names, Labels, and Instructions for Health Food

    Article 69The label and sample copy of the instruction leaflet for a registered health food application shall include the product name, raw materials (including auxiliary materials), functional ingredients/marker ingredients and their content, health functions, suitable population, unsuitable population, recommended intake and method of consumption, specifications, shelf life, storage instructions, and precautions.
    Article 70The naming of health supplements shall comply with the following principles:
(1) Comply with applicable national laws, regulations, rules, standards, and codes.
(2) Accurately reflect the product's true attributes in clear, simple language that follows standard Chinese conventions.
(3) Generic names shall not use drug names that have already been approved for registration.
    Article 71The name of a health food shall consist of three parts: brand name, generic name, and attribute name. The brand name, generic name, and attribute name must comply with the following requirements:
(1) The brand name may use the product's registered trademark or other designations.
(II) Generic names must be accurate and scientific. Terms that explicitly or implicitly suggest therapeutic effects or exaggerate functionality are prohibited.

(3) Attribute names shall reflect the product's objective form and be stated in a standardized, accurate manner.

   Article 72The national food and drug regulatory authority shall review the content of label and instruction drafts based on applicable national standards, regulations, product declaration materials, and sample test results.

Chapter 7: Product Re-registration

    Article 73Product re-registration for health food refers to the approval process in which the national food and drug regulatory authority reviews, according to statutory procedures, conditions, and requirements, an applicant's request to continue producing or importing a health food after its registration certificate expires, and decides whether to approve the application.
    Article 74The applicant for renewal of a health food registration shall be the holder of the health food product registration certificate.
    Article 75Applicants must submit a re-registration application 3 months before the expiration of the health food product registration certificate.
    Article 76To apply for re-registration of domestic health food, the applicant shall complete the "Domestic Health Food Re-application Form" and submit the application materials to the provincial, autonomous region, or municipal food and drug administration where the applicant is located.
The provincial, autonomous region, or municipal food and drug administration department shall review the completeness and conformity of the submission materials within 5 days of receipt. If compliant, an acceptance notice will be issued. If non-compliant, the applicant will be notified to correct the deficiencies. Upon successful correction, an acceptance notice will be issued; otherwise, a notice of non-acceptance will be issued with written reasons provided.

    Article 77The provincial, autonomous regional, or municipal food and drug administration department shall submit the application materials to the National Food and Drug Administration within 20 days of receiving the application.
    Article 78Upon receiving the application materials submitted by the provincial, autonomous regional, or municipal food and drug administration, the national food and drug regulatory authority shall make a review decision within 20 days. For products with adjustments to the evaluation guidelines, the authority shall organize relevant personnel to conduct technical review and administrative approval of the adjusted content within 40 days and issue a review decision. Applications that meet the requirements shall be approved for re-registration; those that do not shall receive an Approval Opinion Notice sent to the applicant. A copy of this notice shall also be sent to the food and drug administration in the province, autonomous region, or municipality where the application was accepted.
    Article 79To apply for the re-registration of imported health food, the applicant shall complete the "Application Form for Re-registration of Imported Health Food" and submit the declaration materials to the National Medical Products Administration.
The national food and drug regulatory authority shall conduct a formal review of the规范性 and completeness of the declaration materials within 5 days of receipt. If compliant, an acceptance notice shall be issued. If non-compliant, the applicant shall be notified to make corrections. Upon resubmission, if compliant, an acceptance notice shall be issued; otherwise, a notice of non-acceptance shall be issued with written reasons provided.
    Article 80The national food and drug regulatory authority shall make a review decision within 20 days of receiving the application. For products with adjustments to the evaluation guidelines, relevant personnel shall conduct technical review and administrative approval of the adjusted content within 40 days and render a review decision. Applications meeting requirements will be approved for re-registration; those that do not meet requirements will receive an Approval Decision Notice.
    Article 81Health food supplements under any of the following circumstances shall not be re-registered:
(1) Failure to submit a renewal application within the prescribed time limit;

(2) Functions not covered by the currently published scope.
(3) No production or sales during the validity period of the product registration certificate.
(4) Other circumstances not in compliance with applicable national regulations.

Chapter 9: Review

    Article 82If the applicant disagrees with the decision by the National Medical Products Administration to deny approval, they may submit an application for review to the Administration within 60 days from the date of receiving the notice of denial.
   Article 83The review is limited to the original application and supporting documents.
    Article 84Applicants requesting a review must complete the "Health Food Registration Review Application Form," state the reasons for the review, and submit relevant supporting documents.
    Article 85Upon receiving a review application, the national food and drug regulatory authority shall conduct the review within the original timeframe and in accordance with the original requirements, and issue a review decision. If the decision to reject approval is revoked, a corresponding health food product registration certificate shall be issued to the applicant. If the original decision is upheld, no further review applications will be accepted; however, the applicant may, in accordance with relevant laws, request administrative reconsideration from the national food and drug regulatory authority or file an administrative lawsuit in a people's court.

Chapter 10: Legal Liability

    Article 86Under any of the following circumstances, the National Medical Products Administration may, upon verification and at the request of an interested party or ex officio, take action in accordance with the provisions of the Administrative Licensing Law:

(1) Where administrative agency personnel abuse their power or neglect their duties in making a decision to approve registration;
(2) Making a decision to grant registration beyond statutory authority;
(3) Granting registration in violation of statutory procedures;
(4) Granting registration to applicants who are not qualified or do not meet statutory requirements.
(5) Other circumstances in which approval documents for health food may be revoked in accordance with the law.

    Article 87The National Medical Products Administration shall cancel the approval number of a health food under any of the following circumstances:
(1) The holder of the approval document for health food applies for cancellation.
(2) Confirmation that the product has safety hazards;
(3) The holder of the health food approval document has legally ceased to exist.
(4) Where approval documents for health food are revoked in accordance with legal and regulatory provisions;
(5) Other circumstances where cancellation is required by law.
    Article 88During the registration of health food, if the National Medical Products Administration or local medical products administrations in provinces, autonomous regions, or municipalities directly under the Central Government, along with their staff, violate the provisions of these Measures, they shall be dealt with in accordance with Articles 73, 74, and 75 of the Administrative Licensing Law.
(1) Failure to accept a health food registration application that meets statutory requirements.
(2) Failure to publish the list of registration declaration materials for health food at the acceptance venue.
(3) Failure to fulfill the statutory obligation of informing the applicant during the acceptance and review process for health food products.

(4) Failure to inform the applicant of all contents that must be corrected in a single notification when submitted health food declaration materials are incomplete or do not comply with statutory forms.
(5) Failure to legally explain the reasons for not accepting or approving a health food registration application.
(vi) Granting registration approval for health food applications that do not meet the conditions stipulated in these Measures, or granting such approval beyond statutory authority;
(7) Failing to grant registration for applications that meet the requirements of these Measures, or failing to make a decision to grant registration within the prescribed time limit.
(8) Imposing unauthorized fees or failing to charge according to legally prescribed standards.
(9) Soliciting or accepting property from others, or seeking other benefits.
    Article 89If the national food and drug regulatory authority violates the provisions of these Measures during the registration process for health food, thereby causing damage to the legitimate rights and interests of any party, compensation shall be provided in accordance with the State Compensation Law.
    Article 90Applicants who conceal relevant information, submit false materials or samples to apply for health food registration shall be denied acceptance or registration by the food and drug regulatory department and shall not be eligible to apply for health food registration within one year.
    Article 91If an applicant obtains a health food product registration certificate through fraudulent or bribery means, the National Medical Products Administration shall revoke the registration certificate and will not accept any new health food registration applications from that applicant for five years.
    Article 92If the test or inspection results issued by an accredited testing or inspection body are inaccurate and cause loss, compensation shall be provided.
If an accredited testing or inspection agency fails to conduct tests or inspections in accordance with these Measures, or if errors or accidents occur during such activities, the National Medical Products Administration shall issue a warning and order corrections within a specified time limit. In serious cases, the "Health Food Inspection Qualification Certificate" shall be revoked.
If an accredited testing or inspection institution issues a false test or inspection report, it shall be punished in accordance with the provisions of the Food Safety Law.

Chapter 11: Supplementary Provisions

    Article 93Meaning of terms used in this measure
Dietary supplements are products designed to provide vitamins and minerals, not energy. They help fill nutritional gaps in the diet, prevent deficiencies, and reduce the risk of certain chronic degenerative diseases.
Product development site refers to the location where an applicant conducts research on formulas, processes, stability, and other relevant studies, as well as trial production and testing activities prior to applying for health food registration.
The basic conditions for Good Manufacturing Practice (GMP) for health food refer to the requirements for equipment, facilities, management systems, personnel, and hygiene.
Safety toxicology testing refers to animal studies conducted by accredited institutions on samples submitted by applicants, following the evaluation procedures and test methods established by the national food and drug regulatory authority. The purpose of these tests is to verify the safety of consumption for health foods.
Functional testing refers to animal and/or human consumption trials conducted by a testing agency on samples submitted by an applicant, using evaluation procedures and testing methods prescribed by the national food and drug regulatory authority or provided by the enterprise, for the purpose of verifying health benefits.
Efficacy or marker component testing refers to the analysis conducted by a testing agency on submitted health food samples, following the methods provided by the enterprise, to measure the content of efficacy or marker components and their changes over the product's shelf life.
A hygiene test is a testing procedure conducted by an inspection agency on submitted samples to evaluate their hygienic quality and product-related indicators (excluding active or marker ingredients), in accordance with methods issued by relevant national authorities or provided by the enterprise.
Stability testing refers to the assessment conducted by a testing agency, using methods published by relevant national authorities or provided by the enterprise, to monitor changes in the hygiene and quality-related indicators (excluding efficacy or marker ingredients) of submitted samples throughout their shelf life.
Registration testing refers to the comprehensive testing of samples provided by the food and drug regulatory authority by a testing agency, conducted in accordance with the quality standards declared by the applicant.
The raw materials of health food refer to the initial materials related to its functional properties.
Excipients in health food products refer to the excipients and other added materials used during production.
    Article 94The term of this regulation is calculated in working days and excludes statutory holidays.
    Article 95Domestic health food approval numbers follow the format: Guo Shi Jian Zi G + 4-digit year code + 6-digit serial number. Domestic health food filing numbers follow the format: Guo Shi Jian Bei Zi G + 4-digit year code + 6-digit serial number. Imported health food approval numbers follow the format: Guo Shi Jian Zi J + 4-digit year code + 6-digit serial number. Imported health food filing numbers follow the format: Guo Shi Jian Bei Zi J + 4-digit year code + 6-digit serial number. Product registration certificates are valid for 5 years.
    Article 96Packaging materials and containers in direct contact with health food must comply with national food safety standards or relevant national requirements.
    Article 97This regulation shall be interpreted by the National Medical Products Administration.