During the Chinese New Year period, the Chinese comedy-drama film YOLO has taken China by storm. The film's director and lead actress, Jia Ling, successfully lost 50 kilograms, reigniting the enduring topic of weight loss on various trending lists in China. Weight-loss foods have also been frequently mentioned.
What is Weight Loss Product?
There are numerous products associated with weight loss on the Chinese market. Generally, these products can be broadly categorized into two types:
1. Functional foods containing ingredients with weight loss benefits
Functional foods in China still lack a clear legal definition, and its regulation falls under general foods.
A weight loss functional food product available for sale on a certain e-commerce platform
The Regulations on Implementation of Food Safety Law stipulates that claims of having health functions for foods other than health foods shall not be made. The National Food Safety Standards -- General Principles for Labeling Pre-packaged Foods (GB 7718) also stipulates that non-health foods shall not explicitly or implicitly indicate health benefits.
2. Health foods with a "Blue Hat", health benefits, and approval number
Health foods are subject to clear legal regulations. Specific regulatory guidelines exist for functional claims, product promotions, and efficacy evaluations before market launch. Each of these health foods is assigned a corresponding approval number.
A weight loss health food product with Blue Hat available for sale on a certain e-commerce platform
In the National Standard for Food Safety - Health Foods (GB 16740), the definition of health food is clear and precise: it refers to foods that claim to have specific health functions or are intended to supplement vitamins and minerals. These foods are suitable for specific populations, have regulatory functions on the body, are not intended to treat diseases, and do not pose any acute, sub-acute, or chronic hazards to human health.
China implements a dual-track system for the registration and filing of health food. Weight-loss health food falls under the category that requires registration. According to the Catalogue of Health Functions Permitted to be Claimed by Health Food Non-Nutrient Supplements (2023 Edition)(hereinafter referred to as Catalogue), the health function related to weight loss has been changed from the original "weight-loss" to "helps control body fat."
In the Methods for Testing and Evaluation of Health Food Functions (2023 Edition), functional testing and evaluation of products claiming to help control body fat are required, including animal experiments and human taste trials.
Regulatory Approaches for Weight Loss Health Foods in China
Cross-border e-commerce is currently the preferred method for selling overseas health food products in China, as it does not require enterprises to register products. However, overseas enterprises that engage in general trade, selling weight loss foods products, and making related functional claims in the Chinese market requires application for products registration. Only after obtaining the registration certificate can sales and promotions be conducted in compliance with regulations.
1. Application Process
2. Application Documents
| Application Documents | |
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(1) |
Application Form for Registration of Domestic Health Food and Undertaking of Legal Responsibility for Authenticity of Application Materials by the Applicant |
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(2) |
Copy of the Registration Certificate of the Applicant |
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(3) |
Product Research and Development Report |
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(4) |
Product Formula Materials |
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(5) |
Product Production Process Materials |
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(6) |
Safety and Health Function Test Evaluation Materials |
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(7) |
Types, Names, and Standards of Packaging Materials Directly in Contact with Health Food |
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(8) |
Drafts of Product Labels and Instructions |
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(9) |
Materials for Checking Non-duplication of Generic Names with Registered Drug Names and Non-duplication of Product Names with Approved Health Food Names. A naming explanation should also be provided if the product's common name indicates its characteristics using words other than raw materials or their abbreviations. |
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(10) |
Samples of the Three Smallest Sales Packages |
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(11) |
Other Materials Related to Product Registration and Evaluation |
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(12) |
Proof of Health Food Sales for Over One Year issued by the government authority or legal service agency of the production country (region) or safety report on overseas sales and consumption situations of the product |
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(13) |
If the product is approved in the exporting country (region), a certificate allowing the product to be sold on the market by the competent authority of the exporting country (region) should be provided |
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(14) |
Original Technical Regulations or Standards related to Health Food from the production country (region) or international organizations |
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(13) |
Actual Samples of Packaging, Labels, and Instructions used in the production country (region) |
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(15) |
For foreign applicants handling registration affairs through a permanent representative office in China, submit the Registration Certificate of Foreign Enterprise Permanent Representative Office in China and its copy; for foreign applicants entrusting domestic agencies to handle registration matters, submit the original notarized power of attorney and a copy of the business license of the entrusted agency. |
Approval Status of Weight Loss Health Foods
As of the end of February 2024, data from the Special Food Information Query Platform of China SAMR showed many weight loss health foods on the market. 41 health foods claiming to help control body fat and 437 products claiming to have a weight loss function. This reflects the high market demand and popularity of weight loss products.
Changing of Health Food Registration Certificate
According to the Catalogue and its related documents issued by SAMR in 2023, health food is about to undergo a comprehensive certificate changing and transition process. There are two types involved:
1. "Double None" Health foods
"Double None" refers to health foods approved by the former Ministry of Health and China Food and Drug Administration (CFDA) at different times, with no expiration date or product technical requirements on their registration certificates. This mainly includes all products labeled with "卫食健字"(which means the approval number of health food products approved by the former Ministry of Health before December 2003) and some products approved during the transitional period from 2003 to 2005. These products need to undergo a renewal and transition process.
On December 27, 2023, China SMAR issued a draft Supporting Documents for the Change of Health Food Registration Certificate, seeking public comments. A series of requirements are being formulated, including safety evaluation of renewal products, adjustment of functional claims, production processes, and product technical requirements.
2. Health foods with approval for weight loss
For such products, SMAR has set a 5-year transition period to standardize the products' health claims. According to the documents related to the renewal policy, products with the original health claim of weight loss evaluated using the 1996 version of the functional evaluation method need to redo the functional tests.
