Health Foods in China: New Rules Approving Functional Claims
On August 2, 2022, China's State Administration of Market Regulation (SAMR) published the draft implementation rules for technical evaluation of new claims for health foods. This is another step the authorities are taking to develop SAMR’s regulatory framework for the registration and notification of health foods. Notably, health foods in China not only include foods that make health claims, but also nutrient supplements, such as vitamins and minerals.
Back in 2016, SAMR created a dual-track system to regulate health foods, i.e., registration and notification. Under such a system, one of the requirements is that industry is only allowed to use a claim that is on the list of permissible functional claims for health foods, e.g., assists in boosting the immunity system, reducing fatigue, etc. A claim beyond SAMR’s list is considered “new,” and, thus, not permissible. SAMR’s new draft rules provide more clarification to help guide industry when applying for the use of new functional claims for health foods.
More specifically, health food claims are categorized into the following three types:
- Supplementing nutritional substances in the diet
- Maintaining or improving health conditions of the human body
- Reducing the risk of incurring diseases
SAMR requires the applicant to apply for the use of a new claim in conjunction with an application seeking approval for the health food bearing such new claim, i.e., one application for the claim and a separate application for the health food. SAMR will then conduct a “joint review” of both applications.
To apply for a new claim, the draft states that one should provide the methodology to evaluate and verify the new function. The evaluation and verification methods of the new claim must be confirmed by local Chinese qualified laboratories. SAMR provides a checklist of data requirements when applying for a new claim, e.g., how the new claim is developed and functioning in the human body, how to evaluate the function, how the claim is regulated in other countries, etc.
Notably, SAMR also created a five-year monitoring period of the new claim, during which the company obtaining the approval of the claim is obligated to collect a range of data, e.g., sales numbers, consumer feedback, etc., and submit annual reports to SAMR for review. During these five years, the new claim is proprietary to the company, and others may not use it. After the end of the monitoring period, if no issues are observed, SAMR will add the new claim to the approved list of claims for health foods. Through such listing, anyone can use the new claim on their health foods.
Please sign up for our newsletters here. If you have any questions on the above or would like to know more about the regulatory requirements of exporting health foods, including dietary supplements, to China, please do not hesitate to contact David Ettinger (firstname.lastname@example.org), Jenny Li (email@example.com), or your existing contact at Keller and Heckman LLP. Keller and Heckman represents the food industry on regulatory matters. China Regulatory Matters (CRM) is intended to update you in a timely manner on any significant Chinese regulatory changes in the areas of food, food packaging, cosmetics, environmental, and chemical control.
 It should be noted that the finished health foods are subject to premarket approval in China. Thus, while one can use a new claim on the list, an application still needs to be filed with SAMR to seek clearance for the health food with the new claim.