November 29, 2022

Volume XII, Number 333


November 28, 2022

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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.[1] This is another step the authorities are taking to develop SAMR’s regulatory framework for the registration and notification of health foods.[2] 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.[3]

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 270

About this Author

David J. Ettinger, Keller Heckman, Partner, Food and Drug Corporation, International Trade Lawyer, Attorney, Shanghai, China

David Ettinger joined Keller and Heckman in 1999. Mr. Ettinger represents domestic and foreign corporations in the area of food and drug law.

Mr. Ettinger relocated to Keller and Heckman's Shanghai office in November 2012 to focus on the Asian market and counsel companies in the Far East on food, drug, and chemical regulatory matters. He has extensive experience counseling clients on product development and product protection of food and drug packaging in the United States, Europe, Asia, Canada, and South America. From 2006-2007, Mr. Ettinger...

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Jenny Li, Keller Heckman, China Food, Drug Regulation, Shanghai, International Trade
Legal Consultant

Jenny Li joined Keller and Heckman in October 2007.

Ms. Li counsels clients on regulatory issues focusing on food and drug, with an emphasis on regulatory regimes in the Asia-Pacific region. She also counsels clients on food labeling, food claims, food additives, as well as, important issues regarding food imports in Asian countries.