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[National Health Commission] Food products that are produced and marketed must not contain Chinese medicinal materials; substances listed in the Pharmacopoeia may be used as food ingredients only if they have been included in the Catalogue of Substances Used as Both Food and Medicine.

Release Date:

2023-05-29 09:06

Dear Representative:

Our Commission attaches great importance to your proposal, “On Strengthening Research and Standardized Management of Food‑Medicine Dual‑Use Substances,” and has included it in the scope of key proposals to be addressed in 2022.

Our Food Division specially invited you, Academician Xiao Peigen, as well as experts from the State Administration for Market Regulation, the National Administration of Traditional Chinese Medicine, the National Center for Food Safety Risk Assessment, the Institute of Medicinal Plant Development of the Chinese Academy of Medical Sciences, and the Center for Chinese Medicinal Resources of the China Academy of Traditional Chinese Medicine, to convene a special symposium and solicit the views and recommendations of relevant departments, institutions, and specialists.

Having sought the views of the State Administration for Market Regulation and the National Administration of Traditional Chinese Medicine, we hereby respond as follows, in accordance with the functions and responsibilities of our Commission:

I. Current Work Status and Progress

In accordance with the relevant provisions of the Food Safety Law, the Catalogue of Substances Used as Both Food and Medicine is formulated and promulgated by the health administrative department under the State Council in conjunction with the food and drug supervision and administration department under the State Council.

In 2019, our commission, in collaboration with the State Administration for Market Regulation and the National Administration of Traditional Chinese Medicine, conducted research to include six substances, including Danggui, in the Catalogue of Substances Used Both as Food and as Medicine, and launched a pilot program for the management of nine substances, including Codonopsis pilosula, under the same regulatory framework.

Local authorities have responded enthusiastically; to date, more than 20 provinces have submitted pilot work plans to our commission and the State Administration for Market Regulation. In accordance with our respective responsibilities, we have promptly reviewed and approved these plans, and the pilot programs are currently progressing smoothly across the country.

In 2021, in accordance with the Food Safety Law and its implementing regulations, our commission formulated the “Regulations on the Administration of the Catalogue of Substances That Are Both Foods and Traditional Chinese Medicinal Materials,” thereby further refining the regulatory framework and operational procedures for the management of such substances.

II. Response to the Proposed Recommendations

(1) With regard to strengthening cultural confidence, preserving and carrying forward the fine traditions of our country’s medicinal‑food culture and its profound ideological essence, and advancing the Healthy China initiative.

Food‑medicine substances are an integral part of China’s traditional Chinese medicine culture. Developing the food‑medicine substance industry is an important means of implementing General Secretary Xi Jinping’s vision of a “grand food security” approach, fostering economic growth, and supporting rural revitalization.

Our commission attaches great importance to the management of food‑medicine substances. In recent years, in collaboration with the State Administration for Market Regulation, we have actively advanced efforts to revise and expand the catalog of such substances, achieving notable progress. However, with the rapid development of the economy and society, the current national catalog of food‑medicine substances no longer fully meets the needs of the public and enterprises.

To strengthen the performance of duties in accordance with the law and implement the Regulations, our commission will, in coordination with relevant departments, carefully study the revision and supplementation of China’s Catalogue of Food‑Drug Substances.

(II) On improving the legal and regulatory framework pertaining to substances that are both food and medicine.

In response to the existing challenges in the management of food‑medicine substances—namely, insufficient investment in basic research, inadequate relevant standards, and lengthy safety‑assessment procedures—the authorities, in collaboration with pertinent departments and on the basis of thorough investigations and comprehensive deliberations, will further refine the regulatory framework for the catalog of food‑medicine substances.

First, we are studying the initiation of revisions to the former Ministry of Health’s “Notice on Further Standardizing the Management of Health Food Raw Materials.”

Second, for existing food‑and‑medicine substances, provide detailed information including the Chinese name, Latin scientific name, family name, and edible parts; upon completion, promptly update and publish this information.

Third, relevant technical institutions have been entrusted to conduct systematic monitoring and evaluation of the catalog of food‑drug substances, while strengthening ongoing dynamic management.

(3) Regarding the establishment of the “Catalogue of Non-Food Substances.”

At present, China has not yet established a legal basis for either a “List of Non-Food Substances” or a “List of Food Substances.” Our commission will organize experts to continue conducting relevant research and to accumulate supporting data.

The Food Safety Law stipulates that “no pharmaceuticals may be added to food in the course of production or operation,” and the term “pharmaceuticals” encompasses traditional Chinese medicinal materials, meaning that the addition of such materials to food is generally prohibited.

At the same time, in order to take into account China’s traditional food culture, for a small number of Chinese medicinal materials that have long been widely used as food ingredients in folk practice, it is specifically stipulated that “however, substances that are traditionally both food and Chinese medicinal materials may be added.”

According to the Food Safety Law, substances listed in the Pharmacopoeia may be used as food ingredients only if they have been included in the Catalogue of Substances Used in Food and Medicine.

(4) On promoting the development of the food and drug substance industry.

Guided by the holistic approach to food, we will encourage industry players and specialized institutions to conduct relevant basic research and steer the development of the food‑medicine substance sector.

Based on the actual efficacy of food‑medicine substances and novel food ingredients, we will develop dietary‑nourishment guidelines and tailored food‑combination packages for the prevention and adjunctive treatment of chronic diseases. We will also organize the formulation of precision‑targeted, personalized “Dietary‑Nourishment Guidelines” to meet the needs of relevant populations in preventing and controlling chronic diseases and malnutrition, thereby continuously advancing the use of food‑medicine substances to support Healthy China initiatives and chronic disease prevention and management, and enhancing the public’s sense of gain.

III. Next Steps: Goals and Plans

Our commission will, in accordance with the State Council’s guiding principles on “delegation, regulation, and service,” continue to advance the reform of the management system for the catalog of food‑medicine substances, further streamlining procedures and enhancing service quality.

In coordination with the State Administration for Market Regulation and other relevant departments, we have initiated the revision and expansion of the catalog outlined in the former Ministry of Health’s “Notice on Further Standardizing the Management of Health Food Ingredients,” and will, as appropriate, begin work on revising the comprehensive catalog of food‑drug substances.

Continue to advance the role of food‑medicine substances in supporting Healthy China and chronic disease prevention and control, encourage and support localities in pursuing reform and innovation to vigorously develop the food‑medicine industry, and make every effort to implement the Healthy China and Rural Revitalization strategies, thereby effectively safeguarding public health and contributing to economic and social development.

Thank you for your concern and support for health and wellness initiatives.

National Health Commission

October 14, 2022

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