On August 6, 2024, the State Administration for Market Regulation (SAMR) published an announcement to solicit suggestions for health functions of dietary supplements, in order to “provide policy and technical consulting services, support research on new functions of health food products, and foster new quality productivity in the field of health food products.”
The said solicited health functions of dietary supplements are to be included in a catalogue, which is defined as a list of health care function information with clear evaluation methods and judgment criteria developed in accordance with the Measures for the Administration of the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Health Functions (the Measures) effective on October 1, 2019.
According to the said Measures, “the health functions included in the catalogue of health functions should meet the following requirements: (a) to supplement dietary nutrients, maintain and improve the health state of the organism, or reduce risk factors for the occurrence of diseases; (b) having a clear health consumption demand that can be correctly understood and recognized; (c) having sufficient scientific basis, as well as scientific evaluation methods and judgment standards; (d) the health care functions guided by traditional health care theories in line with traditional Chinese medicine health care theories; (e) having a clear suitable and unsuitable crowd.” However, “one of the following circumstances shall not be included in the catalogue of health care functions: (a) involving disease prevention, treatment, or diagnosis; (b) vulgar or with feudal superstitions; (c) other circumstances that may mislead consumers.”
Further, any work unit or individual, on the basis of relevant research, can propose to the review body which is the Center for Food Evaluation of the SAMR to include or adjust the health functions catalogue, with following materials: (a) the name, explanation, mechanism and basis of health care function; (b) the health function research report including the health function’s population health needs analysis, the analysis and synthesis of the health function and the body health effect, the health function test’s principle basis, scope of application, as well as other relevant scientific research information; (c) the health care function evaluation methods and judgment standards, the corresponding sample animal testing or human food testing and other functional test reports; (d) the domestic or aboard research application of the same or similar functions; (e) the relevant scientific literature and other materials. In case of proposals to adjust the health functions catalogue, the reasons, basis and relevant materials for the adjustment shall also be provided.
The said review body will conduct a technical review of the said proposals and report to the SAMR regarding its technical evaluation conclusions. Then, the SAMR will review the said material reported by the review body and publish the included or adjusted health functions catalogue that fulfill the said requirements, along with the National Health Commission of the PRC (the NHC) and the National Administration of Traditional Chinese Medicine (the NATCM).
Comment
According to the SAMR, upon soliciting suggestions regarding the health functions catalogue from the work unit or individual under the said Measures, it is good to fully take advantage of the scientific research of the social resources, improve the scientific nature of raw materials and functional evaluation methods, solve the current problem of a single government-led but insufficient scientific research power, and improve the quality and efficiency of catalogue development.
Since the implementation of the Measures in 2019, the SAMR, along with the NHC and the NATCM, have co-issued two of health functions catalogues of dietary supplements respectively, in 2020 and 2023. The suggestion solicitation for the new proposed catalogue herein will expire on December 31, 2024.
The said solicited health functions of dietary supplements are to be included in a catalogue, which is defined as a list of health care function information with clear evaluation methods and judgment criteria developed in accordance with the Measures for the Administration of the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Health Functions (the Measures) effective on October 1, 2019.
According to the said Measures, “the health functions included in the catalogue of health functions should meet the following requirements: (a) to supplement dietary nutrients, maintain and improve the health state of the organism, or reduce risk factors for the occurrence of diseases; (b) having a clear health consumption demand that can be correctly understood and recognized; (c) having sufficient scientific basis, as well as scientific evaluation methods and judgment standards; (d) the health care functions guided by traditional health care theories in line with traditional Chinese medicine health care theories; (e) having a clear suitable and unsuitable crowd.” However, “one of the following circumstances shall not be included in the catalogue of health care functions: (a) involving disease prevention, treatment, or diagnosis; (b) vulgar or with feudal superstitions; (c) other circumstances that may mislead consumers.”
Further, any work unit or individual, on the basis of relevant research, can propose to the review body which is the Center for Food Evaluation of the SAMR to include or adjust the health functions catalogue, with following materials: (a) the name, explanation, mechanism and basis of health care function; (b) the health function research report including the health function’s population health needs analysis, the analysis and synthesis of the health function and the body health effect, the health function test’s principle basis, scope of application, as well as other relevant scientific research information; (c) the health care function evaluation methods and judgment standards, the corresponding sample animal testing or human food testing and other functional test reports; (d) the domestic or aboard research application of the same or similar functions; (e) the relevant scientific literature and other materials. In case of proposals to adjust the health functions catalogue, the reasons, basis and relevant materials for the adjustment shall also be provided.
The said review body will conduct a technical review of the said proposals and report to the SAMR regarding its technical evaluation conclusions. Then, the SAMR will review the said material reported by the review body and publish the included or adjusted health functions catalogue that fulfill the said requirements, along with the National Health Commission of the PRC (the NHC) and the National Administration of Traditional Chinese Medicine (the NATCM).
Comment
According to the SAMR, upon soliciting suggestions regarding the health functions catalogue from the work unit or individual under the said Measures, it is good to fully take advantage of the scientific research of the social resources, improve the scientific nature of raw materials and functional evaluation methods, solve the current problem of a single government-led but insufficient scientific research power, and improve the quality and efficiency of catalogue development.
Since the implementation of the Measures in 2019, the SAMR, along with the NHC and the NATCM, have co-issued two of health functions catalogues of dietary supplements respectively, in 2020 and 2023. The suggestion solicitation for the new proposed catalogue herein will expire on December 31, 2024.