New Regulation on Health Food Products Released
Recently, the State Administration for Market Regulation, the National Health Commission, and the National Administration of Traditional Chinese Medicine have jointly released the "Catalogue on Health Functions Allowed for Health Food Claims - Non-Nutrient Supplements (2023 Edition)" (hereinafter referred to as the "Catalogue") and accompanying document announcements. These regulations aim to standardize the management of health function claims, implement the main responsibilities of enterprises in making health function claims and conducting research and evaluation, and promote industrial innovation and high-quality development.
It is understood that the 24 health function claims included in the "Catalogue" are all those that have historically been approved, have a high degree of social consensus, and have similar functional claims internationally. The accompanying documents of the "Catalogue" mainly include the "Technical Guidelines for the Testing and Evaluation of Health Food Functions," "Methods for the Testing and Evaluation of Health Food Functions," and "Guiding Principles for Ethical Review of Population Feeding Trials for Health Foods," among others.
The State Administration for Market Regulation, adhering to the principles of "scientific rationality, effective connection, smooth transition, and standardized adjustment," has publicly solicited opinions from society three times in March 2019, November 2020, and January 2022, and has revised and improved the "Catalogue" and its supporting documents. The "Catalogue" has adjusted the original 27 health functions to 24, removing three health functions such as "improving growth and development," "promoting lactation," and "improving skin oil content," which had a lower degree of consensus and unclear health demands. The functional evaluation method has been changed from a mandatory method to a recommended method, implementing the main responsibility of enterprises in research and evaluation, and giving full play to the advantages of social resource research.
From the date of issuance of the "Catalogue" and its supporting documents, within a period of 5 years, health food products that are already registered and filed as non-nutrient supplements must be standardized in accordance with the "Administrative Measures for the Catalogue of Health Food Raw Materials and Health Functions" and the provisions of the "Catalogue".
According to the "Catalogue," there are 7 functional names that only require animal function tests, 4 functional names that only require human feeding trials, and 13 functional names that require both animal function tests and human feeding trials.
Based on the "Catalogue," for those health functions that were originally evaluated according to the "Health Food Functional Evaluation Procedures and Testing Methods (1996 Edition)" issued by the former Ministry of Health, a re-evaluation of the functional tests is required. The specific items for the re-evaluation are as follows:
| No. | Health Function Name | Original Health Function Claim | Required Re-evaluation Functional Test Item |
| 1 | Enhances Immunity (Animal Function) | Immune Regulation, Enhances Immunity | Re-conduct Animal Function Test |
| 2 | Antioxidant (Animal Function and Human Feeding Test) | Delays Aging, Antioxidant | Supplement Human Feeding Test |
| 3 | Assists in Improving Memory (Animal Function and Human Feeding Test) | Improves Memory, Assists in Improving Memory | If the human feeding test uses the Wechsler Memory Scale, re-conduct the human feeding test |
| 4 | Relieves Physical Fatigue (Animal Function) |
Anti-Fatigue, Alleviates Physical Fatigue | If the exercise test is limited to the pole climbing test, re-conduct the animal function test. |
| 5 | Hypoxia Tolerance (Animal Function) | Tolerance to Hypoxia, Enhances Hypoxia Tolerance | Re-conduct Animal Function Test |
| 6 | Assists in Controlling Body Fat (Animal Function and Human Feeding Test) | Weight Loss | Re-conduct Functional Test |
| 7 | Helps Maintain Healthy Blood Lipid (Cholesterol) Levels (Animal Function and Human Feeding Test) | Regulates Blood Lipids (Lowers Total Cholesterol, Lowers Triglycerides), Assists in Lowering Blood Lipids | Re-conduct Human Feeding Test |
| 8 | Provides Auxiliary Protection Against the Harm of Ionizing Radiation (Animal Function) | Anti-Radiation, Provides Auxiliary Protection Against Radiation Harm | Re-conduct Animal Function Test |
With the release of the "Technical Guidelines for the Testing and Evaluation of Health Food Functions (2023 Edition)" and a series of other documents by the State Administration for Market Regulation, including the commencement of the certificate renewal process, it is anticipated that the health food industry is poised to enter a new phase of rapid development.