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SAMR Issued Key Points of Literature on Health Functions of Health Food Formula (Draft)

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On July 23, 2020, SAMR issued Key Points of Health Functions of Health Food Formula Literature Review (Draft) for public comments (hereinafter referred as Key Points). The deadline for comments is August 23, 2020.

The Key Points lists the relevant requirements on literature basis, the literature of product raw materials and the discussions, the compatibility and dosage of product formula and the discussions, as well as the determination criterion for review conclusion. The release of the Key Points is intended to further strengthen the technical review on scientific basis of health functions of health food, and to make the health function development and research more solid and more scientific. In order to help you quickly obtain key information, CIRS will take you to understand the important parts of the Key Points:

1. Define the relevant requirements on literature

(1) Scope of literature

① Regulations, standards, guidelines, monographs, etc., which are issued by domestic and foreign government agencies, authorities or organizations.

② Ancient books of traditional Chinese medicine.

③ National textbooks, professional works, academic yearbooks, etc.

④ Scientific research papers, expert treatises and reviews officially published in domestic core journals or international professional journals.

(2) Quality requirements on literature

① The raw materials in the literature is consistent with that in the product, and main components, main process, etc., are relevant to the raw materials in the product. If extracts are used, the amount equivalent to the original material should be clarified.

② The origin of literature should be clear. For the literature such as regulations and standards, traceable information such as query methods should be provided.

③ The test crowds or animal model, research design, test indicators, etc., which are included in the experimental scientific research papers should be related to the functions and suitable crowds. The test results and statistical analysis are reasonable, the test conclusion is clear, and the test dosage can support that the raw materials on the using amount in the product have the claimed functions.

④ The papers on the non-oral administration of the test substance and the in vitro experiment shall not be used as the literature basis for directly supporting that the raw material of the dosage has the claimed function.

2. The literature of main raw materials should support that the raw material of the used dosage has the claimed function

Experimental scientific research papers or literature analysis and evaluation reports based on experimental scientific research papers should be provided. The title, first author, publication, test object, animal or crowd model, test dosage and equivalent human dosage, evaluation indicators, test results, conclusions, etc. in such literature can be listed in the summary table. The dosage of the main raw materials that support the claimed function should be comprehensively described based on the literature provided, and possible dietary intakes should be provided if necessary.

② If the main raw materials are simply processed ordinary foods, the functional components and contents of the raw materials and the dose-effect relationship should also be clearly defined. The raw material test reports, product test reports, etc. should indicate the specific content of functional components. The experimental scientific research papers should indicate the dose-effect relationship between the functional components and the claimed functions.

3. The principle of product formula should be discussed in detail

① If the formula is guided by the theory of Chinese medicine, the source, application and screening basis of the formula should be explained. The compatibility principle of the formula and the function of each raw material should be analyzed, and the claimed functions with the formula should be discussed.

② If the formula is guided by modern medicine and nutritional theories, the claimed functions with the formula should be discussed based on modern medical, nutritional theories and relevant scientific evidence.

③ The claimed functions with the formula should be discussed based on the characteristics of the raw materials, the production process, and the corresponding theory, especially the rationality of the formula containing both traditional animal and plant materials and non-traditional animal and plant materials.

④ For the products with multiple claimed functions, the scientificity and rationality of the claimed functions should be discussed.

CIRS Comments:

The adequacy of scientific evidence is very important for health food registration, and it is necessary to collect sufficient and useful scientific literature during the product development process. The Key Points is based on the Health Food Registration and Filing Regulation, Health Food Registration Application Service Guide, etc., for further refining the requirements on the health function related literature and improving the quality of relevant application materials. After the formal regulations are issued, health food enterprises can prepare relevant application materials according to the Review Key Points, and conduct self-review and improve the application materials.

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