SAMR Consults on Checkpoints for Health Food Function Recipe Literature Review

To further intensify the technical review of scientific evidence and improve the technological support level of health food function research and development, SAMR formulated and opened Checkpoints for Health Food Function Recipe Literature Review ^[1] to public feedback on July 23, 2020. Opinions shall be sent to [email protected] prior to August 23, 2020.

This document is mainly drafted based on Administrative Measures for Registration and Filing of Health Foods ^[2] and Health Food Registration Review and Approval Work Rules ^[3] and is divided into four parts: a) the requirements of referenced literature, b) literature basis and the necessity for the use of ingredients, c) literature support and explanation for the recipe formulation, and d) judging principle for the review conclusion. Here follows a summary of each part. For further translation service, please email [email protected].

Requirements of referenced literature

• Referenced literature shall be provided within the following scope:

1. Regulations, standards, guidelines, monographs, etc. issued by domestic and foreign governments, authorities or organizations;

2. Records and descriptions wrote in ancient books of traditional Chinese medicine;

3. National unified compiled textbooks, national planning textbooks, professional works, academic yearbooks, etc.;

4. Scientific research papers, expert treatises and systematic literature reviews, which were officially published in Chinese core journals or international professional journals

• As for the quality requirements of the support evidence, the literature shall be professional with reliable research data and shall be authoritative in the field with wide recognition. There shall also be a correlation, can be confirmed, between the claimed functions of health food and the description of the ingredients’ function written in the literature, etc.

Literature basis and necessity for the use of ingredients

The principle of using ingredients is, active ingredients shall be the one with claimed functions; other materials shall be used as necessary. Active ingredients here include single ingredients and compound ingredients. It may also be simply-processed ordinary foods.

Hence, applicants shall provide efficient literature to show the active ingredients at a certain dosage have the claimed functions, and the supportive role other ingredients played in the product and its necessity.

Literature support and explanation for the recipe formulation

• The description of recipe formulation shall be normative, clear, with daily consumption amount, and comply with the requirements regulated in the Guideline of Health Food Registration Application (2016) ^[4].

• Recipe shall be formulated and designed appropriately for the target consumers with a clear purpose. And the referenced literature can fully support the function and feature of health food products.

• At last, a critical analysis of the ingredients used and recipe formulation is needed to demonstrate the recipe and dosage possess the claimed function. 

Judging principle for the review conclusion

Once the content of the literature contradicts the function argument report, or it cannot support the function claimed, SAMR will reject the approval. While, if the application is with efficient literature support for the function argument but lacks other materials, a further supplement to the document will be accepted.