What are the precautions for the review and development of health food products?

Functional demonstration and formulation
First, the formula design basis in the description of the raw materials: ● Clear the purpose of the use of raw materials: the main raw materials have the function of declaration, and the remaining raw materials have the necessity and rationality of compatibility.
● Discuss the laws, standards, ancient books and documents on which the main raw materials have the function of declaration.
● When discussing, pay attention to the characteristics of the raw materials and production process of this product; The source of the raw material (Latin name) should be indicated, and the quality inspection report with the content index of the iconic ingredient should be provided.
Second, the design of the amount of formula raw materials (2016 version) After determining the product formula, it is necessary to preliminarily determine the daily amount of the main raw materials in the formula. Principles for determining the daily dosage of main raw materials (3 articles each) : The list needs to be standardized Literature functional dose ≦ formulation dosage ≦ literature safe dose
Literature acceptance: 1, mixed with other raw materials, do not need. 2, can not be converted into the daily amount of the original medicine, do not. 3, the processing technology is different from this product, do not need. 4, commercially available extracts, the process is not clear, do not use. 5, the test method does not meet the standard, do not use. 6. The experimental results of pathological models are not necessary in principle. 7, non-oral experimental results, in principle, do not use.
Functional demonstration report: Main raw materials: should have a clear purpose of use (more than 3 experimental papers) to simple processing of ordinary food as a single raw material, need to provide sufficient domestic and foreign experimental scientific literature, clear efficacy ingredients and content, as well as the dose-effect relationship between the research data. Other raw materials: compatibility necessity analysis and research data
On the “compatibility necessity analysis”, the current scale: 1, the formula should not be too large, the number of raw materials should not exceed 5 flavors. 2, the main raw materials clearly have functional literature, the rest of the raw materials have compatibility research. 3. There are analytical theories. Or there are ancient records of the same compatibility. 4, modern research has a clear formula compatibility principle. Such as: calcium + glycosamin5, compatibility analysis has been carried out to prove that the formula compatibility has a synergistic effect.
Classic literature analysis of a declared product, the daily dosage of formula: ginseng 2.4 g, Astragalus 1.5 g, yellow essence 4 g, Paecilopicillium batricola 1 g, hawthorn 2 g, orange peel 1 g, there are problems: 1, literature: ginseng, Astragalus 2 each, is the literature of total saponins and can not be converted; Some were not dose-supported or intraperitoneal administration; Paecilomyces cordyceps is the literature of cordyceps. The literature of mountain plant and orange peel respectively used chicken and fish as experimental animals to make experimental results. 2. Formula: No research data on compatibility is provided. Conclusion: Not approved.
Report and research and development process