Q: What should be paid attention to in the selection of health food dosage forms and the determination of specifications?

A: When selecting the dosage form and determining the specifications of health food, the applicant should conduct a comprehensive analysis and demonstration of the physical and chemical properties of raw and auxiliary materials, biological characteristics, necessity and rationality of the selection of the dosage form according to the composition of the formula, consumption method, suitable people, etc., and fully clarify the scientific and rational selection of the dosage form and determination of specifications. At the same time, for the same product, it is not allowed to be made into two dosage forms in principle. The release mode of disintegrating and dissolving substances is different from the special dosage forms of general tablets, capsules, particles, powder, oral liquids, etc., and should be supported by sufficient scientific evidence. Dosage forms absorbed under the tongue, sprays, etc. should not be used as health food dosage forms; for products that cannot be consumed at one time and need to be repeatedly opened for consumption and may affect the quality and safety of product, the storage method after opening the container should be clearly defined and be supported by sufficient scientific evidence.

Source: SAMR

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