According to Japanese Cosmetic Regulations, the Pharmaceutical Affairs Law defines a class of substances that are partially cosmetic and partially drugs, which are defined as quasi-drugs. Quasi-drugs are legally classified between cosmetics and drugs and a great number of them are based on folk medicine.
These drugs exert mild actions on the human body
- Prevention of nausea or other discomforts, or prevention of foul breath or body odor
- Prevention of prickly heat, and sores.
- Prevention of falling hair, hair restoration, or depilation
Examples of quasi-drugs, as per Minister of Health and Welfare (MHW Notification No. 14, 1961),
- Cotton products intended for sanitary purposes (including paper cotton)
- Products that cause mild action on the human body, with the purpose of prevention of acne, chapping, itchy skin rash, disinfection of the skin and mouth (so-called medicated cosmetics), and bath preparations.
Quasi-drugs are legally classified between cosmetics and drugs and a great number of thus, any substance that claims to prevent dandruff, razor burn, sunburn, and acne is considered a quasi-drug.
- The products among quasi-drugs are mouth refreshers, antiperspirants, anti-aging products, hair removers, hair growers (nutrients), depilatories, dentifrices, body deodorants, talcum powders, hair dyes and dye removers, bath preparations, medicated soaps and oily skin or acne treatment products.
- The manufacturers of quasi-drugs in Japan are required to obtain government approval before marketing. The following data must be submitted, depending on the kind of ingredients, etc,
- Data on origin, background of discovery, use in foreign countries
- Data on physicochemical properties, specifications, testing methods
- Data on stability
- Data on safety
- Data on indication and effects
For a product under application to be approved as a quasi-drug, it is a prerequisite that the purpose of its use is within the scope stipulated by the Pharmaceutical Affairs Law. Thus, approval of a product as a quasi drug determined by an integrated judgment of various factors such as
- its ingredients, quantity (composition),
- indications and effects,
- usage and dosage,
- and dosage form.
For example, those products whose effects are not mild and thus come under the category of poisons or deleterious drugs are not approved.
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