This is basic knowledge and trivia about medicinal bath additives. It is a contract filling factory for liquid products equipped to handle small to large lots.
Bath additives are regulated under the "Pharmaceuticals and Medical Devices Act" (formerly the Pharmaceutical Affairs Law).
They are classified into two categories: cosmetics and quasi-drugs, depending on their intended use and ingredients.
For bath additives classified as cosmetics, the claims that can be displayed are limited to the range of cosmetic effects, which include:
- Cleansing the skin
- Maintaining healthy skin
- Providing moisture to the skin
(Currently, 56 effects are indicated in administrative notifications.)
On the other hand, quasi-drugs are defined as having "a mild effect on the human body."
The efficacy and effects recognized for bath agents (quasi-drugs) can be individually approved for each product within that scope.
Forms of dosage include powders, granules, tablets, soft capsules, liquids, etc.
Additionally, it is required to clearly state precautions for use and storage.
Quasi-drugs are subject to a manufacturing and sales approval system by the Minister of Health, Labour and Welfare and the governors of prefectures, and are regulated as strictly as pharmaceuticals.
However, on the other hand, there are no specific regulations separating their sale from pharmaceuticals.
In other words, quasi-drugs are considered to be products that do not hinder sales based on their ingredients, effects, and intended use.