ABSTRACT
The cosmetic regulations in Japan are extensive and complex (1). The legal classification of topically applied products is different from the United State and Europe, where they are divided into only two categories, drugs and cosmetics. In Japan, there are additional regulations covering cosmetic products with pharmacological action, called quasidrugs, which are ranked between cosmetics and drugs (2). The definitions of drugs, cosmetics, and, quasidrugs in the regulations (3,4) are as follows:
Drugs are defined as
1. articles recognized in the official Japanese Pharmacopoeia; 2. articles (other than quasidrugs) that are intended for use in the diagnosis,
cure, or prevention of disease in humans or animals, and that are not equipment of instruments (including dental materials, medical supplies, and sanitary materials);
3. articles (other than quasidrugs and cosmetics) that are intended to affect the structure or any function of the body of humans or animals, and that are not equipment or instruments (paragraph 1, article 2 of the law).
