Decoding the Role of the Drug/Non-Drug List for Food Ingredients in Japan

Under Japanese law, products (taken by mouth) are classified into two categories, namely, "pharmaceuticals" and "foods". The Pharmaceutical and Medical Device Act (PMD Act) applies to pharmaceuticals, while the Food Sanitation Act applies to food. Due to regulatory difference between countries, imported health food products may be considered as "unapproved/unpermitted pharmaceutical products*" if they contain ingredients recognized as drugs in Japan. According to the PMD Act, enterprises are prohibited from selling unapproved/unpermitted pharmaceutical products. Otherwise, they will be imprisoned for up to three years or a fine of not more than three million yen (Article 84).