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

Health food with ingredients considered as pharmaceutical ingredients in Japan or claimed to have efficacy like pharmaceuticals cannot be imported and sold as food. The drug/non-drug list will be changed according to the problematic raw materials found in the market and imports. Enterprises are recommended to check with the pharmaceutical department in advance, to avoid problems such as customs rejection.

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).

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