Policy Summary: 

Non-nicotine e-cigarettes are currently not being regulated. However, nicotine-containing e-cigarettes are classified as medicinal products and are regulated under the Japanese pharmaceutical affairs law. Marketing approval for the sale, advertisement, manufacture, importation and distribution of medicinal products must be sought under this law. No medicinal e-cigarettes have been approved.* The Ministry of Health, Labor and Welfare issued a statement permitting the private importation of medicinal e-cigarettes, provided it is for private use only and the amount is less than one month supply.


*Personal communication with in-country experts and/or Ministry of Health representatives

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