Italy was one of the first major markets for heated tobacco, which was first regulated and categorised in 2014 with the Legislative Decree 188/2014 which modified the Legislative Decree 504/1995 art. 39 bis. This decree introduced a definition of these products for tax purposes, “inhalation tobacco without combustion”, and included heated tobacco in the category of manufactured tobacco products for tax purposes. The TPD-implementing decree, Legislative Decree 6/2016, defines these products as novel smokeless tobacco products. This report offers a thorough analysis of the current regulatory regime in place for heated tobacco products in Italy.