U.S. FDA authorizes commercialization of the IQOS Tobacco Heating System

      Updated: 22 December 2021

      On 30 April 2019, the U.S. Food and Drug Administration (FDA) authorized the marketing of the IQOS Tobacco Heating System in the United States. Following a rigorous science-based review through the premarket tobacco products application (PMTA) pathway the agency determined “authorizing these products for the U.S. market is appropriate for the protection of the public health.”

      That standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. Importantly this includes youth. The agency’s evaluation includes reviewing a tobacco product’s components, ingredients, additives and health risks, as well as how the product is manufactured, packaged and labeled. The review for the IQOS products took into account the increased or decreased likelihood that existing tobacco product users will stop using tobacco products, and the increased or decreased likelihood that those who do not use tobacco products will start using them.  

      FDA’s scientific evaluation of the company’s applications, peer-reviewed published literature and other sources, found that the aerosol produced by the IQOS Tobacco Heating System contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke. Additionally, IQOS delivers nicotine in levels close to combustible cigarettes suggesting a likelihood that IQOS users may be able to completely transition away from combustible cigarettes and use IQOS exclusively. Available data, while limited, also indicate that few non-tobacco users would be likely to choose to start using IQOS, including youth.  

      The decision summary available on FDA’s website provides detailed scientific basis for FDA’s decision. The PMTA was submitted to the U.S. FDA on 31 March 2017, seeking FDA's authorization to commercialize the IQOS Tobacco Heating System in the United States, a requirement for new tobacco products that are not substantially equivalent to products commercially marketed in the U.S. as of 15 February 2007. This authorization is for IQOS 2.4 and IQOS 3.0.

      FDA’s separate review of the company’s modified risk tobacco product (MRTP) applications concluded in July 2020. The agency found that the issuance of the modified risk tobacco product orders with reduced exposure information would be “appropriate to promote the public health and is expected to benefit the health of the population as a whole.”