IQOS is PMI’s most advanced non-combustible product. On April 30, 2019, FDA authorized the marketing of IQOS in the U.S. Following a rigorous science-based review through the premarket tobacco product application (PMTA) pathway, the agency determined that 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.
FDA’s Technical Project Lead Review explains in detail the scientific basis underpinning FDA’s decision to authorize IQOS for sale in the U.S.
FDA’s scientific review of IQOS modified risk tobacco product (MRTP) applications, which PMI submitted in December 2016, is continuing. PMI would need to receive an MRTP order from the FDA before it could market IQOS with any implicit or explicit claims that, among other things, a product reduces exposure to certain chemicals or that use of the product is less harmful than another tobacco product or would reduce the risk of disease.
IQOS is available in more than 40 countries overseas and PMI estimates that more than 7 million adult smokers have stopped smoking and switched to IQOS exclusively, which represents around 70% of all IQOS users worldwide