What is IQOS?

IQOS is a novel cigarette alternative that heats, but does not burn tobacco. Decades of scientific research show that the primary cause of smoking-related disease are the harmful and potentially harmful constituents (HPHCs) largely formed by the combustion of tobacco. While cigarettes burn at temperatures that can exceed 1600°F, IQOS heats tobacco to less than 570°F. The heating process releases a tobacco taste to provide current adult smokers who would otherwise continue smoking with a familiar experience and ritual without smoke. The IQOS heat-not-burn system consists of three components: a pocket charger, a holder, and a heated tobacco unit. This animation shows how IQOS works:

Since 2008, Philip Morris International (PMI) has invested over $6 billion and assembled a team of more than 400 world-class scientists and engineers seeking to develop non-combustible cigarette alternatives that replicate the attributes of smoking, while delivering an aerosol that is significantly less harmful. This scientific assessment starts with product development and includes toxicological assessments, clinical studies, a range of premarket perception and behavior studies, as well as postmarket studies and surveillance. We apply rigorous scientific standards to each step of our assessment to ensure the quality and integrity of the product during its complete lifecycle, from concept to commercialization.

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