The Science of Heated Tobacco
IQOS is an electronic device that heats tobacco in HeatSticks to generate nicotine-containing aerosol without combustion, fire, ash or smoke.
IQOS is the only the Food and Drug Administration (FDA)-authorized heated tobacco system. Philip Morris USA has the exclusive rights to distribute IQOS and three Marlboro HeatStick variants — one non-menthol and two menthol — in the U.S. through an agreement with Philip Morris International (PMI).
The Heated Tobacco Product (HTP) category, also known as the Heat-not-Burn (HnB) category, includes products that contain tobacco that is heated and not combusted to produce a nicotine-containing aerosol.
Many of the harmful and potentially harmful compounds found in cigarette smoke form as a result of combustion.
Since these products deliver nicotine without combustion, when cigarette smokers transition to HTP products, they have the potential to significantly reduce their exposures to the toxic constituents found in cigarette smoke.
PMI’s extensive regulatory filings for IQOS present a compelling case for the product’s harm reduction potential. For example, the research demonstrates that IQOS reduces levels of 18 harmful and potentially harmful constituents identified by the FDA by over 90 percent and reduces levels of 15 known carcinogens by more than 95 percent versus conventional cigarettes.
Review the PMTA Application and Marketing Order.
PMI also submitted a Modified Risk Tobacco Product Application (MRTPA) on the IQOS Tobacco Heating System with three Heatstick variants.
On July 7, 2020, FDA issued a Modified Risk Granted Order for the IQOS Tobacco Heating System, including three variants of HeatSticks. FDA has authorized the marketing of the IQOS Tobacco Heating System with the following reduced exposure claim:
On December 7, 2020 the U.S. FDA authorized commercialization of the next generation of the IQOS tobacco heating system device, IQOS 3, in the U.S. FDA authorization follows review of the IQOS 3 PMTA submitted by PMI.
IQOS 3 offers several enhancements to the IQOS 2.4 currently being sold in select U.S. markets, including a longer battery life, faster re-charging time, a side opening mechanism, and magnetic closure.
Review the PMTA Marketing Order.