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).

Heat Not Burn device

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.

The Harm Reduction Opportunity

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.

On April 30, 2019, the FDA authorized sale of the IQOS heated tobacco system in the U.S. market. FDA authorization was based on the Premarket Tobacco Product Applications (PMTAs) submitted by PMI for the IQOS heated tobacco system. FDA found that marketing of the products that were the subject of the PMTAs is appropriate for the protection of public health.

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:

 

"Available Evidence to Date:

  • The IQOS system heats tobacco but does not burn it.
  • This significantly reduces the production of harmful and potentially harmful chemicals.
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

Review the MRTP Application and FDA’s authorization.

Learn More

For additional information on the scientific evidence supporting IQOS, visit the PMI Science website at www.pmiscience.com.