Millions of adults use tobacco products, despite efforts to persuade people never to start or to quit once they do. For these adult tobacco consumers who cannot or will not quit using tobacco products, reduced risk tobacco products offer an opportunity to reduce the harm associated with tobacco use, particularly cigarette smoking.

On April 30, 2019 the Food and Drug Administration (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 Philip Morris International Inc. (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. Under an exclusive licensing agreement with PMI, Philip Morris USA (PM USA) will commercialize the IQOS tobacco heating system in the U.S. with three HeatStick variants.

Click here to view the PMTA Marketing Order.

PMI also submitted a Modified Risk Tobacco Product Application (MRTPA) on the IQOS tobacco heating system with three Heatstick variants. PMI submitted evidence to support its request for a marketing order allowing the use of these claims "Switching completely from cigarettes to the iQOS system can reduce the risks of tobacco-related diseases"

"Switching completely to iQOS presents less risk of harm than continuing to smoke cigarettes".

"Switching completely from cigarettes to the iQOS system significantly reduces your body’s exposure to harmful and potentially harmful chemicals".

Click here to view the MRTP Application on FDA's website. The MRTPA is still under review by the FDA.

U.S. Smokeless Tobacco Company filed a Modified Risk Tobacco Product Application (MRPTA) on Copenhagen Fine Cut Snuff on March 20, 2018. The application requests FDA authorization to make one claim: "IF YOU SMOKE CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer."

The application includes an analysis of U.S. government data from the National Health Interview Survey (NHIS) mortality linkage and the National Longitudinal Mortality Study (NLMS).  These data sets are two large, nationally representative, publicly available data sources maintained by the Centers for Disease Control and the U.S. Census.  We believe these data and decades of epidemiology substantiate the modified risk claim.  Ultimately, FDA will determine whether USSTC can communicate the modified risk claim it is seeking.

Click here to view the application on FDA's website.