Philip Morris International Inc. (PMI) has submitted Premarket Tobacco Product Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs) for IQOS ILUMA heated tobacco products with the U.S. Food and Drug Administration (FDA).
A PMTA marketing order is required to commercialize any new tobacco product in the United States. The company is also seeking an order to market IQOS ILUMA products as modified risk products that reduce exposure to harmful, and potentially harmful chemicals, a claim authorized for previous versions of IQOS.
PMI has submitted applications for three ILUMA devices and five variants of the tobacco sticks: TEREA BLUE, TEREA GREEN, TEREA SIENNA, TEREA BRONZE, TEREA AMBER. IQOS ILUMA products are currently available in 27 markets internationally.
Commenting on the IQOS ILUMA submission, Stacey Kennedy, President Americas & CEO PMI U.S. Business, said: “Tens of millions of American adults today smoke cigarettes and will likely continue to do so. They should have a range of scientifically substantiated better alternative nicotine products to choose from, and PMI is committed to providing them with new choices.
Internationally, IQOS ILUMA products have demonstrated how ground-breaking consumer-centric innovation can lead more adults to stop smoking. We believe that same success can be replicated in the U.S. and drive a rapid decrease in smoking rates among adults. These are strong applications, and we urge the FDA to prioritize them for review.
Since 2008 PMI has invested more than USD 10.5 billion to scientifically research, develop, and commercialize smoke-free products, an investment that was further bolstered last year through our acquisition of Swedish Match. We are focused on providing adults who smoke with alternatives that can reduce their risks compared with smoking and help make America cigarette-free.”