The applications mark the next step in the company's mission to offer adults who smoke a portfolio of innovative, scientifically substantiated nicotine alternatives that can help make America free from conventional cigarettes

Philip Morris International Inc. (PMI) (NYSE:PM) on October 20 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.

• Unlike conventional cigarettes, IQOS products heat — but do not burn — tobacco
• IQOS ILUMA products are PMI's most-innovative heated tobacco products. They deliver substantially similar reductions in the formation of harmful and potentially harmful constituents as earlier versions of IQOS products authorized by FDA
• IQOS ILUMA has demonstrated higher rates of full switching by adults who smoke and improved consumer satisfaction in countries around the world
• IQOS ILUMA products rely on a fundamentally different heating technology from previous versions of IQOS products andcontain numerous technological advancements including improved device and battery longevity
• IQOS ILUMA products are currently available in 27 markets internationally
• PMI's applications are supported by a thorough scientific assessment, including aerosol chemistry, in vitro toxicology, a pharmacokinetic study, and consumer perception and behavior studies, as well as the comprehensive scientific dataset generated with previous versions of the IQOS system
• The IQOS ILUMA devices operate on the SMARTCORE INDUCTION SYSTEM that heats tobacco from within TEREA SMARTCORE STICKS—heated tobacco sticks designed to be used only with IQOS ILUMA devices
• 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

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 $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."

Note to Editor

• PMI will have the full rights to commercialize all IQOS products in the U.S. as of April 30, 2024, per the terms of an agreement with Altria Group, Inc. ending the companies' commercial relationship covering IQOS in the U.S.
• Previous versions of IQOS products have been authorized by the FDA both for sale in the U.S., and as modified risk tobacco products with "reduced exposure" claims
• PMI has announced plans to commercialize these versions of IQOS in two U.S. states in select key cities in Q2 next year
  • IQOS was first launched internationally in 2014, is now available in 70 markets globally, and has not triggered worrisome levels of use by unintended audiences, including those beneath the legal age of purchase