IQOS reauthorized by the U.S. Food and Drug Administration as a Modified Risk Tobacco Product

IQOS, the number 1 tobacco heating system1, from Philip Morris International continues to expand in several countries within the category of smoke-free products, supported by the recent U.S. Food and Drug Administration decision to renew its authorization as a Modified Risk Tobacco Product.

Scientific assessments indicate that a complete switch from cigarettes to IQOS may reduce exposure to certain harmful chemicals compared with smoking.

IQOS heats tobacco instead of burning it, which eliminates combustion. Unlike cigarettes which produce thousands of chemicals at temperatures that may reach around 800°C, heated tobacco products do not exceed 350°C, producing an aerosol instead of smoke.

This reauthorization is based on cumulative scientific assessments that have included different generations of devices, based on pre-market data, clinical and behavioral studies, as well as ongoing reviews of related products.
In this context, Ali Karaman, Managing Director of Philip Morris Egypt and Levant, said:
“The renewal of the U.S. Food and Drug Administration’s authorization reflects an important step supporting PMI’s ambition to phase out cigarettes as soon as possible. It highlights the role that innovation and scientific substantiation can play in providing better alternatives to cigarettes for adult smokers.”

He also added: “Since 2008, PMI has invested more than $16 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke.”

Heated tobacco products, such as IQOS, heat tobacco without burning it, reducing the formation of harmful chemicals created by combustion while delivering real tobacco taste and nicotine satisfaction.

Philip Morris International: A Global Smoke-Free Champion

Philip Morris International is a leading international consumer goods company, actively delivering a smoke-free future and evolving its portfolio for the long term to include products outside of the tobacco and nicotine sector.

The company’s current product portfolio primarily consists of cigarettes and smokefree products, including heat-not-burn, nicotine pouch and e vapor products. Our smoke-free products are available for sale in over 105 markets, and as of December 31, 2025 PMI estimates they were used by over 43 million legal-age consumers around the world, many of whom have moved away from cigarettes or significantly reduced their consumption.

The smoke-free business accounted for 41.5% of PMI’s full year 2025 total net revenues. Since 2008, PMI has invested over $16 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke, with the goal of completely ending the sale of cigarettes. This includes the building of worldclass scientific assessment capabilities, notably in the areas of pre-clinical systems toxicology, clinical and behavioral research, as well as post-market studies.

Following a robust science-based review, the U.S. Food and Drug Administration has authorized the marketing of Swedish Match’s General snus and ZYN nicotine pouches and versions of PMI’s IQOS devices and consumables – the first-ever such authorizations in their respective categories. Versions of IQOS devices and consumables and General snus also obtained the first-ever Modified Risk Tobacco Product authorizations from the FDA.

With a strong foundation and significant expertise in life sciences, PMI has a long-term ambition to expand into wellness areas.

References to “PMI”, “we”, “our” and “us” mean Philip Morris International Inc., and its subsidiaries.

For more information, please visit
www.pmi.com
www.pmiscience.com

1 PMI global estimate of total In-Market Sales of Heated Tobacco Units as of December 2024.