Philip Morris International has announced that IQOS has been reauthorized by the U.S. Food and Drug Administration as a Modified Risk Tobacco Product (MRTP), marking a significant milestone in the company’s smoke-free transformation strategy
The renewed authorization supports the continued global expansion of IQOS, currently recognized as the world’s leading tobacco heating system, within the growing category of smoke-free alternatives
Scientific assessments reviewed by the FDA indicate that completely switching from conventional cigarettes to IQOS may reduce exposure to certain harmful chemicals compared to continued smoking. Unlike traditional cigarettes that burn tobacco at temperatures reaching approximately 800°C, IQOS heats tobacco up to 350°C without combustion, producing an aerosol instead of smoke
According to the company, the FDA’s reauthorization is based on extensive scientific evidence accumulated across multiple generations of IQOS devices, including pre-market data, clinical and behavioral studies, as well as continuous post-market product evaluations
Ali Karaman, Managing Director of Philip Morris Egypt and Levant, stated that the FDA decision represents an important step toward PMI’s ambition to phase out cigarettes as quickly as possible
He added that innovation and scientific substantiation remain central to providing better smoke-free alternatives for adult smokers who would otherwise continue smoking
Karaman also noted that since 2008, PMI has invested more than $16 billion in the development, scientific validation, and commercialization of innovative smoke-free products
Heated tobacco products such as IQOS are designed to heat tobacco rather than burn it, significantly reducing the formation of harmful chemicals associated with combustion while maintaining real tobacco taste and nicotine satisfaction
Philip Morris International’s Smoke-Free Vision
Philip Morris International continues to position itself as a global leader in building a smoke-free future by transforming its business portfolio beyond traditional tobacco and nicotine products
The company’s smoke-free portfolio currently includes heated tobacco devices, nicotine pouches, and e-vapor products, available in more than 105 markets worldwide. As of December 31, 2025, PMI estimates that over 43 million adult consumers globally use its smoke-free products, with many transitioning away from cigarettes or significantly reducing cigarette consumption
Smoke-free products accounted for approximately 41.5% of PMI’s total net revenues during the full year 2025, reflecting the company’s accelerating shift toward alternative nicotine products
Following rigorous scientific reviews, the FDA has also authorized the marketing of Swedish Match’s General snus and ZYN nicotine pouches, in addition to IQOS devices and consumables, making them among the first products in their categories to receive such authorizations
PMI stated that it will continue investing in scientific research, innovation, and wellness-focused solutions as part of its long-term strategy to expand beyond tobacco and nicotine