FDA Supports Public Health Goals with IQOS
Philip Morris International announced on April 17th that it has received reauthorisation from the U.S. Food and Drug Administration for its IQOS heated tobacco products as modified risk tobacco products. This decision enables the continued marketing of IQOS and HEETS variants with reduced-exposure information.
According to the FDA, switching from conventional cigarettes to the IQOS system significantly reduces exposure to harmful chemicals. The reauthorisation covers two versions of the IQOS device and three HEETS consumables: Amber, Green Menthol, and Blue Menthol.
Stacey Kennedy, CEO of PMI U.S., stated, “As the only company to have successfully secured and maintained MRTP authorisations for heated tobacco products in the U.S., we are confident that our science-based alternatives can help adult smokers transition away from combustible cigarettes.”
Scientific Evidence and Impact
The FDA reaffirmed that available evidence suggests a measurable reduction in morbidity or mortality among individual tobacco users is likely. This conclusion reflects the rigorous scientific foundation supporting IQOS.
PMI’s MRTP submission included extensive scientific data demonstrating that the IQOS system produces aerosol with substantially lower levels of harmful constituents compared to cigarette smoke. Data from Japan show reduced cigarette consumption where heated tobacco products are available.
This renewed authorisation allows PMI to continue sharing reduced-risk information with U.S. Adults aged 21 and over who use traditional tobacco products. It aligns with PMI’s ambition to transition adult smokers away from cigarettes through scientifically substantiated smoke-free products.
Since 2008, PMI has invested over $16 billion globally to develop and commercialise smoke-free products. In 2025, the company’s smoke-free products accounted for 41.5% of its total net revenues.
The IQOS 2.4 system was the first heated tobacco product authorised via the FDA’s MRTP process in 2020, following its authorisation through the premarket tobacco product application (PMTA) process in 2019. IQOS 3 secured MRTP authorisation in 2022, following premarket authorisation in 2020.
The FDA continues to review PMTAs for IQOS ILUMA. Because of its strong application and demonstrated track record converting legal age smokers to a better alternative, PMI believes the application warrants expeditious FDA action.
Last updated: 29 June 2026, 12:24 pm
