On Oct. 7, 2025, the U.S. Food and Drug Administration (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) held a day-long hearing regarding a customary review of Philip Morris International’s (PMI) request that the agency renew the Modified Risk Tobacco Product designation previously authorized for IQOS heated tobacco products. TPSAC is comprised of independent scientific researchers which provides nonbinding recommendations to the FDA’s Center for Tobacco Products (CTP).
The IQOS system heats tobacco instead of burning it, which significantly reduces the production of and exposure to harmful chemicals while still providing tobacco taste and the ritual of smoking. As of June 30, 2025, PMI estimates there are approximately 34 million legal-age IQOS consumers globally.
The modified risk tobacco products (MRTPs) submitted for renewal include two versions of the IQOS device and three variants of the tobacco consumables, called HEETS, including:
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IQOS 2.4 System Holder and Charger
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IQOS 3.0 System Holder and Charger
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Amber HEETS
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Green Menthol HEETS
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Blue Menthol HEETS
The FDA initially granted PMI the MRTP designation for IQOS products in 2020. The MRTP designation for the IQOS system authorizes PMI to communicate to legal-age consumers the following messages:
"AVAILABLE EVIDENCE TO DATE:
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The IQOS system heats tobacco but does not burn it.
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This significantly reduces the production of harmful and potentially harmful chemicals.
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Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals."
During the FDA hearing, representatives from PMI and committee members discussed a range of scientific, technical and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented additional evidence and research demonstrating high levels of complete switching among current legal-age smokers while maintaining low levels of use by unintended populations.
TPSAC will now review all the scientific evidence and advice to finalize a recommendation to the CTP regarding the request by PMI for the renewal of the MRTP designation for the IQOS products.
Read more
here.
Watch the full hearing
here.