PMI Urges FDA To Renew IQOS MRTP Status, Citing Strong Evidence Of Reduced Harm And Switching

Philip Morris International (PM) recently presented evidence to the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) to renew the Modified Risk Tobacco Product (MRTP) status for its IQOS heated tobacco products and support pending applications for the newer IQOS ILUMA. The company highlighted data reinforcing the FDA's original conclusions regarding reduced harmful chemical exposure and demonstrating high rates of adult smokers completely switching from traditional cigarettes, alongside low usage among unintended populations. Continued MRTP authorization is critical for PMI's strategy to transition adult smokers to smoke-free alternatives, underpinning its growth in the reduced-harm tobacco market, with an estimated 34 million global IQOS users by mid-2025.

Analysis

(RTTNews) - Philip Morris International Inc. (PM) announced that it recently presented evidence to the Tobacco Products Scientific Advisory Committee (TPSAC), a panel of independent scientific researchers that offers nonbinding recommendations to the U.S. Food and Drug Administration's (FDA) Center for Tobacco Products (CTP). The full-day meeting held on October 7 was part of the FDA's standard review process for PMI's request to continue marketing its IQOS heated tobacco products in the U.S. as modified risk tobacco products (MRTPs). This review is a necessary step while the FDA evaluates pending applications for IQOS ILUMA—a newer version of the IQOS models already authorized—to help transition more legal-age adults away from combustible cigarettes. Stacey Kennedy, CEO of PMI U.S., emphasized that the evidence presented further supports the FDA's original conclusions that led to the authorization of the IQOS system as a modified risk tobacco product. She urged the FDA to maintain a timely scientific review process for smoke-free products, including IQOS ILUMA, which has been under FDA review for nearly two years. Globally, IQOS ILUMA has demonstrated even higher rates of complete switching among legal-age adults from traditional cigarettes, making it a better alternative for those who would otherwise continue smoking. According to the company, the IQOS system operates by heating tobacco rather than burning it, which significantly reduces the production of harmful chemicals and users' exposure to them. It still delivers the taste and ritual of smoking, which helps maximize complete switching from cigarettes. As of June 30, 2025, PMI estimates that approximately 34 million legal-age consumers worldwide use IQOS, many of whom have either quit smoking or significantly reduced their cigarette consumption. The MRTP renewal application includes two device versions—IQOS 2.4 and IQOS 3.0 holders and chargers—and three tobacco consumable variants: Amber HEETS, Green Menthol HEETS, and Blue Menthol HEETS. The FDA originally granted MRTP status to the IQOS system in 2020, allowing PMI to communicate specific claims to legal-age consumers. These include that the IQOS system heats tobacco without burning it, significantly reduces the production of harmful and potentially harmful chemicals, and that scientific studies show complete switching from conventional cigarettes to IQOS reduces exposure to these chemicals. During the meeting, PMI highlighted its responsible marketing practices and presented additional research showing high levels of complete switching among adult smokers, while maintaining low usage rates among unintended populations. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Philip Morris International (PM) recently presented critical evidence to the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) to support the renewal of Modified Risk Tobacco Product (MRTP) status for its IQOS heated tobacco system and advance pending applications for IQOS ILUMA. This October 7th meeting is a standard but crucial step in the FDA's review process, directly impacting PMI's ability to communicate reduced harm claims for these products in the U.S. PMI emphasized evidence reinforcing the FDA's original 2020 conclusions about IQOS significantly reducing harmful chemical production and user exposure. The company showcased research indicating high rates of complete switching among adult smokers to IQOS, while maintaining low usage among unintended populations, underscoring the product's public health potential and responsible marketing. The estimated 34 million global IQOS users by June 30, 2025, highlights the product's significant market adoption. The successful MRTP renewal and authorization of IQOS ILUMA are vital for PMI's long-term strategy of transitioning adult smokers away from combustible cigarettes and solidifying its leadership in the smoke-free category. Continued regulatory endorsement allows PMI to leverage specific claims, critical for consumer adoption and sustaining market share against traditional tobacco products.

Key Decisions for Investors

• Investors should closely monitor the FDA's final decision regarding IQOS MRTP renewal and IQOS ILUMA authorization, as it directly impacts PMI's U.S. market strategy and communication capabilities.
• Evaluate PMI's continued progress in the smoke-free category, particularly the growth rate of IQOS users towards the estimated 34 million by mid-2025, to gauge the success of its transition away from combustible products.
• Assess the potential for regulatory delays or adverse decisions, which could introduce near-term volatility, balanced against the long-term growth potential of a global smoke-free portfolio.