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Tag: IQOS

  • FDA Establishes Closing Date for Public Comments on MRTP Renewal Applications for IQOS Products

    FDA Establishes Closing Date for Public Comments on MRTP Renewal Applications for IQOS Products

    Today (November 6, 2025), FDA established the closing date for the public comment period on the modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A. for several IQOS heated tobacco products. Public comments on these applications must be submitted to the appropriate docket by 11:59 p.m. ET on December 8, 2025, to ensure they are considered by FDA:

    The application materials, redacted in accordance with applicable laws, can be found on FDA’s website. Before making a final determination on an MRTP application, FDA takes into consideration all relevant information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC).

    FDA held a TPSAC meeting to discuss these renewal applications on October 7, 2025. The public was able to attend virtually and present comments to the committee. Materials from the meeting are available on FDA’s website.

    For the latest updates on any MRTP applications under scientific review, sign up to receive email alertsExternal Link Disclaimer. 

  • PMI Reports Strong Q3 Based on Smoke-Free Surge

    PMI Reports Strong Q3 Based on Smoke-Free Surge

    Today (October 21), Philip Morris International reported strong third-quarter 2025 results, with adjusted diluted earnings per share rising 17.3% to $2.24, while reported EPS increased 13.2% to $2.23. The company said it achieved record smoke-free gross profit, supported by higher volumes and favorable pricing. Net revenues grew 5.9% on an organic basis, and adjusted operating income rose 7.5%, driven by strong performance in smoke-free products, despite a 3.2% decline in cigarette volumes.

    PMI’s smoke-free portfolio continued to expand rapidly, now accounting for 41% of total net revenues and 42% of gross profit. Volumes of smoke-free products rose 16.6%, led by the IQOS heated tobacco line and ZYN nicotine pouches. IQOS strengthened its market share across Europe and Asia, while ZYN’s U.S. offtake surged 39% following its return to full availability. The e-vapor brand VEEV also posted a 91% jump in shipments, solidifying PMI’s diversified presence across smoke-free categories.

    Reflecting this momentum, PMI raised its full-year adjusted EPS guidance and boosted its quarterly dividend by 8.9% to $1.47 per share. CEO Jacek Olczak said the company’s smoke-free business “continues to outgrow the industry by a clear margin,” adding that PMI is “on track to exceed” its 2024–2026 growth targets. Despite regulatory challenges in some markets, the company remains focused on transitioning adult smokers toward smoke-free alternatives and expanding its portfolio in 100 markets worldwide.

  • PM Japan Announces Two New Launches

    PM Japan Announces Two New Launches

    Philip Morris Japan (PMJ) announced it will launch the IQOS ILUMA i Galaxy Blue Model on October 29, a limited-edition device inspired by the “mysteries and infinite possibilities of the universe.” The ¥6,980 ($46) model features a deep-space blue charger with a starry gradient design. PMJ’s marketing director, Daniel Sevsik, said the edition was created to reinforce IQOS ILUMA i’s image of “innovation and future possibilities.”

    The company will also release its TEREA Clear Regular on October 27, a “smooth and balanced tobacco stick” for the IQOS ILUMA and ILUMA i series. Sevsik said the regular flavor segment has growth potential, as users tend to be more stable than menthol and flavored product consumers. The new variant becomes the sixth regular option in the TEREA lineup.

  • Philip Morris Urges FDA TPSAC to Recommend Continued Modified-Risk Marketing of IQOS

    Philip Morris Urges FDA TPSAC to Recommend Continued Modified-Risk Marketing of IQOS

    Experts from Philip Morris International presented evidence to the Tobacco Products Scientific Advisory Committee (TPSAC), according to a PMI press release. The committee, comprised of independent scientific researchers, provides nonbinding recommendations to the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP).

    The full-day meeting on October 7 was part of the FDA’s customary review of PMI’s request to continue marketing versions of its IQOS heated-tobacco products in the U.S. as modified-risk tobacco products (MRTPs), a necessary step while FDA completes its review of pending applications for IQOS ILUMA (a later version of the IQOS models that are currently authorized by the FDA) to reach and transition even more legal-age adults away from combustible cigarettes.

    “The evidence presented at this meeting, as also noted by the FDA, further supports the agency’s original conclusions that led the FDA to authorize the IQOS system as a modified-risk tobacco product,” said Stacey Kennedy, PMI U.S.’ CEO. “We encourage the FDA to continue efforts to establish a timely scientific review process for smoke-free products—including for IQOS ILUMA, which has been pending FDA review for nearly two years and has globally shown even higher rates of legal-age adults fully switching from combustible cigarettes—that are a better choice for legal-age adults who would otherwise use traditional tobacco products, including combustible cigarettes.”

    Initially granted by the FDA in 2020, the MRTP designation for the IQOS system authorizes PMI to communicate to legal-age consumers that: “AVAILABLE EVIDENCE TO DATE: The IQOS system heats tobacco but does not burn it. This significantly reduces the production of harmful and potentially harmful chemicals. 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 meeting, 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.

    Addressing committee members, Keagan Lenihan, VP and Chief External Affairs Officer for PMI U.S., said: “CTP’s mission is to make tobacco-related disease and death a part of America’s past. Smoke-free products, like PMI’s IQOS system, play a critical role in helping CTP achieve this mission and provide adults who smoke with a real opportunity to change. The IQOS system, when marketed with the reduced-exposure claim, promotes complete switching from combustible cigarettes.”

  • PMI Announces $37M Upgrade to Wilson, N.C. Facility

    PMI Announces $37M Upgrade to Wilson, N.C. Facility

    Philip Morris International’s U.S. businesses today (October 2) announced a $37 million investment in its Wilson, North Carolina, manufacturing facility to expand operations and strengthen its production of smoke-free alternatives. The Wilson factory currently produces HEETS for IQOS 3.0, the only heated tobacco product authorized by the FDA as a modified risk tobacco product (MRTP) with reduced exposure claims. The new investment will add a production line for TEREA, the consumables for IQOS ILUMA, which is awaiting FDA authorization.

    “Our U.S. manufacturing footprint is critical to producing innovative smoke-free alternatives for adult consumers,” said Stacey Kennedy, CEO of PMI U.S. “We’re proud to increase our investment in Wilson and spur further economic growth in the area.”

    Ryan Simons, President of the Wilson Chamber of Commerce, welcomed the expansion, calling it a sign that Wilson is a place where global companies “can grow and thrive.”

    The Wilson facility employs more than 80 full-time staff and plays a key role in PMI U.S.’s strategy to replace cigarettes with smoke-free alternatives. The company has also announced major U.S. investments in Owensboro, Kentucky, and Aurora, Colorado, totaling more than $800 million and expected to create nearly 1,000 direct jobs.

  • FDA Posts New Materials for IQOS Renewal Applications

    FDA Posts New Materials for IQOS Renewal Applications

    The U.S. Food and Drug Administration announced today that its Tobacco Products Scientific Advisory Committee (TPSAC) will convene October 7, to evaluate the renewal applications of Philip Morris Products S.A. for its IQOS 2.4 and IQOS 3.0 heated-tobacco systems and associated HeatSticks. These devices were originally granted Modified Risk Tobacco Product (MRTP) orders in 2020 and 2022, allowing the marketing of reduced-exposure claims—specifically, that heating (not burning) tobacco significantly lowers exposure to harmful chemicals.

    The renewal will hinge on whether PMI can demonstrate that post-market evidence continues to support those claims under section 911(g)(2) of the Food, Drug, and Cosmetic Act.  The FDA has republished redacted application materials and opened a public comment period; speakers at the TPSAC meeting may submit data supporting or critiquing PMI’s dossier.

    “A vital mission of FDA is to make tobacco-related disease and death a part of America’s past,” officials from PMI said in a statement. “Smoke-free products, like IQOS, play a critical role in helping achieve that mission and provide adults who smoke with a real opportunity to change. IQOS, when marketed with the reduced-exposure claim, promotes complete switching and reduction in cigarette consumption.”

    Should the renewal be approved, PMI would retain authority to market IQOS with MRTP claims; if rejected, those claims could expire, undermining the company’s “reduced-exposure” positioning in the U.S. market.

    The outcome will not only be of interest for PMI, but for the broader heated tobacco and smoke-free sectors looking for regulatory precedents.

  • PMI Reaffirms 2025 EPS Outlook on IQOS, ZYN Momentum

    PMI Reaffirms 2025 EPS Outlook on IQOS, ZYN Momentum

    Philip Morris International reaffirmed its 2025 earnings forecast today (September 2) at the Barclays Global Consumer Staples Conference, projecting reported diluted EPS of $7.24–$7.37 and adjusted diluted EPS of $7.43–$7.56, representing 13–15% growth versus last year. PMI reported better-than-expected combustible volume recovery in Turkey and Egypt, alongside continued growth in IQOS, ZYN, and VEEV globally.

    “With strong volume momentum over the summer months, including IQOS and ZYN offtake, and despite increasing competition in smoke-free products, we are on track to deliver our full-year guidance of 13% to 15% adjusted diluted EPS growth in dollar terms, the strongest since 2011 excluding the pandemic recovery,” said Jacek Olczak, Chief Executive Officer.

    In the U.S., ZYN posted about 32% growth in the first eight weeks of Q3, prompting PMI to forecast shipment growth in line with offtake through year-end.

    An archived copy of the webcast is available at www.pmi.com/irapp.

  • Philip Morris International Reports Record Q2 Earnings

    Philip Morris International Reports Record Q2 Earnings

    Philip Morris International Inc. reported record second-quarter results today (July 22) driven by strong growth in its smoke-free portfolio and resilient performance in combustibles. Net revenues reached an all-time high, with smoke-free products—including IQOS, ZYN, and VEEV—accounting for 41% of total sales. Shipments of smoke-free products rose 11.8%, while gross profit from the category jumped over 23%.

    CEO Jacek Olczak highlighted a “reacceleration” in IQOS and ZYN sales, especially in Europe, Japan, and the U.S., where ZYN’s offtake rose 36% in June. PMI’s e-vapor brand VEEV more than doubled shipment volumes, now leading in several European markets.

    Combustible products like Marlboro remained stable, contributing to a 2.1% revenue increase despite expected volume declines. PMI also declared a quarterly dividend of $1.35 per share. Buoyed by strong year-to-date performance, the company raised its full-year earnings guidance.

    Click here for the full financial report.

  • PMI Launches IQOS ILUMA i in Egypt

    PMI Launches IQOS ILUMA i in Egypt

    Philip Morris Misr launched the IQOS ILUMA i in Egypt, the “latest and most advanced smoke-free device in its portfolio,” according to the company. The device features the Smartcore Induction System, which heats tobacco without combustion, delivering a cleaner, residue-free experience. It includes smart features like a touchscreen, pause mode, FlexPuff, and improved battery technology.

    “We leverage science, world-leading brands, and commercial capabilities to provide better alternatives to our consumers,” said Ali Nevzat Karaman, managing director of Philip Morris Egypt and Levant. “Following the introduction of IQOS ILUMA in Egypt in 2023, we are now taking the IQOS experience to new heights. IQOS ILUMA i is our most innovative device to date—our flagship product in the portfolio of scientifically substantiated, heat-not-burn smoke-free systems.”

    The IQOS ILUMA i is compatible with existing TEREA sticks, avoiding the need for format changes. This launch supports Philip Morris International’s vision of a smoke-free future, backed by over $14 billion in R&D and a goal to eliminate cigarettes. Smoke-free products now make up 42% of PMI’s net revenues, with 38.6 million adult users worldwide as of December 2024.

  • PMFTC Eyes Double-Digit Growth for IQOS in the Philippines

    PMFTC Eyes Double-Digit Growth for IQOS in the Philippines

    PMFTC Inc., the Philippine affiliate of Philip Morris International (PMI), is targeting double-digit growth this year for its smoke-free product, IQOS, as it pushes to expand its market in the country.

    In an interview, PMFTC President Gijs de Best said the Philippines now has around 150,000 IQOS users since the product’s launch in 2020. “People don’t understand what the problem is related to smoking because in the Philippines, 60% of people believe that nicotine is the most harmful ingredient, which it is not,” he said. “It’s the burning that is causing the issue. Simply, when you use a cigarette, once it is lit, harmful chemicals are released. What our technology is all about is heating, not burning.”

    Because it was launched in the market during the COVID-19 pandemic, IQOS gained traction mainly through word of mouth. Now, PMFTC aims to accelerate growth by increasing education around the benefits of heated tobacco. To support its expansion, PMI inaugurated a ₱8.8-billion ($150 million) manufacturing plant in Tanauan, Batangas last year to produce IQOS and other smoke-free products locally. The Philippines is one of 96 global markets for IQOS, with Indonesia currently being the largest in the region.