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  • 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.

  • Global Survey Finds Strong Support for Smoke-Free Alternatives

    Global Survey Finds Strong Support for Smoke-Free Alternatives

    A new international survey commissioned by Philip Morris International and conducted by Povaddo shows overwhelming global support for smoke-free alternatives to cigarettes, alongside growing public concern that tobacco policies are being shaped more by ideology than science.

    The survey of 9,040 adults across nine countries found:

    • 78% agree adult smokers should have access to smoke-free alternatives.
    • 76% worry that public health decisions are influenced by ideology rather than evidence.
    • 87% say governments should prioritize science in making public health policies.
    • In countries where smoke-free products are restricted, such as Argentina, Brazil, and India, concern about bans was even higher (up to 94%).
    • 80% believe public health organizations should share all available evidence on smoke-free alternatives.
    • 77% of respondents outside Sweden think their country should emulate Sweden’s approach to smoke-free products.

    “Countries embracing smoke-free products have seen declines in cigarette sales and smoking rates,” Philip Morris CEO Jacek Olczak said. “There is strong demand globally for fact-based policies that keep pace with innovation and deliver better outcomes for society.”

    The survey was conducted between September 11–17, in Argentina, Brazil, Germany, India, Italy, Japan, Sweden, the U.K., and the U.S., among adults aged 21 and older.

  • Report: Latvia Lost €67M to Illicit Cigarette Trade

    Report: Latvia Lost €67M to Illicit Cigarette Trade

    Latvia lost an estimated €67 million to the illicit cigarette trade in 2024, a 31% increase over the previous year, as reported by KPMG at the National Forum on Smuggling. The study showed that contraband now accounts for 18% of total cigarette consumption in the country, with 340 million units consumed. Belarus remains the main source of smuggled cigarettes according to the report, supplying half of the illicit market, while counterfeit products surged 40% to 140 million units.

    Philip Morris Latvia public affairs head Guntars Grīnvalds warned that simplistic excise tax hikes can exacerbate smuggling rather than increase revenue. He advocated for a differentiated taxation approach: higher duties on traditional cigarettes, but lower rates for less harmful alternatives to encourage switching among adult smokers. The findings underscore the need for balanced excise and regulatory policies, as well as stronger measures against counterfeiting and illegal production, to effectively combat the growing illicit market.

  • PMI: EU Vape Research Should Be Independent

    PMI: EU Vape Research Should Be Independent

    Philip Morris International (PMI) says it supports new research into the health impact of cigarette alternatives like vapes and heated tobacco, as long as it is carried out by an “independent and science-driven third-party Association.” The statement comes as the European Commission prepares to assess e-cigarettes and other nicotine products for the first time under its review of EU tobacco directives. Commission officials said future studies will be funded exclusively with EU funds in line with World Health Organization (WHO) guidelines.

    PMI Europe president Massimo Andolina told Euractiv that the company would welcome such studies to validate its claims that next-generation products are less harmful than traditional cigarettes. But both the WHO and the EU stress that e-cigarettes and heated tobacco remain harmful and could act as a gateway to smoking. Several health and cancer organizations have also urged EU governments to tighten rules, warning that alternative products are fueling nicotine initiation among young people.

    The debate comes as Brussels weighs higher taxes on both cigarettes and new products, while proposing that 15% of national tobacco tax revenues be diverted to the EU budget. EU Health Commissioner Olivér Várhelyi recently called vaping “enormously popular” among youth and a “significant health risk,” adding: “They do not pay taxes yet—and it is clear to me that they should do so.”

  • FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    The U.S. Food and Drug Administration is set to fast-track reviews of nicotine pouches from Philip Morris International, Altria, Reynolds American, and Turning Point Brands in a pilot program launching Monday, according to Reuters. According to transcripts of an agency meeting last Friday, the agency aims to complete assessments by December, providing a quicker path to market for products like Zyn, on!, Velo, Fre, and Alp. The initiative comes amid pressure from the Trump administration to accelerate approvals and streamline the review process for the fastest-growing category of U.S. tobacco alternatives.

    The pilot program will reportedly feature reduced and expedited reviews, more frequent communication between FDA staff and companies, and a focus on essential scientific and safety data, including product characterization, manufacturing consistency, and abuse-liability information. For products already on the market without full authorization, the process could remove uncertainty over legality and potential enforcement actions. Tobacco firms have long lobbied for a faster FDA authorization route, noting that lengthy reviews have allowed competitors to capture market share in the meantime.

    “Adult nicotine and tobacco consumers are increasingly seeking nicotine pouches as a smoke-free alternative, and the industry is rapidly growing in response,” said Laura Leigh Oyler, vice president of U.S. Regulatory Affairs at Haypp Group, who will be speaking at GTNF 2025 in Brussels on the U.S. regulatory landscape. “These consumers deserve a marketplace of FDA-reviewed product choices to support their journey away from more harmful products. 

    “It makes sense that our government should also work to meet the demands of citizens, supporting a regulatory regime that quickly reviews well-designed and well-tested products from responsible and compliant manufacturers. This is a positive step not just for the regulator and the regulated industry, but for the millions of American adults looking for products they can trust.”

  • Philip Morris Gets Wash. Tobacco Deal Fight Sent o Arbitrator

    Philip Morris Gets Wash. Tobacco Deal Fight Sent o Arbitrator

    A Washington state judge ordered R.J. Reynolds Tobacco Co. to arbitrate rival Philip Morris USA Inc.’s claims that it breached a 2017 deal delineating billions of dollars in annual payments. Ruling from the bench on September 3, King County Superior Court Judge Michael Scott granted the motion to force arbitration, contending Philip Morris’ breach-of-contract claim against R.J. Reynolds and the other tobacco producers “clearly arises” out of the 2017 agreement and therefore must be arbitrated.

    The conflict centers on longstanding disagreements over the annual Master Settlement Agreement (MSA) payments to the state. RJR and fellow plaintiffs claim PM USA aims to derail a separate 2025 settlement signed between RJR and Washington by attempting to enforce an arbitration clause dating back to the 2017 agreement. They argue PM USA is improperly interfering in a deal it is not directly part of.

    In June, PM USA submitted its motion to compel arbitration, asserting that RJR and the other defendants are bound by the 2017 arbitration clause and that the court must defer to this private resolution mechanism.

  • Defiance ETFs Launches 2X Philip Morris Fund

    Defiance ETFs Launches 2X Philip Morris Fund

    Defiance ETFs introduced the “Defiance Daily Target 2X Long PM ETF,” an exchange-traded fund (ETF) under the NYSE symbol ZYN. The company clarified that the investment was not a purchase of Philip Morris International (PMI) stock, but an investment in a fund that offers investors twice the daily exposure to PMI. The leveraged product uses swaps and options to achieve its objectives, giving retail investors access to amplified PMI performance without the need for margin accounts.

    PMI, Defiance said, is positioning itself for a future beyond combustible cigarettes, and that the launch reflects investor appetite for targeted exposure to global tobacco majors as they expand their portfolios into smoke-free categories. Defiance said ZYN is designed for sophisticated investors who understand the risks of daily leveraged funds.

  • Pakistan Tobacco Board Criticized over Multinational Quota

    Pakistan Tobacco Board Criticized over Multinational Quota

    Leaders of the Ittehad Kashthkaran Khyber Pakhtunkhwa (IKKP) said a multinational tobacco company was instructed by the Pakistan Tobacco Board (PTB) to purchase 1.5 million kg of flue-cured Virginia (FCV) from Swabi growers, guaranteeing a minimum price of Rs743 ($2.60) per kg, according to an article published today by the local e-paper Dawn.

     “An official of a multinational national company said on condition of anonymity that the quota which was given to Philips Morris International (PMI) Pakistan was actually agreed with the Swabi growers under the agreements executed with them as it was purchased by the PMI in Shergar, Mardan district, but the PTB officials bound them to buy the 1.5 million kg tobacco in Swabi,” the article credited to an unnamed correspondent said.

    In the article, IKKP leaders criticized government inaction and PTB policies, urging that remaining tobacco be purchased promptly to prevent financial losses for farmers, who rely heavily on this crop for their yearly income. They said with a large quantity remaining unpurchased, the PTB should also oblige other companies to buy the crop from the farmers on time and give up the policy of declaring the remaining tobacco surplus to be purchased from the farmers at low price.

    “The PTB has not played its due role,” Daud Jan Khan, central vice-chairman of the IKKP, was quoted. “The companies have also left no stone unturned to cause as much financial damage to tobacco growers as they could.”

  • 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.

  • PM South Africa Pushes Harm Reduction in Tobacco Bill Debate

    PM South Africa Pushes Harm Reduction in Tobacco Bill Debate

    Philip Morris South Africa (PMSA) urged lawmakers on Tuesday (August 26) to adopt a science-driven, harm reduction approach in the pending Tobacco Products and Electronic Delivery Systems Control Bill. PMSA argued that the same harm reduction principles that helped South Africa curb HIV/AIDS could accelerate declines in smoking rates if applied to tobacco. Executives told Parliament’s Health Committee that smoke-free alternatives like heated tobacco, e-cigarettes, and oral nicotine are far less harmful than combustible cigarettes, citing global studies and international precedents.

    “The quit or die approach has not been proven to be effective, and we know it will not work,” said Themba Mathebula, PMSA’s director of external affairs. “Without a doubt, smoke-free products can give smokers a fighting chance, not just to survive, but to quit smoking for good.”

    The company called for a risk-proportionate framework that regulates traditional cigarettes more strictly than reduced-risk products, while tightening youth access and banning marketing that could appeal to minors. PMSA said it has submitted extensive scientific data and is committed to making cigarettes obsolete.

    “It is about 19 books’ worth of research that undeniably shows that smoke-free products are less harmful alternatives for adult smokers who make the choice to continue smoking,” said Buhle Binta, PMSA head of Scientific Engagement. “Scientific evidence needs to be the North Star that informs our health policies.