TobaccoReporter logo

Tag: Zyn

  • FDA Begins Review of Zyn’s Modified Risk Claim

    FDA Begins Review of Zyn’s Modified Risk Claim

    The U.S. Food and Drug Administration (FDA) has officially begun its scientific review of modified risk applications for 20 Zyn nicotine pouch products, submitted by Swedish Match USA, Inc.

    Already authorized for sale in January 2025, the company is now seeking permission to market Zyn with a health-related claim: “Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

    FDA’s review will assess whether this claim is scientifically and legally justified under the Modified Risk Tobacco Product (MRTP) process. The agency will issue a final decision after reviewing scientific evidence, public comments, and recommendations from its Tobacco Product Scientific Advisory Committee (TPSAC).

    “It is a positive development that FDA is progressing the MRTP applications and we hope for an expeditious review,” a PMI spokesperson said. “Swedish Match has presented the agency with a substantive scientific package that the company believes supports authorizing ZYN as appropriate to promote public health. Providing accurate information on the relative risk of different nicotine products to America’s 45 million legal-age nicotine consumers will help accelerate switching to better alternatives than continued cigarette use—the most harmful form of nicotine consumption.”

    Public comments open June 18 at regulations.gov under docket FDA-2025-N-0835. The comment period will remain open for at least 180 days after publication of the Federal Register notice.

    TPSAC meeting details and redacted application materials will be released on a rolling basis at the FDA’s Center for Tobacco Products website.

  • PMI Execs Talk Financials

    PMI Execs Talk Financials

    Today (June 3), Philip Morris International presented at the 2025 dbAccess Global Consumer Conference, showcasing its strategic focus on smoke-free products amid a backdrop of both opportunities and challenges. The company reported strong growth in its smoke-free portfolio, while also managing a resilient combustible business through strategic price adjustments and cost management.

    PMI reported organic revenue growth between 6% and 8% and organic operating income growth of 10.5% to 12.5%. The company said it remains on course to have two-thirds of its revenue come from smoke-free products by 2030.

    PMI said its smoke-free product volume increased by more than 14%, and revenue from smoke-free products grew by over 20% organically. This category was led by its Zyn nicotine pouches, which saw over 50% growth in the U.S. during Q1 2025, and has plans for further expansion in Europe and other markets.

    IQOS experienced nearly 10% growth in Japan and over 7% in Europe despite regulatory challenges, with Veev holding the top position in five EU markets, focusing on profitable growth.

    Emmanuel Babeau, CFO of PMI, said the company plans to expand IQOS in the U.S. and enter new markets such as Turkey, Brazil, and India, and expects to reach a net debt to EBITDA ratio of 2x by the end of 2026.

  • Reno Reporters Stumble into Counterfeit Zyn

    Reno Reporters Stumble into Counterfeit Zyn

    News 4-Fox 11 in Reno, Nevada, is reporting its investigation that found counterfeit Zyn products for sale at a local convenience store that looked identical to the legitimate brand. Last October, an employee of the station bought three cans of “Zyn,” which he said tasted different than usual. The cans were sent to McKinney Specialty Labs in Virginia for testing.

    “They really are misbranded and illegally on the market,” Dr. Roxana Weil, chief regulatory science officer at McKinney, said. The tested product only contained 4.5mg of nicotine, contrary to the 6mg advertised, and additionally contained six methyl nicotine, an additive that should not have been in there. The lab only tested for nicotine, so it’s unclear what else could be in the counterfeit product.

    Dr. Willie McKinney, CEO of McKinney, said, “It was a little bit of a surprise to see six methyl nicotine simply because it’s manufactured. It’s man-made.”

    Representatives from Philip Morris International, the makers of Zyn, and the store owner believe the counterfeit products likely came from a distributor.

    “Our findings are that these are produced from overseas,” said Brian Weinhaus, director for illicit trade at PMI. “They are not produced in the United States.”

  • Baltimore Sues PMI for “Peddling Zyn to Kids”

    Baltimore Sues PMI for “Peddling Zyn to Kids”

    The City of Baltimore filed a lawsuit against Philip Morris yesterday (May 7) in the city’s Circuit Court for violating Baltimore’s Consumer Protection Ordinance through deceptive marketing practices to “peddle Zyn oral nicotine pouches to minors.” The city said PMI used “Big Tobacco’s well-developed playbook” to deceptively market flavored Zyn nicotine pouch products and hook a new generation of nicotine users.”

    “The purpose of creating a flavored tobacco product is clear — it is meant to capture children and adolescents,” the city’s complaint says.

    The complaint cites recent research that nearly 2% of middle and high school students report using nicotine pouches, and a separate survey where more than two-thirds of underage respondents reported Zyn as their favorite brand of tobacco pouches.

    In response, officials from PMI said, “Although we have not yet been served with the complaint and are not in a position to comment, we can assure you that the interests of PMI and its affiliates will be vigorously defended.”

    This is not the first time the city has targeted nicotine-related products with a lawsuit alleging deceptive marketing. Baltimore sued Juul Labs Inc. in 2020, accusing the electronic cigarette maker of promoting to minors. In September, the city reached an $8 million settlement with the California-based company.

  • PMI Hosts Shareholders Meeting

    PMI Hosts Shareholders Meeting

    Philip Morris International Inc. held its 2025 Annual Meeting of Shareholders today (May 7), with board chairman André Calantzopoulos and CEO Jacek Olczak answering questions and presenting the company’s performance.

    “Our smoke-free transformation continues to advance rapidly,” Olczak said. “We marked the 10-year anniversaries for both IQOS and ZYN in 2024 while achieving several key milestones, including our smoke-free business reaching almost $15 billion in net revenues.

    “We are increasingly deploying a multicategory strategy with our leading brands IQOS, ZYN, and VEEV, supporting our position as the global smoke-free champion as we continue to deliver meaningful value for our shareholders.”

    Shareholders elected 11 nominees for director; approved, on an advisory basis, the compensation of named executive officers; and ratified the selection of PricewaterhouseCoopers SA as independent auditors. Final voting results will be included in a Form 8-K that PMI will file with the SEC in the coming days.

    An archived copy of the webcast is available at  www.virtualshareholdermeeting.com/PM2025.

  • IQOS System Commercially Available in Texas

    IQOS System Commercially Available in Texas

    Today, PMI U.S. announced its FDA-authorized IQOS system is now commercially available to residents in the Greater Austin, Texas, area online at www.IQOS.com/us, at select pop-up stores, and other 21+ venues. IQOS is available in more than 70 markets globally since launching in Japan 10 years ago. The launch in Texas marks the first in a series of introductions in markets across the U.S.

    “We’ve seen the impact that a diverse range of smoke-free alternatives—like IQOS and ZYN—can have in helping adults 21+ move away from cigarettes,” said Stacey Kennedy, PMI U.S. CEO. ”We are committed to raising awareness and educating both consumers and public health leaders about the progress being made in harm reduction with our smoke-free products.”

    The news that Austinite’s can now purchase IQOS onlinefollows the March announcement that a permanent IQOS store opened downtown. Since October 2024, more than 5,000 Austin residents signed up to “Be the First” to experience IQOS.

  • PMI Halts U.S. Cigar Sale

    PMI Halts U.S. Cigar Sale

    Bloomberg reported that yesterday Philip Morris International Inc. called off the sale of its $1 billion US cigar business, citing the “current environment” in the latest deal to go awry amid market turmoil.

    PMI said following a thorough review and after taking into account the current environment, it will not shed the cigar unit it acquired as part of its $16 billion purchase of rival Swedish Match. It has previously said it wanted to dispose of US cigars as it continues to pin its future on a shift toward smoke-free alternatives to traditional tobacco products.

    The company said strong sales of Zyn nicotine pouches — also acquired from Swedish Match — were driving performance as it boosted adjusted earnings per share guidance this year to as much as $7.49, compared with a previous targeted high of $7.17.

    The smoke-free business includes Zyn and IQOS heated tobacco sticks and accounted for 42% of the first-quarter total net revenue. Philip Morris wants to generate more than two-thirds of its sales from alternative products by 2030.

  • Federal Judge Allows Zyn Lawsuit to Progress

    Federal Judge Allows Zyn Lawsuit to Progress

    A federal judge in Florida allowed key claims to move forward in two consumer class action lawsuits against Philip Morris and its subsidiary, Swedish Match, over allegations that their Zyn nicotine pouches cause ongoing health issues and are deceptively marketed, especially to young people.

    In March, U.S. District Judge William P. Dimitrouleas partially granted the defendants’ motion to dismiss, tossing a single claim of fraudulent concealment for lacking sufficient detail and a clear connection between the alleged misrepresentation and the plaintiffs’ injuries. However, the claims were reportedly dismissed without prejudice, giving the plaintiffs an opportunity to amend their complaints. The court upheld the bulk of the plaintiffs’ claims, including those for design defects, failure to warn, and negligence. The judge also rejected Philip Morris’ efforts to dismiss the lawsuits for lack of jurisdiction, finding that the companies’ business activities in Florida, including marketing and selling Zyn, provided sufficient basis for the federal court to hear the case.

    Plaintiffs in the Zyn lawsuits allege Philip Morris and Swedish Match falsely maintain Zyn is a smokeless nicotine replacement therapy from cigarettes or e-cigarettes, despite the nicotine concentration levels in Zyn exceeding the levels found in nicotine replacement therapies. Philip Morris said it is reviewing the ruling and intends to “vigorously defend” itself against the remaining claims.

  • Leaked EU Document Calls for “Substantial” Taxes on Nicotine Pouches

    Leaked EU Document Calls for “Substantial” Taxes on Nicotine Pouches

    According to The Vaping Post, a confidential European Commission (EC) document, leaked by Snusjournalen, has revealed a contentious plan to impose a substantial EU-wide tax increase on nicotine pouches (NPs). Spearheaded by the Directorate-General for Taxation and Customs Union (DG TAXUD), the proposed measure could trigger widespread economic, political, and criminal repercussions across the Union.

    Europe already finds itself in a tenuous economic situation, dealing with economic instability that includes inflation and escalating trade tensions with the United States. Worse on the nicotine front, a recent Europol report shared by Euroreporter, “The Changing DNA of Serious and Organised Crime,” highlights the direct link between excessive taxation and the rise of black markets—specifically citing tobacco and nicotine products. The report warns that strict tax policies create opportunities for criminal networks to expand operations, smuggle products across borders, and launder illicit funds. Experts fear that a steep price increase on NPs could drive a surge in illicit sales, with products being illegally imported from non-EU nations like China.

    Although the European Commission has yet to confirm the directive publicly, the leak has already sparked significant concerns among key stakeholders, including law enforcement, investors, and consumer advocacy groups. Given Europol’s warnings on illicit trade and the broader political and economic climate, this proposed tax increase is shaping up to be one of the most contentious regulatory battles in the coming months.

    “In light of these developments, the proposed tax hike on NPs adds yet another layer of uncertainty to an already volatile regulatory and economic landscape,” wrote The Vaping Post. “More importantly, with the vaping industry currently facing such a critical juncture, which could result in less availability of vaping products to smokers using them to quit, a harsh tax set on snus would be currently all the more detrimental to public health.”

  • PMI Earns Real Estate Award for Colorado Zyn Project

    PMI Earns Real Estate Award for Colorado Zyn Project

    Philip Morris International’s (PMI) purchase and planned development of 150 acres of land in Aurora, Colorado, in July 2024 earned a 2025 CoStar Impact Award, as judged by real estate professionals familiar with the market. According to the seller, Opus Development Co., the site acquisition by PMI’s United States-based affiliate, Kairus, Inc., was one of the largest direct land sales to a user and set a record price per square foot based on land area. PMI plans to invest $600 million into building a manufacturing hub for Zyn nicotine pouches.

    “PMI and its U.S. affiliates are accelerating their mission to move adults who smoke away from cigarettes by investing in new manufacturing capacity to meet the increasing demand for nicotine options that are scientifically substantiated as better alternatives,” PMI Americas President and U.S. CEO Stacey Kennedy said in a statement unveiling the company’s development plans. “We believe Colorado is like-minded in its commitment to innovation, economic opportunity and public health, and we’re eager to work with the state and its talented workforce as we expand our U.S. manufacturing presence.”

    The project is expected to generate more than $1 billion in economic contributions for the Denver-area suburb by the time it is fully operational in 2026, and will host at least 500 full-time employees, and generate upward of $550 million annually in economic benefits statewide.