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Tag: Swedish Match

  • 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.

  • PMI Looking to Sell Off Cigar Biz

    PMI Looking to Sell Off Cigar Biz

    The Economic Times reported today (March 3) that Philip Morris International Inc. is exploring a potential sale of its cigar business in the United States. People familiar with the matter said the company is working with advisers to gauge buyer interest as it seeks more than $1 billion for the asset as the tobacco maker continues its shift toward smoke-free products.

    Although still known for its cigarette brands, PMI is trying to reduce its reliance on traditional tobacco-based products. Currently, 40% of the company’s sales come from smoke-free products, a number expected to reach 67% in the next five years.

    “The cigar business was part of Swedish Match AB, which Philip Morris acquired in a $16 billion deal that was completed in 2023,” Carmen Arroyo wrote for Bloomberg. “That deal, which added Zyn nicotine pouches to its portfolio, helped propel Philip Morris’s transition away from traditional cigarettes.”

    According to The Economic Times, deliberations on the cigar sale are ongoing and there’s no certainty they’ll lead to a sale, their sources said, asking not to be identified for discussing confidential information.

  • PMI Settles D.C. Flavor Ban Violations Case

    PMI Settles D.C. Flavor Ban Violations Case

    Image: PMI

    Swedish Match North America (SMNA) will pay $1.2 million to settle an investigation into violations of Washington D.C.’s flavored tobacco ban, reports Reuters.

    The District of Columbia attorney general’s office accused SMNA of facilitating online sales of “tens of thousands” of flavored Zyn nicotine pouches to D.C. consumers between Oct. 1, 2022, when the ban was enacted, and June 30, 2024.

    SMNA parent company Philip Morris International must now monitor its distributor’s compliance with D.C.’s ban quarterly and stop sales of flavored Zyn pouches through Zyn.com and related e-commerce platforms.

    Nicotine pouches became the second most commonly used tobacco product in the U.S. after combustible cigarettes, according to the Centers for Disease Control and Prevention.

    PMI suspended sales on Zyn.com after it had been issued a subpoena by the D.C. attorney general earlier this year.

    Swedish Match would continue to focus on its brick-and-mortar stores, PMI said in a statement e-mailed to Reuters.

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  • Zyn Sued for Overcharging

    Zyn Sued for Overcharging

    TR Archive Photo

    Swedish Match North America is being sued for allegedly overcharging U.S. customers for its popular tobacco-free Zyn nicotine pouches.

    The class action lawsuit, filed on Monday in federal court in Richmond, Virginia, alleges that the Philip Morris International subsidiary is violating federal and state antitrust laws concerning the market for modern oral nicotine pouches.

    The plaintiff, a resident of Florida, claimed that Swedish Match illegally gained monopoly power through various business practices aimed at eliminating rival Dryft from the market, Reuters reports.

    Swedish Match now has an estimated 80 percent of the market for nicotine pouches, which the company sells in different flavors and strengths for about $6 a tin, according to the lawsuit.

    In a statement, Philip Morris, which was not named as a defendant, said, “We believe the plaintiff’s claims are without merit, and we intend to vigorously defend against them.

    Marlboro maker Philip Morris, in 2022, acquired the Swedish tobacco and nicotine products company for $16 billion. Philip Morris has stated an ambition to move away from health-harming cigarettes.

    The consumer lawsuit seeks class action status for Zyn consumers and damages of more than $5 million.

  • FDA Renews MRTPs for General Snus

    FDA Renews MRTPs for General Snus

    After a scientific review, the U.S. Food and Drug Administration issued a renewal of modified risk granted orders to Swedish Match USA, Inc., for eight General Snus products.

    With the renewal, the products may continue to be marketed – as they have been authorized to do so since 2019 – with the following modified risk claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” 

    The products receiving modified risk granted orders are: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large-12ct, General Mint Portion White Large, General Nordic Mint Portion White Large-12ct, General Portion White Large, and General Wintergreen Portion White Large.

    The modified risk granted orders issued by FDA are specific to the products as mentioned above and expire Nov. 7, 2032. If the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.

    “The FDA’s review determined that this modified risk claim is supported by scientific evidence, that consumers understand the claim, and that consumers appropriately perceive the relative risk of these products compared to cigarettes,” the FDA stated in a release. “FDA found that these modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.

    “In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The available evidence does not indicate significant youth initiation of these products.”

    The modified risk granted order does not permit the company to market the product with any other modified risk claim that conveys or could mislead consumers into believing that the products are endorsed or approved by FDA, or that the agency deems the products to be safe for use by consumers.

  • PMI Seeks Dismissal of Zyn Lawsuit

    PMI Seeks Dismissal of Zyn Lawsuit

    Photo: PMI

    Philip Morris International and its Swedish Match North America subsidiary have asked a U.S. federal judge in Connecticut to dismiss a lawsuit claiming they falsely marketed nicotine pouches as safe and targeted adolescents, according to the USA Herald.

    In July, Florida resident Ethan Norris filed a court case claiming that Philip Morris and Swedish Match marketed Zyn nicotine pouches to adolescents by promoting them as a healthy alternative to tobacco. The lawsuit suggests the companies misled consumers by highlighting the pouches’ “food-grade flavorings” and “natural additives.” Norris further alleges that the companies employed social media influencers to target younger consumers.

    In its motion filed Sept. 24, PMI argues that the lawsuit is preempted by federal law as the labeling of its Zyn nicotine pouches is approved by the U.S. Food and Drug Administration.

    In a separate motion, Swedish Match North America made a similar argument and added that because Norris is a Florida resident who purchased and used the products in Florida, the case has no direct connection to Connecticut.

    PMI urged the court to dismiss the lawsuit or require Norris to provide a more specific complaint.

  • PMI to Expand Zyn Production

    PMI to Expand Zyn Production

    Photo: PMI

    Philip Morris International will invest $600 million in in a factory in Aurora, Colorado, USA, to help meet U.S. consumers’ ferocious appetite for the company’s Zyn nicotine pouches. The factory is poised to begin operations by the end of next year with regular production starting in 2026.

    “PMI and its U.S. affiliates are accelerating their mission to move adults who smoke away from cigarettes in the U.S. by investing in new U.S. manufacturing capacity to meet the increasing demand for nicotine options that are scientifically substantiated as better alternatives,” said PMI Americas President and U.S. CEO Stacey Kennedy in a statement.

    “We believe Colorado is likeminded 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.”

    Sales of Zyn jumped 80 percent in the first quarter, leaving PMI struggling to keep up with demand. Retail stores have been experiencing Zyn shortages, with some even limiting the number of cans customers can buy each month.

    Supply was further constrained after the company decided to halt online sales nationwide in June following a subpoena in the District of Columbia asking for information on the sale of flavored pouch products that are banned there.

    PMI is also increasing production of Zyn at its factory in Owensboro, Kentucky. In addition to meeting U.S. demand, the investments will also help create capacity for exports, according to PMI.

    Zyn accounted for more than 70 percent of the $8.6 billion nicotine pouch market in 2023, according to Vaping360. Given the relatively young age of the category, there is little brand loyalty, and analysts believe continued supply constraints may prompt some consumers to defect to other brands.

  • FDA Reposts General Snus MRTP Document

    FDA Reposts General Snus MRTP Document

    Photo: Swedish Match

    The U.S. Food and Drug Administration on July 15 reposted an application document related to the renewal of existing modified risk tobacco product (MRTP) orders for Swedish Match USA’s General Snus products and announced a deadline for public comments.

    The reposted document contains information that was previously redacted, and is available on the Swedish Match MRTP application webpage.

    Public comments on these applications must be submitted to docket FDA-2014-N-1051-0941 on regulations.gov by 11:59 pm ET on Aug. 14 to ensure they receive consideration by the FDA.

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

  • Swedish Match Presents to FDA on General Snus

    Swedish Match Presents to FDA on General Snus

    Image: Tobacco Reporter archive

    Experts from Swedish Match USA, an affiliate of Philip Morris International, presented to the Tobacco Products Scientific Advisory Committee on June 26, 2024, according to a PMI press release. The committee, comprising independent scientific researchers, provides regulatory guidance to the U.S. Food and Drug Administration’s Center for Tobacco Products.

    The half-day meeting was part of the FDA’s review of Swedish Match’s request to continue marketing General Snus products in the U.S. as modified-risk tobacco products (MRTPs) and to expand permitted use of the reduced-risk claim to reach, and transition, more legal-age smokers away from cigarettes.

    Initially granted by the FDA in October 2019, Swedish Match can communicate to legal-age consumers that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” Currently, that message is accessible only on the General Snus website.

    Swedish Match presented to the committee real-world evidence showing the claim is delivering on its promise to reduce harm to individual tobacco users and benefit the health of the population and should be renewed.

    In its renewal submission, Swedish Match is seeking to expand use to additional lawful marketing channels, such as point-of-sale display and direct mail to age-verified consumers.

    “As FDA’s Center for Tobacco Products Director Brian King said when unveiling its new five-year strategic plan, this is a critical moment in the history of tobacco product regulation,” Gerry Roerty, general counsel for Swedish Match, said to committee members. The center’s mission is to make smoking-related disease and death a part of America’s past, and “today, together, we can meaningfully advance that goal,” Roerty told committee members.

    During the meeting, representatives from Swedish Match 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 evidence and research demonstrating low levels of use by unintended populations.

    General Snus is a smokeless tobacco product, traditionally produced in Sweden, that is nonfermented and air cured. The modified-risk products submitted for renewal include eight General Snus varieties that have been made available in the U.S. for more than a decade: General Snus Original (pouch); General Snus Original (loose); General Snus White (pouch); General Snus Mint (pouch); General Snus Wintergreen (pouch); General Snus Mini Mint (pouch); General Snus Classic Blend (pouch); and General Snus Nordic Mint (pouch).

    “We are understandably proud of our commitment to a cigarette-free America, which is achievable much faster if policy is guided by science,” said Stacey Kennedy, president of the Americas region and CEO of PMI’s U.S. business. “America’s 28 million adult smokers have been bombarded with misinformation about smoke-free products, which can cause confusion and prolong the most harmful form of nicotine consumption—smoking. We look forward to continuing dialogue with the FDA as it continues to consider renewal of this modified-risk authorization.”

    The General Snus products were first authorized as “appropriate for the protection of the public health” through the premarket tobacco product application (PMTA) process in 2015 following a PMTA submission earlier that same year.

    Since then, Swedish Match USA has submitted eight annual reports over as many years, the last four of which were combined with MRTP annual reporting.

  • PMI Suspends Zyn Sales Due to DC Probe

    PMI Suspends Zyn Sales Due to DC Probe

    Photo: Swedish MAtch

    Philip Morris International halted sales of Zyn nicotine pouches on its U.S. website as Washington, D.C., officials investigate the company’s compliance with the district’s ban on the sale of flavored tobacco products, reports The Wall Street Journal.

    On June 17, the company’s Swedish Match North America division announced it had received a subpoena from the District of Columbia’s attorney general, requesting among other things information about the unit’s compliance with local restrictions on flavored tobacco.

    A preliminary investigation by the company indicated that there had indeed been sales of flavored nicotine pouch products in the district. According to PMI, these related predominantly to certain online sales platforms and some independent retailers.

    Swedish Match is currently conducting a full review of its sales and supply chain arrangement in D.C. and other U.S. localities where flavor bans apply.

    Pending the investigation, PMI has suspended all online sales on Zyn.com. Sales on this platform have represented “a very small” percentage of the company’s U.S. Zyn volumes, according to PMI.

    In the March quarter, Philip Morris’ shipment volumes of oral smoke-free product volumes surged by 40 percent, mainly driven by Zyn nicotine pouches in the U.S., where shipment volume reached 131.6 million cans.

    Zyn has been available in the U.S. since 2014, but its sales have skyrocketed over the past year and a half, and its parent company is investing in Zyn capacity in the U.S.

    Philip Morris bought Swedish Match in a $16 billion deal in 2022 as the company looked to reduce its reliance on cigarettes amid stricter regulations and a consumer shift toward alternatives to tobacco and traditional cigarettes.