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Tag: Swedish Match

  • FDA Issues MRTP Orders for 20 Zyn Products

    FDA Issues MRTP Orders for 20 Zyn Products

    The U.S. Food and Drug Administration issued Modified Risk Tobacco Product orders for 20 Zyn nicotine pouch products manufactured by Swedish Match USA, making Zyn the first nicotine pouch brand authorized to market reduced-risk claims compared with cigarettes. The FDA-authorized claim states that using Zyn instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The authorization applies to 10 Zyn flavors in both 3 mg and 6 mg nicotine strengths and builds on the products’ January 2025 authorization for sale through the FDA’s premarket tobacco product application pathway.

    The FDA said its decision followed an extensive scientific review of the products’ relative health risks, consumer understanding of the claim, youth use data, and overall population health impact. The agency concluded that the modified-risk claim is scientifically supported, that consumers understand its meaning, and that allowing the claim is expected to benefit public health. The authorization requires Swedish Match USA to conduct post-market surveillance and behavioral studies, and the orders will expire after five years unless renewed. The FDA also noted it retains the authority to withdraw the orders if continued marketing no longer benefits public health, including if youth uptake increases.

    Separately, Philip Morris International said the decision expands its portfolio of FDA-authorized modified-risk products, which also includes IQOS heated tobacco products and General snus. PMI U.S. CEO Stacey Kennedy said the authorization provides adult nicotine consumers with FDA-reviewed, science-based information about the health benefits of switching completely from cigarettes to Zyn.

  • Swedish Match Closing Richmond Office

    Swedish Match Closing Richmond Office

    According to a letter to the Commonwealth of Virginia, Swedish Match will be closing its Richmond office April 17, offering the majority of employees the opportunity to relocate to a location aligned with their role and function. Virginia Business magazine reported yesterday (Feb. 2) that Thomas G. Hayes, president of Swedish Match North America, sent a letter last week notifying Virginia Works of the imminent closure as part of a larger restructuring by its parent company, Philip Morris International. 

    In November 2025, PMI announced plans to restructure in 2026, dividing into two main business units, PMI International and PMI U.S.—along with Aspeya, its wellness business—as it continues to expand its smoke-free portfolio. In a statement, PMI said the Richmond closing is related to changes in its U.S. geographical footprint.

     “This decision was not made lightly, and we recognize the impact it will have on our employees and the local community,” the company said. “Centralizing key capabilities and functions in strategic location hubs will help us operate with greater speed, agility, and consumer focus—driving momentum behind our category-redefining brands, ZYN and IQOS as we work to accomplish a smoke-free America.”

    Headquartered in Stockholm, Swedish Match AB employs about 1,300 people in the United States. “According to Hayes’ letter, employees of PMI subsidiaries and affiliates Triaga Retail, PMI Global Services Unit, Swedish Match Cigars, Swedish Match North America, and Pinkerton Tobacco Co. are impacted,” Virginia Business reported.

  • FDA Posts New Materials in Zyn MRTP Applications

    FDA Posts New Materials in Zyn MRTP Applications

    The FDA posted new materials today (Feb. 2) related to the modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 Zyn nicotine pouch products. The documents are available on the Swedish Match USA, Inc. MRTP application webpage. This is the final set of application materials.

    Accordingly, FDA is establishing the closing date for the public comment period on these MRTP applications. Public comments must be submitted to Docket Number FDA-2025-N-0835-0001 by 11:59 p.m. ET on March 4 to be considered. 

    Read the application materials here.

  • FDA Releases Meeting Materials for Zyn’s MRTP Application  

    FDA Releases Meeting Materials for Zyn’s MRTP Application  

    Today (January 20), the U.S. Food and Drug Administration released meeting materials ahead of a virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 Zyn nicotine pouch products. The materials include a draft agenda, background documents from both the applicant and the FDA, and draft questions for committee consideration, and are available on the FDA’s 2026 TPSAC Meeting Materials and Information page.

    The virtual TPSAC meeting is scheduled for January 22. FDA opened Docket No. FDA-2025-N-0835-0020  for public comments related to the meeting, with submissions due by 11:59 p.m. ET on January 21. Comments specific to the ZYN MRTP applications may also be submitted under a separate docket, Docket No. FDA-2025-N-0835-0001, which was established on June 18, 2025.

    Visit the event webpage to learn more about attending the meeting online

  • Swedish Match Discontinues Four Zyn Products for 2026

    Swedish Match Discontinues Four Zyn Products for 2026

    Swedish Match announced the retirement of four Zyn products for 2026: Apple Mint Mini Extra Strong, Original Mini Normal, Original Mini Extra Strong, and Cucumber Lime Slim Normal. On the company’s website, it suggested alternative products with similar flavors and strengths. The brand’s remaining portfolio, including about 15 mint and apple-based flavors, will continue to be available on the swedishmatch.se platform.

  • Federal Judge Allows Deceptive Claim in Zyn Case

    Federal Judge Allows Deceptive Claim in Zyn Case

    A federal judge in Florida has allowed deceptive practices claims against Philip Morris International (PMI) and its subsidiaries to move forward, according to Law360. On December 12, U.S. District Judge William P. Dimitrouleas of the Southern District of Florida denied the companies’ motion to dismiss claims brought by plaintiff Kovadis Palmer under the Florida Deceptive and Unfair Trade Practices Act (FDUTPA).

    Palmer alleges that PMI and Swedish Match North America LLC misleadingly marketed Zyn nicotine pouches as “tobacco-free,” suggesting a lower addiction risk even though the nicotine is derived from tobacco. He claims he developed nicotine dependence as a result. While the court previously dismissed Palmer’s common-law fraud claims for failing to meet heightened pleading standards, it found that the amended FDUTPA claims advance a distinct legal theory.

    The judge ruled that FDUTPA claims do not require proof of intent to deceive and are not subject to the stricter fraud pleading rules. As a result, the court held that the claims are not merely a repackaging of dismissed fraud allegations and may proceed.

  • FDA Schedules TPSAC Review of ZYN Applications

    FDA Schedules TPSAC Review of ZYN Applications

    The U.S. Food and Drug Administration announced a January 22, 2026, virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA for 20 ZYN nicotine pouch products. These products—already authorized for sale through the PMTA pathway in January 2025—include flavors such as Cool Mint, Citrus, Coffee, Peppermint, and Wintergreen, each in 3 mg and 6 mg strengths. The company is seeking permission to market the pouches with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

    Under federal law, MRTP applications must demonstrate that a product, as actually used by consumers, reduces individual health risks and benefits overall population health. TPSAC’s review will focus on scientific evidence regarding ZYN’s relative health risks, consumer comprehension of the proposed claim, and the potential public health impact of granting a modified risk order. The meeting will be held virtually, open to the public, captioned, and recorded.

    Public comments may be submitted to Docket No. FDA-2025-N-0835 through January 21, 2026, with comments received by January 7 provided directly to TPSAC. The FDA is also inviting individuals to request oral presentation slots during the meeting’s public comment period. Redacted MRTP application materials are available on the FDA’s website, and the agency will consider all public input and TPSAC recommendations before issuing a final decision.

  • 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.

  • 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.