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.
Tag: Swedish Match
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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.
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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.
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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.
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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.
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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.
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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
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.
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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.
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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.