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  • PMI Positive After FDA’s Zyn Hearing

    PMI Positive After FDA’s Zyn Hearing

    Philip Morris International (PMI) believes it moved a step closer to securing permission to market its Zyn nicotine pouches as a reduced-risk alternative to cigarettes in the United States, following a full-day public hearing convened by the U.S. Food and Drug Administration (FDA) yesterday (January 22). At the meeting, PMI scientists presented evidence to the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) in support of a Modified Risk Tobacco Product (MRTP) application that would allow the company to tell adult smokers that switching completely to Zyn lowers the risk of major smoking-related diseases. FDA briefing materials and staff presentations suggested regulators are leaning toward approving the proposed claim, with the agency stating that “the evidence suggests the proposed modified risk claim is scientifically accurate.”

    “The FDA’s Center for Tobacco Product’s mission is to make smoking-related disease and death a part of America’s past,” said Keagan Lenihan, Chief External Affairs Officer for PMI U.S. “Smoke-free products, like Zyn, play a critical role in helping CTP achieve this mission and provide adults who smoke with important information to guide their choices and a real opportunity to change.”

    The proposed language would allow PMI to say that using Zyn instead of cigarettes reduces the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. FDA scientists said the “totality of the evidence” shows Zyn contains substantially lower levels of harmful chemicals than cigarettes, and that consumer research suggests the claim increases awareness of reduced risks without misleading users into believing the product is risk-free. The agency also noted that youth nicotine pouch use remains relatively low, at 2.4% of U.S. high school students in 2024, and that exposure to the proposed claim did not increase young adults’ intentions to use Zyn. PMI executives argued that clearer communication of relative risk could help smokers move away from combustible products, drawing comparisons to Swedish snus, which received an MRTP designation in 2019 and has been linked to Sweden’s low smoking rates.

    However, members of the independent TPSAC panel raised concerns about gaps in long-term data and whether reduced-risk marketing would meaningfully accelerate smoking cessation in the U.S. Public health advocates also warned about the potential appeal of flavored pouches, discreet use, and social-media promotion to underage users. While panelists generally agreed that Zyn is far less harmful than cigarettes, they questioned whether the evidence shows that marketing claims will drive widespread switching. The FDA is not bound by the panel’s non-binding recommendations and has not set a deadline for its final decision, which will determine whether PMI can formally promote Zyn as a reduced-risk product to adult smokers.

    “While the relatively expedited timeline for this MRTP review is encouraging, the fact that the TPSAC did not vote on a recommendation makes me question the reason for these meetings moving forward,” said Laura Leigh Oyler, VP of Regulatory Affairs for Haypp Group, whose subsidiaries sell nicotine pouches online. “The science, and the many public speakers who supported the authorization were clear: Americans deserve honest messaging around these products and their impacts on harm reduction.”

  • Virginia Asks for Stay in Vape Appeal

    Virginia Asks for Stay in Vape Appeal

    The Commonwealth of Virginia asked the U.S. Court of Appeals for the Fourth Circuit to stay a district court order that blocks enforcement of parts of a state law restricting the sale of unauthorized vaping products, according to Law360. Virginia argues that the lower court wrongly found the law preempted by the federal Food, Drug, and Cosmetic Act and the Tobacco Control Act, stating that these statutes permit states to impose stricter sales regulations and do not require state rules to differ from federal standards. The dispute stems from a ruling by U.S. District Judge David J. Novak, who granted partial relief to vape retailers. However, Virginia contends that the decision is an outlier, misreads the TCA’s savings clause, and improperly limits states’ ability to coordinate with federal oversight. The state also argues the plaintiffs lack standing and that a stay is necessary to prevent irreparable harm to public health, noting the products at issue are already illegal under federal law.

  • NY Gov. Vows Crackdown on Illicit Vapes

    NY Gov. Vows Crackdown on Illicit Vapes

    New York Governor Kathy Hochul announced plans to crack down on illegal flavored vapes by directing the state Department of Taxation and Finance to establish a Vapor Products Registry identifying which products may be legally sold in the state. Hochul said that despite state and federal bans enacted in 2020, an estimated 99% of vapes currently on the New York market are flavored and lack FDA authorization, with many manufactured in China and marketed toward youth. The registry, already used in more than a dozen states, is intended to give law enforcement clear authority to seize unlisted products, disrupt illicit supply networks, and support legitimate retailers, as agencies including the NYPD and NYC Sheriff’s Office have increasingly found illegal vapes linked to broader criminal activity.

    “New York is the capital of illicit nicotine trafficking, and these illegal Chinese flavored vapes have made a bad situation even worse,” said former New York City Sheriff Edgar Domenech, who created the Big Apple enforcement strategy targeting illegal cigarette and tobacco sales under then-Mayor Mike Bloomberg. “Creating a clear vapor products registry gives law enforcement the information and transparency they need to quickly identify contraband, protect our children, and shut down bad actors who are almost always involved in dangerous, violent crime.”

  • 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

  • FDA Extending Info Collection for Smokeless Products

    FDA Extending Info Collection for Smokeless Products

    The U.S. Food and Drug Administration (FDA) has submitted a proposed extension of an existing information collection to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act, covering warning plans for certain smokeless tobacco products. The collection, assigned OMB Control Number 0910-0671, relates to statutory requirements that smokeless tobacco packaging and advertising carry one of four mandated health warnings, randomly displayed and rotated quarterly in accordance with FDA-approved warning plans. FDA said manufacturers, importers, distributors, and retailers must submit these plans for review, either electronically via the Center for Tobacco Products (CTP) Portal or in paper form.

    Public comments on the proposal must be submitted through reginfo.gov within 30 days of Federal Register publication, and FDA noted that two comments received during an earlier 60-day notice period were not related to paperwork burden issues.

  • Cabbacis Hosting Webinar Outlining its $7.5M Offering

    Cabbacis Hosting Webinar Outlining its $7.5M Offering

    Cabbacis announced it will host an investor webinar on January 22 at 11:30 EST as part of its ongoing $7.5 million Regulation A offering. During the session, CEO and chairman Joseph Pandolfino will outline the company’s commercialization strategy for its patented iBlend cigarettes and vaporizer pods, which combine very-low-nicotine tobacco with non-intoxicating hemp and are positioned as harm-reduction products aimed at reducing nicotine dependence and supporting quit attempts.

    The company will also update investors on its regulatory pathway with the U.S. Food and Drug Administration, leadership team, and plans for an international rollout later in 2026 to generate early revenue and brand validation ahead of U.S. market entry. Cabbacis said proceeds from the offering are intended to support product development and commercialization, positioning the company ahead of a potential FDA rule to cap nicotine levels in cigarettes, while expanding into reduced-nicotine and alternative tobacco formats.

    Register for the webinar here.

  • K&H Tobacco/Nicotine Symposium Registration Open

    K&H Tobacco/Nicotine Symposium Registration Open

    Keller and Heckman announced it will host its 10th annual E-Vapor, Nicotine, and Tobacco Law Symposium May 4–5 at the Paris Las Vegas Hotel, returning to Las Vegas ahead of the CHAMPS Trade Show. The two-day program is positioned as a comprehensive briefing on the legal, regulatory, and scientific issues shaping the tobacco, nicotine, and CBD/hemp sectors. The symposium is designed for manufacturers, suppliers, distributors, and retailers navigating FDA oversight and evolving compliance requirements.

    Registration is now open, with a Super Early-Bird rate of $999 available through February 6, representing a $200 discount. Early-bird pricing runs through March 27, after which standard registration applies. Organizers say upcoming announcements will detail the agenda and confirm participating scientific experts, FDA officials, and attorneys.

  • Doseology Partners with McKinney to Bring Pouches to Market

    Doseology Partners with McKinney to Bring Pouches to Market

    Doseology Sciences entered a strategic partnership with McKinney Regulatory Science Advisors to guide its U.S. regulatory strategy as it advances oral pouch products toward commercial readiness. Under the agreement, McKinney will advise on formulation strategy, data generation, PMTA preparation, and post-market compliance, positioning Doseology to navigate FDA requirements while strengthening product design and intellectual property protection.

    The company said the collaboration marks a shift from development to regulatory execution, with a focus on dose consistency, consumer safety, and compliance in regulated markets. McKinney’s regulatory roadmap will be integrated into Doseology’s R&D and manufacturing validation plans, supporting structured PMTA readiness for both nicotine and nicotine-analogue products as the company seeks to establish a defensible, science-led position in the oral pouch category.

  • FDA Pushed on ‘De Facto’ Vape Ban by 5th Circ.

    FDA Pushed on ‘De Facto’ Vape Ban by 5th Circ.

    A panel of the U.S. Court of Appeals for the Fifth Circuit signaled skepticism yesterday (January 6) toward the Food and Drug Administration’s claim that it has not effectively banned flavored refillable e-cigarette products, suggesting the agency’s near-total rejection of applications amounts to a de facto prohibition. During oral arguments, Judge Cory T. Wilson noted that the FDA has approved only six applications out of hundreds of thousands of premarket tobacco product applications (PMTAs), remarking that “if you’re effectively at 100% denial on a certain class of products, then it is a de facto ban.”

    The case was brought by VDX Distro Inc., which is challenging the FDA’s refusal to authorize its menthol-flavored refillable vaping products. Government attorney Ben Lewis argued that no ban exists because some products have been approved, but judges pressed the agency on whether it has ever approved a flavored e-cigarette without evidence showing it provides greater smoking cessation benefits than tobacco-flavored products. Counsel for VDX argued the FDA violated the Tobacco Control Act by imposing new, unwritten standards without notice-and-comment rulemaking, effectively blocking all open-system refillable devices.

    Industry amici echoed those concerns, with an attorney for R.J. Reynolds Vapor Co. arguing the FDA applies stricter standards to flavored vaping products than to other nicotine products, such as pouches. The panel did not rule from the bench, but the pointed questioning underscores growing judicial scrutiny of FDA tobacco regulation, with potential implications for future authorization pathways for flavored vaping products closely watched by the tobacco and nicotine industries.

  • 22nd Century Files PMTA Renewal

    22nd Century Files PMTA Renewal

    22nd Century Group, Inc. announced it has filed a renewal application with the U.S. Food and Drug Administration for its Modified Risk Tobacco Product authorization covering VLN reduced nicotine content cigarettes. The original authorization, granted in December 2021, expires in December 2026.

    22nd Century says VLN remains the first and only combustible cigarette authorized by the FDA to reduce the health harms of smoking, with approved claims including “95% less nicotine” and statements that it helps reduce nicotine consumption and smoking frequency. The company cited decades of independent clinical research supporting VLN products, including evidence that lowering nicotine content reduces smoking rates and increases quit attempts. Company CEO Larry Firestone said the renewal builds on FDA recognition that reducing nicotine directly can alter smoking behavior and improve public health outcomes, adding that VLN products align with the FDA’s proposed low-nicotine standard issued in January 2025.