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Tag: PMTA

  • FDA to Host Discussion on PMTAs Feb. 10

    FDA to Host Discussion on PMTAs Feb. 10

    FDA issued a reminder today regarding the Federal Register notice (FRN) roundtable discussion it is hosting tomorrow (February 10) for small tobacco product manufacturers (fewer than 350 employees). The discussion aims to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products and will be held from 9 a.m.–5 p.m. ET.

    The topics to be discussed will include certain components of ENDS PMTAs, such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).

    FDA has also established a docket for public comment on this roundtable discussion. All electronic comments must be submitted on or before March 12. The regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 12.

  • IKE Tech Invited to FDA Roundtable on PMTA Submissions

    IKE Tech Invited to FDA Roundtable on PMTA Submissions

    IKE Tech LLC has been invited by the U.S. Food and Drug Administration to participate in an invitation-only roundtable discussion with small electronic nicotine delivery system (ENDS) manufacturers focused on Premarket Tobacco Product Application (PMTA) submissions. The news was announced by Ispire Technology, a founding partner of IKE Tech.

    The February 10 forum, limited to 30 companies nationwide, is designed to gather direct industry feedback on the PMTA process, with IKE Tech selected to participate in the Manufacturing Controls panel examining operational challenges and compliance practices. The company is developing a blockchain-enabled, Bluetooth-based age-gating system intended to verify legal-age access at the point of use, which has been submitted as a component PMTA for an interoperable age-verification technology. The FDA session is expected to inform future regulatory guidance and potential refinements to the PMTA review framework.

  • 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.”

  • 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.

  • 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.

  • FDA Hosting PMTA Roundtable for Small ENDS Manufacturers

    FDA Hosting PMTA Roundtable for Small ENDS Manufacturers

    The U.S. Food and Drug Administration issued a Federal Register notice announcing a roundtable discussion with small tobacco product manufacturers on February 10, 2026, from 9 a.m. to 5 p.m. ET. The meeting will focus on gathering feedback on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) and is open for public viewing.

    Participation in the roundtable is limited to 30 representatives from manufacturers with fewer than 350 employees who have previously submitted an ENDS PMTA, including applications that are still pending with the FDA. The discussion will give small manufacturers an opportunity to share their experiences and perspectives on the PMTA process, including challenges related to product characterization, manufacturing controls, pharmacological studies, adult benefit research, and toxicological assessments.

    Manufacturers interested in participating as panelists must send an email to register by January 27, 2026, with selections made on a rolling basis and limited to one representative per company. Non-panelists and members of the public will be able to watch the roundtable virtually via information posted on the FDA’s Center for Tobacco Products website. The meeting will be recorded and captioned.

  • FDA Authorizes Six on! PLUS Nicotine Pouch Products

    FDA Authorizes Six on! PLUS Nicotine Pouch Products

    The U.S. FDA authorized the marketing of six nicotine pouch products from Helix Innovations LLC under the on! PLUS brand through the premarket tobacco product application (PMTA) pathway.

    These authorizations mark the first decisions from a pilot program launched in September to streamline the review process for nicotine pouch applications while maintaining the agency’s rigorous scientific standards. Authorized products include mint, tobacco, and wintergreen flavors in 6 mg and 9 mg nicotine strengths. The FDA noted that these products contain lower levels of harmful constituents compared with other smokeless tobacco products and do not contain measurable levels of several carcinogens linked to oral cancer.

    “While today’s actions permit these specific nicotine pouch products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they ‘FDA approved,’” FDA said in a statement.  

    All packaging will feature certified child-resistant cans.

  • FDA Launches Web-Based PMTA Forms

    FDA Launches Web-Based PMTA Forms

    Today (December 3), FDA launched web versions of four forms in CTP Portal Next Generation (CTP Portal NextGen) for applicants submitting and amending premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports. FDA transitioned from CTP Portal to CTP Portal NextGen—a “new, improved web portal” for submitting tobacco product applications electronically—in early 2025. The web forms allow applicants to create, validate, and submit PMTA and SE Report submissions directly through CTP Portal NextGen.

    The web-based forms include Forms FDA 4057, 4057a, 3965, and 3965a. Industry stakeholders with active CTP Portal accounts had the option to test and provide feedback on the new web functionality of the forms during online development. Creating these web-based forms is part of FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process.

    According to the FDA, the new portal includes step-by-step instructions on completing the forms; a more user-friendly interface that helps guide applicants through the submission process; the ability for multiple users to work on a submission at the same time and easily save drafts; and real-time, automatic validation, ensuring all required fields are completed before submission.

    PDF versions of FDA’s PMTA and SE Report forms will remain available for applicants who choose not to use the web-based versions. These PDFs can still be downloaded and submitted electronically through CTP’s Document Control Center or uploaded via eSubmitter. FDA has also released updated PDF versions of Forms 4057, 4057a, 3965, and 3965a, correcting minor technical issues since their original posting in June 2025. Beginning Jan. 2, 2026, applicants using PDF forms must use these updated versions. Failure to use the current forms — or to complete them correctly — will generally result in FDA refusing to accept the application.