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Tag: PMTA

  • 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.

  • 5th Circ. Grills FDA on PMTA Rules

    5th Circ. Grills FDA on PMTA Rules

    A Fifth Circuit panel questioned the U.S. Food and Drug Administration this week, raising doubts about whether it properly considered the impact of its 2021 rule requiring premarket authorization for new tobacco products on small businesses. According to Law 360, the judges questioned whether the agency complied with the Regulatory Flexibility Act, which mandates that regulators assess how new rules affect smaller firms. Vape companies argue the FDA relied on outdated economic data and imposed disproportionate costs that could drive many small manufacturers out of the market.

    During oral arguments in New Orleans, the panel pressed the FDA on its shift in position between 2016 and 2021, when the agency moved from a more flexible approach to requiring extensive scientific evidence for new products. The judges also asked whether the health risk information requirements were discretionary or mandated by the Tobacco Control Act. The skepticism suggests the court is weighing whether the FDA’s rulemaking process adequately accounted for the realities faced by small vape businesses.

    The case comes amid broader challenges to the FDA’s handling of Premarket Tobacco Product Applications (PMTAs), including disputes over flavored e-cigarette denials. If the Fifth Circuit finds the FDA violated the Regulatory Flexibility Act, the agency could be forced to revisit its rulemaking, potentially easing compliance burdens for smaller companies.

  • FDA Deploys Agentic AI to Assist Regulatory Reviews

    FDA Deploys Agentic AI to Assist Regulatory Reviews

    The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities to all agency employees, a move expected to streamline complex, multi-step regulatory tasks — including pre-market reviews, post-market surveillance, inspections, and compliance activities that would be of interest to those in the tobacco and nicotine industries.

    The new systems allow staff to build multi-model AI workflows capable of planning, reasoning, and executing tasks under human oversight. The tools are optional and operate within a secure GovCloud environment, with no training on industry-submitted data.

    In an email to StatNews, an FDA spokesperson called the tool “exploratory” and said that the AI agents do not make regulatory decisions. “All outputs from AI are reviewed and validated” by FDA staff “before being incorporated into any official regulatory action, ensuring that the AI remains a support tool rather than a decision maker,” he wrote.

    The deployment follows the success of Elsa, an internal LLM tool launched in May and now used by more than 70% of FDA personnel. The agency is also launching a two-month Agentic AI Challenge, with selected projects to be showcased in January 2026.

    FDA Commissioner Marty Makary said the upgrades mark a major step in modernizing regulatory operations, while Chief AI Officer Jeremy Walsh highlighted the potential to accelerate and validate safety assessments across all FDA-regulated sectors — including tobacco.

  • 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.