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Tag: PMTA

  • FDA Makes ENDS PMTA Roundtable Materials Available

    FDA Makes ENDS PMTA Roundtable Materials Available

    Today (May 14), FDA released materials from its Feb. 10 Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products, providing the public and industry with a detailed look at discussions between agency officials and small manufacturers. Led by Dr. Matthew Farrelly and moderated by Dr. Todd Cecil, the sessions focused heavily on product characterization, manufacturing controls, pharmacological and toxicological data, and how applicants can demonstrate adult benefit through longitudinal or randomized studies. FDA said the purpose of the roundtable was to solicit feedback on how to improve the efficiency and clarity of PMTA reviews while remaining bound by statutory requirements under the Tobacco Control Act.

    Industry participants used the forum to reiterate concerns about the lack of objective scientific benchmarks guiding ENDS applications, arguing that uncertainty around testing parameters—particularly for open-system products—and the inability to update long-pending PMTAs create significant barriers for small businesses. The Vapor Technology Association, through Executive Director Tony Abboud, said members appreciated the opportunity for dialogue but left the meeting seeking clearer standards and more predictable regulatory expectations.

    Find the FDA’s resources below:

    FDA ENDS Roundtable Hub

    FDA ENDS Roundtable Video

    FDA ENDS Roundtable Transcript

  • CTP Director Touts Progress, Future in Statement

    CTP Director Touts Progress, Future in Statement

    The FDA’s Center for Tobacco Products says it has made significant progress in streamlining the review of premarket tobacco product applications (PMTAs), reducing its backlog by approximately 70% in 2025 and eliminating the queue for initial acceptance review. In a statement dated May 7 and released today (May 13), acting Director Bret Koplow said new efficiencies are allowing applications to move into review almost immediately, while accelerated filing and scientific review processes—particularly for nicotine pouches and electronic nicotine delivery systems—are helping bring compliant products to market more quickly.

    Koplow also highlighted the success of a pilot program for nicotine pouch applications, which led to authorizations for six products within three months, a record pace for the agency. The FDA plans to apply lessons from the pilot more broadly, including expedited review for product modifications and increased real-time communication with applicants, signaling a shift toward faster but still science-based regulatory decision-making in the nicotine category.

    Read the full release here.

  • FDA Files MRTP Renewal for Two 22nd Century Products

    FDA Files MRTP Renewal for Two 22nd Century Products

    Today (May 12), FDA filed two modified risk tobacco product (MRTP) renewal applications for scientific review for 22nd Century Group Inc. products VLN King and VLN Menthol King. Both products are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.

    The renewal follows MRTP orders first granted in 2021, which are set to expire in December 2026, requiring FDA reauthorization for continued marketing with reduced-risk claims. The agency has begun releasing redacted application materials for public access and has opened a docket for public comment, allowing stakeholders to submit data and feedback as part of the review process.

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”

  • 5th Circuit Considering if FDA Overstepped in Vape Flavor Regs

    5th Circuit Considering if FDA Overstepped in Vape Flavor Regs

    A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit heard oral arguments this week in a case brought by seven small vape-liquid companies challenging the FDA’s denial of marketing authorization for flavored electronic nicotine delivery systems. The companies argue the FDA rejected their applications based on a comparative efficacy requirement they say was not disclosed before the 2020 PMTA deadline, in violation of the Tobacco Control Act.

    The FDA defended the denials, saying manufacturers must prove their specific products are appropriate for the protection of public health. Government counsel argued that non-tobacco flavors add youth-use risk and that applicants failed to show added adult switching benefits over tobacco-flavored products.

    The panel questioned both sides on whether the FDA’s approach was lawful adjudication or rulemaking in practice. Courthouse News Service said, this “ruling could affect thousands of pending applications and clarify how much procedural leeway the FDA has when reviewing the flood of vape products submitted after the 2020 PMTA deadline.”

  • Cabbacis Releases 2025 Financials, Eyes 2027 PMTA Application

    Cabbacis Releases 2025 Financials, Eyes 2027 PMTA Application

    Cabbacis reported continued progress on its iBLEND cigarette platform as part of its 2025 annual filing, highlighting ongoing product development and regulatory preparation. The company, which generated no revenue in 2025 and reported a net loss of $1.58 million, is advancing clinical and consumer research to support a planned Premarket Tobacco Product Application (PMTA) submission to the FDA by January 2027.

    Recent studies cited by the company indicate that iBLEND cigarettes—made with very-low-nicotine tobacco and non-intoxicating hemp—reduced cravings and were rated favorably by adult smokers in sensory testing compared to both traditional and other reduced-nicotine products. Cabbacis plans to launch additional real-world usage studies in 2026, while also strengthening its intellectual property portfolio and pursuing a Regulation A capital raise of up to $7.5 million to fund commercialization and regulatory efforts.

  • Farrelly, Industry Experts Debate Ways to Improve PMTA Pathway

    Farrelly, Industry Experts Debate Ways to Improve PMTA Pathway

    At the American Tobacco and Nicotine Forum (ATNF), a panel titled “Building Lasting Regulatory Reforms: Solutions for a Better PMTA Pathway,” brought together legal, regulatory, and scientific experts to examine persistent challenges within the FDA’s premarket tobacco application (PMTA) process and explore potential reforms. Moderated by Issa Abuaita, the head of legal in the U.S. for Haypp Group, the discussion focused on the disconnect between the statutory framework and real-world market dynamics, with panelists broadly agreeing that the current system is slow, costly, and misaligned with both innovation and enforcement realities.

    Industry representatives emphasized the need for clearer guidance and more practical tools to navigate the process. Paige Magness, a senior vice president at Altria Client Services, highlighted the “irony” of a system where youth usage has increased in products that remain unauthorized, raising questions about whether the framework is effectively managing real-world outcomes. Kellsi Booth, the Chief Legal Officer for Black Buffalo, pointed to the gap between regulatory language and day-to-day application, suggesting that decision trees or clearer pathways could help companies determine requirements more efficiently. Piotr Kozarewicz, the global head of regulatory affairs for smoke-free products at PMI, argued for a more product-focused and market-informed approach, stressing that regulators should evaluate how products are actually used rather than relying heavily on predictive behavioral studies that may not reflect reality.

    Clive Bates, the director of Counterfactual, delivered the sharpest critique, arguing that the PMTA system has become “untethered from reality,” with high evidentiary burdens effectively stifling innovation and contributing to the growth of a large illicit market. He noted that while only a small number of vaping products have been authorized, thousands of combustible products remain on the market, creating a regulatory imbalance. Bates called for a shift toward a more pragmatic framework focused on product safety and marketing controls, alongside faster review timelines closer to the statutory 180-day standard. He also suggested that a compliance-based system, where products meeting defined standards receive expedited review, could improve outcomes and reduce barriers to entry.

    Representing the FDA on the panel was Dr. Matthew Farrelly, the director of the Office of Science for the Center for Tobacco Products, who offered several counterpoints, defending the agency’s process while acknowledging its limitations. He noted that the vast majority of PMTA denials stem from incomplete applications, particularly the lack of evidence demonstrating benefits to adult smokers. Farrelly emphasized that FDA is bound by the existing statutory framework and must base decisions on robust scientific evidence, even as it works to clear backlogs and improve engagement with industry. He encouraged earlier dialogue between applicants and regulators and suggested that incremental product changes could be reviewed more efficiently than entirely new designs.

    The panel ultimately underscored a shared recognition that while progress is being made, meaningful reform will require clearer standards, better communication, and a more balanced approach to risk, innovation, and enforcement.

  • FDA, Industry Leaders Explore Product Standards at ATNF

    FDA, Industry Leaders Explore Product Standards at ATNF

    At the American Tobacco and Nicotine Forum (ATNF), a panel titled “Streamlining Product Reviews Through Smokefree Product Standards” brought together regulators, consultants and scientists to examine how standardized frameworks could improve the efficiency of FDA product reviews. Moderated by Dean Cirotta, president of EAS Consulting Group, the discussion centered on whether clearer product standards could reduce uncertainty in the PMTA process, shorten timelines, and create more predictable pathways for bringing reduced-risk products to market.

    Andrew Joyce, the co-founder and president of Sanova, emphasized the need for earlier engagement with regulators and clearer guidance on expectations, arguing that companies are often navigating an unclear “playing field” when designing studies and preparing submissions. Dr. Aruni Bhatnagar, the director of the Christina Lee Brown Envirome Institute at the University of Louisville, framed the issue more broadly, noting that regulation must account for product design, user behavior, and market dynamics, and that product standards could serve as “guardrails” to define acceptable risk thresholds. Rachael Schmidt, a senior consultant for ALINC, highlighted the political and practical challenges, pointing out that PMTA approvals can take five to eight years and span multiple administrations, creating uncertainty that discourages innovation and investment. She stressed the need for interim solutions, such as consensus standards, to avoid prolonged delays that can keep compliant products off the market.

    Dr. Todd Cecil, deputy director of the Office of Science at the FDA’s Center for Tobacco Products, provided detailed views into the agency’s perspective, underscoring both the importance and complexity of establishing formal product standards under Section 907, which gives the FDA authority to do so. He explained that the process is resource-intensive, requiring the agency to review and respond to thousands of public comments, and can take years to finalize, but once implemented, such standards would become non-negotiable benchmarks for applications. Cecil made clear that while FDA supports faster approvals, the agency has yet to receive a submission that is complete and ready for approval at the outset, reinforcing the need for higher-quality applications. He also encouraged greater collaboration with industry groups like CORESTA and stressed that better communication from manufacturers—who understand their products best—could improve review efficiency. While acknowledging industry frustration, Cecil noted that FDA leadership is committed to advancing improvements and that draft standards could provide valuable interim guidance.

    A key tension throughout the discussion was the balance between innovation and regulation. Panelists agreed that while product standards could streamline approvals, they also introduce rigidity that may slow innovation or require costly adjustments. Cecil addressed this directly, warning against trying to “solve everything at once” and suggesting incremental progress may be more realistic. Schmidt added that without clear pathways to modify products post-approval, companies risk being locked out of the market for years if standards shift. Overall, the panel highlighted cautious optimism that clearer standards and improved dialogue between FDA and industry could reduce bottlenecks, but also underscored that meaningful change will require time, coordination, and sustained effort across stakeholders.

  • 22nd Century to File New PMTA for 100mm VLN

    22nd Century to File New PMTA for 100mm VLN

    22nd Century Group, Inc. said it will submit an additional premarket tobacco product application to the U.S. Food and Drug Administration for a new 100mm version of its VLN reduced-nicotine cigarette, building on its status as “the only company with FDA authorization for a low-nicotine combustible product.” The company’s existing 84mm king-size VLN cigarettes received PMTA authorization in 2021.

    The new product, developed under its “Operation 100” initiative, is designed to offer adult smokers a familiar format while significantly lowering nicotine intake. 22nd Century said expanding into the 100mm size responds to retailer and consumer feedback and could widen access to reduced-nicotine alternatives without requiring smokers to switch to non-combustible products.

    Beyond the single submission, the company outlined plans to pursue multiple PMTAs across different combustible formats, blends, and sizes, including filtered cigars, creating a broader portfolio that can be licensed to other tobacco companies. Management said this strategy is intended to accelerate retail penetration of VLN products and to position the company as a provider of regulatory pathways for reduced-nicotine tobacco offerings.

  • Sesh Nicotine Pouches Move to Final PMTA Stage

    Sesh Nicotine Pouches Move to Final PMTA Stage

    Sesh Products US Inc. said the U.S. Food and Drug Administration has accepted its bundled Premarket Tobacco Product Application (PMTA) covering 64 SKUs of its Sesh+ nicotine pouch line for substantive scientific review. The filing determination confirms the application is sufficiently complete to proceed to the final stage of the PMTA process. The submission spans multiple flavors, strengths, and formats aimed at adult consumers.

    The company said the milestone reflects several years of scientific preparation and engagement with regulators, positioning it among a limited number of independent U.S.-based brands advancing through the PMTA pathway.