TobaccoReporter logo

Tag: PMTA

  • 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.

  • Ispire Says FDA Guidance Opens $50B Door

    Ispire Says FDA Guidance Opens $50B Door

    Ispire Technology Inc. says it is positioning itself to capture a multi-billion-dollar opportunity in the U.S. vaping market following the FDA’s newly issued draft guidance on flavored ENDS Premarket Tobacco Product Applications. The guidance, which formally recognized device-level age verification — or Device Access Restrictions (DAR) — as a key factor in determining whether a product meets the “appropriate for the protection of public health” standard, creates a lawful pathway for flavored products that have largely been sold illicitly.

    Ispire said its 40%-owned joint venture, IKE Tech LLC, is uniquely positioned to provide the age-gating and product authentication infrastructure required for compliance, leveraging its blockchain-secured, biometric, and Bluetooth-enabled technology platform that has been validated to prevent underage access while supporting adult consumer use.

    Ispire said the recognition of DAR technologies by the FDA opens a total addressable market estimated at $50 billion, largely comprised of illicit and unauthorized flavored ENDS products. IKE Tech’s SaaS-based compliance model, which Ispire estimates can generate $5 million to $20 million in annual recurring revenue per manufacturer customer, positions the company to capture significant enterprise value even with a limited number of clients. Beyond age verification, the platform also addresses counterfeiting and illicit trade, providing traceability and authentication across the supply chain.

  • FDA Outlines Risk-Based Approach to ENDS Flavors

    FDA Outlines Risk-Based Approach to ENDS Flavors

    Yesterday (March 9), the U.S. Food and Drug Administration (FDA) issued a draft guidance outlining how it will evaluate flavored electronic nicotine delivery systems (ENDS) under the Premarket Tobacco Product Application (PMTA) process. The document clarifies the agency’s current thinking on determining whether such products are “appropriate for the protection of the public health” (APPH), the legal standard under the Federal Food, Drug, and Cosmetic Act. Although non-binding, the guidance emphasizes that applicants must demonstrate a net public health benefit, meaning any potential benefits to adult smokers, such as helping them switch from or reduce combustible cigarette use, must outweigh the risks to non-users, particularly youth.

    The guidance adopts a “risk-proportionate” approach based on the level of youth appeal associated with different flavors. According to the FDA, high-risk flavors such as fruit, candy, dessert, and other sweet varieties face a particularly high evidentiary burden. They must demonstrate significant added benefits for adult smokers compared with tobacco-flavored products. Lower-risk flavors, including menthol, mint, and some novel flavors such as spices, may require a smaller demonstrated adult benefit to meet the APPH standard. Applicants are encouraged to provide scientifically valid evidence, including sensory perception studies, consumer response assessments, and population-level data, to evaluate both youth appeal and potential adult benefits.

    The agency also addressed mitigation strategies designed to reduce youth access, including device access restrictions such as fingerprint authentication or geofencing. While these technologies may form part of a broader youth-prevention strategy, the FDA said they are generally insufficient on their own to offset the risks associated with highly youth-appealing flavors. The guidance reinforces the agency’s product-specific, evidence-based review process, with the most scrutiny applied to flavored products that present the greatest risk of youth initiation.

  • Atlas IoT Gets USPTO Grant for Age-Restricted Vape Technology

    Atlas IoT Gets USPTO Grant for Age-Restricted Vape Technology

    Atlas IoT announced that it secured a patent grant from the United States Patent and Trademark Office for an age-restricted device and system designed for electronic nicotine delivery systems, positioning the technology as a potential pathway to strengthen regulatory compliance and support broader adult-focused flavor approvals. The company’s standalone system uses AI-powered age verification to confirm users are 21 or older without requiring app downloads or storing personal data, followed by a one-time thumbprint enrollment that serves as the device’s unlocking mechanism. A secondary bioimpedance sensor embedded in the mouthpiece is designed to prevent use by minors, creating a dual-verification process intended to block unauthorized access.

    Atlas IoT said it has requested a Q-Submission meeting with the U.S. Food and Drug Administration to discuss a Component Premarket Tobacco Product Application covering the device’s core technology, with plans to partner with e-liquid manufacturers that would file their own PMTAs for compliant flavored pods. The company also emphasized domestic manufacturing and FDA-registered filling operations for its replaceable pods, contrasting its compliance-focused model with the illicit disposable vape market. Atlas IoT said that, if authorized, its platform could establish a new standard for age-restricted ENDS products in the regulated U.S. market.

  • K&H Announces Agenda for Industry Law Symposium

    K&H Announces Agenda for Industry Law Symposium

    Keller and Heckman LLP announced the agenda for its 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium, scheduled for May 4–5, 2026, in Las Vegas, Nevada, ahead of the CHAMPS Trade Show. The two-day seminar will feature the firm’s attorneys alongside industry and scientific guest speakers, offering in-depth insights into legal, regulatory and scientific developments affecting tobacco, nicotine and CBD/hemp product manufacturers, suppliers, distributors and retailers. Organizers also reminded prospective attendees that the super early-bird registration rate expires February 20.

  • Enorama Sues FDA for Disparate Pouch PMTAs

    Enorama Sues FDA for Disparate Pouch PMTAs

    Enorama Pharma Inc. filed a lawsuit against the U.S. Food and Drug Administration in federal court in Washington, D.C., alleging the agency unlawfully imposed costly premarket tobacco application (PMTA) requirements on its nicotine oral pouches. In a complaint filed Feb. 17, the company argues the FDA violated the Regulatory Flexibility Act and Administrative Procedure Act by subjecting pouches to the same regulatory framework as combustible tobacco without properly assessing the impact on small businesses. Enorama contends that although the FDA previously suggested publicly available data could support applications, it now requires product-specific scientific studies, dramatically increasing costs.

    According to the filing, the FDA estimated bundled application costs between $181,686 and $2 million, but Enorama claims actual expenses range from $3 million to more than $15 million — forcing some manufacturers to exit the market. The company also alleges unequal treatment, asserting that larger competitors such as Philip Morris International and Altria Group have been allowed to market similar nicotine pouch products despite pending applications, while Enorama received a refusal-to-file letter. Attorney Eric N. Heyer of Thompson Hine LLP said the company plans to seek a preliminary injunction to halt the FDA’s action.

  • VTA ‘Disappointed’ by Lack of Progress from FDA Roundtable

    VTA ‘Disappointed’ by Lack of Progress from FDA Roundtable

    The Vapor Technology Association said it welcomed the chance to participate in a recent roundtable hosted by the U.S. Food and Drug Administration focused on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS), calling the meeting an opportunity for small businesses to engage directly with regulators. In a statement, VTA Executive Director Tony Abboud said industry representatives advocated for a more transparent, standards-based regulatory framework that would allow companies to invest in vapor technology and navigate product reviews with clearer scientific expectations.

    Abboud said VTA was encouraged by comments from FDA Commissioner Marty Makary acknowledging the need for predictability in regulatory standards but expressed frustration that some agency officials supported maintaining flexible or undefined scientific benchmarks.

    “Small businesses made it completely clear that they wanted and needed transparent and objective scientific standards governing how vape products should be made and how they should perform,” Abboud said. “Unfortunately, we were disappointed by so many FDA representatives throughout the meeting who either argued for continued scientific ambiguity or completely rejected standards. Their comments signaled a lack of alignment among FDA leadership on providing clear and predictable scientific standards or guidance for our industry – or even benchmarks that would ensure product and consumer safety. We received no guarantee of additional clarity on the broken and opaque PMTA rule and process, which has been used to prevent access to the products that Americans who smoke want and need to quit smoking deadly cigarettes.” 

    The association argued that clearer regulatory guidance would align with broader free-market principles supported by Donald Trump’s policy agenda.