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Tag: PMTA

  • FDA Releases Transparency Roadmap

    FDA Releases Transparency Roadmap

    The U.S. Food and Drug Administration issued a press release today (Oct. 2) outlining its Transparency Roadmap that calls for greater disclosure of the scientific and regulatory basis for agency decisions, while protecting confidential commercial information and trade secrets. The Roadmap focuses on five components: complete response letters; investigational stage and marketing application lifecycle disclosures; new approach methodologies and novel biomarkers; patient- and consumer-centered product labeling; and compliance and inspectional records.

    While the new transparency initiative does not directly address tobacco and nicotine products, it could affect industry manufacturers navigating the agency’s premarket review process, particularly as FDA considers changes to its Premarket Tobacco Product Application (PMTA) framework. FDA already publishes marketing orders and related documents for tobacco products, as well as aggregate data on PMTA, substantial equivalence, and exemption applications, but greater transparency could be relevant to how the agency evaluates applications and reaches regulatory decisions.

    The initiative comes as FDA says it intends to evaluate changes to the PMTA framework, citing its experience implementing the current rules, the development of an illicit and unregulated market, and the pace of new product introductions. The agency said a revised framework should provide greater clarity and predictability for applicants.

  • FDA Streamlines Tobacco Product Registration and Listing Process

    FDA Streamlines Tobacco Product Registration and Listing Process

    The U.S. Food and Drug Administration on Sept. 28 launched a redesigned Form FDA 3741 that consolidates establishment registration and product listing submissions for all regulated tobacco product categories, including cigarettes, e-cigarettes, smokeless tobacco, heated tobacco products, and oral nicotine products such as nicotine pouches. The change replaces two previously separate forms, Form FDA 3741 and Form FDA 3741a, and is intended to simplify the process for manufacturers by eliminating the need to determine which form applies to different product categories.

    The redesigned form includes a submission checklist that directs manufacturers to the sections relevant to their filing and allows companies updating existing registrations to change specific information without resubmitting unchanged sections. The FDA is also encouraging manufacturers to use the new Form FDA 3741b spreadsheet for initial product-list submissions or additions to existing product lists. Domestic tobacco product manufacturers must submit annual establishment registrations by Dec. 31, while product listings are due June 30 and Dec. 31 when manufacturers have made certain changes to their products or manufacturing operations.

    The FDA said manufacturers should submit the redesigned Form FDA 3741 electronically through its Tobacco Registration and Listing Module Next Generation (TRLM NG) system, although paper submissions remain available for companies unable to file electronically. Existing registrations and product listings will remain in TRLM NG, and manufacturers do not need to resubmit their entire registration because of the change. The previous versions of Forms FDA 3741 and 3741a have been retired, with existing TRLM NG users receiving prompts to update registration and product-listing information using the new format.

  • Trump Administration Looking to Change PMTA Process

    Trump Administration Looking to Change PMTA Process

    The Trump administration is reportedly preparing changes to the FDA’s review process for new tobacco products that could make it faster and easier for products such as flavored vapes and nicotine pouches to receive marketing authorization, according to The Wall Street Journal. The FDA is expected to revisit requirements established in 2021 for Premarket Tobacco Product Applications (PMTAs), following years of industry criticism over lengthy reviews.

    Reuters reported it could not independently verify the report, but quoted an HHS spokesperson as saying, “The Trump administration is committed to keeping nicotine out of the hands of kids, getting ⁠counterfeit vaping products off the streets and providing safer alternatives for adults who want to quit smoking cigarettes.”

    Industry groups and companies welcomed the potential changes. Laura Leigh Oyler, vice president of regulatory affairs at Haypp Group USA, said the FDA has not met congressional review deadlines for noncombustible products and has authorized fewer than 100 reduced-risk products compared with thousands of combustible products. “An overhaul isn’t just welcome, it’s necessary,” Oyler said, adding that the current process has contributed to the influx of foreign, illicit products.

    Charlie’s Holdings also supported the reported changes, saying it has been seeking FDA authorization for certain tobacco-derived nicotine e-liquids since 2020 and hundreds of synthetic nicotine products since 2022. CEO Henry Sicignano said the PMTA process has imposed high costs on smaller U.S. businesses while illicit products have entered the market. Charlie’s said it currently retains 678 timely filed PMTA assets and expects a streamlined authorization process to increase the value of its portfolio.

  • VTA Launches Ad Campaign on Vaping Regs

    VTA Launches Ad Campaign on Vaping Regs

    The Vapor Technology Association (VTA) launched a seven-figure cable, broadcast, and digital advertising campaign urging President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. to replace the FDA’s current Premarket Tobacco Product Application (PMTA) framework with what the trade group describes as clear, science-based guidance for vapor products. The campaign is running on Fox News programming, Truth Social, and X. VTA said the campaign cites a poll showing 71% support for replacing the current PMTA rules with scientific guidelines.

    VTA said the campaign follows an August 2026 decision by the U.S. Court of Appeals for the Fifth Circuit involving the FDA’s PMTA process. VTA Executive Director Tony Abboud said the proposed framework would provide clearer requirements for manufacturers while strengthening enforcement against noncompliant products.

  • Altria Sues FDA Over Product Review System 

    Altria Sues FDA Over Product Review System 

    Altria announced that it has filed a lawsuit against the U.S. FDA in federal court, seeking to force the agency to overhaul its tobacco product review system, which the company says has become a major barrier to growth in the U.S. market. Altria argues that lengthy review delays, including applications remaining pending for years, disadvantage compliant manufacturers while unauthorized products continue to gain market share. 

    The lawsuit is the latest industry challenge to the FDA’s premarket review regime, which requires new tobacco products to demonstrate a net public health benefit before sale. Altria says the agency has failed to meet the statutory 180-day review deadline and argues that recent FDA changes—including a fast-track pathway for nicotine pouches—still have not resolved the backlog. 

  • VTA Poll Finds Support for Science-Based Vape Regulation Reform

    VTA Poll Finds Support for Science-Based Vape Regulation Reform

    A nationwide survey in the United States commissioned by the Vapor Technology Association (VTA) found broad bipartisan support for reforming the FDA’s regulatory framework for vaping products, with particularly strong backing among President Donald Trump’s voters. Conducted by pollster Kellyanne Conway among 1,204 registered voters, including an oversample of 200 Trump voters, the survey found 71% support replacing the current FDA PMTA framework with science-based standards and 77% favor allowing vapor products with pending FDA applications that do not target youth to remain on the market while a revised system is implemented.

    The poll also found 65% of respondents support FDA reforms that would allow flavored vaping products for adults while maintaining youth protections, and 67% said regulations should reflect adult consumer demand for flavored products. At the same time, respondents strongly supported youth access restrictions, with 86% supporting robust age verification for all vape purchases, 84% favoring tougher penalties for retailers who sell to minors, and 80% supporting bans on youth-oriented marketing and product designs.

    VTA said the findings demonstrate public support for a streamlined, science-based regulatory pathway that differentiates adult access from youth prevention and promotes U.S.-based manufacturing. The association argued the current FDA regulatory system should be replaced with clearer scientific benchmarks that allow adult smokers access to authorized alternatives while enabling smaller manufacturers to compete alongside larger tobacco companies.

  • Pilot Study Promising as AIR Invests $20M in Greentank

    Pilot Study Promising as AIR Invests $20M in Greentank

    AIR Global announced a $20 million investment in vaporization technology company Greentank Innovations, deepening a strategic partnership established in 2023. The investment gives AIR preferred shares based on a $170 million pre-money valuation, a warrant to increase its stake by an additional 20% over the next two years, a board nomination right, and enhanced commercial and technology access. AIR said the investment supports its growth strategy in reduced-risk nicotine products and its planned U.S. premarket tobacco product application for its Crown Switch vape.

    AIR also released results from an independent pilot study of its Greentank-powered Crown Switch device, reporting low or non-detectable levels of several harmful or potentially harmful constituents in the aerosol. According to the company, carbon monoxide, benzene, and 1,3-butadiene were not detected, while formaldehyde, nickel, and other constituents were reported at lower levels than published data for certain FDA-authorized e-cigarettes. AIR said the preliminary findings will be presented at the 2026 Tobacco Science Research Conference and will form part of its PMTA submission, noting that additional testing is underway and future results may differ.

  • 5th Circ. Backs FDA’s Block on Vape Marketing

    5th Circ. Backs FDA’s Block on Vape Marketing

    The U.S. Court of Appeals for the Fifth Circuit upheld the U.S. Food and Drug Administration’s denial of marketing applications for menthol-flavored e-cigarette products submitted by two vape manufacturers, ruling that the agency reasonably concluded the products’ potential benefits for adult smokers did not outweigh the risks of youth initiation. The decision affirms the FDA’s application of the “appropriate for the protection of public health” standard required under the Premarket Tobacco Product Application (PMTA) pathway.

    The ruling, against Triton Distribution and Vapetasia LLC, reinforces the FDA’s authority to reject flavored vaping products where applicants fail to provide sufficient evidence that the products offer a net public health benefit.

  • Zest Gets Injunction Against FDA for Pouches

    Zest Gets Injunction Against FDA for Pouches

    Zest Brands LLC announced that it secured a preliminary injunction from the U.S. District Court for the Middle District of Florida, allowing its ZEO Universe nicotine pouch products to remain on the U.S. market while the company challenges an FDA Refuse-to-File (RTF) decision related to its May 2022 Premarket Tobacco Product Applications. The injunction temporarily stays the FDA’s action as the case proceeds through the courts.

    According to the company, the court found Zest Brands is likely to succeed on claims that the FDA failed to adequately assess the impact of its 2021 PMTA regulations on small businesses, as required under the Regulatory Flexibility Act. The court also indicated that aspects of the agency’s actions may have been “arbitrary and capricious.” Zest said it remains committed to working with the FDA to complete the PMTA process and is currently in discussions with strategic and financial partners to support future growth.

  • Charlie’s Holdings Touts Progress to Shareholders

    Charlie’s Holdings Touts Progress to Shareholders

    Charlie’s Holdings, Inc. sent out a shareholder letter today (June 8), outlining its recent progress and highlighting improved financial stability, portfolio expansion, and regulatory positioning across its premium vapor products business. The company said it strengthened liquidity and operations over the past year, including the $7.5 million sale of 16 PMTA-authorized products to a major tobacco company and the expansion of its U.S. manufacturing footprint to support domestic production, reduce costs, and meet state-level compliance requirements.

    The letter also emphasized Charlie’s strategic focus on regulatory innovation and capital market advancement. The company detailed its licensing agreement with IKE Tech to commercialize an AI-powered age-gating system for disposable vapes, which it believes could unlock significant licensing revenue and potential partnerships. It also noted steps toward a potential uplisting to a national exchange, including a clean 2025 audit, elimination of prior business lines, and shareholder approval of a reverse stock split, while reaffirming its goal of growing compliant nicotine and alternative vapor product sales amid tightening enforcement against illicit products.