TobaccoReporter logo

Tag: FDA

  • K&H Tobacco/Nicotine Symposium Registration Open

    K&H Tobacco/Nicotine Symposium Registration Open

    Keller and Heckman announced it will host its 10th annual E-Vapor, Nicotine, and Tobacco Law Symposium May 4–5 at the Paris Las Vegas Hotel, returning to Las Vegas ahead of the CHAMPS Trade Show. The two-day program is positioned as a comprehensive briefing on the legal, regulatory, and scientific issues shaping the tobacco, nicotine, and CBD/hemp sectors. The symposium is designed for manufacturers, suppliers, distributors, and retailers navigating FDA oversight and evolving compliance requirements.

    Registration is now open, with a Super Early-Bird rate of $999 available through February 6, representing a $200 discount. Early-bird pricing runs through March 27, after which standard registration applies. Organizers say upcoming announcements will detail the agenda and confirm participating scientific experts, FDA officials, and attorneys.

  • 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.

  • Truth Initiative Report Says Industry Targeting Youth

    Truth Initiative Report Says Industry Targeting Youth

    A new report from Truth Initiative claims that the tobacco and nicotine industry continues to market youth-appealing products, including high-tech “smart” vapes, flavored disposable e-cigarettes, and oral nicotine pouches, which raises concerns about addiction and a potential reversal of recent prevention gains. The report says these products often deliver higher nicotine levels, come in sweet flavors, and are sold at low prices, while recent cuts to federal prevention and cessation funding heighten the public health risk.

    According to the report, data show that about one-third of youth and young adults used “smart” vapes in the past month, while nicotine pouches became the fastest-growing nicotine category, with sales nearly tripling between 2023 and 2024. Flavored products dominate youth use, despite limited FDA authorization, and rising nicotine concentrations have driven a 249% increase in total nicotine sold in e-cigarettes since 2020.

    The report also points to growing dependence and co-use of multiple nicotine products among youth and young adults. Truth Initiative called for stronger enforcement against illegal products, expanded regulation of flavored nicotine products, and greater investment in youth-focused quitting support.

  • Nicokick and Northerner Increase Commitment to Responsible Retailing

    Nicokick and Northerner said they are strengthening their commitment to responsible and compliant retailing for adult consumers aged 21 and over, citing clearer regulatory direction from the U.S. Food and Drug Administration. The companies said their focus is on consumer safety, preventing youth access, and maintaining transparency as regulatory oversight of the category increases. Both retailers enforce a nationwide minimum purchase age of 21 and require age and identity verification through third-party provider Veratad, with orders denied or canceled if verification cannot be completed. Nicokick and Northerner said they also limit sales to states where online nicotine pouch sales are permitted and comply with state-specific requirements, including flavor rules. Products sold on their platforms must show evidence of FDA submissions and undergo third-party quality testing.

    “With enforcement ramping up and scrutiny intensifying, responsible retailing isn’t just a nice-to-have; it’s the backbone of credibility, consumer protection, and the viability of the category’s future,” said Laura Leigh Oyler, vice president for regulatory affairs with Haypp Group (parent company of Nicokick and Northerner). “Our ambition is for Nicokick and Northerner to continue standing as paragons of responsibility in the online nicotine retail space.”

    Additional safeguards include sourcing products directly from manufacturers, applying order and SKU limits, using fraud-detection systems, and restricting marketing and promotions to adult audiences. The companies said educational resources and product information are provided to support informed use, positioning responsible retailing as central to the long-term viability of the nicotine pouch category.

  • 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.

  • Pennsylvania Vape Registry Bill Draws Opposition From Both Sides

    Pennsylvania Vape Registry Bill Draws Opposition From Both Sides

    Vaping industry representatives and anti-smoking advocates are both opposing legislation moving through Pennsylvania’s General Assembly that would establish a statewide list of sanctioned nicotine vape products, according to the Altoona Mirror. The state Senate has passed an amended version of House Bill 1425, which would require vape products to appear on a state-managed directory—based on FDA authorization—to be legally sold, and the bill now returns to the House for a concurrence vote.

    Supporters say the measure would help prosecutors crack down on illicit vape sales, but critics argue it would disproportionately benefit large tobacco companies whose products dominate the FDA registry, while forcing hundreds of independent vape shops out of business. Industry groups warn thousands of jobs could be affected, while public health advocates contend the bill could legitimize flavored products that appeal to youth. Under the proposal, manufacturers would face registration fees, and retailers selling non-listed products could be fined, with enforcement beginning after a phased implementation period.

  • Philippines Requires Licenses for Vape Products With Health Claims

    Philippines Requires Licenses for Vape Products With Health Claims

    The Philippines’ Food and Drug Administration (FDA) mandated that all establishments selling vaporized nicotine and non-nicotine products (VNNPs) and novel tobacco products (NTPs) with medicinal or therapeutic claims must secure a License to Operate. Under Advisory 2025-1487, manufacturers, importers, distributors, wholesalers, and retailers are required to apply for licenses as pharmaceutical establishments.

    The FDA also said such products must be registered as pharmaceutical products through the Center for Drug Regulation and Research. The agency urged stakeholders to comply, citing the need to ensure the safety, efficacy, and quality of vape and novel tobacco products making health-related claims.

  • 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.