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Tag: FDA

  • NY Gov. Vows Crackdown on Illicit Vapes

    NY Gov. Vows Crackdown on Illicit Vapes

    New York Governor Kathy Hochul announced plans to crack down on illegal flavored vapes by directing the state Department of Taxation and Finance to establish a Vapor Products Registry identifying which products may be legally sold in the state. Hochul said that despite state and federal bans enacted in 2020, an estimated 99% of vapes currently on the New York market are flavored and lack FDA authorization, with many manufactured in China and marketed toward youth. The registry, already used in more than a dozen states, is intended to give law enforcement clear authority to seize unlisted products, disrupt illicit supply networks, and support legitimate retailers, as agencies including the NYPD and NYC Sheriff’s Office have increasingly found illegal vapes linked to broader criminal activity.

    “New York is the capital of illicit nicotine trafficking, and these illegal Chinese flavored vapes have made a bad situation even worse,” said former New York City Sheriff Edgar Domenech, who created the Big Apple enforcement strategy targeting illegal cigarette and tobacco sales under then-Mayor Mike Bloomberg. “Creating a clear vapor products registry gives law enforcement the information and transparency they need to quickly identify contraband, protect our children, and shut down bad actors who are almost always involved in dangerous, violent crime.”

  • FDA Releases Meeting Materials for Zyn’s MRTP Application  

    FDA Releases Meeting Materials for Zyn’s MRTP Application  

    Today (January 20), the U.S. Food and Drug Administration released meeting materials ahead of a virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 Zyn nicotine pouch products. The materials include a draft agenda, background documents from both the applicant and the FDA, and draft questions for committee consideration, and are available on the FDA’s 2026 TPSAC Meeting Materials and Information page.

    The virtual TPSAC meeting is scheduled for January 22. FDA opened Docket No. FDA-2025-N-0835-0020  for public comments related to the meeting, with submissions due by 11:59 p.m. ET on January 21. Comments specific to the ZYN MRTP applications may also be submitted under a separate docket, Docket No. FDA-2025-N-0835-0001, which was established on June 18, 2025.

    Visit the event webpage to learn more about attending the meeting online

  • 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.

  • Cabbacis Hosting Webinar Outlining its $7.5M Offering

    Cabbacis Hosting Webinar Outlining its $7.5M Offering

    Cabbacis announced it will host an investor webinar on January 22 at 11:30 EST as part of its ongoing $7.5 million Regulation A offering. During the session, CEO and chairman Joseph Pandolfino will outline the company’s commercialization strategy for its patented iBlend cigarettes and vaporizer pods, which combine very-low-nicotine tobacco with non-intoxicating hemp and are positioned as harm-reduction products aimed at reducing nicotine dependence and supporting quit attempts.

    The company will also update investors on its regulatory pathway with the U.S. Food and Drug Administration, leadership team, and plans for an international rollout later in 2026 to generate early revenue and brand validation ahead of U.S. market entry. Cabbacis said proceeds from the offering are intended to support product development and commercialization, positioning the company ahead of a potential FDA rule to cap nicotine levels in cigarettes, while expanding into reduced-nicotine and alternative tobacco formats.

    Register for the webinar here.

  • 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.