TobaccoReporter logo

Tag: FDA

  • FDA Allows Fontem to Continue Selling Pouches Amid Court Battle

    FDA Allows Fontem to Continue Selling Pouches Amid Court Battle

    The U.S. Food and Drug Administration confirmed it will not block production or sales of Fontem US’s Zone nicotine pouches while a lawsuit over the product’s pending premarket tobacco product application proceeds, Law 360 reported. Fontem argued that the agency unlawfully delayed reviewing its application, leaving the product in regulatory limbo.

    The FDA said it will not take enforcement action during the litigation, allowing the pouches to remain on the market. Fontem recently voluntarily dismissed its suit in Texas and plans to refile in Washington, D.C. The case underscores ongoing tension between regulators and manufacturers over PMTA backlogs and the treatment of newer oral nicotine products, which differ from traditional cigarettes and vapes.

    According to Law 360, industry observers believe the court battle could set a precedent for how the FDA handles delayed applications and exercises enforcement discretion in the growing nicotine pouch sector.

  • Filing Shows FDA Rescinded 229 CTP RIF Notices

    Filing Shows FDA Rescinded 229 CTP RIF Notices

    A court filing in the U.S. District Court for the District of Rhode Island shows that the U.S. Food and Drug Administration Center for Tobacco Products has fully reversed a wave of 2025 reduction-in-force (RIF) notices affecting 229 employees. In a declaration filed March 27, FDA official Melanie M. Keller detailed how the notices, issued March 31, April 1, and May 2, 2025, were rescinded in stages beginning May 1 and continuing through September 12, 2025, across multiple CTP offices, including health communication and education, compliance and enforcement, management, regulations, and public health education.

    The declaration states that on February 3, 2026, all remaining RIF notices were rescinded except for eight employees who had already moved to other CTP divisions. The final rescissions covered staff responsible for public complaints, small business assistance, IT business process support, industry outreach, and management of contracts and grants. The filing also notes that two Office of Science leaders placed on administrative leave after proposed reassignments returned to their roles by November 6, 2025, and that none of the affected employees remains on administrative leave.

    The filing is part of State of New York vs Robert F. Kennedy, Jr., lawsuit.

  • FDA’s Pouch Fast-Track Scheme Stalling Over Youth Worries

    FDA’s Pouch Fast-Track Scheme Stalling Over Youth Worries

    A fast-track review program at the U.S. Food and Drug Administration aimed at accelerating authorizations for nicotine pouch products has stalled, as agency scientists weigh concerns about youth uptake and risks to non-users against potential harm-reduction benefits for smokers, according to sources cited by Reuters. Reuters said applications tied to pouch brands from Philip Morris International (Zyn) and British American Tobacco (Velo) remain under review despite expectations that decisions would be made by the end of 2025 under the pilot scheme. The FDA has already authorized six products under Altria Group’s on! brand, but reviewers are said to be taking a more cautious stance on other applications where evidence of net public-health benefit is viewed as less clear-cut.

    While FDA data shows pouch use among middle- and high-school students remains relatively low, it has been rising, prompting heightened scrutiny. Tobacco companies argue the pilot program is critical for restoring legal market competition amid a surge of unregulated products, while public-health advocates warn that rapid authorizations could fuel new addiction trends. The FDA said decisions continue to be guided by science and statutory standards rather than external pressure.

  • Nicokick Urges Clarity on Smoke-Free Information

    Nicokick Urges Clarity on Smoke-Free Information

    Nicokick.com, owned by Haypp Group, called on policymakers and health professionals to provide clearer, evidence-based information distinguishing the risks of combustible cigarettes from non-combusted nicotine products. The appeal follows a report by the Foundation for American Innovation highlighting high tobacco and nicotine use among U.S. servicemembers and recommending that institutions recognize differences between product types when addressing health and readiness. Nicokick cited the U.S. Food and Drug Administration’s recognition of a “continuum of risk” across tobacco products and said improved adult-focused communication could help consumers and healthcare professionals better understand these distinctions while reinforcing that smoke-free products are intended only for existing adult users.

  • Pouch Maker to Refile FDA Lawsuit in D.C.

    Pouch Maker to Refile FDA Lawsuit in D.C.

    Fontem US, the maker of Zone nicotine pouches, has dropped its lawsuit against the U.S. Food and Drug Administration after a Texas federal court transferred the case to South Carolina, saying it plans to refile in Washington, D.C. The company had alleged the FDA was unfairly delaying review of its premarket tobacco product application, which is required to market new nicotine products in the U.S.

    U.S. District Judge Mark T. Pittman in Texas said Fontem had little connection to the state and its congested Northern District, and sent the case to South Carolina, where Fontem is based. By voluntarily dismissing the case, the company is seeking a more favorable venue in D.C. federal court, where many regulatory disputes involving federal agencies are typically heard. Zone is manufactured by TJP Labs in Canada, and marketed by ITG Brands, a subsidiary of Imperial Brands.

  • 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 Releases Raw NYTS Data Without Comment

    FDA Releases Raw NYTS Data Without Comment

    Last week, the U.S. Food and Drug Administration released the raw data from the 2025 National Youth Tobacco Survey (NYTS), an annual, school-based survey that collects data on tobacco use among students in grades 6 through 12 across the country. Unlike previous years, the FDA released the data without comment, leaving industry members to interpret it independently.

    The survey tracks students’ tobacco behaviors, attitudes, and exposure to pro- and anti-tobacco messaging, providing nationally representative data. First conducted in 1999, it has guided youth tobacco policy and was jointly run by the U.S. Food and Drug Administration and Centers for Disease Control and Prevention since 2012, before moving fully under FDA oversight in 2025. 

    “Youth use of tobacco and nicotine has been the FDA’s sole focus in its policy and decision making for so many years, with adult education programs centered on the risk continuum of these products seemingly still far off,” said Laura Leigh Oyler, VP of Regulatory Affairs at Nicokick.com. “It’s been a big question throughout the industry as to why they’ve chosen to release this data with no fanfare, and with no guidance on how to interpret it. The FDA has essentially left the industry and other stakeholders to analyze and determine the use rates on their own.”

    Altria Client Services released a “high-level” summary of the data, finding overall tobacco usage by middle and high school students declined for the third straight year, dropping to 7.5%, the lowest rate since the study became annual in 2011, and down from the all-time high of 23.3% in 2019.

    Cigarette usage remained steady at 1.4%, while all other categories dropped from 2024, with e-cigarettes going from 5.9% to 5.2%, pouches from 1.8% to 1.7%, smokeless tobacco going from 1.2% to 0.6%, and heated tobacco products going from 0.8% to 0.7%.

    “With the continued low youth use rates, we think this is something worth celebrating,” Oyler said. “The data shows that targeted public‑health interventions, combined with thoughtful regulation like raising the legal age for nicotine purchases, can make a meaningful difference.”

    “The law is clear: tobacco and nicotine products are strictly for adults 21 and older,” said Matthew T. Sheaff, director of U.S. regulatory communications for Philip Morris International. “At PMI U.S., we are committed to guarding against underage access to our products, while continuing to provide adults 21 and older with better alternatives to smoking and traditional tobacco.

    “For example, we direct our marketing to adult nicotine consumers and do not pay social media influencers to endorse our products in the U.S. This is a shared responsibility—regulators, policymakers, retailers, and manufacturers all have an important role to play.”

    With the news generally positive in terms of youth usage, Oyler suggested emphasis be given to adults 55 and older, whose smoking rates have remained mostly steady, dropping from 18.7% in 2016 to 16.7% in 2023.

    “If anything, this data raises questions less about youth access and more about what we can do to educate adults on the differences between nicotine and tobacco products, and how they can reduce their risk,” Oyler said. “This is the population most at risk of smoking-related disease. This is the population with the most to gain from moving away from cigarettes. And this is the population that has been historically underserved by cessation efforts and innovation.

    “To drive the next major improvement in public health, we must accelerate support for adults who smoke and ensure that they have access to better alternatives, and ultimately, better outcomes.”

  • Keller and Heckman Responds to FDA’s ENDS Guidance  

    Keller and Heckman Responds to FDA’s ENDS Guidance  

    Following the FDA’s March 9 draft guidance on flavored electronic nicotine delivery systems, Keller and Heckman LLP highlighted the agency’s continued focus on youth-risk concerns while providing more clarity on the evidentiary expectations for adult-benefit claims. Keller and Heckman encouraged industry stakeholders to submit comments during the 60-day public comment period to ensure FDA considers the latest evidence on youth use and adult-benefit outcomes.

    The firm emphasized that FDA’s risk-proportionate framework formalizes how the evidentiary burden rises with youth appeal, but that the guidance does not yet incorporate the 2025 National Youth Tobacco Survey (NYTS) data showing a substantial decline in youth vaping. Keller and Heckman noted that evolving data could inform public comments, particularly on whether the agency should recalibrate its comparative-efficacy requirement, given that factors beyond flavors—such as peer influence, boredom, and experimentation—also drive youth use. Keller and Heckman said the draft also opens the door to using non-clinical sensory studies to assess relative appeal and clarifies the limited role of device access restrictions in mitigating youth risk.

    The firm will further address the guidance and other regulatory updates at its 2026 E-Vapor, Nicotine, and Tobacco Law Symposium on May 4–5 in Las Vegas, offering attendees practical insights into navigating the PMTA process under FDA’s clarified expectations.

  • 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.