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Tag: FDA

  • 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itself to capture a multi-billion-dollar opportunity in the U.S. vaping market following the FDA’s newly issued draft guidance on flavored ENDS Premarket Tobacco Product Applications.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.

  • Holman Defends CTP’s ‘Notable Improvement’

    Holman Defends CTP’s ‘Notable Improvement’

    On Feb. 24, the Wall Street Journal’s editorial board published a piece titled, “Who’s in charge of the FDA?” arguing that internal tensions at the U.S. Food and Drug Administration could be undermining efforts across all departments. The piece points to decisions affecting emerging products and suggests a broader debate within the FDA over how flexible the approval process should be.

    In response, Matthew R. Holman, vice president of U.S. Scientific Engagement & Regulatory Strategy at Philip Morris International and a former chief scientist at the FDA’s Center for Tobacco Products, wrote a letter that the WSJ published yesterday (March 5), saying that despite criticism and organizational challenges facing the FDA, the organization — and the CTP in particular — has shown notable improvement.

    “Over the past year, the FDA’s Center for Tobacco Products has become a notable bright spot — delivering real results for an agency working through significant institutional challenges,” he wrote. “The CTP has been responsive to industry experts and congressional leaders.”

    Responding to concerns raised in a 2022 Reagan-Udall Foundation report and congressional hearings about transparency and a backlog of smoke-free product applications, Holman said the center has become more receptive to industry and lawmakers, pointing to actions such as a pilot program to fast-track nicotine pouch reviews and upcoming advisory committee hearings on smoke-free products.

    “The CTP has taken several notable actions in the past year and is poised for more positive developments,” Holman wrote. “There’s still more work to be done to ensure the CTP is meeting its mission and properly regulating tobacco products in the marketplace with a focus on authorizing scientifically substantiated smoke-free products. But the progress we have seen in the first year of this administration is notable.”

  • Fifth Circuit Affirms FDA’s Vape Rule

    Fifth Circuit Affirms FDA’s Vape Rule

    The U.S. Court of Appeals for the Fifth Circuit upheld a 2021 rule issued by the U.S. Food and Drug Administration requiring manufacturers seeking premarket tobacco product authorization to investigate and disclose health effects data, according to Law 360. In a unanimous opinion, the three-judge panel found the agency complied with the Regulatory Flexibility Act by reasonably certifying that the rule would not have a significant economic impact on a substantial number of small entities, affirming a February 2025 summary judgment in FDA’s favor.

    Plaintiffs, including e-liquid manufacturers and the United States Vaping Association, argued the FDA improperly relied on economic analysis from its 2016 deeming rule and failed to consider less burdensome alternatives. The court rejected those claims, holding that the 2016 assessment provided an adequate factual basis and that key requirements — such as submitting all known health-risk information — are mandated by the Tobacco Control Act and cannot be waived by regulation. The decision leaves the 2021 PMTA rule intact in Kealani Distribution LLC et al. v. FDA.

  • FDA COO Says Balance is the ‘Gold Standard’

    FDA COO Says Balance is the ‘Gold Standard’

    In an open letter today (Feb. 26), FDA Deputy Commissioner for Operations and Chief Operating Officer Dr. Barclay Butler underscored the FDA’s dual mandate to promote regulatory transparency while rigorously safeguarding sensitive commercial and personal data submitted by regulated industries. Titled, “Why Protecting Confidential Information is Key to the FDA’s ‘Gold Standard,’” his remarks highlighted the agency’s role as both public health watchdog and custodian of proprietary information, emphasizing that while the Freedom of Information Act supports disclosure, statutes such as the Trade Secrets Act and Privacy Act require strict confidentiality around trade secrets, confidential commercial information (CCI), personal health data, and law enforcement materials.

    Barclay reiterated that manufacturing processes, product formulas, financial data, and other proprietary submissions remain legally protected, a subject of particular importance tobacco and nicotine product companies navigating the FDA’s premarket review pathways. He also stressed the importance of shielding adverse event reports, inspection records, and internal deliberative documents to preserve investigative integrity and candid scientific review. Barclay said that improper disclosure can carry criminal liability and undermine market fairness, particularly given the market-moving potential of regulatory decisions. He said the FDA’s strict ethics and insider trading safeguards are central to maintaining trust, institutional integrity, and a level playing field across regulated sectors.

  • 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.

  • 22nd Century Reports Momentum for VLN Products

    22nd Century Reports Momentum for VLN Products

    22nd Century Group touted early sales momentum for its VLN low-nicotine cigarettes, distributing approximately 8,800 cartons to about 1,700 new retail outlets nationwide in the fourth quarter of 2025, with initial sell-through data indicating growing adoption across its 22nd Century VLN, Pinnacle VLN, and Smoker Friendly VLN brands. The company said expanding retail placement across convenience stores, wholesalers, and independent chains supports its plan to exceed 5,000 points of distribution in 2026.

    22nd Century positioned its progress alongside regulatory developments, including a January 2025 proposed rule by the U.S. Food and Drug Administration to cap nicotine levels in cigarettes at 0.7 mg per gram of tobacco, and broader global support for nicotine reduction under the World Health Organization Framework Convention on Tobacco Control.