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Tag: ENDS

  • A New Direction for ENDS

    A New Direction for ENDS

    ~ What FDA approvals mean for ENDS flavoured tobacco products ~

    The FDA’s decision to authorise flavoured Electronic Nicotine Delivery System (ENDS) products marks one of the most significant regulatory developments the sector has seen in recent years. While tobacco and menthol authorisations had already signalled a gradual shift in regulatory thinking, the approval of mango and blueberry flavoured products suggests the agency is increasingly willing to assess reduced-risk nicotine products through a broader public health lens. Here, Chris Allen, CEO of nicotine testing and regulatory consultancy Broughton, explains the significance of this decision and why it reflects a growing emphasis on evidence-based harm reduction, behavioural science and product safeguards.

    Central to the FDA’s assessment process is its “Appropriate for the Protection of Public Health” (APPH) standard, which requires regulators to weigh the potential benefits for adult smokers against the possible risks associated with youth uptake. Emerging evidence suggests that flavoured alternatives may help some adult smokers move away from combustible cigarettes, particularly those who do not successfully transition using tobacco-flavoured products alone.

    One longitudinal study published via the National Library of Medicine found that adult users of sweet or fruit-flavoured nicotine vaping products were more likely to transition away from cigarette smoking than those using tobacco-flavoured alternatives.

    In draft guidance published in early 2026, the FDA acknowledged that non-tobacco flavoured ENDS products may, “in certain circumstances”, support adult smokers in switching away from combustible cigarettes or increasing quit attempts. However, ENDS products continue to face heightened scrutiny due to historic concerns surrounding youth access, abuse liability and the toxicological considerations associated with inhaled products.

    Importantly, the latest authorisations should not be interpreted as a relaxation of regulatory expectations. If anything, they reinforce the extent to which manufacturers are now expected to integrate public health and compliance considerations into product development at an early stage. For ENDS products in particular, this means fully characterising products from a toxicological perspective, understanding behavioural risk factors and demonstrating that appropriate controls are built into the product itself.

    The FDA’s continued scrutiny of inhaled nicotine products – particularly flavoured variants – means manufacturers must increasingly show not only that products can support adult smokers in moving away from combustible cigarettes, but also that meaningful steps have been taken to restrict youth access and minimise unintended use. This will likely place greater emphasis on access-control technologies and submission-ready behavioural data as regulators continue to refine their expectations around next-generation nicotine products. For developers, regulatory strategy can no longer be treated as a final-stage compliance exercise; they must be incorporated into product design from the outset.

    The latest authorisations may also have implications beyond the US market. While regulatory approaches continue to vary globally, the FDA’s decision reflects a broader shift towards more nuanced, evidence-led discussions around harm reduction and the role alternative nicotine products may play in supporting smoke-free ambitions. Increasingly, the debate is moving away from whether reduced-risk products should exist at all, and towards how they can be appropriately regulated to maximise public health benefits while minimising unintended consequences.

    Ultimately, the significance of these authorisations extends far beyond the approval of two flavoured products. They signal that regulators are willing to consider the full public health picture – including adult switching potential, behavioural evidence and technological safeguards – when assessing alternative nicotine products. For manufacturers that raises the bar for scientific substantiation, product stewardship and regulatory preparedness. However, it also demonstrates that innovation supported by robust evidence and responsible product design can still find a pathway through even the most rigorous regulatory environments.

    As the regulatory environment for nicotine products continues to evolve, manufacturers face growing pressure to navigate increasingly complex submission requirements across multiple international markets. Broughton supports businesses through the product lifecycle, combining scientific expertise with regulatory insight across ENDS, nicotine pouches and other alternative nicotine products. To find out how Broughton can help support your submission, visit its website.

  • BAT Stock Surges, Despite Legacy Combustibles Shrinking

    BAT Stock Surges, Despite Legacy Combustibles Shrinking

    Shares of British American Tobacco climbed 13.99% in London trading last week to £48.64 on May 15, as investors reacted to a mix of regulatory, legal, and capital signals. Market attention followed the U.S. Food and Drug Administration authorization of flavored Glas ENDS products, seen as a reference point for how flavored e-cigarettes may fare under the PMTA pathway, even though the decision did not involve BAT’s Vuse brand. Sentiment was further supported after a U.S. court dismissed a sanctions-related criminal case tied to BAT’s prior North Korea compliance matter, confirming the company had fulfilled its deferred prosecution agreement, alongside continued focus on BAT’s planned £1.3 billion 2026 share buyback and growth prospects for its newer nicotine portfolio, including VELO.

    In contrast, BAT Bangladesh reported a 14% year-on-year drop in cigarette volumes and a 34% decline in profit for Q1 2026 amid higher taxes, inflationary pressure, and weaker consumer purchasing power, underscoring the diverging performance between BAT’s legacy combustible markets and investor expectations tied to reduced-risk product expansion.

  • FDA Makes ENDS PMTA Roundtable Materials Available

    FDA Makes ENDS PMTA Roundtable Materials Available

    Today (May 14), FDA released materials from its Feb. 10 Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products, providing the public and industry with a detailed look at discussions between agency officials and small manufacturers. Led by Dr. Matthew Farrelly and moderated by Dr. Todd Cecil, the sessions focused heavily on product characterization, manufacturing controls, pharmacological and toxicological data, and how applicants can demonstrate adult benefit through longitudinal or randomized studies. FDA said the purpose of the roundtable was to solicit feedback on how to improve the efficiency and clarity of PMTA reviews while remaining bound by statutory requirements under the Tobacco Control Act.

    Industry participants used the forum to reiterate concerns about the lack of objective scientific benchmarks guiding ENDS applications, arguing that uncertainty around testing parameters—particularly for open-system products—and the inability to update long-pending PMTAs create significant barriers for small businesses. The Vapor Technology Association, through Executive Director Tony Abboud, said members appreciated the opportunity for dialogue but left the meeting seeking clearer standards and more predictable regulatory expectations.

    Find the FDA’s resources below:

    FDA ENDS Roundtable Hub

    FDA ENDS Roundtable Video

    FDA ENDS Roundtable Transcript

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”

  • FDA Authorizes Four New ENDS Products

    FDA Authorizes Four New ENDS Products

    The U.S. Food and Drug Administration has authorized four Glas electronic nicotine delivery system products through the PMTA pathway, including Classic Menthol, Fresh Menthol, Gold, and Sapphire pods containing 5% nicotine. The decision marks the first FDA authorization of ENDS products beyond traditional tobacco and menthol flavors, expanding the range of legally marketed vaping products in the U.S. to 45.

    The agency said the authorization was based on evidence that the products’ device access restriction technology—requiring age verification via government ID, smartphone pairing, and biometric checks—can effectively limit youth access.

    “By helping to prevent youth use, device access restrictions are a potential game changer,” said Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “This technology is also an indication of the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable [the] availability of an expanded array of flavored options for adults who smoke who may use these products to completely switch away from regular cigarettes.”

    The FDA emphasized that marketing must be targeted to adults and that the company must monitor and report on youth prevention measures, while noting that authorization could be withdrawn if compliance requirements are not met or if youth usage increases.

  • FDA Sends ENDS Comment Period Reminder

    FDA Sends ENDS Comment Period Reminder

    Today (April 8), the U.S. Food and Drug Administration’s Center for Tobacco Products issued a reminder that the public has until 11:59 p.m. EDT on May 11 to submit comments on its draft guidance for flavored e-cigarette applications, docketed as FDA-2026-D-1817 on Regulations.gov.

    The reminder relates to draft guidance the agency released on March 11, titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk,” which outlines how the FDA plans to weigh the youth appeal of flavored products against any added benefit they may provide to adults compared with tobacco-flavored options, including expectations for evidence on adult switching, youth initiation risk, and the potential use of device access-restriction technology.

  • 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.

  • 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.

  • 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.