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  • 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    In draft guidance published in early 2026, the FDA acknowledged that non-tobacco flavoured ENDS products may, “in certain circumstances”, support adult smokers in switching away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.

  • Durbin Urges RFK Jr. to Reject Flavored-Vape Progress

    Durbin Urges RFK Jr. to Reject Flavored-Vape Progress

    Illinois Senator Dick Durbin urged U.S. Health Secretary Robert F. Kennedy Jr. to reject recent efforts by the U.S. Food and Drug Administration to ease restrictions on flavored vaping and nicotine pouch products, arguing the policy shift benefits major tobacco companies at the expense of youth health. In a May 20 letter, Durbin criticized the FDA’s recent authorization of certain fruit-flavored vape products and proposals to allow some nicotine products onto the market before full scientific review, calling the changes “short-sighted” and influenced by industry lobbying and political donations.

  • FDA Targets ‘Disguised’ Nicotine Products in Retail Crackdown

    FDA Targets ‘Disguised’ Nicotine Products in Retail Crackdown

    The U.S. Food and Drug Administration issued warning letters to eight retailers for selling unauthorized nicotine pouches and dissolvable tobacco products designed to resemble candy, breath strips, and cough drops, raising concerns that the items could both appeal to children and be accidentally ingested by young kids. According to the agency, the products’ labeling, advertising, and design mimic everyday consumer goods, “disguising” them and making it easier for youth to conceal their use from adults.

    Acting Center for Tobacco Products Director Bret Koplow said no tobacco product should look like candy and described the practice as a tactic to mask the products’ true nature. The retailers were cited for violating the Federal Food, Drug, and Cosmetic Act by selling products without FDA authorization and were ordered to correct the violations or face potential penalties, including seizures, injunctions, and/or fines. The action follows recent FDA guidance outlining enforcement priorities for unauthorized electronic nicotine delivery systems and nicotine pouch products, part of a broader push to remove youth-appealing products from the market.

    The agency noted it has now issued more than 800 warning letters to manufacturers and distributors and over 1,000 to retailers over unauthorized tobacco sales, and reminded retailers to consult its updated list of legally marketed products and use available compliance materials.

  • Researchers: Flavored-Vape Debate Needs to Follow Science, Not Politics

    Researchers: Flavored-Vape Debate Needs to Follow Science, Not Politics

    The resignation of FDA Commissioner Marty Makary on May 12 over reported tensions with President Donald Trump regarding the agency’s approval of two fruit-flavored nicotine vapes brought the flavored-vape battle front and center in American politics. The decision marked a shift from the FDA’s previous authorization of only tobacco and menthol flavors and reignited debate over flavored vaping products.

    Three public health researchers warned the debate over fruit-flavored nicotine vapes should be guided by evidence, not politics. Dr. Jamie Hartmann-Boyce from the University of Massachusetts Amherst, Dr. Holly Jarman from the University of Michigan School of Public Health, and Dr. Claire L. Ma from the University of Michigan, who study scientific evidence, health policy, and regulation, respectively, acknowledged both sides of the debate, where studies show that sweet and fruity flavors can attract youth and non-smokers, but also that vaping is significantly less harmful than smoking and may help adult smokers quit. The authors urged lawmakers and regulators to follow scientific findings when shaping vape policy, as researchers continue to discover the benefits and risks of vape use.

  • 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.

  • How LIMS supports GMP compliance

    How LIMS supports GMP compliance

    ~ The impact of LIMS in modern labs, from data integrity and traceability to materials management and quality control ~

    Good Manufacturing Practice (GMP) compliance is fundamental for laboratories operating in regulated industries such as pharmaceuticals, medical devices, medicinal cannabis, and reduced-risk nicotine products. Ensuring data integrity, maintaining traceability, and enforcing controlled processes are all essential components of GMP. Here, Chris Allen, CEO of contract research organisation Broughton, explains the critical role of laboratory information management systems (LIMS) in supporting these requirements.

    Regulators are no longer just inspecting facilities; they are interrogating data. From the US Food and Drug Administration (FDA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada, there is a clear and consistent expectation that companies must demonstrate complete data integrity, traceability and control across the product lifecycle.

    Paper-based systems or fragmented digital tools can make this difficult to achieve consistently. Against this backdrop, LIMS are rapidly evolving from operational tools into critical infrastructure for GMP compliance.

    Ensuring data integrity and traceability

    A well-designed LIMS embeds these controls directly into laboratory workflows, helping ensure processes are followed correctly and records remain secure, complete, and auditable.

    Key capabilities of LIMS that support GMP data integrity include full audit-trail systems that record user actions and changes, version control for methods, products, and specifications, electronic signatures for reviews and approvals, and permission-based access controls to manage user roles and system permissions.

    Together, these features help laboratories maintain confidence in their data while ensuring they are inspection-ready. This both reduces the chances of failing inspections and makes audits less disruptive.

    Traceability of materials and proper equipment management are also essential elements of GMP compliance. Laboratories must maintain visibility over the reagents and materials used during testing, while ensuring that instruments remain calibrated and fit for purpose.

    A LIMS can support this through integrated management of lab resources, including stock batch traceability, stock expiry monitoring, stock status controls, and equipment maintenance and calibration scheduling.

    By centralising this information, laboratories can reduce compliance risks while improving operational efficiency.

    Importantly, the impact of LIMS goes beyond compliance alone. Leading organizations use these systems to gain greater operational control and insight as real-time visibility of laboratory data allows quality teams to identify trends, investigate anomalies and make informed decisions more quickly. This can support faster batch release timelines, improved product consistency and more proactive risk management. In this sense, LIMS is not just a compliance tool, but a platform for continuous improvement.

    Supporting quality control

    Quality management processes, such as identifying and investigating out-of-specification results, are essential components of GMP laboratory operations. Managing these processes manually can introduce delays or increase the risk of errors.

    Within a LIMS environment, testing results can be automatically assessed against predefined specifications, allowing the system to immediately flag potential issues. Investigation workflows can then be initiated and tracked in the system, ensuring corrective actions are documented and managed consistently.

    Embedding these quality processes in the LIMS helps laboratories maintain structured, auditable procedures that align with regulatory expectations.

    Future-proofing labs with LIMS

    As regulatory expectations continue to evolve, the importance of robust digital infrastructure will only increase. Laboratories must manage growing data volumes, support increasingly complex supply chains, and respond to more stringent oversight.

    In this environment, LIMS is no longer a ‘nice to have’, but a foundational component of modern GMP compliance that enables organizations to meet today’s requirements while preparing for those of the future.

    For companies operating in highly regulated sectors, the question is no longer whether to adopt LIMS, but how effectively it can be implemented to support both compliance and long-term operational excellence.

    Broughton has developed its own LIMS platform, LabHQ, to address the real-world challenges laboratories face when operating in highly regulated environments. Drawing on its experience delivering GMP testing services, LabHQ was designed to support the workflows, traceability and data integrity requirements that laboratories need to meet regulatory expectations. To find out more, visit the Lab HQ website.

  • RFK Jr.’s Spokesperson Resigns Over Flavored Vape Shift

    RFK Jr.’s Spokesperson Resigns Over Flavored Vape Shift

    Richard Danker, assistant secretary for public affairs at the U.S. Department of Health and Human Services, resigned in a letter to Donald Trump after the U.S. Food and Drug Administration authorized several fruit-flavored e-cigarette products, arguing the decision could expose minors to nicotine addiction and health risks. According to ABC News, Danker said the authorization conflicted with recent department guidance on youth risks from flavored nicotine and criticized senior officials in Robert F. Kennedy Jr.’s office for supporting it. An HHS spokesperson said political appointees are expected to advance the administration’s “Make America Healthy Again” agenda and that those who disagree are free to leave. The development follows the departure of former FDA commissioner Marty Makary, who reportedly clashed with the White House over pressure to approve flavored vape products. The FDA recently authorized four devices by GLAS, including mango and blueberry pods, marking a notable shift as the agency continues efforts to curb illicit youth-targeted vaping products.

  • 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

  • CTP Director Touts Progress, Future in Statement

    CTP Director Touts Progress, Future in Statement

    The FDA’s Center for Tobacco Products says it has made significant progress in streamlining the review of premarket tobacco product applications (PMTAs), reducing its backlog by approximately 70% in 2025 and eliminating the queue for initial acceptance review. In a statement dated May 7 and released today (May 13), acting Director Bret Koplow said new efficiencies are allowing applications to move into review almost immediately, while accelerated filing and scientific review processes—particularly for nicotine pouches and electronic nicotine delivery systems—are helping bring compliant products to market more quickly.

    Koplow also highlighted the success of a pilot program for nicotine pouch applications, which led to authorizations for six products within three months, a record pace for the agency. The FDA plans to apply lessons from the pilot more broadly, including expedited review for product modifications and increased real-time communication with applicants, signaling a shift toward faster but still science-based regulatory decision-making in the nicotine category.

    Read the full release here.

  • Makary Resigns, Diamantas New Interim FDA Head 

    Makary Resigns, Diamantas New Interim FDA Head 

    Today (May 12), President Donald Trump confirmed earlier reports from White House officials that FDA Commissioner Dr. Marty Makary was stepping down after just over a year in the role, following a turbulent tenure that included growing friction over tobacco and nicotine policy. A White House official said the resignation was tied to “process at the FDA” rather than a single issue, though pressure had been building around the agency’s pace on key decisions, including flavored vape authorizations. Reports in recent weeks indicated frustration within the administration that the FDA had moved too slowly on advancing nicotine-related priorities, with one official bluntly stating: “What a mess Makary turned out to be.” He will be replaced on an interim basis by FDA food chief Kyle Diamantas.

    Makary’s leadership coincided with heightened scrutiny over the FDA’s handling of next-generation nicotine products, particularly flavored vapes, which have remained largely blocked pending extensive scientific review. The issue became a flashpoint within the administration, with critics arguing the agency had failed to align with broader policy goals aimed at expanding alternatives for adult smokers. At the same time, the FDA maintained its stance on requiring strong evidence of public health benefit, leaving the market tightly restricted and contributing to ongoing tension between regulators, industry stakeholders, and policymakers.

    His tenure was also shaped by broader political battles that indirectly impacted tobacco regulation, including disputes over drug approvals and internal agency direction, which critics said created uncertainty around regulatory timelines. For the tobacco and nicotine sector, Makary’s departure could signal a potential shift in FDA priorities, particularly as pressure mounts to accelerate decisions on reduced-risk products and flavored alternatives. The leadership change comes at a critical moment for the industry, with regulatory direction expected to play a central role in shaping market dynamics and product innovation in the years ahead.

    Since the news broke, interested observers have been responding in what is generally seen as a positive for the industry.

    “We have been disappointed by the pace of nicotine product reviews at the Center for Tobacco Products,” said Laura Leigh Oyler, VP of Regulatory Affairs at Nicokick.com. “If recent reporting is accurate, Commissioner Makary’s removal should be treated as an opportunity to refocus the FDA on timely, evidence-based decision-making. Adult consumers, responsible manufacturers, and retailers need a regulatory process that produces decisions, not indefinite uncertainty.

    “CTP already has the scientific expertise needed to evaluate nicotine product applications and make appropriate determinations under the law. The next FDA commissioner should remove unnecessary bottlenecks and make clear that pending reviews will be decided by FDA scientists, not politicians.”

    Vapor Technology Association Executive Director Tony Abboud said he met with Makary last week and felt the Commissioner realized the PMTA process needed to improve quickly.

    “The VTA now looks forward to continuing its constructive engagement with Acting FDA Commissioner Kyle Diamantas and whoever is ultimately selected to permanently lead the agency moving forward,” Abboud said. “For years, VTA has advocated for a regulatory framework that provides clear scientific requirements, transparent standards, and consistent enforcement against bad actors and illicit products.

    “We remain committed to working with FDA leadership, the Administration, and policymakers to modernize the PMTA process, strengthen responsible marketing standards, and ensure the United States leads with a balanced regulatory approach grounded in science, harm reduction, and common sense.”

    One of the bluntest responses came from Ross Marchand, Executive Director of the Taxpayers Protection Alliance, who said, “At long last, Makary is out. Since taking the helm of the agency last April, the Commissioner has made it far more difficult than it needs to be to bring new therapies to market. Millions of Americans have paid the price for this soap opera of suddenly spurned approvals, goalpost shifting, and even apparent violations of trade secret law.

    “The FDA needs a leader who will stand up for patients and allow access to new and innovative therapies. Makary’s successor must embrace market innovation and break with the prohibitionary policies of the past.”