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Tag: FDA

  • FDA Memo Questions Flavored-Vape Reversal: AP  

    FDA Memo Questions Flavored-Vape Reversal: AP  

    A newly released FDA memo is raising questions about the agency’s watershed authorization of fruit-flavored e-cigarettes after revealing that the products were not significantly more effective at helping smokers quit than tobacco-flavored alternatives, according to the Associated Press. The decision drew criticism from public health groups and Democratic lawmakers, who argue the authorization departs from the agency’s long-standing position that fruit and dessert flavors require a particularly high evidentiary standard because of their appeal to youth.

    The six-page document, published weeks after the FDA approved mango- and blueberry-flavored vaping products from Glas Inc., acknowledged that study data showed no statistically significant difference in smoking cessation outcomes between users of the fruit-flavored products and those using tobacco-flavored e-cigarettes. The finding contrasts with previous FDA authorizations of flavored products, including menthol e-cigarettes from Juul Labs and NJOY, which demonstrated measurable benefits over tobacco-flavored products.

    However, the AP said regulators explained that the Glas flavored vapes “did not have to demonstrate added adult benefit,” because young people were unlikely to use them. Glas requires users to unlock each e-cigarette with an age-verifying cellphone app. The memo indicates that FDA regulators instead relied heavily on the company’s age-verification technology, concluding that youth uptake was unlikely because users must unlock devices through a smartphone app.  The approval was finalized shortly before the departure of former FDA Commissioner Marty Makary and comes amid broader scrutiny of the agency’s recent approach to vaping regulation.

  • Report Accuses Trump of Cashing in on FDA Changes

    Report Accuses Trump of Cashing in on FDA Changes

    A report by KFF Health News accuses President Donald Trump of expanding his personal investments in major tobacco companies and benefiting from substantial political donations from industry interests as his administration simultaneously pursued policies favorable to the tobacco and nicotine industry. The report alleges that Trump increased his holdings in several tobacco companies, including Philip Morris International and Altria Group, as his administration pushed the FDA for regulatory changes, drawing criticism from public health advocates and former regulators who argue the measures benefit tobacco companies at the expense of tobacco-control efforts.

    The report also highlights more than $20 million in contributions from tobacco and vaping interests to Trump-aligned political groups and inauguration activities since late 2023, including multimillion-dollar donations from industry players such as Reynolds American. While the White House rejected suggestions of improper influence and said its nicotine-related policies are based on scientific evidence supporting harm reduction for adult smokers, critics cited in the report contend that the administration’s actions represent one of the most industry-friendly tobacco policy shifts in recent years.

  • Zest Gets Injunction Against FDA for Pouches

    Zest Gets Injunction Against FDA for Pouches

    Zest Brands LLC announced that it secured a preliminary injunction from the U.S. District Court for the Middle District of Florida, allowing its ZEO Universe nicotine pouch products to remain on the U.S. market while the company challenges an FDA Refuse-to-File (RTF) decision related to its May 2022 Premarket Tobacco Product Applications. The injunction temporarily stays the FDA’s action as the case proceeds through the courts.

    According to the company, the court found Zest Brands is likely to succeed on claims that the FDA failed to adequately assess the impact of its 2021 PMTA regulations on small businesses, as required under the Regulatory Flexibility Act. The court also indicated that aspects of the agency’s actions may have been “arbitrary and capricious.” Zest said it remains committed to working with the FDA to complete the PMTA process and is currently in discussions with strategic and financial partners to support future growth.

  • ACHE Cites Evidence That Youth Tobacco Measures Are Working

    ACHE Cites Evidence That Youth Tobacco Measures Are Working

    Today (May 27), the Asian Coalition for Health Empowerment (ACHE) shared its outlook based on the FDA’s 2025 National Youth Tobacco Survey (NYTS) data that was released earlier this year, pointing to continued declines in youth tobacco and nicotine use while calling for more balanced, evidence-based regulation. The FDA data showed overall youth tobacco use fell to 7.5% in 2025 from 8.1% in 2024, while youth e-cigarette use dropped to 5.2% — the lowest level recorded in a decade. Use of nicotine pouches remained relatively low and stable at 1.7%, while use of other oral nicotine products, such as gums and lozenges, declined sharply to 0.6%.

    Following the release of the data, ACHE brought together public health experts and policy voices to discuss implications for tobacco harm reduction and future regulation. Dr. Anjum Datta said the results highlight the value of sustained public health strategies that combine awareness, regulation, and behavioral interventions, while cautioning against policies that could unintentionally limit harm reduction options for adult smokers. Dr. Dewesh Kumar said the findings support targeted regulation and youth protections without relying on “extreme prohibitive measures,” adding that adult smoking cessation efforts should remain part of the broader public health discussion.

  • FDA Releases Environmental Review for Oral Nicotine Products

    FDA Releases Environmental Review for Oral Nicotine Products

    Today (May 21), the U.S. Food and Drug Administration published a programmatic environmental assessment covering nicotine pouches and other oral nicotine products reviewed through the premarket tobacco product application (PMTA) process. The assessment applies to products categorized as “other,” including nicotine pouches, lozenges, tablets, gums, discs, dissolvable tobacco products, and nicotine-infused products, while excluding traditional smokeless tobacco products such as snus, dip, and chewing tobacco.

    The FDA concluded that the environmental impact of these products is generally minimal, citing the absence of airborne emissions during use and relatively limited environmental contamination from product waste. According to the agency, these products reduce or eliminate secondhand and thirdhand exposure risks compared with combustible products, while the waste generated contains comparatively fewer harmful chemicals that persist or bioaccumulate in the environment.

    The agency said the assessment is intended to support transparency and may be referenced by FDA reviewers evaluating individual product applications. However, the FDA emphasized that authorization decisions will continue to be made on a case-by-case basis based on the specific scientific evidence submitted for each product.

  • NYT Report Draws Attention to RJR Donation and FDA Policy Shift

    NYT Report Draws Attention to RJR Donation and FDA Policy Shift

    Reynolds American is under scrutiny following a The New York Times report linking a $5 million donation to a pro-Donald Trump super PAC with recent shifts in U.S. Food and Drug Administration policy on flavored vaping products. The report said Reynolds executives met with Trump shortly before the FDA issued guidance that could ease market access for certain flavored vape and nicotine pouch products, potentially benefiting major tobacco companies in the growing U.S. e-cigarette market.

    The White House denied any connection between the donations and policy decisions, stating that FDA actions are based on scientific evidence and public health considerations.

  • 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.