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Category: Around the Industry

  • 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.”

  • ITC Rules ‘No Violation’ in RJR Complaint

    ITC Rules ‘No Violation’ in RJR Complaint

    The U.S. International Trade Commission issued a final determination in its investigation into certain disposable vaporizer devices, ruling that there was no violation of Section 337 in the case brought by R.J. Reynolds Tobacco Company, which targeted brands like Elf Bar and Geek Bar. This followed an earlier denial of a temporary exclusion order due to a lack of evidence regarding the likelihood of success on the merits.

    R.J. Reynolds began pivoting its legal strategy with a new investigation instituted by the USITC on March 3, which shifts focus to alleged violations of the PACT Act, state flavor bans, and tax laws by Chinese manufacturers and U.S. distributors. While the previous patent-based case is closed, the commission has begun its review of these new, broader regulatory and competition-based allegations.

    Following the ruling, the Vapor Technology Association’s executive director, Tony Abboud, issued a statement, saying, “The ITC’s decision represents a positive path forward for our industry. It proves that, unlike the misguided FDA, some federal agencies are still willing to stand up to corporate interests for the good of our free market and American public health. The ITC’s decision, rejecting all of the claims, is a decisive blow against those seeking to use government agencies to corner a market and a huge step for President Trump’s America First agenda. 

    “We appreciate the ITC referencing our submission in its final decision and take this inclusion as a sign that the ITC seriously listened to the concerns of the massive American independent vaping industry.” 

  • 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.

  • Exploding Vape Lawsuit Focuses on Chinese Maker  

    Exploding Vape Lawsuit Focuses on Chinese Maker  

    A lawsuit over an exploding vape battery in the U.S. is now focusing on a Chinese manufacturer after the plaintiff agreed to drop claims against the product’s domestic distributor. The case, filed in the U.S. District Court for the Eastern District of North Carolina, was brought by a man who says he suffered second- and third-degree burns when a vape battery exploded in his pocket. While the distributor has been dismissed from the case, the plaintiff will continue pursuing claims against LG Chem Ltd., the China-based company that manufactured the e-cigarette device.

  • Cigar Bar Bill Passes Iowa Senate

    Cigar Bar Bill Passes Iowa Senate

    The Iowa Senate approved legislation that would allow premium cigar bars to operate despite the state’s public smoking ban, advancing a measure that could open a new hospitality segment for the cigar industry. Lawmakers voted 27–18 to pass Senate File 2444, which would amend the Iowa Smokefree Air Act to permit licensed establishments where customers can smoke premium cigars while being served alcoholic beverages. To qualify, venues would need to generate at least 35% of revenue from premium cigars and accessories, restrict entry to those 21 and older, maintain a walk-in humidor, and prohibit food service and other tobacco products. The bill now moves to the Iowa House of Representatives for further consideration.

  • Don’t Criminalize Nicotine Over Illicit Vapes: CAPHRA

    Don’t Criminalize Nicotine Over Illicit Vapes: CAPHRA

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates cautioned governments in Asia not to use the rise of etomidate-laced “zombie vapes” as a pretext to restrict regulated nicotine products. While authorities have reported health risks linked to illicit vapes, CAPHRA stresses that adults using safer, legal alternatives to quit smoking should not face penalties.

    CAPHRA calls for stronger enforcement against criminal traffickers, enhanced testing and surveillance, and clear public warnings on adulterated products, while maintaining access to regulated nicotine alternatives as part of credible tobacco harm reduction strategies.

  • Nasco Files to Have Claims Thrown Out of Hestia Lawsuit

    Nasco Files to Have Claims Thrown Out of Hestia Lawsuit

    Nasco Products LLC asked a federal judge in North Carolina to dismiss portions of a lawsuit filed by the owners of Hestia Tobacco, arguing that the complaint fails to clearly identify the contracts it allegedly interfered with or provide sufficient details to support claims of fraud. In the new filings, Nasco contends that the plaintiffs rely on vague allegations and have not specified which agreements were disrupted or how the company’s actions constituted fraudulent conduct.

    The lawsuit was filed in January by The Tobacco Company, which operates the Hestia Tobacco brand, against its former manufacturer, Nasco, in the U.S. District Court for the Middle District of North Carolina. Hestia alleges that Nasco breached their manufacturing and supply agreement by sharply increasing production prices and then encouraging retailers to remove Hestia products from store shelves, actions the company says harmed its sales and business relationships. The suit seeks monetary damages and was filed under federal diversity jurisdiction.

  • Pakistan Probes Theft of $900K of Cigarettes From FBR Warehouses

    Pakistan Probes Theft of $900K of Cigarettes From FBR Warehouses

    A Senate sub-committee in Pakistan called on relevant authorities to explain the theft of 2,828 cartons of cigarettes worth Rs250 million ($900,000) from Federal Board of Revenue (FBR) warehouses in Swabi and Mardan. Chaired by Senator Saifullah Abro, the panel directed the FBR and Federal Investigation Agency (FIA) to identify those responsible and ensure recovery of the stolen goods. The committee criticized the absence of senior FIA officials during proceedings and noted prior incidents of cigarette theft, including one in April 2024, raising concerns that consignments are being specifically targeted.

    Officials reported that CCTV cameras were installed in all FBR godowns as of January 14, and a new SOP was introduced to strengthen monitoring. Ten officers have been suspended, while others with potential links to the business community were transferred. The panel also highlighted weak coordination between the FIA and Khyber Pakhtunkhwa Police, instructing authorities to implement stronger security measures and provide consolidated records of all godowns since 2012 to prevent future theft and smuggling activities.

  • 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.”

  • Report Examines Power of Pouches for Women’s Cessation

    Report Examines Power of Pouches for Women’s Cessation

    In advance of International Women’s Day on March 8, Smoke Free Sweden released its Empowerment in a Pouch report, focused on encouraging women to quit smoking by using alternative nicotine products. The report says women often face unique challenges with smoking cessation, including stronger behavioral cues linked to stress, weight management, and social contexts. As a result, many women have adopted alternatives such as e-cigarettes in attempts to reduce or replace cigarette use, drawn by features such as reduced odor, perceived lower health risks compared with combustible cigarettes, and the ability to use them discreetly in daily life. Surveys in several markets indicate that women who vape frequently cite convenience, control over nicotine intake, and the absence of smoke as key factors influencing their choice.

    The report also discusses how access to tobacco-free nicotine pouches has accelerated Sweden’s progress towards becoming smoke-free, particularly among women. The report was sent to governments around the world as policymakers, researchers, and health organizations continue to debate how alternative products affect women’s health, smoking cessation trends, and long-term nicotine dependence across different populations.

    “Sweden’s experience shows what happens when women are given realistic alternatives to smoking,” said Professor Marewa Glover, behavioral scientist and co-author. “When safer options are accessible, women quit in large numbers. If those options are restricted, progress slows, and smoking persists.”