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Tag: FDA

  • FDA Expands AI Capabilities to Improve Efficiency  

    FDA Expands AI Capabilities to Improve Efficiency  

    The U.S. Food and Drug Administration announced that it launched upgraded internal AI capabilities as part of a broader modernization initiative, introducing Elsa 4.0 and a new unified data platform, HALO. The agency said the integration of more than 40 systems into HALO will allow staff to access and analyze regulatory data more efficiently, with Elsa now operating directly on consolidated datasets to support workflows across scientific review, compliance, and enforcement.

    “Removing tedious burdens for staff enables them to focus more on science and makes their work streams more efficient and enjoyable,” said FDA Commissioner Marty Makary. “We have some of the best scientists in the world, and we need to take good care of them.”

    New features in Elsa 4.0 include document generation, data analysis tools, improved search functions, and automation capabilities, aimed at streamlining regulatory processes. The FDA said the enhanced AI infrastructure is designed to improve efficiency and support faster decision-making, with potential implications for the review and oversight of regulated products, including tobacco and nicotine products.

  • Charlie’s Holdings Talks Opportunities as FDA Flavor Stance Shifts  

    Charlie’s Holdings Talks Opportunities as FDA Flavor Stance Shifts  

    Charlie’s Holdings said it is well-positioned to capitalize on potential regulatory changes in the U.S. flavored vape market, highlighting its portfolio of 678 PMTA-submitted products and its planned rollout of age-gated devices using AI-powered verification technology. The company said its ability to combine pending applications with advanced access-restriction systems could align with evolving FDA expectations around youth prevention, positioning it to bring new products to market if approvals expand.

    The company pointed to recent reports that President Donald Trump has urged the FDA to accelerate flavored vape authorizations, along with the agency’s approval of four new ENDS products—including its first flavored pod authorizations using age-gating—as signals of a possible policy shift. Charlie’s said these developments could support broader regulatory acceptance of flavored products and create new commercial opportunities for companies able to meet stricter access and compliance requirements.

  • 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.

  • WSJ Reports Trump Pressuring FDA to Move on Flavored Vapes

    WSJ Reports Trump Pressuring FDA to Move on Flavored Vapes

    According to The Wall Street Journal, President Donald Trump has criticized FDA Commissioner Marty Makary for not moving quickly enough to approve flavored vaping and nicotine products, raising the issue in recent discussions with advisers. The report, citing people familiar with the matter, said Trump sought input on the role of flavored products among key voter groups and questioned the pace of regulatory decisions, with some advisers describing the FDA’s approach as an obstacle to the administration’s stated position on vaping.

    The FDA has so far authorized only 41 vape products for sale in the U.S., all in tobacco or menthol flavors, maintaining a requirement for strong evidence that flavored products provide benefits to adult smokers that outweigh youth risks. According to the report, Makary has discussed the possibility of adjusting the agency’s stance, with some sources indicating he may be considering a more open approach to flavored product approvals, though no formal policy change has been confirmed.

  • 5th Circuit Considering if FDA Overstepped in Vape Flavor Regs

    5th Circuit Considering if FDA Overstepped in Vape Flavor Regs

    A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit heard oral arguments this week in a case brought by seven small vape-liquid companies challenging the FDA’s denial of marketing authorization for flavored electronic nicotine delivery systems. The companies argue the FDA rejected their applications based on a comparative efficacy requirement they say was not disclosed before the 2020 PMTA deadline, in violation of the Tobacco Control Act.

    The FDA defended the denials, saying manufacturers must prove their specific products are appropriate for the protection of public health. Government counsel argued that non-tobacco flavors add youth-use risk and that applicants failed to show added adult switching benefits over tobacco-flavored products.

    The panel questioned both sides on whether the FDA’s approach was lawful adjudication or rulemaking in practice. Courthouse News Service said, this “ruling could affect thousands of pending applications and clarify how much procedural leeway the FDA has when reviewing the flood of vape products submitted after the 2020 PMTA deadline.”

  • PMI Announces FDA Reauthorization of IQOS as MRTP

    PMI Announces FDA Reauthorization of IQOS as MRTP

    Today (April 29), Philip Morris announced that it has received renewed Modified Risk Tobacco Product (MRTP) authorizations from the U.S. Food and Drug Administration for its IQOS heated tobacco devices and associated HEETS consumables. The renewal covers two IQOS device versions and three HEETS variants, allowing the company to continue communicating reduced-exposure information to adult smokers in the U.S. The FDA said the decision is appropriate for the protection of public health, citing evidence that switching completely from cigarettes to IQOS significantly reduces exposure to harmful chemicals.

    The agency reaffirmed that available scientific evidence supports a measurable and substantial reduction in harm compared to combustible cigarettes, even without long-term epidemiological data. IQOS was first authorized through the FDA’s premarket pathway in 2019, with its initial MRTP designation granted in 2020 and expanded in subsequent years. The renewed orders maintain PMI’s position as the only company with MRTP authorizations for heated tobacco products in the U.S.

    The authorization applies to the IQOS 2.4 and IQOS 3 systems, along with HEETS Amber, Green Menthol and Blue Menthol variants. PMI said the decision supports its ongoing strategy to transition adult smokers away from cigarettes, as the company continues to invest in and expand its smoke-free product portfolio while awaiting further regulatory review of newer devices.

  • Farrelly, Industry Experts Debate Ways to Improve PMTA Pathway

    Farrelly, Industry Experts Debate Ways to Improve PMTA Pathway

    At the American Tobacco and Nicotine Forum (ATNF), a panel titled “Building Lasting Regulatory Reforms: Solutions for a Better PMTA Pathway,” brought together legal, regulatory, and scientific experts to examine persistent challenges within the FDA’s premarket tobacco application (PMTA) process and explore potential reforms. Moderated by Issa Abuaita, the head of legal in the U.S. for Haypp Group, the discussion focused on the disconnect between the statutory framework and real-world market dynamics, with panelists broadly agreeing that the current system is slow, costly, and misaligned with both innovation and enforcement realities.

    Industry representatives emphasized the need for clearer guidance and more practical tools to navigate the process. Paige Magness, a senior vice president at Altria Client Services, highlighted the “irony” of a system where youth usage has increased in products that remain unauthorized, raising questions about whether the framework is effectively managing real-world outcomes. Kellsi Booth, the Chief Legal Officer for Black Buffalo, pointed to the gap between regulatory language and day-to-day application, suggesting that decision trees or clearer pathways could help companies determine requirements more efficiently. Piotr Kozarewicz, the global head of regulatory affairs for smoke-free products at PMI, argued for a more product-focused and market-informed approach, stressing that regulators should evaluate how products are actually used rather than relying heavily on predictive behavioral studies that may not reflect reality.

    Clive Bates, the director of Counterfactual, delivered the sharpest critique, arguing that the PMTA system has become “untethered from reality,” with high evidentiary burdens effectively stifling innovation and contributing to the growth of a large illicit market. He noted that while only a small number of vaping products have been authorized, thousands of combustible products remain on the market, creating a regulatory imbalance. Bates called for a shift toward a more pragmatic framework focused on product safety and marketing controls, alongside faster review timelines closer to the statutory 180-day standard. He also suggested that a compliance-based system, where products meeting defined standards receive expedited review, could improve outcomes and reduce barriers to entry.

    Representing the FDA on the panel was Dr. Matthew Farrelly, the director of the Office of Science for the Center for Tobacco Products, who offered several counterpoints, defending the agency’s process while acknowledging its limitations. He noted that the vast majority of PMTA denials stem from incomplete applications, particularly the lack of evidence demonstrating benefits to adult smokers. Farrelly emphasized that FDA is bound by the existing statutory framework and must base decisions on robust scientific evidence, even as it works to clear backlogs and improve engagement with industry. He encouraged earlier dialogue between applicants and regulators and suggested that incremental product changes could be reviewed more efficiently than entirely new designs.

    The panel ultimately underscored a shared recognition that while progress is being made, meaningful reform will require clearer standards, better communication, and a more balanced approach to risk, innovation, and enforcement.

  • FDA, Industry Leaders Explore Product Standards at ATNF

    FDA, Industry Leaders Explore Product Standards at ATNF

    At the American Tobacco and Nicotine Forum (ATNF), a panel titled “Streamlining Product Reviews Through Smokefree Product Standards” brought together regulators, consultants and scientists to examine how standardized frameworks could improve the efficiency of FDA product reviews. Moderated by Dean Cirotta, president of EAS Consulting Group, the discussion centered on whether clearer product standards could reduce uncertainty in the PMTA process, shorten timelines, and create more predictable pathways for bringing reduced-risk products to market.

    Andrew Joyce, the co-founder and president of Sanova, emphasized the need for earlier engagement with regulators and clearer guidance on expectations, arguing that companies are often navigating an unclear “playing field” when designing studies and preparing submissions. Dr. Aruni Bhatnagar, the director of the Christina Lee Brown Envirome Institute at the University of Louisville, framed the issue more broadly, noting that regulation must account for product design, user behavior, and market dynamics, and that product standards could serve as “guardrails” to define acceptable risk thresholds. Rachael Schmidt, a senior consultant for ALINC, highlighted the political and practical challenges, pointing out that PMTA approvals can take five to eight years and span multiple administrations, creating uncertainty that discourages innovation and investment. She stressed the need for interim solutions, such as consensus standards, to avoid prolonged delays that can keep compliant products off the market.

    Dr. Todd Cecil, deputy director of the Office of Science at the FDA’s Center for Tobacco Products, provided detailed views into the agency’s perspective, underscoring both the importance and complexity of establishing formal product standards under Section 907, which gives the FDA authority to do so. He explained that the process is resource-intensive, requiring the agency to review and respond to thousands of public comments, and can take years to finalize, but once implemented, such standards would become non-negotiable benchmarks for applications. Cecil made clear that while FDA supports faster approvals, the agency has yet to receive a submission that is complete and ready for approval at the outset, reinforcing the need for higher-quality applications. He also encouraged greater collaboration with industry groups like CORESTA and stressed that better communication from manufacturers—who understand their products best—could improve review efficiency. While acknowledging industry frustration, Cecil noted that FDA leadership is committed to advancing improvements and that draft standards could provide valuable interim guidance.

    A key tension throughout the discussion was the balance between innovation and regulation. Panelists agreed that while product standards could streamline approvals, they also introduce rigidity that may slow innovation or require costly adjustments. Cecil addressed this directly, warning against trying to “solve everything at once” and suggesting incremental progress may be more realistic. Schmidt added that without clear pathways to modify products post-approval, companies risk being locked out of the market for years if standards shift. Overall, the panel highlighted cautious optimism that clearer standards and improved dialogue between FDA and industry could reduce bottlenecks, but also underscored that meaningful change will require time, coordination, and sustained effort across stakeholders.

  • 22nd Century Expands Low-Nicotine Research with NC State

    22nd Century Expands Low-Nicotine Research with NC State

    22nd Century Group entered a testing services agreement with North Carolina State University to validate new low-nicotine tobacco varieties designed to improve yield and leaf quality while maintaining reduced nicotine levels, the company said. The research will evaluate genetic traits, crop performance, and commercial scalability as the company looks to strengthen its supply chain.

    The initiative builds on 22nd Century’s proprietary reduced-nicotine platform, which underpins its FDA-authorized VLN cigarette products. The company said the collaboration is aimed at supporting long-term production efficiency and aligning with evolving regulatory focus on nicotine reduction.

  • FDA Issues NSE Orders for Seneca’s 28 Cigarette Products

    FDA Issues NSE Orders for Seneca’s 28 Cigarette Products

    Today (March 23), the U.S. Food and Drug Administration issued Not Substantially Equivalent (NSE) orders for 28 cigarette products manufactured by Seneca Manufacturing Company, determining they do not meet the legal standard to remain on the market. As a result, these products, sold under the Heron and Sands brands, can no longer be distributed, imported, marketed, or sold in the United States.

    The affected products were previously allowed to remain on the market under provisional substantial equivalence status while under FDA review. With the final NSE determinations now posted, retailers have been instructed to coordinate with manufacturers or suppliers to remove remaining inventory.

    The agency said it will exercise enforcement discretion until May 23, after which non-compliant sales could face penalties. FDA noted that enforcement actions may include warning letters, fines, product seizures, or injunctions. The agency also pointed retailers to its searchable tobacco products database, which lists authorized products eligible for legal sale, as part of ongoing efforts to support compliance with federal tobacco regulations.

    Seneca Manufacturing Company is a tobacco manufacturer founded in 2006 after obtaining its federal TTB license, initially operating with a small team and focusing distribution within Seneca Nation territory in the New York area before expanding to multiple U.S. states and other Indigenous markets.