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Tag: FDA

  • 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.

  • FDA Expands List of Harmful Tobacco Constituents

    FDA Expands List of Harmful Tobacco Constituents

    The U.S. Food and Drug Administration announced that it finalized the addition of 18 chemicals to its list of Harmful and Potentially Harmful Constituents (HPHCs), bringing the total to 111 substances identified in tobacco products, smoke, or aerosol. The list is intended to highlight compounds that pose known or potential risks to human health and applies across cigarette, e-cigarette, cigar, and hookah tobacco product categories.

    The newly added constituents include a range of flavoring agents, solvents, and byproducts, many of which are commonly associated with e-liquid formulations. FDA said the update provides greater transparency for the public while also signaling to manufacturers which chemicals may receive increased scrutiny during the review of new product applications. The agency emphasized that inclusion on the HPHC list does not constitute a ban, but triggers reporting requirements under the Federal Food, Drug, and Cosmetic Act.

    The agency also opened a new consultation on three additional compounds—pulegone, furfuryl alcohol, and methyl eugenol—frequently used as flavoring ingredients, with public comments due by May 26. In addition, FDA confirmed that respiratory toxicants identified by the National Institute for Occupational Safety and Health (NIOSH) will now be considered as a criterion for future additions to the list. The agency said it expects to continue updating the HPHC list as new scientific evidence emerges.

    The constituents added to the Register are: Acetic Acid, Acetoin (also known as 3-hydroxy-2-butanone), Acetyl Propionyl (also known as 2,3-pentanedione), Benzyl Acetate, Butyraldehyde, Diacetyl, Diethylene Glycol, Ethyl Acetate, Ethylene Glycol, Furfural, Glycerol, Glycidol, Isoamyl Acetate, Isobutyl Acetate, Methyl Acetate, n-Butanol, Propionic Acid, and Propylene Glycol.

  • ATNF Panel Examines State-Level Policy Challenges for Harm Reduction

    ATNF Panel Examines State-Level Policy Challenges for Harm Reduction

    At the American Tobacco and Nicotine Forum (ATNF), a panel moderated by Beth Oliva, a partner at Fox Rothschild, brought together industry, policy, and regulatory experts to examine how state and local policymaking is shaping harm reduction. Panelists Dr. Jeff Willett from the Progressive Policy Institute, Sarah McQuillan from JTI Liggett, Andrew Nunes from PwC, and Laura Leigh Oyler from Haypp Group, repeatedly emphasized a core issue: a widespread lack of understanding among state lawmakers about federal tobacco regulation and the FDA’s role. Several speakers noted that policymakers are often making decisions without a clear grasp of existing frameworks, definitions, or scientific standards, contributing to fragmented and sometimes contradictory regulations.

    A major theme was the disconnect between data and policymaking. Panelists pointed to declining cigarette use alongside growth in alternative products, yet said state responses are often driven more by headlines than evidence. Willett highlighted progress in reducing youth vaping since 2019 and stressed the importance of fact-based policy, while others noted that tax increases, flavor bans, and regulatory gaps can unintentionally push consumers toward illicit markets or cross-border purchases. Nunes and Oyler both underscored how inconsistent tax structures and regulatory approaches across states are distorting markets and complicating compliance for manufacturers and retailers.

    The panel also focused heavily on the growth of illicit markets, with speakers linking it to unmet consumer demand and regulatory gaps. Oyler argued that the lack of authorized products has created a “vacuum” filled by unregulated alternatives, while Willett pointed to evidence that high taxes and restrictions are driving illicit sales in markets like New York. Broader inconsistencies—such as stricter rules for nicotine compared to cannabis or alcohol—were cited as further complicating enforcement and public perception. Panelists warned that states are increasingly reliant on tobacco tax revenue, which can influence policy decisions, and called for more coordinated, evidence-based approaches rather than a patchwork of state-by-state rules.

    Finally, the discussion turned to communication and public health messaging. Speakers argued that the current narrative around nicotine lacks nuance, with limited recognition of the continuum of risk or the role of reduced-risk products. Several panelists called for the FDA to take a more active role in educating both lawmakers and the public, while also stressing the need for better data to be incorporated into legislative debates. Without improved communication and alignment between federal science and state policy, the panel suggested that regulatory fragmentation and market distortions are likely to persist.

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  • 7th Circuit Upholds Wisconsin Ban on Unauthorized Vape Sales

    7th Circuit Upholds Wisconsin Ban on Unauthorized Vape Sales

    The U.S. Court of Appeals for the Seventh Circuit has ruled that federal law does not preempt Wisconsin’s authority to ban the sale of e-cigarettes that lack FDA authorization, allowing the state to continue enforcing its restrictions. The decision rejects arguments from vaping industry groups that federal tobacco regulations should override state-level controls on product sales and marketing.

    The court found that while the FDA regulates tobacco products at the federal level, states retain the power to impose their own rules on how such products are sold within their borders. The ruling reinforces the ability of states to take independent action against unauthorized vaping products, particularly those that have not received marketing authorization from the FDA.

  • Panel: From Pilot to Progress in Product Authorizations

    Panel: From Pilot to Progress in Product Authorizations

    The panel on the FDA’s nicotine pouch pilot program, moderated by Roxana Weil from McKinney Specialty Labs, was a great discussion between the FDA’s Cristi Stark, Reynolds American’s Carolina Garcia-Canton, Altria Client Service’s Sydana Rogers Hollins, and Kleinfeld, Kaplan, and Becker’s Stacy Ehrlich about the status of the pilot program and what both the FDA and the industry have learned from in the process.

    The pouch pilot program was introduced in 2025, and according to Stark, it started with four applicants and is ending with the same four applicants. She stated that the program aimed for more communication and that the program started at filing. Stark noted that one of the biggest changes the FDA made in the pilot program versus the normal authorization pathway was that the regulatory body followed up with the four pilot companies via email rather than just the more formal letters. The panel participants all noted that the use of email communication was a huge benefit because it allowed for more communication, and more informal communication that helped them to get a better understanding of what the FDA is looking for in their applications.

    One of the biggest points of discussion and agreement was that the pilot program has been successful in creating better lines of communication between the FDA and the industry when it comes to market authorization applications and what is expected and needed to help move the review process along and get product authorized. According to Garcia-Canton, the biggest success has been communication, not necessarily increasing the speed of the review process. Ehrlich agreed that the communication was much better but stated that the FDA needs to be substantially more transparent.

    A point of contention has always been that applicants and the industry feel that the FDA takes too long to review products—the process has taken much longer than the stated 180 days. Ehrlich stated that the process timing needs to be equal for the applicants and the regulatory body; the FDA takes lots of time to review the applications, but companies aren’t necessarily given the time they need to address issues. Stark’s response to the amount of time the process takes was to lay out the process the organization goes through and to emphasize utilizing the pre-submission process and meetings to avoid running into things like timing issues, especially for small companies as they may not have the resources or time to complete longer studies that the FDA may request.

    In discussing the differences in the pilot program versus the normal submission process, Rogers Hollins noted that the FDA’s engagement and tone in the pilot program has been “super helpful and impactful.” She noted that communicating via email was very different than her previous experience with the FDA and that it was helpful as well as being able to gain insights on the FDA’s preferences. In her words, “tone, tenor, and transparency” were the key positive differences.

    According to Garcia-Canton, she noticed that in the beginning, especially, there was a lot of awkwardness between the scientists and the FDA. The idea that the scientists are worried about saying or doing the wrong thing in the FDA’s eyes was iterated by both Garcia-Canton and Stark, but Garcia-Canton emphasized that “this is the place for scientific debate.”

    Stark was asked whether scientists are learning and taking information away from the program. “Change is hard for a lot of people,” Stark said. She noted that there was a lot of confusion over deficiency letters and what was expected from applicants. The FDA’s takeaway, according to Stark, was that it needs to reframe the deficiency letters to better communicate and clear up what the organization needs. She also noted that the scientists, through these communications, are learning that there may be other ways to do things.

    One of the big questions to the panel was whether the FDA made expectations clear from the beginning of the program. Ehrlich was quick to say that they were not entirely clear in the beginning. Garcia-Canton noted that she can sympathize with the FDA reviewers and that both sides can do better with communicating information. “I was not surprised by the request for information,” she said. Adding on to Stark’s notes on deficiency letters, Garcia-Canton noted that she did not always understand what the FDA was asking for and even used AI to ask what the letters meant; she received different answers from different AI programs. However, she noted that she believes the program will help with focus and clarity for future submissions. Rogers Hollins was honest that having gone through it, “I still can’t explain the whole process.” She said that getting more insight would be really helpful and that it would be useful to have more information more easily available in a more informal manner.

    The conversation turned to many of the misperceptions of the pilot program, which Stark cleared up by discussing the theory that the companies in the pilot program are just being pushed through and rubber stamped. She stated that the organization has “not given up on scientific rigor” and that “100% of what was submitted was reviewed” and that the companies heard about any questions that the organization had. Rogers Hollins confirmed that the FDA has been “upholding the scientific standard,” and Garcia-Canton said that the FDA is “keeping up scientific content” and upholding a very high quality.

    An audience member asked if the pilot program is something that can be realistically sustained, to which Stark answered, “Yes, with some changes.” She noted that the FDA needs engaged interaction and increased communication with industry to continue moving forward.

    Another valid question for Stark was what small companies can do to prepare for the submission process. “The standard is the same whether small, medium, or large,” she said. Small businesses may need a little bit more development time or may need to use consultants, though. Stark recommended utilizing the pre-submission review process and meeting with the FDA prior to submissions. Her advice was to plan early, communicate with the FDA, and give time to apply guidance before submission.

    The question of what the biggest challenge is for the existing applicants that are still waiting was asked. Ehrlich stated that applicants “want to know what the noise is—what don’t we need to do?” She also asked whether the wheel needs to be reinvented every time or if there is a way to rely on the existing data for these, very similar, products to help streamline the process. Her takeaway from that question was one of her own: “What is essential and what are the different ways of getting to that, and what is just noise?”

    Stark responded that the FDA is looking at four focused areas for pouches: product characterization, consistent manufacturing, adult benefit, and preventing youth use.

    The panel seemed to agree that the definition of “benefit” in this regard concerns relative risk. Stark noted that she does “not personally agree” with the recent media reports on pouches. The FDA is always concerned about youth access, she said.

    Stark outlined the many meetings with different groups involved in the review of products that help ensure consistency of applications. This also helped to explain part of why the review process takes so long currently. “Is it changing?” she said. “Yes.” She went on to note that “We don’t need to have six meetings a week anymore.” That being said, she emphasized that they are looking over all information and trying to fill in any holes that may exist as they review product applications.

    The panel ended with appreciation of the open conversation and communication. “I’m incredibly excited to be here,” Stark said. “We have a shared effort.” She noted that the pilot program is currently expanding to other programs as well. ENDS is actively progressing, she said. It is no longer a pilot. “We can’t control everything, but we’re looking to learn every step of the way,” Stark said.