TobaccoReporter logo

Tag: CTP

  • FDA Rolls out New Features in CTP Portal to Assist Submission Process

    FDA Rolls out New Features in CTP Portal to Assist Submission Process

    Today (July 17), the U.S. Food and Drug Administration introduced new enhancements to its Center for Tobacco Products Portal NextGen, expanding its web-based submission system for premarket tobacco product applications and substantial equivalence (SE) reports. New features include the ability to upload folders and subfolders, label submission documents directly within the portal, and save contact information for future filings, reducing administrative burden and improving submission consistency. Based on user feedback, the updates are intended to streamline the application process for tobacco manufacturers and applicants.

    As part of the transition, the FDA will phase out eSubmitter for PMTA and SE submissions after Nov. 14, with applicants expected to use the web-based forms in CTP Portal NextGen. PDF forms will remain available for those unable to use the portal, while eSubmitter will continue to support other submission types, such as ingredient listings and harmful and potentially harmful constituent reports, until additional web forms are introduced. The agency said it plans to provide further training and guidance as it expands the portal’s capabilities.

  • Former CTP Toxicologist Accuses FDA of Approving Zyn Without Full Facts

    Former CTP Toxicologist Accuses FDA of Approving Zyn Without Full Facts

    A report published yesterday (July 14) by The Examination and STAT raised questions about the U.S. Food and Drug Administration’s review process for Philip Morris International’s Zyn nicotine pouches, alleging that agency scientists had unresolved concerns about the composition and potential health implications of the pouch material before the product was authorized for sale. The report said FDA toxicologist Christy Leppanen questioned whether regulators had adequately assessed possible microplastic exposure after conducting informal tests that found Zyn pouches did not dissolve when exposed to saliva or other conditions. Leppanen alleged that the FDA did not seek additional information from PMI about the pouch material before approving the product, while former FDA officials cited in the report questioned whether the agency fully evaluated all product components as required under federal law.

    The allegations come as nicotine pouches have become one of the fastest-growing segments of the tobacco and nicotine market. The U.S. nicotine pouch market is estimated to grow 37% in 2026 to $6.8 billion, according to TobaccoIntelligence, with companies promoting pouches as lower-risk alternatives to combustible cigarettes because they deliver nicotine without smoke exposure. The FDA has authorized certain nicotine pouches, including Zyn, based on a review of whether the products are appropriate for the protection of public health, weighing potential risks such as youth uptake against potential benefits for adult smokers transitioning away from cigarettes. PMI defended the authorization process, citing the FDA’s scientific review, while the FDA said its evaluation did not identify additional concerns regarding the ingredients or materials used in Zyn products. Concerns raised by Leppanen and other scientists center on whether pouch materials could release microscopic particles during use and what long-term effects those exposures may have. The FDA’s recent decision allowing PMI to communicate that Zyn use instead of cigarettes lowers the risk of certain smoking-related diseases represented a major regulatory milestone for the category, but, according to The Examination, the allegations in the report may fuel additional debate over product standards, disclosure requirements, and the depth of scientific reviews for emerging nicotine products.

  • FDA Releases PATH Study Data from Wave 8

    FDA Releases PATH Study Data from Wave 8

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) and the National Institutes of Health’s National Institute on Drug Abuse (NIDA) released the Wave 8 Public-Use Files from the Population Assessment of Tobacco and Health (PATH) Study, providing researchers with nationally representative survey data collected between January and December 2024. The longitudinal study tracks tobacco and nicotine use among U.S. adults and youth and is a key source of evidence used by FDA to inform tobacco regulatory decisions under the Family Smoking Prevention and Tobacco Control Act.

    The agencies also updated the Wave 7 Biomarker Restricted-Use File with new tobacco-specific nitrosamine and F2-isoprostane data, expanding the resources available for studying tobacco exposure and health effects. Researchers can request access to the restricted-use biomarker files, while the public-use datasets, documentation, and updated master linkage files are available for download.

    The PATH Study is one of the most widely used data sources for analyzing trends in tobacco and nicotine product use, including cigarettes, e-cigarettes, and oral nicotine products. The latest data release is expected to support ongoing research into consumer behavior, product use patterns, and health outcomes that inform both FDA regulatory science and industry analysis.

  • 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.

  • 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.

  • Filing Shows FDA Rescinded 229 CTP RIF Notices

    Filing Shows FDA Rescinded 229 CTP RIF Notices

    A court filing in the U.S. District Court for the District of Rhode Island shows that the U.S. Food and Drug Administration Center for Tobacco Products has fully reversed a wave of 2025 reduction-in-force (RIF) notices affecting 229 employees. In a declaration filed March 27, FDA official Melanie M. Keller detailed how the notices, issued March 31, April 1, and May 2, 2025, were rescinded in stages beginning May 1 and continuing through September 12, 2025, across multiple CTP offices, including health communication and education, compliance and enforcement, management, regulations, and public health education.

    The declaration states that on February 3, 2026, all remaining RIF notices were rescinded except for eight employees who had already moved to other CTP divisions. The final rescissions covered staff responsible for public complaints, small business assistance, IT business process support, industry outreach, and management of contracts and grants. The filing also notes that two Office of Science leaders placed on administrative leave after proposed reassignments returned to their roles by November 6, 2025, and that none of the affected employees remains on administrative leave.

    The filing is part of State of New York vs Robert F. Kennedy, Jr., lawsuit.

  • 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.”

  • PMI Positive After FDA’s Zyn Hearing

    PMI Positive After FDA’s Zyn Hearing

    Philip Morris International (PMI) believes it moved a step closer to securing permission to market its Zyn nicotine pouches as a reduced-risk alternative to cigarettes in the United States, following a full-day public hearing convened by the U.S. Food and Drug Administration (FDA) yesterday (January 22). At the meeting, PMI scientists presented evidence to the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) in support of a Modified Risk Tobacco Product (MRTP) application that would allow the company to tell adult smokers that switching completely to Zyn lowers the risk of major smoking-related diseases. FDA briefing materials and staff presentations suggested regulators are leaning toward approving the proposed claim, with the agency stating that “the evidence suggests the proposed modified risk claim is scientifically accurate.”

    “The FDA’s Center for Tobacco Product’s mission is to make smoking-related disease and death a part of America’s past,” said Keagan Lenihan, Chief External Affairs Officer for PMI U.S. “Smoke-free products, like Zyn, play a critical role in helping CTP achieve this mission and provide adults who smoke with important information to guide their choices and a real opportunity to change.”

    The proposed language would allow PMI to say that using Zyn instead of cigarettes reduces the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. FDA scientists said the “totality of the evidence” shows Zyn contains substantially lower levels of harmful chemicals than cigarettes, and that consumer research suggests the claim increases awareness of reduced risks without misleading users into believing the product is risk-free. The agency also noted that youth nicotine pouch use remains relatively low, at 2.4% of U.S. high school students in 2024, and that exposure to the proposed claim did not increase young adults’ intentions to use Zyn. PMI executives argued that clearer communication of relative risk could help smokers move away from combustible products, drawing comparisons to Swedish snus, which received an MRTP designation in 2019 and has been linked to Sweden’s low smoking rates.

    However, members of the independent TPSAC panel raised concerns about gaps in long-term data and whether reduced-risk marketing would meaningfully accelerate smoking cessation in the U.S. Public health advocates also warned about the potential appeal of flavored pouches, discreet use, and social-media promotion to underage users. While panelists generally agreed that Zyn is far less harmful than cigarettes, they questioned whether the evidence shows that marketing claims will drive widespread switching. The FDA is not bound by the panel’s non-binding recommendations and has not set a deadline for its final decision, which will determine whether PMI can formally promote Zyn as a reduced-risk product to adult smokers.

    “While the relatively expedited timeline for this MRTP review is encouraging, the fact that the TPSAC did not vote on a recommendation makes me question the reason for these meetings moving forward,” said Laura Leigh Oyler, VP of Regulatory Affairs for Haypp Group, whose subsidiaries sell nicotine pouches online. “The science, and the many public speakers who supported the authorization were clear: Americans deserve honest messaging around these products and their impacts on harm reduction.”

  • FDA Extending Info Collection for Smokeless Products

    FDA Extending Info Collection for Smokeless Products

    The U.S. Food and Drug Administration (FDA) has submitted a proposed extension of an existing information collection to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act, covering warning plans for certain smokeless tobacco products. The collection, assigned OMB Control Number 0910-0671, relates to statutory requirements that smokeless tobacco packaging and advertising carry one of four mandated health warnings, randomly displayed and rotated quarterly in accordance with FDA-approved warning plans. FDA said manufacturers, importers, distributors, and retailers must submit these plans for review, either electronically via the Center for Tobacco Products (CTP) Portal or in paper form.

    Public comments on the proposal must be submitted through reginfo.gov within 30 days of Federal Register publication, and FDA noted that two comments received during an earlier 60-day notice period were not related to paperwork burden issues.

  • Philip Morris Urges FDA TPSAC to Recommend Continued Modified-Risk Marketing of IQOS

    Philip Morris Urges FDA TPSAC to Recommend Continued Modified-Risk Marketing of IQOS

    Experts from Philip Morris International presented evidence to the Tobacco Products Scientific Advisory Committee (TPSAC), according to a PMI press release. The committee, comprised of independent scientific researchers, provides nonbinding recommendations to the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP).

    The full-day meeting on October 7 was part of the FDA’s customary review of PMI’s request to continue marketing versions of its IQOS heated-tobacco products in the U.S. as modified-risk tobacco products (MRTPs), a necessary step while FDA completes its review of pending applications for IQOS ILUMA (a later version of the IQOS models that are currently authorized by the FDA) to reach and transition even more legal-age adults away from combustible cigarettes.

    “The evidence presented at this meeting, as also noted by the FDA, further supports the agency’s original conclusions that led the FDA to authorize the IQOS system as a modified-risk tobacco product,” said Stacey Kennedy, PMI U.S.’ CEO. “We encourage the FDA to continue efforts to establish a timely scientific review process for smoke-free products—including for IQOS ILUMA, which has been pending FDA review for nearly two years and has globally shown even higher rates of legal-age adults fully switching from combustible cigarettes—that are a better choice for legal-age adults who would otherwise use traditional tobacco products, including combustible cigarettes.”

    Initially granted by the FDA in 2020, the MRTP designation for the IQOS system authorizes PMI to communicate to legal-age consumers that: “AVAILABLE EVIDENCE TO DATE: The IQOS system heats tobacco but does not burn it. This significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

    During the meeting, representatives from PMI and committee members discussed a range of scientific, technical, and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented additional evidence and research demonstrating high levels of complete switching among current legal-age smokers while maintaining low levels of use by unintended populations.

    Addressing committee members, Keagan Lenihan, VP and Chief External Affairs Officer for PMI U.S., said: “CTP’s mission is to make tobacco-related disease and death a part of America’s past. Smoke-free products, like PMI’s IQOS system, play a critical role in helping CTP achieve this mission and provide adults who smoke with a real opportunity to change. The IQOS system, when marketed with the reduced-exposure claim, promotes complete switching from combustible cigarettes.”