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Tag: CTP

  • 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.”

  • U.S. Retail Groups Urge White House to Crack Down on Illegal Chinese Vapes

    U.S. Retail Groups Urge White House to Crack Down on Illegal Chinese Vapes

    A coalition of major U.S. retail and energy associations is calling on the White House to take urgent action against the surge of illegal vape products entering the country from China. In a joint letter sent July 18, the National Association of Convenience Stores (NACS), along with Energy Marketers of America, National Association of Tobacco Outlets (NATO), National Association of Truck Stop Operators (NATSO), and the Society of Independent Gasoline Marketers of America (SIGMA), said illicit vapes are undercutting legitimate retailers and exposing regulatory failures.

    The groups blame the FDA’s Center for Tobacco Products (CTP) for poor enforcement and slow product approvals, urging reforms and tighter border controls.

    “The convenience store and travel center industries are facing a crisis of illicit product from China,” the letter said. “Vape and e-cigarette products have been flooding our country for years and drawing business away from law-abiding retailers.

    “We need change at the Center for Tobacco Products and help from the federal enforcement agencies to clean up this mess. We are asking for your help to do that.”

  • Thoughts on FDA Reform

    Thoughts on FDA Reform

    Prioritizing Education on Smoke-Free Alternatives

    By Dr. Tom Price

    The recent marketing authorization by the U.S. Food and Drug Administration (FDA) of 20 Zyn nicotine pouch products is a good step forward in building a more robust market for smoke-free nicotine and tobacco products. This critical decision, coupled with the Trump administration, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and expected FDA Commissioner Marty Makary’s stated priority to “Make America Healthy Again,” foretells an emerging regulatory landscape in the U.S. that presents a meaningful opportunity to expand access to smoke-free products that can help adults who smoke make the switch away from cigarettes.

    This paradigm shift has been a long time coming, and I am thrilled to see it happening in real time. Now, it is time for the FDA to step up its education efforts—with both consumers as well as the medical community—to raise awareness of these products and how, although not risk free, they are a better choice than continuing to smoke or using other traditional tobacco products.

    In clearing the FDA’s extensive premarket tobacco product application (PMTA) process, which includes years of scientific review, ZYN became the first and only FDA-authorized nicotine pouch in the U.S. In the FDA’s announcement, the Director of the Office of Science at the FDA’s Center for Tobacco Products (CTP), Matthew Farrelly, Ph.D., noted that these “products offer greater benefits to population health than they do risks,” and the data shows that ZYN nicotine pouches “meet that bar by benefitting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

    While this should be good news for the 45 million American nicotine consumers, there is still more work for the FDA to do to clearly illustrate the potential benefits of nicotine pouches and other smoke-free products to consumers and medical experts alike. However, that will require clearing up a long history of misinformation.

    According to the FDA, it is not nicotine but a toxic mix of chemicals contained in tobacco and tobacco smoke that drives the serious health threats facing tobacco users. Despite the science proving that smoke-free products represent a better option compared to smoking, various groups, such as the American Lung Association (ALA), continue to spread misinformation about the potential benefits of Zyn nicotine pouches for smokers and other tobacco users, directly contradicting the FDA and scientific evidence.

    Even America’s medical community seems flummoxed by what should be a clear distinction between nicotine consumption and the serious side effects tied to cigarette smoking. According to one study, 60 percent of nurses mistakenly believe that nicotine causes cancer. Another one found that more than 80 percent of physicians “strongly agreed” that nicotine “directly contributes to the development of cardiovascular disease (83.2 percent), chronic obstructive pulmonary disease (COPD) (80.9 percent), and cancer (80.5 percent).”

    Of course, none of this is true, underscoring the dire need for the FDA and CTP to prioritize educating the public and medical community with accurate information about the vital role smoke-free products could play in helping Americans who smoke to reduce their exposure to harm.

    CTP Director Brian King, Ph.D., M.P.H., recently acknowledged as much, saying that “misperceptions among physicians and other healthcare professionals” may result in advising patients in a manner that is “not consistent with existing scientific evidence.” Moreover, he continued, these “misperceptions are associated with lower odds of completely transitioning from cigarettes” to a noncombustible product.

    While misinformation abounds, there is still some hope. Even passionate anti-smoking groups, such as the Truth Initiative, have—to some degree—begun to acknowledge the benefits of nicotine pouches, noting that the FDA’s authorization of ZYN nicotine pouch products “addresses an ongoing need to provide adults who smoke with access to less harmful alternatives to combustible cigarettes.”

    The FDA and CTP may be well aware of the misperceptions behind smoke-free products. Still, neither has taken meaningful action to counter the spread of misinformation with proper, accurate education for healthcare providers and adults who smoke. That must change, and it must change soon.

    The FDA has a responsibility to not only help provide adults who smoke with more smoke-free options, but also to ensure the medical community and public at large understand the benefits and risk these products provide—both in terms of personal and public health. Recent events have made me hopeful that, together, we can build a healthier country, but the FDA and CTP must lead the way there.

    Tom Price, M.D., was the 23rd Secretary of the U.S. Department of Health and Human Services and is a former member of Congress (GA06), and an advisor to PMI U.S. Corporate Services Inc.

  • Koplow Tabbed New CTP Chief

    Koplow Tabbed New CTP Chief

    U.S. Food and Drug Administration Commissioner Marty Makary announced that Bret Koplow will be acting director of the Center for Tobacco Products, according to emailed announcements reported by Bloomberg.

    Koplow has worked for the agency in various roles since 2011, serving as senior counselor to the commissioner in the Immediate Office of the Commissioner since early 2020, where he focused principally on regulatory, policy, and operational matters involving CTP, including work on e-cigarettes, cigars, and other tobacco products. Before joining the Commissioner’s Immediate Office, he served as senior counsel in the FDA’s Office of the Chief Counsel, and before that served in the FDA’s Office of Legislation as the Senior Advisor for Oversight.

    The agency is facing pressure to crack down on illicit products, improve new product submission procedures, and change how it approaches foreign inspections.

    “Bret Koplow—an attorney and longtime FDA bureaucrat,” Gregory Conley, a harm-reduction advocate posted on X. “This would seem to signal the Biden era status quo will continue for now.”

    Makary also announced Elizabeth Miller will serve as the acting associate commissioner for the Office of Inspections and Investigations, filling two high-profile vacancies. The former top tobacco regulator, Brian King, was pushed out during agency-wide layoffs in April.