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Tag: FDA

  • FDA Posts Additional Materials for 22nd Century MRTP Renewals

    FDA Posts Additional Materials for 22nd Century MRTP Renewals

    Today (Nov. 3), the U.S. Food and Drug Administration posted additional materials related to modified risk tobacco product renewal applications submitted by 22nd Century Group for VLN King and VLN Menthol King cigarettes. The FDA originally authorized the two products as MRTPs in December 2021, permitting the company to make specific reduced-exposure claims, including “95% less nicotine” and “Helps reduce your nicotine consumption.” The orders also require the company to include the statement “Helps you smoke less” when using the authorized claims.

    The FDA filed the renewal applications for scientific review on May 12. The original modified risk orders are valid for a fixed period, and renewal applications are required to continue marketing the products under MRTP authorization. The renewal materials include postmarket surveillance and study results required under the original orders. Public comments can be submitted through Regulations.gov under docket FDA-2019-N-0994. The FDA has not yet set a deadline for comments.

  • Skoka Raises $21.5 Million, Submits PMTA for 55 Pouch Products

    Skoka Raises $21.5 Million, Submits PMTA for 55 Pouch Products

    Skoka Inc. said it has raised $21.5 million and submitted a bundled Premarket Tobacco Product Application to the U.S. Food and Drug Administration covering 55 nicotine pouch products across 11 varieties and five strengths. The company submitted the application Oct. 1 and plans to begin U.S. retail distribution in 2027, subject to FDA authorization. Skoka said it has committed $15 million to its regulatory program, including pharmacokinetic studies, toxicology, stability testing, actual-use research, and label-comprehension studies.

    Founded in 2024 by Dan Aziz, Skoka developed its own formulations and has filed two patent applications covering ingredients and blending methods. The products are manufactured in the United States using globally sourced ingredients. Investors include executives and professional athletes, who invested in their individual capacities rather than as brand endorsers.

  • FDA Tabs Jessica Zeller for CTP Compliance and Enforcement

    FDA Tabs Jessica Zeller for CTP Compliance and Enforcement

    The U.S. Food and Drug Administration announced that it selected Jessica Zeller as director of the Center for Tobacco Products’ Office of Compliance and Enforcement, effective Nov. 1. Zeller joins CTP from Edwards Lifesciences, where she served as vice president corporate counsel and general counsel for quality.

    Zeller previously held senior positions within CTP’s Office of Compliance and Enforcement, including serving as its inaugural deputy director. She also served as the FDA Office of Regulatory Affairs’ inaugural ombudsman and as an associate chief counsel and trial attorney in the agency’s Office of Chief Counsel. She has more than 20 years of experience in compliance, enforcement, and legal and regulatory affairs.

  • FDA Seeks Two New Voting Members for Tobacco Advisory Committee

    FDA Seeks Two New Voting Members for Tobacco Advisory Committee

    The U.S. Food and Drug Administration is seeking nominations by Dec. 14 to fill two vacancies on its Tobacco Products Scientific Advisory Committee (TPSAC), which advises the agency on scientific, technical, and policy issues related to tobacco regulation. Candidates may be self-nominated or nominated by individuals or organizations and should have expertise in oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, engineering, or other relevant fields. Selected members may serve terms of up to four years. Nominations submitted after the deadline will be considered for future vacancies. The Federal Register notice provides submission instructions.

    The FDA also announced four new voting members: Holger Behrsing, Ph.D.; Kim “Skip” Murray, representing the general public; Margaret Nolan, M.D.; and Andrew A. Strasser, Ph.D. Their expertise spans preventive medicine, chronic diseases, tobacco cessation and harm reduction, toxicology, cell biology, and health communication. The agency also selected Eric Ray Walker, Ph.D., as an alternate nonvoting member representing tobacco growers. TPSAC has 12 members, including a chair, and evaluates tobacco-product risks, dependence, and health effects to provide advice and recommendations to the FDA commissioner.

  • Geek Bar Leads with Youth Vapers

    Geek Bar Leads with Youth Vapers

    About 1.44 million U.S. middle and high school students used e-cigarettes in early 2025, with 64.1% of youth vapers reporting use of Geek Bar, according to an Oct. 5 Public Health Alert published by the University of Minnesota’s Center for Infectious Disease Research and Policy and NEJM Evidence. The analysis of the 2025 National Youth Tobacco Survey found that 5.2% of students currently vaped, while approximately 460,000 used nicotine pouches, 69.2% of whom reported using Zyn.

    Fruit was the most popular vape flavor, while mint led among pouch users. The report noted that Geek Bar’s share had increased sharply from 2024, when Elf Bar was the leading brand. The FDA has said Geek Bar products are not authorized for sale in the United States.

  • Ill. Rep Questions FDA Review of Vape Rules

    Ill. Rep Questions FDA Review of Vape Rules

    This week, Rep. Raja Krishnamoorthi (D-Ill.) asked FDA Acting Commissioner Kyle Diamantas for information about the agency’s Sept. 28 announcement that it is considering replacing the 2021 rules governing Premarket Tobacco Product Applications (PMTAs). Krishnamoorthi, co-chair of the Congressional Caucus to End Youth Vaping, questioned whether changes could reduce the scientific requirements for new tobacco products and asked whether FDA consulted tobacco manufacturers, industry associations, or parties challenging the current framework before announcing the review. He also requested communications between FDA officials and Altria, Reynolds American, their subsidiaries, and other parties involved in challenges to the rules.

    Krishnamoorthi also cited FDA’s recent authorizations of flavored e-cigarettes and Juul products in raising concerns about the agency’s approach to scientific review. He asked FDA to identify provisions of the 2021 PMTA rule it may change, explain the evidence supporting those changes, address the relationship between the illicit market and lawful product authorization requirements, and outline additional enforcement actions against unauthorized e-cigarettes. He requested written responses by Oct. 20.

  • GAO Finds FDA Holding 130K Tobacco Applications to End 2025

    GAO Finds FDA Holding 130K Tobacco Applications to End 2025

    Vaping 360 reports that nearly 132,000 tobacco product applications remained unresolved at the end of 2025, with the applications awaiting decisions for an average of 1,266 days, according to a new Government Accountability Office audit of the FDA’s tobacco product review program. The FDA received more than 26.6 million applications from 2018 through 2025 and completed reviews of about 26.5 million, with most applications submitted after the 2020 deadline for products covered by the agency’s Deeming Rule involving e-cigarettes.

    The GAO found that completed reviews across three premarket pathways averaged 507 days and that FDA systems do not consistently capture information needed to determine whether the agency meets the 180-day statutory target for the scientific-review phase of Premarket Tobacco Product Applications. The FDA has reduced screening times and introduced automated application checks, while also applying lessons from its nicotine pouch pilot to e-cigarette reviews. The GAO recommended that FDA improve data collection to monitor scientific-review timelines, and the Department of Health and Human Services agreed.

  • FDA Releases Transparency Roadmap

    FDA Releases Transparency Roadmap

    The U.S. Food and Drug Administration issued a press release today (Oct. 2) outlining its Transparency Roadmap that calls for greater disclosure of the scientific and regulatory basis for agency decisions, while protecting confidential commercial information and trade secrets. The Roadmap focuses on five components: complete response letters; investigational stage and marketing application lifecycle disclosures; new approach methodologies and novel biomarkers; patient- and consumer-centered product labeling; and compliance and inspectional records.

    While the new transparency initiative does not directly address tobacco and nicotine products, it could affect industry manufacturers navigating the agency’s premarket review process, particularly as FDA considers changes to its Premarket Tobacco Product Application (PMTA) framework. FDA already publishes marketing orders and related documents for tobacco products, as well as aggregate data on PMTA, substantial equivalence, and exemption applications, but greater transparency could be relevant to how the agency evaluates applications and reaches regulatory decisions.

    The initiative comes as FDA says it intends to evaluate changes to the PMTA framework, citing its experience implementing the current rules, the development of an illicit and unregulated market, and the pace of new product introductions. The agency said a revised framework should provide greater clarity and predictability for applicants.

  • FDA Seeks New Scientific, Consumer Voices for Advisory Committees

    FDA Seeks New Scientific, Consumer Voices for Advisory Committees

    The U.S. Food and Drug Administration launched a nationwide recruitment effort for scientific, technical, professional, and consumer representatives to serve on FDA advisory committees. The agency said it is seeking candidates with expertise across multiple scientific fields and will consider nominations for current and anticipated vacancies, with terms of up to four years.

    The recruitment could be relevant to the tobacco sector because FDA advisory committees can provide independent scientific and consumer input on FDA-regulated products, although the announcement does not specifically identify tobacco-related committee vacancies. The FDA said nominations for consumer representatives should be submitted by Nov. 15, while nominations for scientific, technical, professional, and other voting members should be submitted by Nov. 30 for consideration for current and near-term vacancies.

    The news comes after Dr. Bret Koplow, director of the FDA CTP, told attendees at GTNF 2026 in Lisbon that the Center is short-staffed and was looking to hire more scientists.

  • Sen. Schumer Urges FDA to Crack Down on Illicit Chinese Vapes

    Sen. Schumer Urges FDA to Crack Down on Illicit Chinese Vapes

    New York Sen. Chuck Schumer is calling on the U.S. Food and Drug Administration to provide more information on how it identifies illicit nicotine products and investigate whether Chinese manufacturers are using chemical substitutes to evade FDA oversight. In a letter to acting FDA Commissioner Kyle Diamantas, Schumer also urged the agency to use its enforcement authorities to remove unlawful products from the market. He cited concerns that unauthorized products manufactured in China are entering the U.S. market and being marketed in ways that appeal to youth.

    Schumer cited estimates that unauthorized products account for 70% of U.S. e-cigarette sales, including more than 97% of disposable e-cigarette sales, and requested a response from the FDA within 30 days. He also raised concerns about FDA staffing and its ability to monitor illicit nicotine products following workforce reductions in 2025.