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Category: FDA

  • Trump Administration Looking to Change PMTA Process

    Trump Administration Looking to Change PMTA Process

    The Trump administration is reportedly preparing changes to the FDA’s review process for new tobacco products that could make it faster and easier for products such as flavored vapes and nicotine pouches to receive marketing authorization, according to The Wall Street Journal. The FDA is expected to revisit requirements established in 2021 for Premarket Tobacco Product Applications (PMTAs), following years of industry criticism over lengthy reviews.

    Reuters reported it could not independently verify the report, but quoted an HHS spokesperson as saying, “The Trump administration is committed to keeping nicotine out of the hands of kids, getting ⁠counterfeit vaping products off the streets and providing safer alternatives for adults who want to quit smoking cigarettes.”

    Industry groups and companies welcomed the potential changes. Laura Leigh Oyler, vice president of regulatory affairs at Haypp Group USA, said the FDA has not met congressional review deadlines for noncombustible products and has authorized fewer than 100 reduced-risk products compared with thousands of combustible products. “An overhaul isn’t just welcome, it’s necessary,” Oyler said, adding that the current process has contributed to the influx of foreign, illicit products.

    Charlie’s Holdings also supported the reported changes, saying it has been seeking FDA authorization for certain tobacco-derived nicotine e-liquids since 2020 and hundreds of synthetic nicotine products since 2022. CEO Henry Sicignano said the PMTA process has imposed high costs on smaller U.S. businesses while illicit products have entered the market. Charlie’s said it currently retains 678 timely filed PMTA assets and expects a streamlined authorization process to increase the value of its portfolio.

  • FDA Names Koplow as Tobacco Center Director

    FDA Names Koplow as Tobacco Center Director

    The U.S. Food and Drug Administration has selected Bret Koplow, Ph.D., J.D., as director of the Center for Tobacco Products, giving the center a permanent leader with more than a decade of legal, policy, and regulatory experience at the agency. Koplow has served at FDA since 2011, including as senior counselor to the FDA commissioner, where he focused on regulatory, policy, and operational matters involving tobacco products. He had been serving as CTP’s acting director before the appointment.

    According to the Department of Health and Human Services, Koplow will lead CTP around two priorities: promoting innovation and access to less harmful alternatives for adults who smoke while taking action to protect youth and minors from tobacco and nicotine. His appointment was part of four senior FDA leadership selections announced by HHS, including Jared Seehafer as the agency’s first deputy commissioner for technology and artificial intelligence, Michael Davis as director of the Center for Drug Evaluation and Research and Karim Mikhail as director of the Center for Biologics Evaluation and Research.

    HHS Secretary Robert F. Kennedy Jr. said the appointments are intended to advance reforms and strengthen FDA’s leadership in medical innovation. Acting FDA Commissioner Kyle Diamantas said the selections “signal the direction we are heading” as the agency seeks to build its workforce and infrastructure and accelerate innovation across its centers.

  • FDA Authorizes Three Juul2 Products

    FDA Authorizes Three Juul2 Products

    The U.S. Food and Drug Administration announced it has authorized three products in the Juul2 e-cigarette system made by Juul Labs through the premarket tobacco product application pathway. The authorization covers the Juul2 device and 18 mg/mL tobacco- and menthol-flavored pods, equivalent to roughly 1.5% to 1.6% nicotine concentration. The FDA previously authorized several Juul products in tobacco and menthol flavors at 3% and 5% nicotine concentrations in July 2025.

    The FDA said its review found that a substantial proportion of adults who smoke completely switched from cigarettes to the authorized Juul2 products. At six weeks, 19.9% to 34.6% of users of the tobacco-flavored pod and 28.4% to 49.3% of users of the menthol pod had stopped smoking completely, with the menthol product showing the higher switching rate. Adults who switched completely were exposed to lower levels of harmful chemicals than if they had continued smoking.

    The FDA determined that the population-health benefits for adults who smoke outweighed the risks of the menthol product, including its potential appeal to youth. The agency stressed that complete switching provides greater health benefits than dual use of cigarettes and e-cigarettes. The three authorizations bring the total number of e-cigarette products authorized by the FDA to 48.

  • FDA Releases New Smoking Cessation Posters

    FDA Releases New Smoking Cessation Posters

    The U.S. Food and Drug Administration’s Center for Tobacco Products has released new posters encouraging adults who smoke cigarettes to keep trying to quit. The free materials feature positive, motivational messages and direct smokers to EveryTryCounts.gov, a cessation website developed with the National Cancer Institute that offers online counseling and quitting resources. The posters are available to healthcare professionals, community organizations, and other stakeholders to order, download, and print through FDA’s Tobacco Education Resource Library.

  • FDA authorizes 11 additional ZYN nicotine pouches

    FDA authorizes 11 additional ZYN nicotine pouches

    Today (Aug. 21), the U.S. Food and Drug Administration authorized 11 new nicotine pouch products from Swedish Match USA under the Zyn Ultra brand through the premarket tobacco product application pathway. The products include 10 9-milligram varieties and one 11-milligram variety, covering flavors such as Chill, Citrus, Cool Mint, Deep Freeze, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen.

    The FDA said its review found the products contain lower levels of most harmful and potentially harmful constituents than other oral and smokeless tobacco products. The agency also said product-specific data indicated the pouches appeal primarily to adults who currently smoke cigarettes or use smokeless tobacco and could provide sufficient nicotine to reduce cravings and withdrawal symptoms, potentially supporting switching among adult tobacco users.

    “We are delighted with the FDA’s decision to authorize a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” said Stacey Kennedy, PMI U.S. CEO. “We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.” 

    The authorizations bring the number of FDA-authorized nicotine pouch products to 43, including 23 approved through the agency’s nicotine pouch pilot program. The FDA said the pilot has streamlined PMTA reviews and reduced the time needed to resolve deficiencies, with efficiencies now being applied to other tobacco-product applications.

  • FDA Proposal Would Allow Oversight of Foreign Manufacturers

    FDA Proposal Would Allow Oversight of Foreign Manufacturers

    The U.S. Food and Drug Administration proposed a rule requiring foreign tobacco product manufacturers to register their manufacturing facilities and list the tobacco products they sell in the U.S., closing a regulatory gap that currently exempts overseas manufacturers from requirements already imposed on domestic companies. The agency said the proposal would strengthen its ability to identify and take action against illegal tobacco products—particularly unauthorized disposable e-cigarettes—and create a more level playing field for U.S. manufacturers.

    If finalized, the rule would require both foreign and domestic manufacturers to register their establishments, submit detailed product information, and update registrations annually and product listings twice a year. Foreign facilities would also become subject to FDA inspections, giving the agency greater oversight of products before they enter the U.S. market. Manufacturers would also be required to maintain records of labeling, advertising, and consumer information for at least four years.

    According to the FDA, the proposal would improve enforcement by providing more comprehensive information on tobacco products manufactured for the U.S. market and expanding oversight of foreign producers. Acting Center for Tobacco Products Director Bret Koplow said the rule would help ensure all companies selling tobacco products in the U.S. operate under the same standards while strengthening the agency’s ability to keep illegal products out of the marketplace. Public comments will be accepted through Sept. 14.

  • FDA Reports Efforts Prevented 450K Youth from Vaping

    FDA Reports Efforts Prevented 450K Youth from Vaping

    The U.S. Food and Drug Administration published new information in a special issue of the American Journal of Preventive Medicine highlighting the measurable public health impact of its youth tobacco prevention efforts, particularly the “The Real Cost” campaign. According to studies featured in the issue, the campaign is estimated to have prevented roughly 444,252 U.S. youth from initiating e-cigarette use between 2023 and 2024, while also reducing an estimated $42 million in illegal e-cigarette sales that would have otherwise been consumed by minors. The findings are based on peer-reviewed research and analyses conducted by FDA scientists and external collaborators, reinforcing the campaign’s effectiveness in shaping youth behavior at scale.

    FDA officials, including leadership from the Center for Tobacco Products, emphasized that the results demonstrate how sustained, evidence-based public education can materially shift youth attitudes and reduce nicotine initiation. The special journal issue compiles 12 studies examining campaign reach, audience segmentation, behavioral impact, and cessation engagement. One analysis found that roughly three-quarters of surveyed youth reported exposure to at least one prevention ad, with especially strong reach among higher-risk groups, while another showed more than 253,000 visits driven to the SmokefreeTeen cessation platform, including over 11,000 completed quit plans.

    The FDA’s broader claim is that “The Real Cost” campaign — launched in 2014 for cigarettes and expanded in 2018 to address vaping — has become a long-running model for data-driven prevention messaging. Officials argue that its demonstrated impact on youth behavior and attitudes provides a foundation for expanding educational efforts, including potential messaging aimed at influencing adults who smoke toward cessation and harm reduction, while maintaining a continued focus on preventing youth initiation.

  • FDA: Youth Tobacco Use Remains Near Historic Lows

    FDA: Youth Tobacco Use Remains Near Historic Lows

    Today (June 23), the U.S. Food and Drug Administration reported continued declines in youth tobacco use, releasing findings from its 2025 National Youth Tobacco Survey showing that current use of tobacco products among middle and high school students fell between 2022 and 2025 across overall tobacco products, combustible products and e-cigarettes. Earlier this year, the FDA released raw NYTS data without comment.

    In 2025, approximately 2 million students, or 7.2% of U.S. middle and high school students, reported using any tobacco product in the past 30 days, while 2.7% reported using multiple tobacco products and 2.6% reported using combustible products.

    E-cigarettes remained the most commonly used category at 5.2%, followed by nicotine pouches at 1.7% and cigarettes at 1.4%. While nicotine pouch use increased among high school students over the 2022-2025 period, FDA said overall youth use remained low and was stable between 2024 and 2025. The agency said the findings support ongoing youth prevention efforts, including enforcement against unauthorized tobacco products and educational campaigns, while continuing to inform regulatory reviews of new tobacco and nicotine products.

  • Zest Gets Injunction Against FDA for Pouches

    Zest Gets Injunction Against FDA for Pouches

    Zest Brands LLC announced that it secured a preliminary injunction from the U.S. District Court for the Middle District of Florida, allowing its ZEO Universe nicotine pouch products to remain on the U.S. market while the company challenges an FDA Refuse-to-File (RTF) decision related to its May 2022 Premarket Tobacco Product Applications. The injunction temporarily stays the FDA’s action as the case proceeds through the courts.

    According to the company, the court found Zest Brands is likely to succeed on claims that the FDA failed to adequately assess the impact of its 2021 PMTA regulations on small businesses, as required under the Regulatory Flexibility Act. The court also indicated that aspects of the agency’s actions may have been “arbitrary and capricious.” Zest said it remains committed to working with the FDA to complete the PMTA process and is currently in discussions with strategic and financial partners to support future growth.

  • FDA Targets ‘Disguised’ Nicotine Products in Retail Crackdown

    FDA Targets ‘Disguised’ Nicotine Products in Retail Crackdown

    The U.S. Food and Drug Administration issued warning letters to eight retailers for selling unauthorized nicotine pouches and dissolvable tobacco products designed to resemble candy, breath strips, and cough drops, raising concerns that the items could both appeal to children and be accidentally ingested by young kids. According to the agency, the products’ labeling, advertising, and design mimic everyday consumer goods, “disguising” them and making it easier for youth to conceal their use from adults.

    Acting Center for Tobacco Products Director Bret Koplow said no tobacco product should look like candy and described the practice as a tactic to mask the products’ true nature. The retailers were cited for violating the Federal Food, Drug, and Cosmetic Act by selling products without FDA authorization and were ordered to correct the violations or face potential penalties, including seizures, injunctions, and/or fines. The action follows recent FDA guidance outlining enforcement priorities for unauthorized electronic nicotine delivery systems and nicotine pouch products, part of a broader push to remove youth-appealing products from the market.

    The agency noted it has now issued more than 800 warning letters to manufacturers and distributors and over 1,000 to retailers over unauthorized tobacco sales, and reminded retailers to consult its updated list of legally marketed products and use available compliance materials.