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Tag: FDA

  • FDA’s Koplow to Address NATO’s Anniversary Event

    FDA’s Koplow to Address NATO’s Anniversary Event

    The National Association of Tobacco Outlets announced that Acting FDA Center for Tobacco Products Director Dr. Bret Koplow will deliver a keynote address and participate in a fireside chat at the association’s 25th Anniversary Celebration & Legislative Update on Sept. 29-30 in Washington, D.C. Koplow is expected to discuss regulatory developments involving the CTP.

    The event will also feature a bipartisan review of the political landscape, FDA analysis, legislative and Capitol Hill engagement sessions, and a NATO membership listening session.

  • Wyden Seeks Records Over Donations and Policy Changes

    Wyden Seeks Records Over Donations and Policy Changes

    Sen. Ron Wyden, the ranking Democrat on the Senate Finance Committee, launched an investigation seeking documents related to what he alleges are potential links between political donations from the tobacco and kratom industries and subsequent Trump administration policy decisions, according to the International Business Times. In letters sent to Health and Human Services Secretary Robert F. Kennedy Jr., Reynolds American, and other parties, Wyden requested records concerning regulatory actions affecting flavored e-cigarettes and kratom products.

    According to Wyden’s letters, Reynolds American donated $5 million to the pro-Trump political action committee MAGA Inc. in April, followed by a meeting between a company executive and President Donald Trump. Wyden alleges the timing raises questions about whether later policy changes, including actions affecting flavored vaping products, were influenced by industry interests. The letters also raise concerns about Homeland Security Secretary Markwayne Mullin’s reported financial interest in kratom company Botanic Tonics while advocating policies related to the sector. Wyden requested responses by Aug. 31.

    The letters contain allegations only, and no evidence of wrongdoing has been established. Reynolds American, Botanic Tonics, and the Department of Health and Human Services have disputed or declined to comment on the allegations.

  • VTA Poll Finds Support for Science-Based Vape Regulation Reform

    VTA Poll Finds Support for Science-Based Vape Regulation Reform

    A nationwide survey in the United States commissioned by the Vapor Technology Association (VTA) found broad bipartisan support for reforming the FDA’s regulatory framework for vaping products, with particularly strong backing among President Donald Trump’s voters. Conducted by pollster Kellyanne Conway among 1,204 registered voters, including an oversample of 200 Trump voters, the survey found 71% support replacing the current FDA PMTA framework with science-based standards and 77% favor allowing vapor products with pending FDA applications that do not target youth to remain on the market while a revised system is implemented.

    The poll also found 65% of respondents support FDA reforms that would allow flavored vaping products for adults while maintaining youth protections, and 67% said regulations should reflect adult consumer demand for flavored products. At the same time, respondents strongly supported youth access restrictions, with 86% supporting robust age verification for all vape purchases, 84% favoring tougher penalties for retailers who sell to minors, and 80% supporting bans on youth-oriented marketing and product designs.

    VTA said the findings demonstrate public support for a streamlined, science-based regulatory pathway that differentiates adult access from youth prevention and promotes U.S.-based manufacturing. The association argued the current FDA regulatory system should be replaced with clearer scientific benchmarks that allow adult smokers access to authorized alternatives while enabling smaller manufacturers to compete alongside larger tobacco companies.

  • FDA Authorizes Four New on! Nicotine Pouches

    FDA Authorizes Four New on! Nicotine Pouches

    The U.S. Food and Drug Administration announced the authorization of four additional on! nicotine pouch products through the premarket tobacco product application (PMTA) pathway: Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg. Manufactured by Helix Innovations LLC, the products were reviewed under the FDA’s nicotine pouch pilot program, which is designed to streamline PMTA reviews and improve review efficiency. The agency said lessons from the pilot are now being applied to other PMTA reviews.

    The FDA concluded that the newly authorized products contain lower levels of most harmful and potentially harmful constituents than traditional oral and smokeless tobacco products. The agency said adults 21 and older who completely switch from cigarettes or smokeless tobacco to FDA-authorized nicotine pouches may reduce their exposure to harmful chemicals, while noting that dual use does not provide the same level of risk reduction. With the latest authorizations, the FDA has now authorized 30 nicotine pouch products through the PMTA pathway.

  • Pilot Study Promising as AIR Invests $20M in Greentank

    Pilot Study Promising as AIR Invests $20M in Greentank

    AIR Global announced a $20 million investment in vaporization technology company Greentank Innovations, deepening a strategic partnership established in 2023. The investment gives AIR preferred shares based on a $170 million pre-money valuation, a warrant to increase its stake by an additional 20% over the next two years, a board nomination right, and enhanced commercial and technology access. AIR said the investment supports its growth strategy in reduced-risk nicotine products and its planned U.S. premarket tobacco product application for its Crown Switch vape.

    AIR also released results from an independent pilot study of its Greentank-powered Crown Switch device, reporting low or non-detectable levels of several harmful or potentially harmful constituents in the aerosol. According to the company, carbon monoxide, benzene, and 1,3-butadiene were not detected, while formaldehyde, nickel, and other constituents were reported at lower levels than published data for certain FDA-authorized e-cigarettes. AIR said the preliminary findings will be presented at the 2026 Tobacco Science Research Conference and will form part of its PMTA submission, noting that additional testing is underway and future results may differ.

  • Retail Groups Urge Processors to Revise Vape Enforcement Policies

    Retail Groups Urge Processors to Revise Vape Enforcement Policies

    The National Association of Convenience Stores and several retail and tobacco trade associations urged Global Payments and Mastercard to revise policies that penalize retailers for selling certain electronic nicotine delivery system products, according to CSP. In letters to the companies, the groups argued the payment processors’ enforcement standards do not reflect the U.S. Food and Drug Administration’s updated enforcement priorities, which allow enforcement discretion for certain products with pending premarket tobacco product applications.

    The letters, also signed by the National Association of Tobacco Outlets, Energy Marketers of America, and the Convenience Distribution Association, expressed support for removing illicit vaping products from the market but said responsible retailers should not face penalties that exceed current FDA policy. The request follows updated FDA guidance issued in May and comes after a coalition of state attorneys general urged major payment networks to take action against merchants selling unauthorized vaping products.

  • 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.

  • Minnesota AG Sues Local Company for Selling Flavored Vapes

    Minnesota AG Sues Local Company for Selling Flavored Vapes

    Minnesota AG Keith Ellison filed a lawsuit against local e-cigarette manufacturer Maduro Distributors, alleging the company sold banned flavored vape products under its The Loon brand that were marketed in ways appealing to youth. The complaint, filed in Ramsey County District Court, accuses the Fridley-based company of selling products with flavors including cotton candy and blue razz slushy, using “kid-friendly characters” in promotions, and falsely representing some products as FDA-approved.

    The Loon sells disposable and refillable vapes as well as nicotine pouches and previously received an FDA warning letter for marketing unauthorized products, according to The Minnesota Star Tribune. Maduro said it had changed flavor names before Minnesota’s 2024 ban took effect and removed the FDA approval claim from a third-party website, arguing it had cooperated with state officials.

  • 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.

  • Public Health Groups Sueing FDA Over New Vape, Pouch Stance

    Public Health Groups Sueing FDA Over New Vape, Pouch Stance

    A coalition of public health organizations, including the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Heart Association, and American Lung Association, filed a federal lawsuit yesterday (July 14) challenging the U.S. Food and Drug Administration’s May 2026 enforcement guidance for e-cigarettes and nicotine pouches. The plaintiffs argue the policy unlawfully allows unauthorized products to remain on the market without the premarket scientific review required under the Tobacco Control Act, creating an enforcement safe-harbor for products that FDA has previously identified as posing significant youth appeal.

    Filed in the U.S. District Court for the District of Maryland, the lawsuit seeks to overturn the guidance, alleging it violates both the Tobacco Control Act and the Administrative Procedure Act, and could have significant implications for manufacturers and retailers by determining whether products with pending marketing applications can continue to be sold while awaiting FDA review.