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Tag: FDA

  • Trump Taps White House Policy Aide Heidi Overton to Lead FDA

    Trump Taps White House Policy Aide Heidi Overton to Lead FDA

    According to a Bloomberg report, President Donald Trump has chosen White House policy aide Heidi Overton to lead the Food and Drug Administration, according to a person familiar with the matter. Overton is deputy assistant to the president for domestic policy, where she works on health issues, and previously worked at the America First Policy Institute. She is a medical doctor with a doctorate in clinical investigation from Johns Hopkins University and served as a White House fellow during Trump’s first administration.

    Overton would take over an agency that has experienced significant leadership turnover and internal turmoil. Former FDA Commissioner Marty Makary resigned in May after 13 months in the position, followed by the departures of several senior officials. The new commissioner will also face Senate confirmation under Health Committee Chair Bill Cassidy, R-La., who has clashed with both Trump and Health Secretary Robert F. Kennedy Jr.

    Overton and the White House had not immediately commented on the reported selection.

  • 5th Circuit Blocks FDA’s 11 Graphic Cigarette Warnings

    5th Circuit Blocks FDA’s 11 Graphic Cigarette Warnings

    The 5th U.S. Circuit Court of Appeals ruled that the FDA exceeded its authority by requiring cigarette packages and advertisements to carry 11 graphic health warnings, upholding a lower-court order that blocked the rule from taking effect. The ruling, reported by Reuters, is a setback for the FDA’s long-running effort to implement the warning-label provisions of the 2009 Family Smoking Prevention and Tobacco Control Act.

    Writing for the three-judge panel, U.S. Circuit Judge Don Willett said Congress authorized nine specific warnings and that the FDA could not add two additional warnings on its own. The FDA’s proposed images covered health effects including bladder, head and neck cancers, fatal lung disease, impaired fetal growth, cataracts, and Type 2 diabetes. “The FDA may require the nine warnings Congress prescribed — no more,” Willett wrote.

    The case was brought by R.J. Reynolds Tobacco Co., ITG Brands, and JTI Liggett after the FDA revived the graphic-warning requirement in 2019 following years of litigation. The 5th Circuit previously rejected a First Amendment challenge to the rule in 2024, but a Texas federal judge later blocked it on separate statutory grounds. The latest ruling addresses that issue and leaves the FDA’s implementation of the 2009 warning requirement facing further legal obstacles. The case is R.J. Reynolds Tobacco Company v. Food and Drug Administration, No. 25-40137.

  • Charlie’s Holdings Reports 116% Growth, Optimism on FDA Front

    Charlie’s Holdings Reports 116% Growth, Optimism on FDA Front

    Charlie’s Holdings reported second-quarter revenue of $3.8 million, up 116% from $1.8 million a year earlier, driven by higher sales of nicotine-based and nicotine-alternative products. Gross profit rose 130% to $1.1 million, while gross margin increased to 29.4% from 27.6%. Operating expenses increased 63% to $2.4 million, resulting in an operating loss of $1.2 million, compared with $1 million in Q2 2025.

    The company said the FDA has tentatively identified 30 PACHA SKUs with submitted premarket tobacco applications for inclusion on a public webpage covering products for which the agency generally does not intend to prioritize enforcement of PMTA requirements. Charlie’s said the development could improve the regulatory outlook for the products, although the company described the status as tentative. The company also cited the FDA’s May authorization of four flavored ENDS products from Glas as a potentially significant development for the U.S. vapor market.

    Charlie’s said it remains on schedule to test-market what it describes as the first age-gated flavored disposable vape in the U.S. through hundreds of retail stores. The company also launched SBX 25K Virginia Tobacco disposables in California and said it has received California Unflavored Tobacco List authorization for four modern disposable products. Charlie’s ended the quarter with $500,000 in cash, down from $1.3 million at year-end 2025, while total assets increased to $12.8 million. Management and directors purchased 1.35 million restricted shares during the first half at $0.20 per share.

  • 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.