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Tag: FDA

  • Altria Sues FDA Over Product Review System 

    Altria Sues FDA Over Product Review System 

    Altria announced that it has filed a lawsuit against the U.S. FDA in federal court, seeking to force the agency to overhaul its tobacco product review system, which the company says has become a major barrier to growth in the U.S. market. Altria argues that lengthy review delays, including applications remaining pending for years, disadvantage compliant manufacturers while unauthorized products continue to gain market share. 

    The lawsuit is the latest industry challenge to the FDA’s premarket review regime, which requires new tobacco products to demonstrate a net public health benefit before sale. Altria says the agency has failed to meet the statutory 180-day review deadline and argues that recent FDA changes—including a fast-track pathway for nicotine pouches—still have not resolved the backlog. 

  • 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.

  • 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.