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Tag: flavored vape

  • Researchers: Flavored-Vape Debate Needs to Follow Science, Not Politics

    Researchers: Flavored-Vape Debate Needs to Follow Science, Not Politics

    The resignation of FDA Commissioner Marty Makary on May 12 over reported tensions with President Donald Trump regarding the agency’s approval of two fruit-flavored nicotine vapes brought the flavored-vape battle front and center in American politics. The decision marked a shift from the FDA’s previous authorization of only tobacco and menthol flavors and reignited debate over flavored vaping products.

    Three public health researchers warned the debate over fruit-flavored nicotine vapes should be guided by evidence, not politics. Dr. Jamie Hartmann-Boyce from the University of Massachusetts Amherst, Dr. Holly Jarman from the University of Michigan School of Public Health, and Dr. Claire L. Ma from the University of Michigan, who study scientific evidence, health policy, and regulation, respectively, acknowledged both sides of the debate, where studies show that sweet and fruity flavors can attract youth and non-smokers, but also that vaping is significantly less harmful than smoking and may help adult smokers quit. The authors urged lawmakers and regulators to follow scientific findings when shaping vape policy, as researchers continue to discover the benefits and risks of vape use.

  • NJOY Sues FDA Over Delays in Flavored E-Cigarette Approval

    NJOY Sues FDA Over Delays in Flavored E-Cigarette Approval

    NJOY LLC, a subsidiary of Altria Group, filed a lawsuit in federal court in Louisiana last week (August 21), accusing the U.S. Food and Drug Administration (FDA) of unlawfully delaying its review of applications to market flavored e-cigarettes. According to NJOY, the FDA has failed to adhere to statutory deadlines stipulated in the Family Smoking Prevention and Tobacco Control Act. The company claims such delays unfairly hinder its efforts to provide adult smokers with reduced-risk alternatives to combustible tobacco.

    According to the filing, in December 2020, the FDA denied NJOY’s application with only one deficiency listed: that the flavored products’ applications did not show they “would increase the likelihood of complete switching among adult smokers, compared to the Rich Tobacco and Menthol varieties” (products that were granted marketing authorization). In March 2021, NJOY responded, providing data showing the flavored products’ switch rates were 29-68% higher than the approved products after six months of use. The FDA has yet to respond despite repeated requests for updates, leading to last week’s lawsuit.

    Additionally, the filing states that documents received during a Freedom of Information Act request revealed that the Office of Science’s epidemiology staff concluded that NJOY adequately addressed the flavor-specific deficiency and that the products were associated with higher rates of cessation, and also that unrequested sales restrictions and reporting requirements offered by NJOY would, according to the Office of Health Communication and Education, mitigate concerns about potential youth initiation.

    The lawsuit underscores growing tensions between major industry firms and the FDA, which is facing a massive backlog of Premarket Tobacco Product Applications, particularly as sales of unauthorized flavored vaping products continue to surge. NJOY argues the delays not only burden its business, but also limit smokers’ access to potentially less harmful products.