You are here

  • Home
  • Online First
  • Unauthorised therapeutic claims on e-cigarette and nicotine pouch company websites in the USA

Article Text

Article menu
Download PDFPDF
Industry watch
Unauthorised therapeutic claims on e-cigarette and nicotine pouch company websites in the USA
  1. Meagan O’Neill Robichaud1,
  2. Kevin R J Schroth1,2,
  3. Michael B Steinberg1,3,
  4. Cristine D Delnevo1,2
  1. 1Rutgers Institute for Nicotine & Tobacco Studies, New Brunswick, New Jersey, USA
  2. 2Department of Health Behavior, Society and Policy, Rutgers School of Public Health, Piscataway, New Jersey, USA
  3. 3Department of Medicine, Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey, USA
  1. Correspondence to Dr Meagan O’Neill Robichaud; mr2142{at}ints.rutgers.edu

https://doi.org/10.1136/tc-2025-059338

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    Unsubstantiated, false or misleading health claims can lead consumers to use products not tested for safety and effectiveness. This paper highlights misleading cessation claims for two products: KickNic, a disposable vaping device containing a ‘nicotine substitute’, and YELLO, a nicotine pouch.1 2 Both manufacturers violate the Federal Food, Drug and Cosmetic Act (FDCA) by making misleading therapeutic claims. In the USA, the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) oversees therapeutic claims.3 4 Drugs must demonstrate safety and effectiveness—in this case, as nicotine cessation aids—for CDER approval.3 4 Alternatively, the FDA’s Center for Tobacco Products (CTP) authorises reduced risk claims for commercial tobacco and nicotine products.5 6 No e-cigarettes or nicotine pouches have been authorised to make reduced risk claims or approved as cessation aids by the FDA.7–9

    KickNic resembles a disposable e-cigarette but contains ‘NoNic6’, which is described as a ‘non-nicotine compound that provides users an experience similar to traditional nicotine liquids.’10 Since KickNic does not contain nicotine, it does not meet the federal definition of a tobacco product and is outside …

    View Full Text

    Footnotes

    • X @Robichaud_MO, @kevinschroth, @crisdelnevo

    • Contributors KRJS and CDD conceptualised the manuscript. MOR and KRJS led the writing of the manuscript with contributions and editing from all co-authors.

    • Funding This work was funded in part by grants U01CA278695 and U54CA229973 from the National Cancer Institute and the US Food and Drug Administration. The content is solely the responsibility of the authors and does not necessarily represent the official view of NIH or FDA.

    • Competing interests No, there are no competing interests.

    • Provenance and peer review Not commissioned; externally peer reviewed.