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Oral nicotine pouch manufacturer’s reduced exposure claims require evidence and regulatory oversight
  1. Mahmood A Alalwan1,2,
  2. Darren Mays1,2,
  3. Micah L Berman2,3,4,
  4. Ahmad El-Hellani2,5,
  5. Brittney L Keller-Hamilton1,2,
  6. Marielle C Brinkman2,6,
  7. Theodore L Wagener1,2,
  8. Alayna P Tackett1,2
  1. 1Department of Internal Medicine, The Ohio State University College of Medicine, Columbus, Ohio, USA
  2. 2Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA
  3. 3Division of Health Services Management and Policy, The Ohio State University College of Public Health, Columbus, Ohio, USA
  4. 4The Ohio State University Moritz College of Law, Columbus, Ohio, USA
  5. 5Division of Environmental Health Sciences, The Ohio State University, Columbus, Ohio, USA
  6. 6Division of Epidemiology, The Ohio State University College of Public Health, Columbus, Ohio, USA
  1. Correspondence to Dr Mahmood A Alalwan, Department of Internal Medicine, The Ohio State University College of Medicine, Columbus, Ohio, USA; alalwan.2{at}osu.edu

https://doi.org/10.1136/tc-2024-058610

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    Starting in 2020, several nicotine product manufacturers (eg, Puff Bar and Fre) exploited a loophole in the Tobacco Control Act (TCA) by claiming their products contained tobacco-free synthetic nicotine (SyN) and were not subject to the Food and Drug Administration’s (FDA) authority.1–3 In response, the US Congress passed a law in March 2022 expanding the TCA’s definition of ‘tobacco products’ to include products containing nicotine ‘from any source,’ including SyN. Non-therapeutic products containing SyN are subject to FDA regulation as tobacco products and must comply with all applicable regulations. As part of its enforcement against illegal nicotine products, FDA has issued warning letters to manufacturers (eg, Puff Bar in October 2022) and retailers of products purportedly containing SyN, and it has issued civil money penalties.4

    FDA’s regulatory authority includes oversight of modified-risk tobacco products (MRTPs). An MRTP is defined, in part, as any product with labelling or advertising that ‘explicitly or implicitly’ claims to reduce risks (‘reduced harm’ claims) or exposure to specific substances (‘reduced exposure’ claims) in comparison to other tobacco products.5 Product labelling and advertising cannot include such claims unless they have been reviewed and authorized by …

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    Footnotes

    • X @TheodoreWagener

    • Contributors MAA led the writing of the manuscript’s first draft. APT conceptualized the study and contributed substantially to writing and editing the manuscript. DM, MLB, AEH, BKH, MCB and TLW contributed substantially to writing and editing the manuscript.

    • Funding The research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health (NIH) and the Food and Drug Administration Center for Tobacco Products (CTP) under grant number U54CA287392. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration.

    • Competing interests None declared.

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