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Spree Bar, a vaping system delivering a synthetic nicotine analogue, marketed in the USA as ‘PMTA exempt’
  1. Sven Eric Jordt1,2,
  2. Sairam V Jabba1,2,
  3. Patricia J Zettler3,4,
  4. Micah L Berman3,4
  1. 1Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina, USA
  2. 2Yale Tobacco Center of Regulatory Science, Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA
  3. 3College of Public Health, The Ohio State University, Columbus, Ohio, USA
  4. 4The Ohio State University Moritz College of Law, Columbus, Ohio, USA
  1. Correspondence to Professor Sven Eric Jordt, Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina, USA; sven.jordt{at}duke.edu

https://doi.org/10.1136/tc-2023-058469

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    Background

    In February 2021, the popular vaping company, PuffBar, started selling disposable e-cigarettes in the USA containing synthetic nicotine, claiming to be exempt from federal and state laws regulating products containing tobacco-derived nicotine.1 US lawmakers responded to the emerging synthetic nicotine market by clarifying that synthetic nicotine products are subject to the US Food and Drug Administration’s (FDA) regulatory regimen for tobacco products.1–3 As of 14 April 2022, the FDA has been authorised to regulate tobacco products containing nicotine from any source, including laboratory synthesis, requiring manufacturers to submit a premarket tobacco product application (PMTA).3 In October 2022, the FDA sent a warning letter to the company, alerting the owners that its products are ‘marketed unlawfully and are subject to enforcement action at FDA’s discretion’.4 5 Currently, the company appears to be selling Puffbar-branded e-cigarette products without nicotine only.6

    While many countries have updated their tobacco product laws to cover synthetic nicotine, or are in the process of doing so, a recent WHO report warned that non-nicotine tobacco alkaloids or synthetic nicotine analogues could be used by manufacturers to bypass regulatory schemes focusing on nicotine alone.2 Non-nicotine tobacco alkaloids such as anabasine, nornicotine, anatabine and myosmine have well-known addictive and reinforcing effects.7–10 Starting in the 1970s, tobacco companies also developed various synthetic nicotine analogues and studied whether they could be used to dissociate nicotine’s central and peripheral effects, to create more desirable products, to circumvent regulation or to develop pharmaceuticals.11 The tobacco companies, however, never used these synthetic nicotine analogues in commercial products until now.

    Spree Bar, a ‘PMTA exempt’ electronic cigarette system

    The concern that companies might use synthetic nicotine analogues in order to avoid regulation is no longer hypothetical. As of October 2023, vape stores in the USA had started selling a new electronic cigarette pod system named Spree …

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    Footnotes

    • Twitter @sejordt, @pzettler

    • Contributors SEJ and MLB conceptualised and designed the study and wrote the first draft of the paper; SVJ provided advice on product choice and figures design. SVJ and PJZ contributed to revision of the manuscript. All authors critically reviewed, edited and approved the final draft before submission. SEJ attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

    • Funding This work was supported by grant R56DA055996 and cooperative agreement U54DA036151 (Yale Tobacco Center of Regulatory Science) to SEJ from the National Institute on Drug Abuse and cooperative agreement U54CA287392 (Ohio State Tobacco Center of Regulatory Science) to MLB from the National Cancer Institute of the National Institutes of Health, and by the USFood and Drug Administration Center for Tobacco Products.

    • Disclaimer The funding organisation had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; nor in the decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not necessarily represent the views of National institutes of Health or the Food and Drug Administration.

    • Competing interests No, there are no competing interests.

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