Article Text

Levels of nicotine and tobacco-specific nitrosamines in oral nicotine pouches
  1. Nadja Mallock,
  2. Thomas Schulz,
  3. Sebastian Malke,
  4. Nadine Dreiack,
  5. Peter Laux,
  6. Andreas Luch
  1. Department of Chemical and Product Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany
  1. Correspondence to Dr Nadja Mallock, Department of Chemical and Product Safety, German Federal Institute for Risk Assessment (BfR), 10589 Berlin, Germany; nadja.mallock{at}


Background Nicotine pouches without tobacco are new products that deliver nicotine into the body via the oral mucosa. There is a lack of independent research on the chemical composition and product characteristics of these products, contributing to uncertainties regarding product regulation. This study sought to address knowledge gaps by assessing levels of nicotine and screening for tobacco-specific nitrosamines (TSNAs) in a sample of these products.

Methods Nicotine pouches (n=44) and nicotine-free pouches (n=2) from 20 different manufacturers were analysed regarding their contents of nicotine and TSNAs by gas chromatography with flame ionisation and liquid chromatography–tandem mass spectrometry, respectively. Product labelling and pH values of aqueous extracts were determined.

Results Nicotine contents of products ranged from 1.79 to 47.5 mg/pouch; median product weight, pH, and proportion of free-base nicotine were 0.643 g, 8.8, and 86%, respectively. A clear labelling of the nicotine content was missing on 29 products and nicotine strength descriptions were ambiguous. TSNAs were detected in 26 products, with a maximum of 13 ng N-nitrosonornicotine/pouch.

Conclusion Although nicotine pouches may potentially be a reduced risk alternative for cigarette smokers or users of some other oral tobacco products, nicotine contents of some pouches were alarmingly high. Presence of carcinogenic TSNAs in the nicotine pouches is of serious concern. Better manufacturing processes and quality control standards should be implemented. Labels of nicotine strength on most products are misleading. A strict regulation regarding nicotine contents and its labelling would be advisable.

  • Nicotine
  • Packaging and Labelling
  • Non-cigarette tobacco products
  • Carcinogens

Data availability statement

All data relevant to the study are included in the article or uploaded as supplemental information.

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Data availability statement

All data relevant to the study are included in the article or uploaded as supplemental information.

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  • Contributors NM, TS, PL and AL contributed to the implementation and design of this study. Project administration was carried out by NM. NM, TS, PL and AL supervised the study. NM, SM and ND established and validated the analytical methods and performed the experiments and data analysis. NM drafted the manuscript. All authors have reviewed and refined the manuscript. NM is the guarantor of this work.

  • Funding The project was financially supported by intramural funding of the German Federal Institute for Risk Assessment (BfR) (SFP Grant No. 1322-772).

  • Competing interests None declared.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.