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Systematic Review
Oral nicotine pouches (ONP) emerged in the late 2000s, but have gained popularity since their introduction to the global market in 2016, with claims about their harm reduction potential.
These are preportioned pouches containing nicotine, sold in various flavours and nicotine strengths. They are similar in appearance and use to snus. Snus is a form of smokeless tobacco placed between the gum and lip that is popular in Nordic countries, but whose sale is banned in the UK and European Union countries excluding Sweden. Unlike snus, nicotine pouches do not contain tobacco leaf. Like nicotine e‐cigarettes and pharmaceutical forms of nicotine replacement therapy (such as nicotine patches and gums), oral nicotine pouches may be able to help people transition away from harmful forms of tobacco/nicotine product use by replacing them with a product that does not contain tobacco leaf and which, unlike e‐cigarettes, does not involve inhaling vapour into the lungs.
The authors wanted to find out if oral nicotine pouches can help people transition away from smoking, nicotine vaping, or other forms of tobacco use.
The authors included four small studies (n < 150 for each, total n = 284; 3 independent, 1 industry‐funded; 3 at high risk of bias and 1 at unclear risk of bias). All were RCTs in people who smoked combustible cigarettes at baseline. Three were conducted in the USA, and one in New Zealand. Two compared higher‐ versus lower‐nicotine dose ONP. Two compared ONP to instructions to continue smoking as usual. One each compared ONP to electronic cigarettes (e‐cigarettes), snus, and pharmaceutical nicotine replacement therapy (NRT).
The studies were conducted between 2006 and 2023, and in those that reported race or ethnicity, were conducted in majority white populations. The average age across studies ranged from 34 to 50 years. The average number of cigarettes smoked by participants at study start was between 14 and 23 per day.
Smoking abstinence
Smoking abstinence may be slightly higher in people randomised to ONP compared to no intervention at eight‐week follow‐up (RR 1.58, 95% CI 0.07 to 35.32; 1 study, 27 participants; very low‐certainty evidence (risk of bias and imprecision; CI incorporated possibility of no difference)), but the evidence is very uncertain. Low‐certainty evidence (serious imprecision; CI incorporated possibility of no difference) suggests there may be lower abstinence rates in those randomised to ONP compared to e‐cigarettes (RR 0.25, 95% CI 0.03 to 2.02; 1 study, 36 participants). Evidence from one study (n = 30) comparing higher‐ versus lower‐dose ONP found a higher quit rate in the higher‐dose arm, but again with wide CI encompassing the possibility of no difference and of higher quit rates in the lower‐dose arm (RR 5.00, 95% CI 0.26 to 96.13; evidence certainty not assessed).
There is limited evidence on the use of ONP for cessation or reduction of cigarette use. There is no evidence on the use of ONP for cessation or reduction of other tobacco or nicotine products or on the effects of ONP on prevalence of tobacco use/nicotine vaping. Low‐certainty evidence suggests that people randomised to ONP may be slightly less likely to quit smoking than those randomised to e‐cigarettes, but data were from one small study and therefore imprecise. Limited, short‐term data did not identify any serious health harms from ONP when used to help people transition away from tobacco smoking.
More research on the effects of ONP for cessation or reduction of use of other tobacco or non‐pharmaceutical nicotine products is urgently needed. Future trials should prioritise comparing ONP to other active interventions (e.g. NRT and e‐cigarettes).