Key messages
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Limited evidence from three small studies found no short-term serious health harms of oral nicotine pouches in people who smoke.
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We are uncertain if oral nicotine pouches help people quit smoking compared to instructions to continue smoking as usual or no support to quit.
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Future research is needed, in particular comparing oral nicotine pouches to other active treatments (e.g. nicotine replacement therapy and e-cigarettes).
What are oral nicotine pouches?
Oral nicotine pouches 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.
Common brand names of oral nicotine pouches include Zyn, Velo, and Nordic Spirit.
What did we want to find out?
We wanted to find out if oral nicotine pouches can help people transition away from smoking, nicotine vaping, or other forms of tobacco use. We also wanted to know if oral nicotine pouches caused any unwanted effects when used for this purpose.
What did we do?
We searched for studies where people who smoked, vaped, or used other tobacco products were given oral nicotine pouches as a way to quit. We included studies if they tracked tobacco use or vaping for at least four weeks or looked at unwanted effects or chemical changes in the blood, breath, or urine for at least one week.
What did we find?
We found four studies including a total of 284 people who were smokers at study start. 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. The longest study ran for eight weeks. Three studies were independently funded, and one was funded by a tobacco manufacturer.
Based on two small studies, it was not clear whether using nicotine pouches helped more people to quit smoking compared to instructions to continue smoking as usual or no support to quit, and there may be lower quit rates in those using nicotine pouches compared to those using a nicotine e-cigarette (vaping).
No serious health harms occurred in any group in the three studies that reported this information, so it is unclear if using nicotine pouches affects the chances of experiencing a serious health harm.
We also looked at certain chemicals measured in blood, breath, or urine that can signal exposures to harmful substances. Tobacco use exposes the body to cancer-causing chemicals. NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), a chemical formed when these cancer-causing chemicals enter the body, measures exposure to harmful ingredients in tobacco smoke. One small study reported lower levels of NNAL in people using oral nicotine pouches compared to those given no specific treatment to stop smoking. Combined evidence from two studies suggested no difference in NNAL levels between people receiving higher- versus lower-dose nicotine pouches. Carbon monoxide is a poisonous gas present in tobacco smoke. When carbon monoxide binds with blood haemoglobin, it forms a substance called carboxyhaemoglobin. Carboxyhaemoglobin measures how much carbon monoxide a person has been exposed to in their blood. One study found lower levels of carboxyhaemoglobin in people using oral nicotine pouches compared to those who continued smoking. When comparing higher- versus lower-dose nicotine pouches, the same study found very slightly lower carboxyhaemoglobin levels in the higher-dose group.
What are the limitations of the evidence?
We have little to very low confidence in the evidence because the studies were relatively small, and there are not enough studies to be certain about the results. Also, some studies had issues with the way they were designed that could have affected their results. Many studies are currently underway, and we plan to update this review when their findings become available.
How up-to-date is this evidence?
The evidence is current to January 2025.
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Matlamat
Primary objectives
• To evaluate the benefits and harms of ONP when used to help people transition away from combustible tobacco use (smoking).
• To evaluate the impact of ONP on the prevalence of combustible tobacco use.
Secondary objectives
• To evaluate the benefits and harms of ONP when used to help people transition away from other non-combustible tobacco/commercial nicotine product use.
• To evaluate the impact of ONP on the prevalence of use of other non-combustible tobacco/commercial nicotine products.
Kaedah Pencarian
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO from 2000 to 13 January 2025. We also covered ClinicalTrials.gov and the WHO ICTRP through our search of CENTRAL.
Kesimpulan Pengarang
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).
Funding
This Cochrane review was funded by the National Cancer Institute of the National Institutes of Health (NIH) and FDA Center for Tobacco Products (CTP) under Award Number 2U54CA229974. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food & Drug Administration.
Registration
Registration: Cochrane, via protocol available via DOI:10.1002/14651858.CD016220.