As governments consider tighter rules for nicotine pouches, flavours have become one of the most contested parts of the debate. Policymakers face a legitimate concern: products containing nicotine should not be designed or marketed in ways that encourage uptake among young people or people who otherwise would not use nicotine.
The regulatory question becomes more difficult when adults who smoke are considered. Could flavour choice affect whether a smoker finds a smoke-free alternative acceptable enough to reduce or replace cigarettes?
A newly accepted randomised controlled trial in Drug and Alcohol Dependence provides useful evidence on that question. The study examined whether access to flavoured nicotine pouches affected cigarette consumption and smoke exposure among adults who smoked daily and were interested in replacing cigarettes with a smoke-free product. Its findings are more nuanced than arguments on either side of the flavour debate sometimes suggest.
What the Researchers Studied
The researchers enrolled 402 adults aged 22 to 65 who smoked at least five cigarettes per day and expressed an interest in replacing cigarettes with a smoke-free tobacco product. Data from 400 participants were included in the analysis. At baseline, participants smoked an average of approximately 13 cigarettes per day.
Participants were assigned to different conditions over six weeks. One group had access throughout the study to seven varieties of 4 mg on! nicotine pouches, including Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee and an unflavoured Original product. Another group received only the unflavoured product. A third group initially received the unflavoured pouch before gaining access to the complete flavour range after three weeks.
This design allowed the researchers to examine more than whether people simply liked flavours. They could assess whether flavour availability translated into measurable differences in cigarette consumption, carbon monoxide exposure and smoke-free days.
That distinction matters for policy.
Flavours Did Not Improve Every Outcome
The main finding deserves careful interpretation.
After six weeks, immediate access to flavoured nicotine pouches did not produce a statistically significant advantage over access to the unflavoured pouch on the study’s main measures of smoke exposure.
The proportion achieving at least a 50% reduction in expired-air carbon monoxide was 14.3% in the flavour group and 14.2% in the unflavoured group. Mean carbon monoxide levels were also similar.
The same broad pattern appeared for cigarette consumption. By Week 6, 50.3% of participants in the flavour group had reduced their cigarettes per day by at least half, compared with 51.6% in the unflavoured group. Carbon-monoxide-verified seven-day smoking abstinence was 9.3% and 8.9%, respectively. None of these differences was statistically significant.
This is an important finding because it cautions against making sweeping claims about flavours. The trial does not show that providing a range of flavours universally improves smoking reduction compared with providing an unflavoured pouch.
Yet that is only part of the story.
Where Flavour Appeared to Matter
The more interesting result emerged among participants who initially struggled to reduce their cigarette consumption.
After three weeks, researchers identified participants using the unflavoured product who had not achieved at least a 50% reduction in cigarettes smoked per day. Some continued receiving only the unflavoured pouch, while those in the delayed-flavour group gained access to the complete flavour range.
By Week 6, 33.3% of the early non-responders who gained access to flavours had achieved at least a 50% reduction in cigarette consumption. Among those who continued with the unflavoured product, the figure was 18.6%. The difference was statistically significant.
The researchers describe this as a potential “rescue effect.”
It does not establish that flavours are necessary for smokers to move away from cigarettes. Many participants reduced their smoking while using the unflavoured product. Instead, the result suggests that product choice may become more important for some adults when the first alternative they try is not sufficiently acceptable.
There was another signal in the early stages of the trial. Participants given flavour access had higher odds of reporting smoke-free days than those restricted to the unflavoured product. This difference gradually declined, and by around Week 4 the confidence intervals between the groups overlapped.
The pattern raises an interesting possibility: flavour may matter most during the initial transition away from cigarettes or among smokers who do not respond well to a more limited product choice.
That possibility deserves further investigation.
Acceptability Is Part of the Switching Question
The trial also found that participants with access to the full flavour range reported greater overall product liking than participants restricted to the unflavoured product. Mint, Wintergreen and Coffee were among the more highly rated varieties, while the Original product generally received lower ratings when consumers had other options available.
Product liking should not automatically be interpreted as a public-health benefit. A product can be appealing without producing beneficial changes in smoking behaviour, and increased appeal among people who would otherwise remain nicotine-free would create a different public-health concern.
For adults who already smoke, however, acceptability cannot simply be ignored.
A smoke-free product can only substitute for cigarettes if people are willing to use it consistently enough to replace smoking. Characteristics such as nicotine delivery, ease of use and sensory experience may therefore influence whether substitution occurs.
The new trial provides some experimental evidence that flavour choice may be part of that equation for certain smokers, while also showing that its effect should not be exaggerated.
The Biomarker Results Require Caution
One of the most important details in the study is the difference between reported cigarette reduction and measured carbon monoxide.
Participants across all three groups reported substantial reductions in cigarettes smoked per day. Average consumption fell from around 13 cigarettes per day at baseline to approximately six cigarettes per day by Week 6.
The carbon-monoxide results were considerably less pronounced.
The researchers discuss several possible explanations. People who reduce the number of cigarettes they smoke may compensate by smoking the remaining cigarettes differently, while expired-air carbon monoxide itself has a relatively short half-life and can be affected by the timing of measurements and other factors. The study’s intermittent carbon-monoxide measurements may also have been insufficient to capture longer-term changes in exposure.
This discrepancy is important. Reducing cigarette consumption does not necessarily produce a proportional reduction in toxicant exposure, and complete switching away from combustion remains a more meaningful harm-reduction objective than simply smoking fewer cigarettes.
The findings should therefore be read as evidence about short-term smoking behaviour rather than proof of a corresponding reduction in long-term disease risk.
What the Study Cannot Tell Us
There are other reasons for caution.
The intervention lasted six weeks. That is enough to examine short-term behavioural changes, but it cannot establish whether participants would maintain their reductions, switch completely or return to previous smoking patterns over a longer period.
Participants also received the nicotine pouches free of charge and had regular contact with the study. Real-world consumers make decisions in an environment shaped by price, availability and competing products.
The participants were specifically recruited because they were interested in replacing cigarettes with a smoke-free product. The findings therefore should not automatically be generalised to all people who smoke.
The study also found relatively low rates of complete smoking abstinence. Most participants continued to report some cigarette smoking at Week 6.
These limitations matter when translating research into regulation.
Funding and Conflicts Should Be Transparent
The funding source also needs to be considered when assessing the evidence.
The study was funded by Altria Client Services LLC. Several authors were current or former Altria employees, while other researchers disclosed research funding, employment, consulting or financial relationships involving tobacco and nicotine companies. The paper provides these disclosures explicitly.
Industry funding does not by itself determine whether a study’s findings are valid. The trial was randomised, its protocol had been preregistered, and it incorporated an objective carbon-monoxide measure alongside self-reported smoking behaviour.
The appropriate response is transparency and critical appraisal. These results should be considered alongside independent research and future replication, particularly when they are used to inform public policy.
What This Means for Flavour Regulation
The findings arrive at a time when governments are deciding how far flavour restrictions on newer nicotine products should go.
Youth protection remains essential. Nicotine products should be subject to effective age restrictions, responsible marketing rules and appropriate product standards. Regulators have good reason to monitor product characteristics that could contribute to youth initiation.
But this study illustrates why the adult side of the equation also deserves attention.
A blanket flavour restriction assumes, implicitly or explicitly, that removing flavour choice will have little meaningful effect on adults who use these products as substitutes for cigarettes. The evidence from this trial suggests that assumption should be tested rather than taken for granted.
For many participants, the unflavoured product appeared sufficient to support substantial cigarette reduction. For some early non-responders, however, gaining access to flavours was associated with a greater likelihood of subsequently reducing their smoking by at least half.
Neither result should be ignored.
The challenge for regulators is therefore to determine whether youth protection can be achieved through measures targeted at youth access and appeal while retaining product characteristics that may help some adult smokers move away from combustible cigarettes.
That requires more evidence, particularly independent and longer-term studies.
A More Evidence-Based Regulatory Test
For GINN, the study reinforces the importance of assessing nicotine regulation according to measurable outcomes rather than assumptions about individual product characteristics.
The appropriate policy question is broader than whether flavours are good or bad. Regulators need to understand who uses particular flavours, whether they influence initiation among non-users, whether they affect switching among adults who smoke, and what happens when flavour availability is restricted.
This trial contributes one piece to that evidence base. It suggests that flavour availability does not necessarily determine cigarette reduction for every smoker, while indicating that choice may matter during the transition away from smoking for some individuals.
That distinction is important.
As nicotine-pouch regulation develops, policymakers should remain cautious about drawing broad conclusions from any single study. The same caution should apply when introducing broad restrictions whose effects on adult switching are uncertain.
Protecting young people and reducing smoking-related harm are both legitimate public-health objectives. Good regulation should examine how different interventions affect each of them and adjust as the evidence develops.
The emerging research on nicotine-pouch flavours makes that task more complicated. It also makes evidence-based, risk-proportionate policymaking more important.
Source:
Karelitz JL, Rose JE, Kennedy JN, et al. Effect of Flavored on! Nicotine Pouch Products on Smoking Behaviors: A Sequential, Multiple Assignment, Randomized Controlled Trial. Drug and Alcohol Dependence. Accepted 15 August 2026. DOI: 10.1016/j.drugalcdep.2026.113328.
