Abstract
Objective
This study examined the effect of menthol flavor on e-cigarette users’ satisfaction, enjoyment, and sensory experiences.
Methods
A randomized crossover trial was conducted among 77 current e-cigarette users aged 21–35 in Miami, Florida. Participants used the same e-cigarette device in two separate sessions, differing by flavor (menthol/tobacco) in random order. Each session involved ad-libitum 60-minute vaping after 12-hour plasma nicotine-validated abstinence. The primary outcomes were satisfaction, pleasure, enjoyment, appeal, and sensory experiences measured after each session.
Results
Higher scores were observed in measures of satisfaction, product liking, interest to use in future, willingness to use again, enjoyment, puff liking, taste and craving reduction during the menthol-flavored e-cigarette session compared to tobacco flavor (all p<0.05). Additionally, participants in moderate to high-dependence group had overall better subjective experiences [e.g., user satisfaction (psychological reward, β= 5.34, p<0.001), appeal and sensory experience (puff liking, β= 0.64, p=0.04)] in the menthol condition (vs. tobacco) compared to low-dependent users. Females also had better experience [e.g., user satisfaction (psychological reward, β= 3.82, p=0.01)] than males in the menthol condition (vs. tobacco).
Conclusions
In this randomized crossover clinical trial, menthol-flavored e-cigarettes significantly enhanced e-cigarette use experience compared to tobacco flavor. These findings provide important evidence that menthol flavor plays a substantial role in making e-cigarettes more appealing, suggesting that menthol in e-cigarettes poses a risk to nicotine-naïve youth to initiate e-cigarette use and keep those young people currently using, addicted. Therefore, it could be a potential target for regulatory action to limit e-cigarette use among young people.
Trial registration:
Keywords: Electronic Nicotine Delivery Systems (e-cigarette), Menthol, Subjective experience
INTRODUCTION
Electronic nicotine delivery systems (ENDS, also called e-cigarettes, vape) emerged in China in 2003 and have since become a worldwide phenomenon. It entered the United States (US) marketplace around 2007 and soon after (2014) became the most-used tobacco product among US youth.1 Data from the 2021 Population Assessment of Tobacco and Health (PATH) study shows that 14.5% of young adults aged 18–24 reported regular use of e-cigarettes compared to 3.8% in 2013.2
Several factors have contributed to the increase in e-cigarette popularity among young people in the US, including appealing design, flavors, and marketing on social media.3 Among these factors, flavors, in particular, is thought to be a major driver of e-cigarette initiation and continued use in young people. In 2024, 87.6% of current e-cigarette users among middle and high school students reported using flavored (most popular flavors include fruit, candy, desserts, or other sweets, mint, and menthol) e-cigarettes.4 Several studies have shown that flavors play an important role in enhancing the e-cigarette use experience5–10 potentially contributing to the perception of a less harmful product.1,11As a result, in 2020, the US Food and Drug Administration (FDA) implemented restrictions on flavors of cartridge-based e-cigarettes (pod-mods) except for menthol and tobacco.12 However, due to this partial restriction, sales of other types of flavored e-cigarettes that were not included in the ban (e.g., disposables increased more than 500% from 2019 to 2023),13 as well as menthol e-cigarettes, skyrocketed. For example, following the FDA e-cigarette flavor directive, sales of menthol e-cigarettes rose immediately by 82.8% (over 8 weeks)13,14 and continued to rise over the years (175% increase from 2019 to 2023).
Menthol, a well-documented enhancer of tobacco use and addiction, exerts its effects through multiple mechanisms, including analgesic effects and a cooling sensation mediated by the transient receptor potential melastatin 8 (TRPM8) in the mouth and airways.15 Menthol’s stimulation of this “cold’ receptor helps mask the sensory aversive effects of tobacco and nicotine inhalation on the respiratory tract.16,17 By mitigating aerosol irritation, menthol’s effect on the respiratory tract can potentially facilitate the inhalation of e-cigarette aerosol, leading to increased deposition of its constituents, nicotine exposure, and harm.15,18 Furthermore, menthol enhances nicotine dependence by modifying nicotinic acetylcholine receptors in the brain, increasing nicotine’s bioavailability and effect.15 Finally, menthol tobacco products appeal particularly to young people and minorities.19,20
Several studies showed that smoking menthol cigarettes is associated with greater subjective reward, satisfaction, and better sensory experience than non-menthol cigarettes.20,21 However, to date, few studies have looked at the effect of menthol on young e-cigarette users’ subjective experiences, puffing patterns, and exposure. This is particularly important given the difference between aerosol constituents and use patterns between cigarettes and e-cigarettes (e.g., e-cigarette intermittent prolonged use vs time-defined bouts of intensive smoking of cigarettes). Our pilot study provided preliminary evidence of enhanced e-cigarette use experience with mint/menthol-flavors22; however, most of this study’s participants used mint rather than menthol flavor. Menthol is a bioactive compound with significant sensorimotor effects, whereas mint is a distinct, milder flavorant characterized by sweeter, less intense sensory qualities.23 Given the prominent position of menthol flavor in the regulatory landscape of tobacco products24, this study aims to address this gap by examining the impact of menthol’s effects on e-cigarette users’ satisfaction, pleasure, enjoyment, and sensory experiences using a sensitive within-subject crossover design.
METHODS
Study overview
This clinical trial used a randomized crossover design25 and obtained approval from the Institutional Review Board of Florida International University (FIU). The study was registered with ClinicalTrials.gov (NCT05338801). Before the session, every participant provided informed consent and received $75 as compensation for their time for each session. The study adhered to the guidelines set forth by the Consolidated Standards of Reporting Trials (CONSORT) for randomized crossover clinical trials.
Study design and procedures
A total of 77 current (past 30-day) e-cigarette users aged 21–35 years were recruited via flyers, social media advertisements, and word-of-mouth from Miami between June 2022 and November 2024. This age group allowed us to stay focused on young adults (e-cigarette available legally ≥ 21 years) who are particularly at risk of e-cigarette use, and obtain insights from adults with longer experiences with e-cigarettes. Participants were excluded if they reported chronic health problems, psychiatric conditions, regular use of prescription medications (excluding vitamins or birth control pills), current use of tetrahydrocannabinol (THC) in e-cigarettes, and current use of more than 5 cigarettes or other tobacco/nicotine products in the past month. Women who were breastfeeding or tested positive for pregnancy (confirmed through urinalysis during screening) were also excluded. After a 12-hour nicotine abstinence, confirmed by expired air carbon monoxide (CO ≤5 ppm) and baseline plasma nicotine concentration (≤5 ng/ml), participants completed a baseline assessment. Subsequently, they participated in two ~2-h lab sessions that involved 60-min of e-cigarette use ad libitum and differed by the flavor condition (menthol vs. tobacco). The sessions’ orders were randomized and separated by at least 48 hours as a washout period to avoid any carryover and order effects.
In this study, three different types of fourth-generation e-cigarettes (JUUL, Standardized Research E-Cigarette (SREC), or NJOY) were used based on their availability and likely standardized content for menthol and nicotine concentrations. Participants selected their preferred nicotine concentration and were randomly assigned to either menthol or tobacco flavor in the first session. Additionally, they were blinded to the session’s conditions (menthol or tobacco). Participants were seated in a private room with a comfortable reclining chair, given a choice to use any electronic device, and instructed to use e-cigarettes at their natural pace. Data for subjective measures were collected after the vaping session and puffing topography data were collected during the vaping sessions.
Measures
Demographic information (age, sex, race and ethnicity, educational status, employment status, BMI (kg/m2), and e-cigarette use-related information (duration of e-cigarette use, device ownership, type of e-cigarette, vaping frequency, and pod use) were collected before the session. The Penn State Electronic Cigarette Dependence Index (PSECDI) was used to measure nicotine dependence for study participants at baseline.26 It consists of 10-item questions including e-cigarette users’ urge, quit, craving, and other information rated on a multiple-score scale (with scores ranging from 0 to 20), where total scoring: 0–3= not dependent, 4–8 low-dependence, 9–12 medium-dependence, 13+ = high-dependence. For this analysis, participants were categorized into two groups, “low-dependence” (score scale 0 to 8) and “moderate to high-dependence” (score scale 9 to 20).27
Subjective measures
Pleasure and enjoyment
Post sessions users’ pleasure and enjoyment were assessed using a validated Visual Analog Scale (VAS).28 This scale contains 10-item questions including the user’s desire, pleasure, satisfaction, future use, and other information rated on an analog scale (0 not at all to 100 extremely).
Appeal and sensory experience
Appeal and puff sensory experience was measured post-session using the Duke Sensory Questionnaire (DSQ).29 This validated questionnaire contains 9-item questions rated on a 7-point Likert scale (1 not at all to 7 extremely). Participants were asked four questions regarding product appeal (e.g., ‘How much did you like the puffs?’) and five questions regarding the sensory experience (e.g., rate the strength of the puffs on throat) of this product.
User satisfaction
Post-session satisfaction levels were measured using the validated Modified Cigarette Evaluation Questionnaire (mCEQ) tool.30 The mCEQ contains 11-item questions under five subscales: Satisfaction, psychological reward, enjoyment of respiratory tract sensations, craving reduction, and aversive experience rated on a 7-point Likert scale (1 not at all to 7 extremely). `
Puff-topography
E-cigarette puff topography was assessed using a validated mouthpiece-connected topography-recording device, eTop (American University of Beirut).31 This device was connected through an adapter to the puff topography instrument, which monitored and recorded the participant’s puffing behavior throughout the lab session. The topography software converts signals to airflow (ml/s) and integrates the flow data, producing measures of total use time, total puff volume, puff duration, number, inter puff interval, numbers of puffs, total volume inhaled, and average puff volume.
Data analysis
All statistical analyses were conducted using STATA software version 17, and results were considered significant at an alpha level of 0.05. The normality of data was assessed using histogram and QQ plots. The mean with standard deviation of continuous variables and the frequencies and proportions of categorical variables were reported. The means of the different subjective outcome measures were compared between flavor sessions using two-tailed paired t-test. Wilcoxon signed-rank test was applied to compare the median (IQR, Interquartile Range) or distributional equality between flavor conditions (menthol vs. tobacco) for each outcome of topography parameters separately. We have tested these outcomes under one hypothesis that was supported by consistent changes across multiple parameters (in the same direction), which are biologically plausible. This adds to the practical significance of the results.32,33
As a secondary analysis, linear mixed models were constructed to predict the change in all subjective measure outcomes at different levels of (a) users’ nicotine dependency and (b) sex. In the analysis, we adjusted for potential confounders, such as age, sex (excluded for the secondary analysis for sex), race, device type, preferred flavor, nicotine dependence (excluded for the secondary analysis for nicotine dependence) and concentration.
RESULTS
In total, 961 participants were approached for telephone screening, and 879 were excluded (647 did not meet the inclusion criteria and 232 declined or excluded for other reasons). Among 82 eligible participants, 5 did not complete session 2. In final analysis, 77 participants were included who completed both sessions (Supplementary file, Figure S1).
Among 77 study participants, 63.64 % were males, 63.64% were currently employed, and 51.95% were Hispanic/Latino. The mean age [SD] of the participants was 24.55 [3.69], and the mean BMI [SD] was 28.05 [7.30]. Most participants (80.52%) started using e-cigarettes more than one year ago and belong to low nicotine dependence groups (53.25%). The majority own e-cigarette devices (84.21%) and vape daily (71.43%) (Supplementary file, Table S1).
Subjective measures
Pleasure and enjoyment
Participants reported better experiences (in terms of pleasure and enjoyment) when using the menthol-flavored product compared to tobacco flavor. For example, the mean scores were significantly higher in the menthol condition compared to the tobacco condition for product liking (37.19 vs. 30.65; p=0.02), product enjoyment (39.36 vs. 34.26; p=0.02), product satisfaction (42.10 vs. 36.39; p =0.04), interest to use in future (32.87 vs. 26.29; p=0.03), and willingness to use (38.92 vs. 32.16; p=0.03) (Table 1).
Table 1:
Means for post-session subjective responses for Visual Analogue Scale (VAS) by flavor condition (menthol and tobacco) (N=77)
| Menthol Mean (SD) |
Tobacco Mean (SD) |
p-value | |
|---|---|---|---|
| Pleasure and enjoyment | |||
| Pleasantness (How pleasant would the product you just used be to use again right now?) | 32.45 (22.37) | 29.58 (24.37) | 0.31 |
| Desire/urge (How much of a desire or urge do you have to vape the product you just used right now, just for the pleasure of vaping?) | 31.51 (23.86) | 27.55 (24.64) | 0.16 |
| Need to use for relief (How much do you need to vape the product you just used right now, just for relief?) | 32.38 (25.97) | 26.60 (26.57) | 0.05 |
| Want to vape (How much do you want to vape the product you just used?) | 27.78 (23.48) | 23.95 (22.32) | 0.14 |
| Like the product (To what extent did you like the product you just used?) | 37.19 (22.82) | 30.65 (24.78) | 0.02 |
| Enjoy the product (To what extent did you enjoy the product you just used?) | 39.36 (23.11) | 34.26 (26.07) | 0.02 |
| Pleasurable to use (To what extent did you find the product pleasurable to use?) | 42.27 (23.28) | 33.45 (23.51) | 0.05 |
| Satisfaction (To what extent was the product satisfying?) | 42.10 (23.71) | 36.39 (24.87) | 0.04 |
| Interest to use in the future (How interested are you in using the product you just used again in the future?) | 32.87 (25.91) | 26.29 (25.67) | 0.03 |
| Willingness to use (How willing would you be to use the product you just used again?) | 38.92 (28.06) | 32.16 (26.71) | 0.03 |
Paired t-test; SD= Standard Deviation
Appeal and sensory experience
Participants reported better appeal and sensory experiences when using the menthol-flavored product compared to tobacco flavor. For example, the mean score for puff liking (3.64 vs. 3.26; p= 0.01) was significantly higher in the menthol-flavored condition. Also, the mean score of the strength of the puffs on the nose (2.85 vs. 3.19; p=0.04) was significantly lower in the menthol-flavored condition (vs. tobacco flavor) (Table 2).
Table 2:
Means for post-session subjective responses for Duke Sensory Questionnaire by flavor condition (menthol and tobacco) (N=77)
| Menthol Mean (SD) |
Tobacco Mean (SD) |
p-value | |
|---|---|---|---|
| Appeal and sensory experience | |||
| Puff liking (How much did you like the puffs?) | 3.64 (1.21) | 3.26 (1.44) | 0.01 |
| Puff satisfaction (How satisfying were the puffs?) | 3.72 (1.22) | 3.51 (1.46) | 0.17 |
| Perception about nicotine content (How high in nicotine were the puffs?) | 3.85 (1.13) | 3.95 (1.07) | 0.49 |
| Similarity with their own brand (How similar to your own brand/flavor were the puffs?) | 2.74 (1.49) | 2.45 (1.47) | 0.13 |
| Puff strength | |||
| Rate the strength of the puffs on the tongue | 3.42 (1.15) | 3.57 (1.19) | 0.32 |
| Rate the strength of the puffs on the nose | 2.85 (1.33) | 3.19 (1.17) | 0.04 |
| Rate the strength of the puffs on the back of mouth and throat | 3.82 (1.54) | 3.89 (1.28) | 0.63 |
| Rate the strength of the puffs on the windpipe | 3.65 (1.48) | 3.81 (1.33) | 0.34 |
| Rate the strength of the puffs on the chest | 3.58 (1.53) | 3.61 (1.34) | 0.87 |
Paired t-test; SD= Standard Deviation
User satisfaction
Participants reported better experience (satisfaction, psychological reward, enjoyment of respiratory tract sensations, and craving reduction) when using the menthol-flavored product compared to tobacco flavor. For example, menthol flavor was significantly associated with better taste (3.39 vs. 2.79; p=0.001), satisfaction (4.09 vs. 3.77; p=0.03) and more craving reduction (4.30 vs.3.84; p=0.03) than the tobacco session (Table 3).
Table 3:
Means for post-session subjective responses for e-cigarettes in response to Modified Cigarette Evaluation Questionnaire (m-CEQ) by flavor condition (menthol and tobacco) (N=77)
| Menthol Mean (SD) |
Tobacco Mean (SD) |
p-value | |
|---|---|---|---|
| User satisfaction | |||
| Satisfaction | |||
| Was it satisfying? | 4.09 (1.38) | 3.77 (1.38) | 0.03 |
| Did it taste good? | 3.39 (1.38) | 2.79 (1.49) | 0.001 |
| Psychological reward | |||
| Did it calm you down? | 3.70 (1.62) | 3.48 (1.75) | 0.24 |
| Did it make you feel more awake? | 2.88 (1.60) | 2.87 (1.57) | 0.93 |
| Did it make you feel less irritable? | 2.51 (1.48) | 2.49 (1.53) | 0.92 |
| Did it help you concentrate? | 3.00 (1.54) | 2.79 (1.60) | 0.22 |
| Did it reduce your hunger for food? | 2.62 (1.73) | 2.70 (1.76) | 0.63 |
| Enjoyment of respiratory tract sensations | |||
| Did you enjoy the sensations of vaping in your throat and chest? | 3.38 (1.41) | 3.22 (1.53) | 0.18 |
| Craving reduction | |||
| Did it immediately reduce your craving for e-cigarettes? | 4.30 (1.69) | 3.84 (1.89) | 0.03 |
| Aversion | |||
| Did it make you dizzy? | 2.66(1.46) | 2.79 (1.61) | 0.46 |
| Did it make you feel nauseous? | 1.52 (0.82) | 1.67 (1.10) | 0.13 |
Paired ttest done; SD= Standard Deviation
Puffing topography measures according to flavor conditions (menthol vs. Tobacco)
After a 60-minute ad libitum e-cigarette use session, higher values were observed for most topography parameters in the menthol-flavored session compared to tobacco. For example, the median total inhaled volume (1571.24 [IQR: 866.99, 3632.20] ml vs. 1306.31 [IQR: 730.50, 2965.56] ml) was higher with menthol-flavored e-cigarette use session compared to the tobacco-flavored session. However, the results were not statistically significant. Therefore, we are waiting for more subjects to publish the full results.
Subjective measures outcomes according to dependence, sex, and flavor conditions
Results from adjusted models showed that in sessions with menthol flavor (vs. tobacco), compared to low-dependent, mid- to high-dependent e-cigarette users had overall better subjective experience as they experienced higher user satisfaction (psychological reward, β= 5.34, p<0.001; enjoyment of respiratory tract sensation, β=1.02, p=0.001, craving reduction, β=0.99, p=0.01), better appeal and sensory experience (puff liking, β= 0.64, p=0.04; puff satisfaction, β= 0.58, p=0.03; puff strength, β= 3.19, p=0.004). Additionally, Female users had better user satisfaction (psychological reward, β= 3.82 p=0.01), pleasure & enjoyment (pleasantness, β= 10.55, p=0.02; need to use for relief, β= 12.42, p=0.04; product liking, β= 11.32, p=0.03) than males (Table 4).
Table 4:
Comparison of Nicotine Dependence and Sex Among E-cigarette Users (N=77)
| Measures | Dependencea | Sexb | ||||
|---|---|---|---|---|---|---|
| Low | Moderate to high | Male | Female | |||
| β (SE) | P value | β (SE) | P value | |||
| User Satisfaction | ||||||
| Satisfaction | Ref | 0.52 (0.60) | 0.39 | Ref | 0.83 (0.60) | 0.17 |
| Psychological reward | Ref | 5.34 (1.27) | <0.001 | Ref | 3.82 (1.40) | 0.01 |
| Enjoyment of Resp. tract Sensation | Ref | 1.02 (0.31) | 0.001 | Ref | −0.13(0.32) | 0.69 |
| Craving Reduction | Ref | 0.99 (0.39) | 0.01 | Ref | 0.02 (0.39) | 0.96 |
| Aversion | Ref | 0.80 (0.48) | 0.10 | Ref | −0.13 (0.44) | 0.77 |
| Appeal and sensory experience | ||||||
| Puff liking | Ref | 0.64 (0.30) | 0.04 | Ref | 0.13 (0.34) | 0.67 |
| Puff satisfaction | Ref | 0.58 (0.27) | 0.03 | Ref | 0.33 (0.27) | 0.23 |
| Similarity with their own brand | Ref | 0.55 (0.34) | 0.10 | Ref | 0.30 (0.33) | 0.36 |
| Perception about nicotine content | Ref | 0.22 (0.22) | 0.31 | Ref | −0.07(0.22) | 0.74 |
| Puff strength | Ref | 3.19 (1.37) | 0.004 | Ref | 1.31 (1.12) | 0.24 |
| Pleasure & enjoyment | ||||||
| Pleasantness | Ref | 5.86 (4.63) | 0.21 | Ref | 10.55 (4.66) | 0.02 |
| Desire/urge | Ref | 9.27 (4.88) | 0.06 | Ref | 9.42 (4.91) | 0.06 |
| Need to use for relief | Ref | 10.60 (5.67) | 0.06 | Ref | 12.42 (5.94) | 0.04 |
| Want to Vape | Ref | 8.96 (4.84) | 0.07 | Ref | 8.83 (4.62) | 0.06 |
| Like the product | Ref | 7.73 (5.09) | 0.13 | Ref | 11.32 (5.18) | 0.03 |
| Enjoy the product | Ref | 8.72 (5.20) | 0.10 | Ref | 10.17 (5.36) | 0.06 |
| Pleasurable to use | Ref | 10.06 (5.31) | 0.06 | Ref | 4.51 (5.34) | 0.40 |
| Satisfaction | Ref | 12.00 (5.35) | 0.03 | Ref | 10.30 (5.50) | 0.06 |
| Interest to use in the future | Ref | 10.07 (5.70) | 0.08 | Ref | 4.77 (5.74) | 0.40 |
| Willingness to use | Ref | 9.52 (6.01) | 0.11 | Ref | 8.28 (6.05) | 0.17 |
β=Beta coefficient; SE = Standard Error; Ref = Reference
Linear mixed effect model analysis after adjusting for participants' age, sex, race and ethnicity, device type, preferred flavor, smoking duration and concentration
Linear mixed effect model analysis after adjusting for participants' age, race and ethnicity, nicotine dependence device type, preferred flavor, concentration, and dependence
DISCUSSION
This within-subject crossover clinical study assessed the effects of menthol flavor on young primarily e-cigarette users’ experience and satisfaction. Compared to the tobacco-flavored session, menthol-flavored e-cigarettes produced greater ratings on various subjective measures, including enjoyment, satisfaction, appeal, and sensory experience. These effects showed differential patterns according to users’ level of nicotine dependence, with participants in the moderate to high-dependent group having overall better subjective experiences in the menthol condition compared to low-dependent users. They also differed by sex, with women users showing greater satisfaction and better experience during menthol-flavored sessions (vs. tobacco) compared to men. These findings provide evidence that menthol flavor plays a substantial role in enhancing e-cigarette use experience, reinforcing the need for regulatory actions to limit e-cigarette use among young people.
Previous studies on subjective responses associated with menthol-flavored e-cigarettes have shown mixed results. While some studies suggest that menthol e-liquid flavor has minimal acute impact on subjective experience, behavioral intentions, or craving,34,35 other studies suggest positive associations with higher satisfaction, greater user appeal, and suppression of the aversive effects of nicotine.6,36 However, these studies suffered from considerable design limitations. First, some studies limited puffing protocol6,36 or employed short session duration34, which is inconsistent with natural patterns of e-cigarette use characterized by intermittent puffing over extended periods.37 Furthermore, several studies did not apply or validate a sufficient abstinence period6,36 or a between-session washout interval34, which makes it hard to interpret the effect of abstinence on study parameters given the bio pharmacology of nicotine in the body (a single use of tobacco nicotine remains in the body up to 12 hours).38 Finally, most studies used established smokers who were willing to use e-cigarettes rather than studied primarily e-cigarette users,6,34,35 making it difficult to interpret their results in terms of how much they are applicable to e-cigarette users. We addressed these shortcomings by allowing ad libitum puffing for up to 60 minutes, recruiting primarily e-cigarette users, and strictly imposing 12-hour abstinence before each study session validated by plasma nicotine (<5 ng/ml), which allowed us to isolate the effects of study conditions (menthol flavor) from prior to session use of any tobacco product.
Our study also showed that psychological reward, appeal, and sensory experience were higher among highly dependent users in response to menthol flavor than less dependent users. This effect is likely due to the vape-soothing effect of menthol during the dynamic post-abstinence puffing patterns expected in highly dependent users. This is supported by our observation that e-cigarette users with higher dependence levels (vs. low dependence) are likely to puff e-cigarettes more vigorously in menthol sessions due to lower aversion to menthol e-cigarettes and thus consume larger amounts of nicotine. Furthermore, an enhanced topographic pattern was also observed in menthol sessions (compared to tobacco), which further supports the effect of menthol-flavored e-cigarettes. We could also demonstrate that in response to menthol (compared to tobacco), females had higher psychological rewards than males. This finding can be explained by the biological preference of females for the analgesic effects of menthol, given that they are known to be less tolerant to bitter taste sensations.39
Recently, the FDA proposed a product standard prohibiting menthol-flavored cigarettes and cigars, which is a potentially important step to reduce tobacco-related burden, especially among minority populations.40 However, critics raise concerns that applying similar restrictions on e-cigarettes might affect cigarette smokers who prefer mentholated e-cigarettes to help them quit or reduce their harm.41,42 In 2023, the FDA issued initial marketing denial orders (MDOs) for menthol e-cigarette products, citing the lack of substantial evidence supporting the claim that menthol e-liquid, as opposed to tobacco, helps adult smokers switch or reduce their cigarette smoking.43 However, in 2024, the FDA authorized four menthol-flavored e-cigarettes, considering the overall benefit for adult cigarette smokers in terms of harm reduction.44 Although in randomized control trials among adult cigarette smokers willing to switch to e-cigarettes to reduce their harm, participants reported similar acceptance and adoption rates for both non-menthol and menthol e-cigarettes.34,35They can also be made available to adult smokers with smoking cessation or harm reduction treatment settings45 rather than products for mass marketing, given their dependence-enhancing properties and preference among young users. This is particularly important given that e-cigarettes are increasingly used by tobacco naïve youth as the 1st product on the path to multiple tobacco products on the market.46 It is also consistent with the FDA’s mandate to “ensure that the marketing of new tobacco products is appropriate for the protection of the public health”.47 However, new non-menthol synthetic coolants pose a regulatory challenge for menthol tobacco product oversight, as they can mimic menthol’s sensory effects and may create loopholes in future tobacco control policies.48,49
STRENGTHS AND LIMITATIONS
Our study has the apparent strengths of using a within-subject crossover design, primarily e-cigarette users with their preferred nicotine concentration, using the same e-cigarette device in both sessions, strictly enforcing 12-hour nicotine abstinence prior to each session, counterbalancing the order of sessions, and allowing at least 48 hours washout period between them.
Our study has limitations, including the lab setting environment, which precludes natural patterns of e-cigarette use. However, our lab setting is necessary to make standardized assessments that enable valid comparisons between sessions and ensure that the detected differences are mainly due to the study conditions. Moreover, we used a limited number of e-cigarettes (JUUL, NJOY/SREC), which can differ from what the participants usually use. However, the selection of JUUL, NJOY, and SREC was mainly due to the availability of menthol and tobacco flavors needed for this study and their likelihood of being more standardized compared to numerous e-cigarette brands available on the market, given that they are FDA ‘authorized’ or applied for authorization.50 We also kept the same device constant throughout both sessions for each participant, which ensures that all study parameters are constant between the two sessions except for the investigated flavor. Finally, using an acute lab model in current e-cigarette users, our study does not answer the question about the long-term effects of limiting menthol flavor on e-cigarette uptake and experience among young users.
CONCLUSIONS
Using a sensitive within-subject design and plasma nicotine-validated abstinence in primarily young e-cigarette users, our study demonstrates that menthol flavor significantly enhances e-cigarette use experience among young users. These findings underscore the potential of menthol as a potential target for product regulations aiming at limiting e-cigarette use among young people. Future research investigating the effect of menthol on e-cigarette users’ puffing behavior and exposure to toxicants can further substantiate this argument, as well as studies looking at the long-term effects of limiting mentholated e-cigarettes on young nonsmokers as well as older smokers.
Supplementary Material
KEY MESSAGES.
What is already known on this topic
Menthol has the potential to contribute to youth vaping by masking the harshness of nicotine, boosting sensory appeal, and escalating addiction risk. After the flavor restriction by the FDA in cartridge-based e-cigarettes, menthol became more popular, yet experimental evidence on the extent to which menthol’s ability to alter the use experience and how these affect dependence among young people is limited.
What this study adds
This randomized crossover clinical trial, which involved 77 current e-cigarette users, showed that compared to tobacco-flavored e-cigarettes, menthol-flavored e-cigarettes elicited greater ratings on various subjective measures, including enjoyment, satisfaction, appeal, and sensory experience.
How this study might affect research, practice and/or policy
These findings provide important evidence that menthol flavor plays a substantial role in enhancing e-cigarette use experience, making it a potential target for regulatory action to limit e-cigarette use among young people.
Acknowledgments
The authors thank the lab manager (Katherine Pita, BSc Nursing) and three paid research assistants (Arpita Paul, MPH; Sheida Khosravaniardakani, MPH; Christina Cabrera Elizondo, BA Psychology) of the Clinical Research Lab for Tobacco Smoking at FIU for their support in recruitment and data collection. The first author (SC) has full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Funding
Funding for this study was supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) (R01 DA055937; ClinicalTrials.gov number, NCT05338801). OO is supported by the National Institute on Drug Abuse of the National Institutes of Health under award number K01DA055127. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Footnotes
Conflict of interest disclosures
The authors declared no conflict of interest.
Data sharing statements
Individual participant data that underlie the results reported in this article can be shared after deidentification (text, tables, and appendices). Any researcher who provides a methodologically sound proposal can have access to the data. Proposals should be directed to the corresponding author (WM). Data requestors will need to sign a data access agreement to gain access.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Individual participant data that underlie the results reported in this article can be shared after deidentification (text, tables, and appendices). Any researcher who provides a methodologically sound proposal can have access to the data. Proposals should be directed to the corresponding author (WM). Data requestors will need to sign a data access agreement to gain access.
