Decisions of the FDA on premarket tobacco product applications: Changes in the number of unique devices and liquids used by US adults who frequently use electronic nicotine delivery systems, 2020-2023.

INTRODUCTION: The majority of decisions on electronic nicotine delivery system (ENDS) premarket tobacco product applications (PMTAs) were made from October 2020 to February 2023; 99% (>25 million) had determinations by March 2023 and just twenty-three received marketing granted orders. We examined the unique devices and liquids used among US adults frequently using ENDS before, during, and after a majority of PMTA decisions were made. METHODS: Data are from waves 1-5 (W1: May-Oct 2020, n=1179; W5: Feb-Apr 2023, n=1290) of a longitudinal survey of US adults (≥21 years) using ENDS ≥5 days/week. User-submitted photos of participants' most used devices and liquids were coded. Descriptive analyses and Wilcoxon signed-rank tests were used to understand the number and types of unique devices and liquids used in W1-W5, and the top brands in each wave. RESULTS: From W1-W5, the number of unique ENDS device models and liquid products used by participants increased from 279 to 357 (p<0.001) and 546 to 695 (p<0.001), respectively. More unique devices in W5 versus W1 were disposable (W1: 16.5%; W5: 36.1%); fewer were disposable pod (W1: 6.5%; W5: 3.1%) or tank (W1: 53.8%; W5: 30.8%) devices. Liquids were primarily sweet-flavored (W1: 81.1%; W5: 82.0%). The median liquid nicotine concentration increased from 12 to 50 mg/mL. In W5, few participants used FDA-approved devices (n=17; 1.3%) or liquids (n=6; 0.5%), and Elf Bar was the most commonly used device and liquid brand. Results for all waves are reported. CONCLUSIONS: Despite PMTA decisions, an increase in the number of unique device models and liquid products used among adults who frequently use ENDS was observed from 2020 to 2023. Few participants in 2023 were using FDA-approved devices or liquids. Further research and monitoring are needed to inform how FDA prioritizes enforcement actions and what types of enforcement actions are effective.

Heterogeneity in sociodemographic characteristics of people who use different ENDS devices.

Background: The electronic nicotine delivery systems (ENDS) market is heterogeneous with a wide variety of devices and liquids available to consumers. People with distinct sociodemographic characteristics may have different ENDS device and liquid preferences. Methods: 1290 U.S. adults (21 + ) using ENDS 5 + days/week completed the Wave 5 (February-April 2023) VAPER study survey and submitted photos of their most used ENDS device and liquid. Latent class analysis (LCA) was performed based on sociodemographic characteristics and cigarette smoking status to identify groups among respondents. We examined the association between identified groups and the device (disposable device/disposable pod/refillable pod/tank, power/airflow/coil modifiability)/liquid (nicotine salt/freebase) groupings found by exploratory factor analysis. Results: Among our sample, there were three groups of adults frequently using ENDS: (1) group of women who are older, heterosexual, and have smoked cigarettes (62 % of the sample); (2) group of men who are higher-income and heterosexual (23 % of the sample); and (3) group of women who are younger and LGBTQ+ (16 % of the sample). The third group was more likely to use non-adjustable disposable devices with a nicotine salt liquid and less likely to use adjustable tanks with a freebase liquid than the other two groups (p < 0.001). Conclusions: We found three distinct groups of adults frequently using ENDS. The group of younger LGBTQ + women was different from the other two groups in use of device and liquid characteristics. Our findings can enhance understanding of people using ENDS and inform the expected impacts of ENDS regulatory efforts to protect public health.

Menthol and Other Flavor Chemicals in Cigarettes from Vietnam and the Philippines.

INTRODUCTION: Tobacco product flavors can increase product appeal, adolescent initiation and experimentation, and difficulty quitting. Flavored tobacco products are not restricted in Vietnam or the Philippines despite the high smoking prevalence among those 15 years of age and older (24% and 23%, respectively). There are no published reports to our knowledge on the levels of flavor chemicals in the cigarettes sold in these two countries. METHODS: Cigarettes were purchased in Vietnam (32 brand variants) and the Philippines (19 brand variants) during 2020. Chemical analyses gave the mg/filter, mg/rod, and mg/stick (= mg/(filter + rod)) values for 180 individual flavor chemicals. Values were calculated for menthol, clove-related compounds, and "other flavor chemicals" (OFCs). RESULTS: Five flavor groupings were found among the brand variants purchased in Vietnam: menthol + OFCs (n = 15), OFCs only (n = 8), nonflavored (n = 7), menthol + OFCs with a clove flavorant (n = 1) and menthol only (n = 1). Three flavor groupings were found among the brand variants purchased in the Philippines: menthol + OFCs (n = 10), nonflavored (n = 5), and menthol only (n = 4). CONCLUSIONS: A range of flavored cigarette products are being offered by tobacco companies in Vietnam and the Philippines, presumably to maximize cigarette sales. Regulation of flavor chemicals should be considered in these two countries. IMPLICATIONS: Article 9 of the WHO Framework Convention on Tobacco Control (FCTC), ratified by both Vietnam and the Philippines, states that "there is no justification for permitting the use of ingredients, such as flavoring agents, which help make tobacco products attractive." Flavors increase product appeal, adolescent initiation and experimentation, and difficulty quitting. These analyses found that cigarettes purchased in Vietnam and the Philippines contained menthol and other flavor chemicals. Tobacco companies are offering multiple flavor chemical profiles and nominally nonflavored versions in these countries; regulation of flavor chemicals should be considered in these two countries.

Exploring Different Incentive Structures Among US Adults Who Use e-Cigarettes to Optimize Retention in Longitudinal Web-Based Surveys: Case Study.

BACKGROUND: Longitudinal cohort studies are critical for understanding the evolution of health-influencing behaviors, such as e-cigarette use, over time. Optimizing follow-up rates in longitudinal studies is necessary for ensuring high-quality data with sufficient power for analyses. However, achieving high rates of follow-up in web-based longitudinal studies can be challenging, even when monetary incentives are provided. OBJECTIVE: This study compares participant progress through a survey and demographics for 2 incentive structures (conditional and hybrid unconditional-conditional) among US adults using e-cigarettes to understand the optimal incentive structure. METHODS: The data used in this study are from a web-based longitudinal cohort study (wave 4; July to September 2022) of US adults (aged 21 years or older) who use e-cigarettes ≥5 days per week. Participants (N=1804) invited to the follow-up survey (median completion time=16 minutes) were randomly assigned into 1 of 2 incentive structure groups (n=902 each): (1) conditional (US $30 gift code upon survey completion) and (2) hybrid unconditional-conditional (US $15 gift code prior to survey completion and US $15 gift code upon survey completion). Chi-square tests assessed group differences in participant progress through 5 sequential stages of the survey (started survey, completed screener, deemed eligible, completed survey, and deemed valid) and demographics. RESULTS: Of the 902 participants invited to the follow-up survey in each group, a higher proportion of those in the conditional (662/902, 73.4%) than the hybrid (565/902, 62.6%) group started the survey (P<.001). Of those who started the survey, 643 (97.1%) participants in the conditional group and 548 (97%) participants in the hybrid group completed the screener (P=.89), which was used each wave to ensure participants remained eligible. Of those who completed the screener, 555 (86.3%) participants in the conditional group and 446 (81.4%) participants in the hybrid group were deemed eligible for the survey (P=.02). Of those eligible, 514 (92.6%) participants from the conditional group and 401 (89.9%) participants from the hybrid group completed the survey and were deemed valid after data review (P=.14). Overall, more valid completions were yielded from the conditional (514/902, 57%) than the hybrid group (401/902, 44.5%; P<.001). Among those who validly completed the survey, no significant differences were found by group for gender, income, race, ethnicity, region, e-cigarette use frequency, past 30-day cigarette use, or number of waves previously completed. CONCLUSIONS: Providing a US $30 gift code upon survey completion yielded higher rates of survey starts and completions than providing a US $15 gift code both before and after survey completion. These 2 methods yielded participants with similar demographics, suggesting that one approach is not superior in obtaining a balanced sample. Based on this case study, future web-based surveys examining US adults using e-cigarettes could consider providing the full incentive upon completion of the survey. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/38732.

Transitions in device and liquid characteristic groupings among US adults frequently using electronic nicotine delivery systems (ENDS) over three timepoints, 2020-2021.

INTRODUCTION: Electronic nicotine delivery system (ENDS) and liquid characteristics affect nicotine and toxicant exposure and use behaviors. Little is known about how adults who frequently use ENDS transition between ENDS device/liquid groupings. METHODS: A total of 379 US adults (≥21 years) using ENDS frequently (≥5 days/week) self-reported and uploaded photos of their most used ENDS device and liquid in three waves of online surveys (May 2020 - November 2021). Device/liquid grouping was defined by device (i.e. disposable/refillable tank/refillable pod or cartridge/disposable pod or cartridge, adjustable/no adjustable settings) and liquid (i.e. salt/freebase) characteristics. Participants using the same grouping across waves were considered stable users. RESULTS: The most prevalent wave (W) 1 grouping was tank (freebase, adjustable settings; 36.8%). From W1 to W3, the number of disposable device (salt, no adjustable settings) users increased 156.4% and the number of disposable pod/cartridge (salt, no adjustable settings) users decreased 15.2%. In W2 and W3, compared to stable users, participants using tank (freebase, adjustable settings) in W1 and another grouping in W2 and/or W3 reported significantly higher nicotine concentrations (mg/mL) (W2: 15.1 vs 5.5, p<0.001; W3: 22.9 vs 5.6, p<0.001) and lower device power (watt) (W2: 46.8 vs 58.7, p=0.02; W3: 34.0 vs 57.2, p<0.001). CONCLUSIONS: Over a 1.5-year period, a rapid growth in disposable device (salt, no adjustable settings) use and a decrease in disposable pod/cartridge (salt, no adjustable settings) use were observed. Participants who transitioned from tank (freebase, adjustable settings) to other groupings were more likely to increase liquid nicotine concentration and reduce device power compared to stable users.

Assessing Electronic Nicotine Delivery Systems Device Type Accurately in Surveys.

INTRODUCTION: The electronic nicotine delivery systems (ENDS) market is highly heterogeneous and changing rapidly in the United States, making classification of devices complicated, especially for surveys. We assessed the percentage of concordant responses between self-reported device type and device type reported by manufacturer/retailer sites for three ENDS brands. AIMS AND METHODS: Population Assessment of Tobacco and Health Study wave 5 (2018-2019) asked adult ENDS users about their ENDS device type with the following multiple-choice question: "What kind of electronic nicotine product [is/was] it?" with response options: (1) A disposable device, (2) A device that uses replaceable prefilled cartridges, (3) A device with a tank that you refill with liquids (4) A mod system, and (5) Something else. Participants using only one ENDS device and reporting brands of JUUL (n = 579), Markten (n = 30), or Vuse (n = 47) were included. Responses were dichotomized as "concordant=1" (prefilled cartridge for these three brands) and "discordant = 0" (other responses) to assess the concordance. RESULTS: The overall concordance between self-reports and manufacturer/retail sites was 81.8% (n = 537). This percentage was 82.7% (n = 37) among Vuse users, 82.6% (n = 479) among JUUL users, and 69.1% (n = 21) among Markten users. Almost one in three people who use Markten did not indicate that their device uses replaceable prefilled cartridges. CONCLUSIONS: While at least 70% concordance could be acceptable, collecting more information about device type (eg, liquid container (pod/cartridge/tank), refillability; and submitting pictures) may improve the accuracy of the information. IMPLICATIONS: This study is particularly relevant for researchers analyzing smaller samples for example when examining disparities. Monitoring the characteristics of ENDS accurately in population-based studies is critical for regulatory authorities to understand ENDS toxicity, addiction, health effects, and use behaviors at the population level. There is evidence that higher concordance can be achieved with other questions- and methods. Adjusting survey questions about ENDS device type (eg, more descriptive response options, inclusion of separate questions asking about tank, pod, cartridge) and potentially including photos of participants' devices may help to classify ENDS device types more accurately.

Device and liquid characteristics used with sweet, menthol/mint, and tobacco ENDS liquid flavors: The population-based VAPER study.

INTRODUCTION: Electronic nicotine delivery system (ENDS) device and liquid characteristics (e.g., wattage, nicotine concentration) are diverse and important in determining product appeal, aerosol volume/nicotine levels, and toxicity. Little is known about how device and liquid characteristics vary by flavor; we address this gap to identify potential regulatory implications. METHODS: Data are from a longitudinal cohort study (Waves 2 and 3; December 2020-December 2021) of adult (≥21 years) U.S. ENDS users (≥5 days of use/week). Participants (n = 1809) reported on and submitted photos of their most used device and liquid. Participants were categorized into flavor groups of high prevalence in our sample and in prior literature: sweet, menthol/mint, or tobacco. Participants using liquids without nicotine or flavors other than sweet, menthol/mint, or tobacco were excluded (n = 320). Data were analyzed cross-sectionally. Chi-square and linear regression (n = 1489) were used to examine device and liquid characteristics by flavor. RESULTS: Sweet flavors were most common (n = 1135; 76.2%), followed by menthol/mint (n = 214, 14.4%) and tobacco (n = 140, 9.4%). Sweet flavors were less common among participants using reusable devices with disposable pods/cartridges (nicotine salt) than those using other device-liquid groupings (5.2% vs 86.5-93.9%; p < 0.001). Sweet flavors were less common among those using ENDS for non-flavor reasons vs the flavor (73.5% vs 90.4%; p < 0.001). Sweet flavors correlated with lower nicotine concentrations, higher wattages, and lower ages of ENDS first use (p < 0.001). CONCLUSIONS: Regulatory agencies must consider how regulations on device and liquid characteristics may affect ENDS users' behaviors (e.g., limiting availability of sweet flavors may encourage use of non-sweet flavors and lower wattages).

The Vaping and Patterns of e-Cigarette Use Research Study: Protocol for a Web-Based Cohort Study.

BACKGROUND: In total, 3.2% of American adults report using e-cigarettes every day or some days. The Vaping and Patterns of E-cigarette Use Research (VAPER) Study is a web-based longitudinal survey designed to observe patterns in device and liquid use that suggest the benefits and unintended consequences of potential e-cigarette regulations. The heterogeneity of the e-cigarette devices and liquids on the market, the customizability of the devices and liquids, and the lack of standardized reporting requirements result in unique measurement challenges. Furthermore, bots and survey takers who submit falsified responses are threats to data integrity that require mitigation strategies. OBJECTIVE: This paper aims to describe the protocols for 3 waves of the VAPER Study and discuss recruitment and data processing experiences and lessons learned, including the benefits and limitations of bot- and fraudulent survey taker-related strategies. METHODS: American adults (aged ≥21 years) who use e-cigarettes ≥5 days per week are recruited from up to 404 Craigslist catchment areas covering all 50 states. The questionnaire measures and skip logic are designed to accommodate marketplace heterogeneity and user customization (eg, different skip logic pathways for different device types and customizations). To reduce reliance on self-report data, we also require participants to submit a photo of their device. All data are collected using REDCap (Research Electronic Data Capture; Vanderbilt University). Incentives are US $10 Amazon gift codes delivered by mail to new participants and electronically to returning participants. Those lost to follow-up are replaced. Several strategies are applied to maximize the odds that participants who receive incentives are not bots and are likely to possess an e-cigarette (eg, required identity check and photo of a device). RESULTS: In total, 3 waves of data were collected between 2020 and 2021 (wave 1: n=1209; wave 2: n=1218; wave 3: n=1254). Retention from waves 1 to 2 was 51.94% (628/1209), and 37.55% (454/1209) of the wave 1 sample completed all 3 waves. These data were mostly generalizable to daily e-cigarette users in the United States, and poststratification weights were generated for future analyses. Our data offer a detailed examination of users' device features and specifications, liquid characteristics, and key behaviors, which can provide more insights into the benefits and unintended consequences of potential regulations. CONCLUSIONS: Relative to existing e-cigarette cohort studies, this study methodology has some advantages, including efficient recruitment of a lower-prevalence population and collection of detailed data relevant to tobacco regulatory science (eg, device wattage). The web-based nature of the study requires several bot- and fraudulent survey taker-related risk-mitigation strategies, which can be time-intensive. When these risks are addressed, web-based cohort studies can be successful. We will continue to explore methods for maximizing recruitment efficiency, data quality, and participant retention in subsequent waves. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38732.

Combinations of electronic nicotine delivery system device and liquid characteristics among U.S. adults.

INTRODUCTION: The combination of electronic nicotine delivery systems (ENDS) device and liquid characteristics affect user nicotine and toxicant exposure, however population-level national survey studies have not reported device and liquid features jointly nor in detail. We examined combinations of characteristics of devices and liquids used by adult ENDS users. METHODS: U.S. adults (21+) using ENDS at least five days/week (n = 1,179) completed an online survey in 2020 and uploaded photos of their most used device and liquid. Device/liquid combinations were analyzed to determine and describe the most common pairings. Data were weighted to the U.S. population of adult daily ENDS users. RESULTS: Five device/liquid combinations accounted for 87 % of those reported. The most prevalent combination, reported by 36.2 %, was re-useable devices with adjustable settings and a tank refilled with a free-base nicotine liquid with a median nicotine concentration of 5.2 mg/mL. The second most frequent combination - re-usable devices with no adjustable settings and a nicotine salt liquid in a disposable pod or cartridge - was reported by 22.8 % and the median nicotine concentration was 49.4 mg/mL. Wattage, voltage and resistance varied across device/liquid combination. Overall, 66.5 % refilled their device's tank or pod and 64.2 % had the ability to manipulate device characteristics (power, airflow, and/or coil). CONCLUSIONS: Analyzing ENDS device/liquid combinations rather than each separately can allow researchers to better evaluate relationships between use and key outcomes, such as quitting cigarettes and abuse liability. Additional research may reveal whether certain combinations are more effective at helping smokers quit and which device/liquid combinations should remain on the market.

Identifying credible attribution sources for cigarette health warning labels in China: results from a cross-sectional survey of Chinese adults.

OBJECTIVE: The Framework Convention on Tobacco Control recommends health warning labels (HWLs) include an attribution source. Little is known regarding the perceived credibility and effectiveness of different message sources. This study examined perceptions of four HWL attribution sources among adults in China - the world's largest consumer of cigarettes. DESIGN: Cross-sectional experimental survey design. PARTICIPANTS: Data were collected in 2017 from a convenience sample of 1999 adults across four cities in China; 80% of the sample were current smokers. MAIN OUTCOME MEASURES: Participants viewed four versions of the same HWL, each with a different attribution source: the China Center for Disease Control (ref. group); the regulatory arm of China's domestic tobacco company (STMA); Liyuan Peng, China's first lady; and the WHO. Respondents indicated which HWL was the most: (1) credible, (2) effective at making people quit and (3) effective at preventing youth initiation. RESULTS: Multinomial logistic regression models estimated adjusted relative risk ratios (aRRRs) of the three outcomes. Controlling for demographics and smoking status, HWLs attributed to STMA and Liyuan Peng, respectively, were perceived as significantly less credible (aRRR=0.81, p<0.001; aRRR=0.31, p<0.001), less effective at making people quit (aRRR=0.46, p<0.001; aRRR=0.24, p<0.001) and less effective at preventing young smoking (aRRR=0.52, p<0.001; aRRR=0.39, p<0.001) than the China CDC HWL. There were no significant differences in perceived effectiveness of between the WHO and China CDC HWLs. Participants viewed the WHO HWL as significantly more credible (aRRR=1.21, p<0.001) than the China CDC HWL. CONCLUSION: Results suggest the unique role of health organisations in conveying smoking-related messages that appear credible and effective at motivating others to quit smoking or never start smoking in China. Findings can inform global recommendations regarding HWL attribution sources.

Agreement Between Self-reports and Photos to Assess e-Cigarette Device and Liquid Characteristics in Wave 1 of the Vaping and Patterns of e-Cigarette Use Research Study: Web-Based Longitudinal Cohort Study.

BACKGROUND: e-Cigarette device and liquid characteristics are highly customizable; these characteristics impact nicotine delivery and exposure to toxic constituents. It is critical to understand optimal methods for measuring these characteristics to accurately assess their impacts on user behavior and health. OBJECTIVE: To inform future survey development, we assessed the agreement between responses from survey participants (self-reports) and photos uploaded by participants and the quantity of usable data derived from each approach. METHODS: Adult regular e-cigarette users (≥5 days per week) aged ≥21 years (N=1209) were asked questions about and submitted photos of their most used e-cigarette device (1209/1209, 100%) and liquid (1132/1209, 93.63%). Device variables assessed included brand, model, reusability, refillability, display, and adjustable power. Liquid variables included brand, flavor, nicotine concentration, nicotine formulation, and bottle size. For each variable, percentage agreement was calculated where self-report and photo data were available. Krippendorff α and intraclass correlation coefficient (ICC) were calculated for categorical and continuous variables, respectively. Results were stratified by device (disposable, reusable with disposable pods or cartridges, and reusable with refillable pods, cartridges, or tanks) and liquid (customized and noncustomized) type. The sample size for each calculation ranged from 3.89% (47/1209; model of disposable devices) to 95.12% (1150/1209; device reusability). RESULTS: Percentage agreement between photos and self-reports was substantial to very high across device and liquid types for all variables except nicotine concentration. These results are consistent with Krippendorff α calculations, except where prevalence bias was suspected. ICC results for nicotine concentration and bottle size were lower than percentage agreement, likely because ICC accounts for the level of disagreement between values. Agreement varied by device and liquid type. For example, percentage agreement for device brand was higher among users of reusable devices (94%) than among users of disposable devices (75%). Low percentage agreement may result from poor participant knowledge of characteristics, user modifications of devices inconsistent with manufacturer-intended use, inaccurate or incomplete information on websites, or photo submissions that are not a participant's most used device or liquid. The number of excluded values (eg, self-report was "don't know" or no photo submitted) differed between self-reports and photos; for questions asked to participants, self-reports had more usable data than photos for all variables except device model and nicotine formulation. CONCLUSIONS: Photos and self-reports yield data of similar accuracy for most variables assessed in this study: device brand, device model, reusability, adjustable power, display, refillability, liquid brand, flavor, and bottle size. Self-reports provided more data for all variables except device model and nicotine formulation. Using these approaches simultaneously may optimize data quantity and quality. Future research should examine how to assess nicotine concentration and variables not included in this study (eg, wattage and resistance) and the resource requirements of these approaches.

A scoping review on disparities in exposure to advertising for e-cigarettes and heated tobacco products and implications for advancing a health equity research agenda.

BACKGROUND: Disparities in exposure to and density of tobacco advertising are well established; however, it is still unclear how e-cigarette and heated tobacco product (HTP) advertising vary by age, education, sex, gender identity, race/ethnicity, sexual orientation, socioeconomic status (SES), and/or urban/rural area. Through a scoping review, we sought to identify potential disparities in exposure to e-cigarette and HTP advertising and promotion across populations. METHODS: In January 2020, a systematic literature search was conducted in five databases: PubMed, Scopus, Embase, Web of Science, and the Cochrane Library. The search was updated in October 2020. Articles reporting on exposure to e-cigarette and/or HTP advertising and promotion across age, education, sex, gender identity, race/ethnicity, sexual orientation, SES, and/or urban/rural areas were included for full-text review (n = 25). Of those, 15 were deemed relevant for data extraction. RESULTS: The majority of the studies were from the U.S. (n = 12) and cross-sectional (n = 14). Studies were published between 2014 and 2020 and focused on determining causal relationships that underlie disparities; only one study assessed HTP advertising and promotion. Exposure to e-cigarette and HTP advertising was assessed at the individual-level (e.g., recall seeing ads on television) and at the neighborhood-level (e.g., ad density at the point-of-sale). Studies addressed differences across age (n = 6), education (n = 2), sex (n = 6), gender identity and sexual orientation (n = 3), race/ethnicity (n = 11), SES (n = 5), and urban/rural (n = 2). The following populations were more likely to be exposed to e-cigarette advertising: youth, those with more than a high school diploma, males, sexual and gender minorities, Whites, and urban residents. At the neighborhood-level, e-cigarette advertisements were more prevalent in non-White neighborhoods. CONCLUSIONS: Exposure to e-cigarette/HTP advertising varies based on sociodemographic characteristics, although the literature is limited especially regarding HTPs. Higher exposure among youth might increase tobacco-related disparities since it can lead to nicotine/tobacco use. Research should incorporate and apply a health equity lens from its inception to obtain data to inform the elimination of those disparities.