Results of an observational, descriptive study quantifying topography characteristics of twenty first generation electronic nicotine delivery system users in their natural environment for a one week observation period are presented. The study quantifies inter-participant variation in puffing topography between users and the intra-participant variation for each user observed during one week of use in their natural environment. Puff topography characteristics presented for each user include mean puff duration, flow rate and volume for each participant, along with descriptive statistics of each quantity. Exposure characteristics including the number of vaping sessions, total number of puffs and cumulative volume of aerosol generated from ENDS use (e-liquid aerosol) are reported for each participant for a one week exposure period and an effective daily average exposure. Significant inter-participant and intra-participant variation in puff topography was observed. The observed range of natural use environment characteristics is used to propose a set of topography protocols for use as command inputs to drive machine-puffed electronic nicotine delivery systems in a controlled laboratory environment.

SignificanceProtocols for testing and reporting emissions of Harmful and Potentially Harmful Constituents (HPHCs) from electronic cigarettes (e-cigs) are lacking. The premise of this study is that multi-path relationships may be developed to describe interactions between product characteristics, use behavior and emissions to develop appropriate protocols for tobacco product regulatory compliance testing.MethodsThis study proposes a framework consisting of three component terms: HPHC mass concentration, HPHC mass ratio and total particulate mass (TPM) concentration. The framework informs experiments to investigate dependence of aerosol emissions from five electronic cigarettes spanning several design generations and three e-liquids for six repeated trials at each of ten flow conditions.ResultsResults are reported for TPM concentration as a function of flow conditions spanning the range of natural environment topography observed in prior studies. An empirical correlation describing TPM concentration as a function of flow conditions and coil power setting (6, 7.5 and 10 watts) for the Innokin iTaste MVP 2.0 vaporizer with Innokin iClear 30 dual coil tank is presented. Additional results document the impact of flow conditions and wick and coil design on TPM concentration through comparison of the Innokin iClear 30 (upper coil, capillary action wick) and the Innokin iClear X.I (lower coil, gravity fed wick) operated at 7.5 watts. The impact of e-liquid on TPM concentration is illustrated by comparing emissions from an NJOY Vape Pen filled with AVAIL Arctic Blast, Tobacco Row, and Mardi Gras e-liquids. TPM concentration is shown to depend upon flow conditions across a range of e-cigarette product designs including cig-a-like, pen-style, box-mod and emergent disposable-cartridge style devices.ConclusionsA framework provides a foundation for reporting emissions across a variety of e-cigs, e-liquids and research laboratories. The study demonstrates TPM concentration is a function of topography behavior (i.e. puff flow rate and puff duration) for varying device operating power and product characteristics.

Electronic Nicotine Delivery Systems (ENDS) offer an alternate means to consume nicotine in a variety of flavored aerosols. Data are needed to better understand the impact of flavors on use behavior. A natural environment observational study was conducted on experienced ENDS users to measure the effect of e-liquid flavor on topography and consumption behavior. The RIT wPUMTM monitor was used to record to record the date and time and puff topography (flow rate, volume, duration) for every puff taken by N = 34 participants over the course of two weeks. All participants used tobacco flavor for one week, and either berry or menthol flavor for one week. Results provide strong evidence that flavor affects the topography behaviors of mean puff flow rate and mean puff volume, and there is insufficient evidence to support an influence of flavor on mean puff duration and mean puff interval. There was insufficient evidence, due to the low power associated with the limited number of observation days, to establish a relationship between flavor and cumulative consumption behavior. While the results indicate that an effect may be evident, additional observation days are required to establish significance.

Standardized topography protocols for testing cigarette emissions include the Federal Trade Commission/International Standard Organization (FTC/ISO), the Massachusetts Department of Health (MDPH), and Health Canada (HC). Data are lacking for how well these protocols represent actual use behavior. This study aims to compare puff protocol standards to actual use topography measured in natural environments across a range of cigarette brands. Current smokers between 18 and 65 years of age were recruited. Each participant was provided with a wPUM™ cigarette topography monitor and instructed to use the monitor with their usual brand cigarette ad libitum in their natural environment for one week. Monitors were tested for repeatability, and data were checked for quality and analyzed with the TAP™ topography analysis program. Data from n = 26 participants were analyzed. Puff flow rates ranged from 17.2 to 110.6 mL/s, with a mean (STD) of 40.4 (21.7) mL/s; durations from 0.7 to 3.1 s, with a mean (STD) of 1.5 ± 0.5 s; and volumes from 21.4 to 159.2 mL, with a mean (STD) of 54.9 (29.8) mL. Current topography standards were found to be insufficient to represent smoking across the wide range of real behaviors. These data suggest updated standards are needed such that emissions tests will provide meaningful risk assessments.

In electronic nicotine delivery systems (ENDS), coil resistance is an important factor in the generation of heat energy used to change e-liquid into vapor. An accurate and unbiased method for testing coil resistance is vital for understanding its effect on emissions and reporting results that are comparable across different types and brands of ENDS and measured in different laboratories. This study proposes a robust, accurate and unbiased method for measuring coil resistance. An apparatus is used which mimics the geometric configuration and assembly of ENDS reservoirs, coils and power control units. The method is demonstrated on two commonly used ENDS devices—the ALTO by Vuse and JUUL. Analysis shows that the proposed method is stable and reliable. The two-wire configuration introduced a positive measurement bias of 0.086 (Ω), which is a significant error for sub-ohm coil designs. The four-wire configuration is far less prone to bias error and is recommended for universal adoption. We observed a significant difference in the coil resistance of 0.593 (Ω) (p < 0.001) between the two products tested. The mean resistance and standard deviation of the reservoir/coil assemblies was shown to be 1.031 (0.067) (Ω) for ALTO and 1.624 (0.033) (Ω) for JUUL. The variation in coil resistance between products and within products can have significant impacts on aerosol emissions.

Background: Natural environment inhalation topography provides useful information for toxicant exposure, risk assessment and cardiopulmonary performance. Commercially available wearable respiratory monitors (WRMs), which are currently used to measure a variety of physiological parameters such as heart rate and breathing frequency, can be leveraged to obtain inhalation topography, yet little work has been done. This paper assesses the feasibility of adapting these WRMs for measuring inhalation topography. Methods: Commercially available WRMs were compiled and assessed for the ability to report chest motion, data analysis software features, ambulatory observation capabilities, participant acceptability, purchasing constraints and affordability. Results: The following WRMs were found: LifeShirt, Equivital EQ02 LifeMonitor, Smartex WWS, Hexoskin Smart Garment, Zephyr BioHarness, Nox T3&A1, BioRadio, SleepSense Inductance Band, and ezRIP & zRIP Durabelt. None of the WRMs satisfied all six assessment criteria in a manner enabling them to be used for inhalation topography without modification and development. Conclusions: The results indicate that there are WRMs with core technologies and characteristics that can be built upon for ambulatory inhalation topography measurement in the NE.

This work investigated the effects of manufacturing variations, including coil resistance and initial pod mass, on coil lifetime and aerosol generation of Vuse ALTO pods. Random samples of pods were used until failure (where e-liquid was consumed, and coil resistance increased to high value indicating a coil break). Initial coil resistance, initial pod mass, and e-liquid net mass ranged between 0.89 to 1.14 [Ω], 6.48 to 6.61 [g], and 1.88 to 2.00 [g] respectively. Coil lifetime was µ (mean) = 158, σ (standard deviation) = 21.5 puffs. Total mass of e-liquid consumed until coil failure was µ = 1.93, σ = 0.035 [g]. TPM yield per puff of all test pods for the first session (brand new pods) was µ = 0.0123, σ = 0.0003 [g]. Coil lifetime and TPM yield per puff were not correlated with either variation in initial coil resistance or variation in initial pod mass. The absence of e-liquid in the pod is an important factor in causing coil failure. Small bits of the degraded coil could be potentially introduced to the aerosol. This work suggests that further work is required to investigate the effect of e-liquid composition on coil lifetime and TPM yield per puff.

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