Effect of third-party components on emissions from a pod style electronic cigarette.

Electronic nicotine delivery systems (ENDS) have been associated with a dramatic increase in youth becoming addicted to nicotine following decades-long decline in cigarette smoking uptake. The United States Food and Drug Administration, Center for Tobacco Products (FDA/CTP) is responsible for regulating devices and consumable materials associated with ENDS. State and federal regulations regarding flavoring compounds in ENDS liquids (e-liquids) may be circumvented when vendors market refillable reservoirs side-by-side with noncompliant e-liquids. This study investigated the effect of third-party refillable versus manufacturer-supplied single-use reservoirs on total particulate matter (TPM) and nicotine emissions. The maximum TPM yield per puff was 5.6 times higher for the third-party (Blankz) reservoir (12.4 mg/puff) in comparison with the manufacturer's (JUUL) reservoir (2.2 mg/puff), whereas the maximum TPM concentration was over 7 times higher for third party (0.200 mg/ml) versus manufacturer (0.028 mg/ml) pod. The third-party pod was tested with nicotine concentrations ranging from 0% to 4%. The mass ratio of nicotine present in the aerosol (mg Nic/mg TPM) was found to be approximately the same as the mass ratio of the e-liquid (mg Nic/mg e-liquid) for both pods and all 3 nicotine laden e-liquids tested. Toxicant exposure may increase when consumers use third-party pods with ENDS devices. Refillable reservoirs are a significant barrier to regulatory restrictions on potentially toxic additives to e-liquids. It is recommended FDA/CTP require emissions characterization of third-party reservoirs used with each ENDS they are compatible with and should be required to demonstrate no increased potential toxicant exposure in comparison with manufacturer-provided reservoirs.

Proposed Standard Test Protocols and Outcome Measures for Quantitative Comparison of Emissions from Electronic Nicotine Delivery Systems.

This study introduces and demonstrates a comprehensive, accurate, unbiased approach to robust quantitative comparison of electronic nicotine delivery systems (ENDS) appropriate for establishing substantial equivalence (or lack thereof) between inhaled nicotine products. The approach is demonstrated across a family of thirteen pen- and pod-style ENDS products. Methods employed consist of formulating a robust emissions surface regression model, quantifying the empirical accuracy of the model as applied to each product, evaluating relationships between product design characteristics and maximum emissions characteristics, and presenting results in formats useful to researchers, regulators, and consumers. Results provide a response surface to characterize emissions (total particulate matter and constituents thereof) from each ENDS appropriate for use in a computer model and for conducting quantitative exposure comparisons between products. Results demonstrate that emissions vary as a function of puff duration, flow rate, e-liquid composition, and device operating power. Further, results indicate that regulating design characteristics of ENDS devices and consumables may not achieve desired public health outcomes; it is more effective to regulate maximum permissible emissions directly. Three emissions outcome measures (yield per puff, mass concentration, and constituent mass ratio) are recommended for adoption as standard quantities for reporting by manufacturers and research laboratories. The approach provides a means of: (a) quantifying and comparing maximal emissions from ENDS products spanning their entire operating envelope, (b) comparative evaluation of ENDS devices and consumable design characteristics, and (c) establishing comparative equivalence of maximal emissions from ENDS. A consumer-oriented product emissions dashboard is proposed for comparative evaluation of ENDS exposure potential. Maximum achievable power dissipated in the coil of ENDS is identified as a potentially effective regulatory parameter.

A Comparison between Cigarette Topography from a One-Week Natural Environment Study to FTC/ISO, Health Canada, and Massachusetts Department of Public Health Puff Profile Standards.

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.

Effect of user puffing topography on total particulate matter, nicotine and volatile carbonyl emissions from narghile waterpipes.

OBJECTIVES: Puffing topographies of waterpipe users vary widely as does the puff-to-puff topography of an individual user. The aim of this study was to determine if puff duration and flow rate have an effect on the characteristics of the mainstream emission from waterpipes, including total particulate matter (TPM), mass ratio of nicotine and mass concentration of volatile carbonyls. METHODS: Puffing parameters were chosen to encompass a significant portion of the perimeter space observed from a natural environment study. Tested conditions were 150, 200 and 250 mL sec-1; each run at 2, 3.5 and 5 s durations; 25 s interpuff duration and ~100 puffs per session. Each session was run in quadruplicate using the Programmable Emissions System-2 (PES-2) emissions capture system under identical conditions. Particulate matter, for quantification of TPM and nicotine, was collected on filter pads every ~5 L of aerosol resulting in 6 to 25 samples per session. Volatile carbonyls were sampled using 2,4-Dinitrophenylhydrazine (DNPH)-coated silica. RESULTS: Mass concentration of TPM linearly decreased with increased flow rate, with no dependency on puff duration. Nicotine mass ratio was independent of topography, with average mass ratio of nicotine to TPM of 0.0027±0.0002 (mg/mg). The main carbonyls observed were acetaldehyde and formaldehyde. Puff duration increased emissions of some carbonyls (eg, formaldehyde) but not others (eg, acetaldehyde). CONCLUSIONS: The results presented here highlight that topographies influence the emissions generated from waterpipes including TPM, total nicotine and volatile carbonyls. For laboratory studies to be representative of user exposure, a range of topographies must be studied. Using a range of topographies within a controlled laboratory environment will better inform regulatory policy.

A Proposed Waterpipe Emissions Topography Protocol Reflecting Natural Environment User Behaviour.

Usage of waterpipes is growing in popularity around the world. Limited waterpipe natural environment topography data reduces the ability of the research community to accurately assess emissions and user exposure to toxicants. A portable ergonomic waterpipe monitor was provided to study participants to use every time they smoked their own waterpipe during a one-week monitoring period in conjunction with their own choice shisha tobacco. Users provided demographic information and logged their product use to supplement electronic monitor data. A total of 44 prospective study participants were invited to an intake appointment following an on-line pre-screening survey. Of these, 34 individuals were invited to participate in the study and data for 24 individuals who completed all aspects of the 1-week monitoring protocol is presented. 7493 puffs were observed during 74 waterpipe sessions accumulating over 48 h of waterpipe usage. The 95% CI on mean puff flow rate, duration, volume and interval are presented, yielding grand means of 243 [mL/s], 3.5 [s], 850 [mL], and 28 [s] respectively. The middle 95% of puff flow rates ranged between 62 to 408 [mL/s], durations from 0.8 to 6.8 [s], and puff volumes from 87 to 1762 [mL]. A waterpipe emissions topography protocol consisting of 13 flow conditions is proposed to reflect 93% of the observed range of puff flow rate, puff duration and puff volume with representative inter-puff interval, cumulative session time and aerosol volumes.

Framework to Estimate Total Particulate Mass and Nicotine Delivered to E-cig Users from Natural Environment Monitoring Data.

A framework describing the joint effect of user topography behavior and product characteristics of one exemplar device on the total particulate mass (TPM) and aerosol constituent yield delivered to a user is presented and validated against seven user-specific 'playback' emissions observations. A pen-style e-cig was used to collect emissions across puff flow rates and durations spanning the range observed in the natural environment. Emissions were analyzed with GC-MS and used to construct empirical correlations for TPM concentration and nicotine mass ratio. TPM concentration was demonstrated to depend upon both puff flow rate and duration, while nicotine mass ratio was not observed to be flow-dependent under the conditions presented. The empirical model for TPM and nicotine yield demonstrated agreement with experimental observations, with Pearson correlation coefficients of r = 0.79 and r = 0.86 respectively. The mass of TPM and nicotine delivered to the mouth of an e-cig user are dependent upon the puffing behavior of the user. Product-specific empirical models of emissions may be used in conjunction with participant-specific topography observations to accurately quantify the mass of TPM and nicotine delivered to a user.

A framework to investigate the impact of topography and product characteristics on electronic cigarette emissions.

SIGNIFICANCE: Protocols 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. METHODS: This 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. RESULTS: Results 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. CONCLUSIONS: A 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.

Determination of Nicotine Content and Delivery in Disposable Electronic Cigarettes Available in the United States by Gas Chromatography-Mass Spectrometry.

INTRODUCTION: Electronic cigarettes (E-Cigs) are popular alternatives to conventional tobacco cigarettes. Disposable E-Cigs are single-use devices that emit aerosols from a nicotine-containing solution (e-liquid) by activating a heating coil during puffing. However, due to lack of regulations and standards, it is unclear how product claims are aligning with actual content and performance. Some analytical methods for characterizing E-Cigs are still in an exploratory phase. METHODS: Five products of disposable E-Cigs (purchased March-April, 2014 from a local smoke shop and an on-line US distributor) were studied for nicotine content, number of puffs obtained before depletion, portion of nicotine delivered via aerosolization, and e-liquid pH. Protocols were developed to consistently extract e-liquid from puffed and unpuffed E-Cigs. An in-house mechanical puffing machine was used to consistently puff E-Cig aerosols onto filter pads. A gas chromatography-mass spectrometry method was developed that produced sensitive and repeatable nicotine determinations. RESULTS: Under our experimental parameters, results showed a disparity between nicotine content and number of puffs achieved relative to what was claimed on product packaging. The portion of nicotine delivered to filter pads was often less than half that which was available, indicating much of the nicotine may be left in the E-Cig upon depletion. CONCLUSIONS: Analyses of unpuffed E-Cigs by gas chromatography-mass spectrometry indicate the nicotine content of these products can be considerably different from manufacture's labeling. Furthermore, a large portion of the nicotine in E-Cigs may not be transferred to the user, and that which is transferred, may often be in the less bioavailable form.