Smoking Regimes Research Articles

Effects of Switching to a Heat-Not-Burn Tobacco Product on Biologically Relevant Biomarkers to Assess a Candidate Modified Risk Tobacco Product: A Randomized Trial.

Cigarette smoking increases the risk of chronic diseases; heating instead of burning tobacco can lower these risks, contributing to tobacco harm reduction. This study (with 984 adult American smokers) examined whether favorable changes occur in 8 co-primary endpoints (HDL-C, WBC, FEV1%pred, COHb, Total NNAL, sICAM-1, 11-DTX-B2, 8-epi-PGF2α) indicative of biological and functional effects when cigarette smokers switch to the heat-not-burn Tobacco Heating System 2.2 (THS). Additionally, these biomarkers of exposure (BoExp) were quantified: MHBMA, 3-HPMA, Total NNN, CEMA, 3-OH-B[a]P, HMPMA, Total 1-OHP, NEQ, and CO exhaled. Participants were randomized to continued smoking of their preferred cigarette brand (n = 496) or to using THS (IQOS brand; n = 488) for 6 months. THS has a maximum heating temperature of 350°C, delivering 1.21 mg nicotine/stick and 3.94 mg glycerin/stick under the Health Canada Intense smoking regimen. The main outcome was a favorable change 6 months after baseline, with statistically significant improvements in 5 of 8 biomarkers of effect (HDL-C, WBC, FEV1%pred, COHb, Total NNAL) when smokers switched to THS compared with those who continued to smoke cigarettes. Likewise, BoExp were markedly reduced. All endpoints showed favorable changes in the same direction as with smoking cessation and improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking, with similar nicotine levels in both groups. Improvements in 5 of 8 biomarkers of effect are supportive of the research hypothesis, suggestive of disease risk reduction potential for smokers switching to THS instead of continuing to smoke cigarettes.

Analysis of Toxic Metals in Electronic Cigarette Aerosols Using a Novel Trap Design.

Since 2006 the domestic popularity and sales of electronic cigarettes (i.e., electronic nicotine delivery systems or ENDS) have grown rapidly. Although the constituents of the aerosol produced by ENDS have been previously investigated, differences in puff regimens and aerosol trapping schema in published literature often complicate result comparisons and data interpretation. As the ENDS product designs continue to evolve, there is a critical need to develop and validate robust methodologies for laboratory testing, appropriate aerosol generation and trapping media required for accurate determinations of ENDS aerosol metals deliveries. A simple, high metals purity, fluoropolymer trap was developed and validated that meets standard machine puffing regimen (CORESTA Recommended Method 81) specifications and exhibits negligible acid extractable metal backgrounds. Using a standard machine puffing regimen in combination with a fluoropolymer condensation trap, aerosol was generated and collected from select ENDS devices for analysis of chromium, nickel, copper, zinc, cadmium, tin, and lead with triple quadrupole inductively coupled plasma mass spectrometry. Devices tested spanned a range of commercial products, including flavored variants of JUUL pods, refillable tank systems, rechargeable cartridges, and single-use ENDs devices. Results showed that for aerosols generated under a fixed puffing regimen (50 puffs/collection), metal concentrations ranged from below the detection limits (LOD) to 614ng copper and 339ng zinc per 10 puffs. Cadmium concentrations were below LOD for all devices tested. Device specific aerosol levels of Sn and Pb ranged from below LOD to low nanogram levels. Cr and Ni were transported in aerosols at levels equivalent to, or slightly higher than in mainstream cigarette smoke using a standard smoking regimen. The generally lower levels of specific metals, Cd and Pb, transmitted in ENDS aerosols compared to mainstream cigarette smoke reflect possible reduction of harm for smokers who substitute the use of ENDS as cessation devices in place of smoking cigarettes.

Comparative levels of carbonyl delivery between mass-market cigars and cigarettes

The recent 2016 deeming of cigars by the US Food and Drug Administration (FDA) has led to increased interest in cigar science, including ways to accurately measure the harmful and potentially harmful constituents (HPHCs) found within mainstream cigar smoke. At present, there are standardized methods for evaluating HPHCs in mainstream cigarette smoke but none specific to cigar analysis except for nicotine and carbon monoxide. This study sought to analyze carbonyl delivery in marketed cigars and cigarillos and compare them against levels found in cigarettes. To accomplish this the standard cigarette method, CORESTA recommended method 74 (CRM-74), was optimized for cigar smoking including an evaluation of the trapping efficiency and the stability of the carbonyl-hydrazone adducts due to the increased smoke time required for cigar collection. On a per product basis, carbonyl delivery from cigars smoked under CRM-64 conditions was found to yield similar levels of formaldehyde and greater levels of acetaldehyde, acrolein and crotonaldehyde than measured in mainstream cigarette smoke collected under conditions prescribed under ISO standard 3308. Furthermore, on a per product basis, cigarettes smoked under the ISO 20778 intense smoking regime delivered higher levels of formaldehyde, acrolein and crotonaldehyde as compared to cigars smoked under the CORESTA regime, while acetaldehyde was found to be higher in mainstream cigar smoke. Given the recent deeming, this work expands upon previously reported work, limited in scope by either number of products or analytes reported, through the analysis of carbonyl delivery found in the mainstream smoke for 12 brands of cigars and cigarillos.

Heated Tobacco Products: Volatile Emissions and Their Predicted Impact on Indoor Air Quality.

This study characterized emissions from IQOS, a heated tobacco product promoted as a less harmful alternative to cigarettes. Consumable tobacco plugs were analyzed by headspace GC/MS to assess the influence of heating temperature on the emission profile. Yields of major chemical constituents increased from 4.1 mg per unit at 180 °C to 6.2 mg at 200 °C, and 10.5 mg at 220 °C. The Health Canada Intense smoking regime was used to operate IQOS in an environmental chamber, quantifying 33 volatile organic compounds in mainstream and sidestream emissions. Aldehydes, nitrogenated species, and aromatic species were found, along with other harmful and potentially harmful compounds. Compared with combustion cigarettes, IQOS yields were in most cases 1-2 orders of magnitude lower. However, yields were closer to, and sometimes higher than electronic cigarettes. Predicted users' daily average intake of benzene, formaldehyde, acetaldehyde and acrolein were 39 μg, 32 μg, 2.2 mg and 71 μg, respectively. Indoor air concentrations were estimated for commonly encountered scenarios, with acrolein levels of concern (over 0.35 μg m-3) derived from IQOS used in homes and public spaces. Heated tobacco products are a weaker indoor pollution source than conventional cigarettes, but their impacts are neither negligible nor yet fully understood.

The delegitimisation of smoking in Denmark and the US

Tobacco smoke continues to be one of the largest causes of premature deaths on a global level. Denmark and the United States of America (US), however, represent two examples of successful transition, where the number of daily smokers has decreased significantly throughout the past 70 years. In this paper, we point out key institutional and moral entrepreneurs that paved the way for transition of the Danish and US smoking regimes. The paper investigates proponents as well as opponents of (progressive) anti-smoking legislation. We apply the theory of institutional and moral entrepreneurs to select important events and actors. In the two countries that we study in detail, Denmark and the US, we find different drivers of change: the court system in the US and institutional and moral entrepreneurs in Danish civil society. In both countries, however, the Parliament in Denmark and the Congress in the US played significant roles in maintaining and supporting the smoking regimes.

Investigation of menthol content and transfer rates in cigarettes and Tobacco Heating System 2.2

Menthol cigarettes account for a significant market share in many countries. However, little recent data exists on menthol levels in cigarettes and in mainstream smoke, limited to some markets or specific cigarette designs, such as cigarettes containing capsules filled with flavoring liquids. Samples of mentholated cigarettes bought worldwide with a variety of cigarette designs were analyzed for menthol content in cigarettes and in cigarette mainstream smoke with two analytical machine smoking regimes. A wide range of menthol content in cigarettes, from 1 to 22 mg/cigarette, was observed. The transfer of menthol to the cigarette mainstream smoke was generally slightly higher than the transfer of nicotine, with a range of 17%–40% using an intense smoking regime and 1%–17% using the ISO smoking regime. For the Tobacco Heating System (THS) 2.2, the menthol content was 12.8 mg/stick, and the transfer of menthol into the aerosol was about 17% with the ISO intense smoking regime, similar to the transfer of nicotine. The menthol content of the novel product THS 2.2 corresponds to the midpoint of the menthol content range of cigarettes, and the transfer of menthol to its aerosol is in the low range of cigarette menthol transfer.

Modeling of cigarette smoke constituents - From intense to less intense smoking regime

Since it was first required to measure and to report NFDPM and nicotine yields in a limited number of countries, there has been an increasing trend for more testing and reporting requirements. Historically, the ISO 3308 smoking regime has been used to determine NFDPM and nicotine yields. However recommendations from the World Health Organization, now include the use of two smoking regimes such as the ISO 3308 and the WHO TobLabNet Official Method SOP01, the latter being considered as an intense smoking regime. Considering the increase in data produced and similarities between some smoke constituents formed during combustion, we explored possible correlations between emissions under intense and less intense smoking conditions. A set of 22 commercial cigarettes was tested. Eighty five smoke constituents were determined under both intense and less intense regimes. In addition 36 tobacco constituents, 14 cigarette design parameters and eight cigarette burning features were determined. A computational process was designed to implement multiple linear regression analyses enabling the identification of the best subsets of explanatory variables among emissions under intense conditions, cigarette design parameters, tobacco constituents and burning parameters. We succeeded in building simple linear models, involving four to six variables, while reaching satisfactory goodness of fit and R-squared values ranging from 0.87 to 1.00. Our findings suggest, in the range of products tested, that the additional data gained by using a second smoking regime does not necessarily increase the volume of information and consequently does not necessarily improve knowledge. This study supports the premise that the application of two smoking regimes does not produce a more comprehensive product characterisation compared to using one.

Simultaneous determination of tobacco minor alkaloids and tobacco-specific nitrosamines in mainstream smoke by dispersive solid-phase extraction coupled with ultra-performance liquid chromatography/tandem orbitrap mass spectrometry.

The minor alkaloids in tobacco play an important role in the chemical composition of cigarette smoke, and they are precursors of tobacco-specific nitrosamines (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), N-nitrosonornicotine (NNN), N-nitrosoanabasine (NAB) and N-nitrosoanatabine (NAT)). NNN and NNK are classified as group 1 carcinogens. A method quantitating both tobacco minor alkaloids and tobacco-specific nitrosamines in mainstream smoke has not been reported. Tobacco minor alkaloids and tobacco-specific nitrosamines in cigarette mainstream smoke were extracted by sonication. The extract was cleaned up by dispersive solid-phase extraction, and separation was achieved via ultra-performance liquid chromatography/tandem orbitrap mass spectrometry. The method was validated by analysis of six replicate samples spiked with three levels of the analyses. The mean recoveries for the six replicates were from 84.7% to 118% with less than 15% relative standard deviation except myosmine at the low spiked level and the calculated detection limits were 0.066 to 13.2ng/cig, respectively. The mean concentrations of nicotyrine, anabasine, nornicotine, anatabine, myosmine, 2,3-bipyridine, cotinine, nicotelline, N-formylnornicotine, NNK, NNN, NAB and NAT in 30 different brands of commercial cigarette smoke under the ISO smoking regimen were 2.50μg/cig, 2.34μg/cig, 3.21μg/cig, 5.78μg/cig, 2.83μg/cig, 1.05μg/cig, 1.55μg/cig, 0.55μg/cig, 2.48μg/cig, 6.06ng/cig, 3.62ng/cig, 0.40ng/cig and 6.15ng/cig, respectively. The proposed method was suitable for analysis of tobacco minor alkaloids and tobacco-specific nitrosamines in cigarette mainstream smoke.

Sensitive and selective gas chromatography-tandem mass spectrometry method for the detection of nitrobenzene in tobacco smoke

Nitrobenzene, a potentially harmful compound found in tobacco smoke, has been largely excluded from prior analysis due to difficulties with quantification. Quantifying harmful compounds in cigarette smoke is useful to compare products, to examine the impact of design parameters on delivery, and to help estimate exposures. A sensitive high-throughput method has been developed for quantifying nitrobenzene in machine-generated mainstream cigarette smoke using isotope dilution gas chromatography-tandem mass spectrometry (ID-GC-MS/MS). This method has sufficient sensitivity to measure vapor phase nitrobenzene concentrations in the low nanogram range, with a 418 pg/cig method limit of detection. Precision estimates from two quality control cigarette products resulted in percent relative standard deviations of 11.5% and 14.9%; product variability estimates from 13 cigarette products resulted in percent relative standard deviations ranging from 2.8% to 16.9%. Nitrobenzene in the machine-generated, mainstream smoke from 15 cigarette products are reported and range from 18 to 38 ng/cig under the Health Canada Intense smoking regimen.

Analysis of crotonaldehyde puff-by-puff release in mainstream cigarette smoke under various smoking regimens by high-performance liquid chromatography with the modified QuEChERS method.

To study puff-by-puff release characteristics of crotonaldehyde in mainstream cigarette smoke under diverse intensive smoking regimens, we designed an RM20H smoking machine with a puff-by-puff smoke collection unit to automatically trap crotonaldehyde in the mainstream cigarette smoke. Using this process, we trapped, puff-by-puff, crotonaldehyde in mainstream smoke generated by different smoking regimens and quantitatively analysed the levels of crotonaldehyde using high-performance liquid chromatography with a modified QuEChERS sample pretreatment method. On the basis of the crotonaldehyde in each puff, we determined crotonaldehyde's puff-by-puff release characteristics. The results showed that crotonaldehyde's puff-by-puff release remained nearly constant for the International Organization for Standardization mode while increased polynomial trend was seen (n ≥ 6) under the Massachusetts and Health Canada smoking regimens. The equation fit for various regimens was good (R2 > 0.9192). Release characteristics by puff were classified into four categories: (1) first, second and third puffs; (2) fourth and fifth puffs; (3) sixth puff; and (4) seventh and eighth puffs.

Cigarette Filter Ventilation and Smoking Protocol Influence Aldehyde Smoke Yields.

The WHO study group on tobacco product regulation (TobReg) advised regulating and lowering toxicant levels in cigarette smoke. Aldehydes are one of the chemical classes on the TobReg smoke toxicants priority list. To provide insight in factors determining aldehyde yields, the levels of 12 aldehydes in mainstream cigarette smoke of 11 Dutch brands were quantified. Variations in smoking behavior and cigarette design affecting human exposure to aldehydes were studied by using four different machine testing protocols. Machine smoking was based on the International Standardization Organization (ISO) and Health Canada Intense (HCI) regime, both with and without taping the filter vents. The 11 cigarette brands differed in (i) design and blend characteristics; (ii) tar, nicotine, and carbon monoxide (TNCO) levels; (iii) popularity; and (iv) manufacturer. Cigarette smoke was trapped on a Cambridge filter pad and carboxen cartridge. After being dissolved in methanol/CS2 and derivatization with DNPH, the aldehyde yields were determined using HPLC-DAD. Using an intense smoking regime (increased puff volume, shorter puff interval) significantly increased aldehyde yields, following the pattern: ISO < ISO-taped < HCI-untaped < HCI. For all of the regimes, acetaldehyde and acrolein yields were strongly correlated (r = 0.804). The difference in TNCO and aldehyde levels between regular and highly ventilated low-TNCO cigarettes (as measured using ISO) diminished when smoking intensely; this effect is stronger when combined with taping filter vents. The highly ventilated low-TNCO brands showed six times more aldehyde production per mg nicotine for the intense smoking regimes. In conclusion, acetaldehyde and acrolein can be used as representatives for the class of volatile aldehydes for the different brands and smoking regimes. The aldehyde-to-nicotine ratio increased when highly ventilated cigarettes were smoked intensely, similar to real smokers. Thus, a smoker of highly ventilated low-TNCO cigarettes has an increased potential for higher aldehyde exposures compared to a smoker of regular cigarettes.

Influence of Smoking Puff Parameters and Tobacco Varieties on Free Radicals Yields in Cigarette Mainstream Smoke.

Cigarette smoke is a major exogenous source of free radicals, and the resulting oxidative stress is one of the major causes of smoking-caused diseases. Yet, many of the factors that impact free radical delivery from cigarettes remain unclear. In this study, we machine-smoked cigarettes and measured the levels of gas- and particulate-phase radicals by electron paramagnetic resonance (EPR) spectroscopy using standardized smoking regimens (International Organization of Standardization (ISO) and Canadian Intense (CI)), puffing parameters, and tobacco blends. Radical delivery per cigarette was significantly greater in both gas (4-fold) and particulate (6-fold) phases when cigarettes were smoked under the CI protocol compared to the ISO protocol. Total puff volume per cigarette was the major factor with radical production being proportional to total volume, regardless of whether volume differences were achieved by changes in individual puff volume or puff frequency. Changing puff shape (bell vs sharp vs square) or puff duration (1-5 s), without changing volume, had no effect on radical yields. Tobacco variety did have a significant impact on free radical production, with gas-phase radicals highest in reconstituted > burley > oriental > bright tobacco and particulate-phase radicals highest in burley > bright > oriental > reconstituted tobacco. Our findings show that modifiable cigarette design features and measurable user smoking behaviors are key factors determining free radical exposure in smokers.

Optimized method for determination of 16 FDA polycyclic aromatic hydrocarbons (PAHs) in mainstream cigarette smoke by gas chromatography\u2013mass spectrometry

A gas chromatography–mass spectrometry (GC–MS) method was validated for the determination of 16 polycyclic aromatic hydrocarbons (PAHs) from the FDA list of 93 harmful or potentially harmful constituents of mainstream cigarette smoke (MCS). Target analytes were extracted from total particulate matter using accelerated solvent extraction with a toluene/ethanol solvent mixture. Matrix artefacts were removed by two-step solid-phase extraction process. Three different GC–MS systems [GC–MS (single quadrupole), GC–MS/MS (triple quadrupole) and GC–HRMS (high resolution, magnetic sector)] using the same separation conditions were compared for the analysis of MCS of 3R4F Kentucky reference cigarettes generated under ISO and intense smoking regimes. The high mass resolution (m/∆m ≥ 10,000) and associated selectivity of detection by GC–HRMS provided the highest quality data for the target PAHs in MCS. Owing to the HR data acquisition mode enabling measurement of accurate mass, limits of quantification for PAHs were 5 to 15-fold lower for GC–HRMS than for GC–MS/MS and GC–MS. The presented study illustrates that the optimised sample preparation strategy followed by GC–HRMS analysis provides a fit-for-purpose and robust analytical approach allowing measurement of PAHs at (ultra)low concentrations in MCS. Furthermore, the study illustrates the importance and benefits of robust sample preparation and clean-up to compensate for limited selectivity when low-resolution MS is used.

Mixture risk assessment of selected mainstream cigarette smoke constituents generated from low-yield cigarettes in South Korean smokers

A total of 38 hazardous constituents in mainstream cigarette smoke of low-yield cigarettes sold in Korea were selected and analyzed using established methods. Risk calculations were performed using risk algorithms employed in previous studies and Korean population-based exposure parameters. The median cumulative incremental lifetime cancer risk of male smokers could vary from 828 × 10−6 to 2510 × 10−6, and that of female smokers could range from 440 × 10−6 to 1300 × 10−6, depending on the smoking regimens. The median hazard index as the sum of hazard quotients of male smokers varied from 367 to 1,225, and that of female smokers varied from 289 to 970, depending on the smoking regimens. The sensitivity analysis for this risk assessment indicated that the constituent yields in mainstream cigarette smoke, average number of cigarettes smoked per day or year, and mouth-spill rate are the main risk factors. Statistical positive correlations between the average daily dose calculated by the exposure algorithm used in this study for individual smokers and biomarkers verified the reliability of this assessment. It could be concluded that inhalation of the constituents present in the mainstream of low-yield cigarettes has significant cancer and non-cancer health risks, although its effect on risk reduction is still unknown under the fixed machine-smoking conditions.

An approach to testing undiluted e-cigarette aerosol in vitro using 3D reconstituted human airway epithelium

The data presented here show that to provide an estimate of the relative cytotoxicity and therefore potency of e-cigarettes, undiluted aerosol techniques can be used. With the emergence of electronic nicotine delivery systems, fit-for-purpose in vitro screening methods are required.Reconstituted 3D human airway epithelium, was exposed to undiluted aerosols at the air-liquid interface, using a Vitrocell VC 10. TEER, cilia beat frequency and cytotoxic responses were assessed. Using two smoking regimes (ISO and HCI) a 3R4F reference cigarette, produced IC50s of 5.2 and 2.1 min, 1458 ng/mL and 1640 ng/mL nicotine respectively. Using an open tank e-cigarette device, a full cytotoxicity dose-response curve was obtained giving an IC50 of 30 min with corresponding nicotine of 10,957 ng/mL, 6–14 times less cytotoxic than cigarette smoke.A commonly used e-liquid flavourant cinnamaldehyde and known skin sensitizer was added to the standard e-liquid formulation and used as an aerosolised positive control, at 0.1, 0.025, 0.01 and 0%, demonstrating a full dose response.The delivery of undiluted aerosols in vitro has resulted in increased method sensitivity, throughput and quantitative e-cigarette comparisons. A positive control aerosol generated from a ‘safe’ e-liquid benchmark can inform risk assessments on supportable levels of flavour ingredients.

Chemical Analysis and Simulated Pyrolysis of Tobacco Heating System 2.2 Compared to Conventional Cigarettes.

Tobacco Heating System 2.2 (THS 2.2, marketed as iQOS) is a heat-not-burn (HNB) tobacco product that has been successfully introduced to global markets. Despite its expanding market, few independent and systematic researches into THS 2.2 have been carried out to date. We tested a comprehensive list of total particulate matter (TPM), water, tar, nicotine, propylene glycol, glycerin, carbon monoxide, volatile organic compounds, aromatic amines, hydrogen cyanide, ammonia, N-nitrosamines, phenol, and polycyclic aromatic hydrocarbon under both ISO and HCI regimes. We also simulated pyrolysis of THS 2.2 heating sticks and made comparisons with conventional cigarette tobacco fillers using comprehensive gas chromatography-mass spectrometry (GC × GC-MS) to determine whether the specially designed ingredients help reduce harmful constituents. Other than some carbonyls, ammonia, and N-nitrosoanabasine (NAB), the delivered releases from THS 2.2 were at least 80% lower than those from 3R4F. Tar and nicotine remained almost the same as 3R4F. Interestingly, the normalized yield of THS 2.2 to 3R4F under the HCI regime was lower than that under the ISO regime. THS 2.2 delivered fewer harmful constituents than the conventional cigarette 3R4F. Simulated pyrolysis results showed that the lower temperature instead of specially designed ingredients contributed to the distinct shift. In particular, if smoking machines are involved to evaluate the HNB products, smoking regimes of heat-not-burn tobacco products should be carefully chosen. To our knowledge, few independent studies of HNB products have been published. In this paper, a comprehensive list of chemical releases was tested systematically and compared to those from 3R4F. Although THS 2.2 generates lower levels of harmful constituents, the nicotine and tar levels were almost identical to 3R4F.The results should be discussed carefully in the future when assessing the dual-use with other conventional cigarettes, nicotine dependence of HNB products, etc. This study also suggests that regulatory agencies should pay attention to the smoking regimes that are adopted to evaluate HNB tobacco products.

Determination of Mercury in Aerosol by Inductively Coupled Plasma Mass Spectrometry

Summary Based on the knowledge gained from published studies, a new analytical method has been developed for the quantification of mercury (Hg) in the gas-vapor phase of mainstream cigarette smoke and in heated tobacco aerosol generated by a tobacco heating system (THS) using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). From a preliminary test, the mercury concentration in the particulate matter of mainstream smoke from Kentucky reference cigarettes 3R4F generated under the International Organization for Standardization (ISO) smoking regimen was compared with the mercury concentration in the gasvapor phase to assure that mercury is only measurable in the gas-vapor phase, as reported in an earlier published study. The particulate matter was collected using an electrostatic precipitation trap and was analyzed by ICP-MS after a mineralization step. The gas-vapor phase was trapped in the same smoking run as for the particulate matter using two impingers containing a nitric acid-hydrochloric acid-gold solution. The impingers were connected in series behind the electrostatic precipitation trap and the combined impinger solution was analyzed by ICP-MS after sample dilution without further sample treatment. The addition of gold has shown to be efficient for maintaining mercury in an ionized form in the impinger solution and to minimize the mercury memory effect in the sample introduction system of the ICP-MS. Only mercury in the gas-vapor phase could be quantified whereas the signal for mercury in the particulate matter was found close to those of blank solutions and was not measurable, as already mentioned in an earlier study. Following this preliminary test, the electrostatic precipitation trap was replaced by a Cambridge filter pad for the separation of the gas-vapor phase from the particulate matter where only mercury in the gas-vapor phase was quantified. The method for the quantification of mercury in the gas-vapor phase of aerosols obtained under Health Canada (HC) and ISO smoking regimens was validated according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Association of Official Analytical Chemists (AOAC) guidelines. Accuracy profiles were evaluated as described in Association Française de Normalisation (AFNOR). The regression curve was shown to be linear within the evaluated concentration range from 25 pg/mL to 1000 pg/mL with a weighting factor 1/x. The coefficients of variation for repeatability (r) were 3.6% for 3R4F and 4.8% for THS under HC smoking regimen and 3.6% for 3R4F and 4.6% for THS under ISO smoking regimen. The coefficients of variation for intermediate precision (IP) were 7.7% for 3R4F and 7.7% for THS under HC smoking regimen and 4.7% for 3R4F and 4.6% for THS under ISO smoking regimen. The nominal mercury concentrations for 3R4F obtained during the validation under both HC and ISO smoking regimens were found to be in line with results reported in a previously published CORESTA study.

Selected Constituent Yield Variation in the Smoke of Commercial Cigarette Brands on the Japanese Market

Summary This study focused on the variation in the yields of constituents in smoke from commercial cigarette brands available on the Japanese market. Nineteen commercial cigarette brands were sampled five times every two months from 2009 to 2010. The target constituents were benzo[a]-pyrene, 1,3-butadiene, benzene, formaldehyde, acetaldehyde, acrolein, N-nitrosonornicotine (NNN), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), carbon monoxide, “tar”, and nicotine. The results of this study showed that the coefficient of variation (CV) values varied greatly by brands, constituents, and smoking regimes. The yields of NNN and NNK in the smoke were strongly correlated to their yields in the tobacco filler blend for most brands. The yields of benzo[a]pyrene under the International Organization for Standardization (ISO) and the Health Canada Intense (HCI) smoking regimes and 1,3-butadiene under the HCI smoking regime were found to be influenced by the measurement. It was shown that factors for variation were highly varied among constituents. The grand mean of CV values for NNN and formaldehyde associated with cigarette manufacturing over ten months and measurement at the JT laboratory under the HCI smoking regimes were 17.1% and 6.6% respectively. The grand mean of CV values for NNN and formaldehyde associated with both cigarette manufacturing over ten months and measurement at different laboratories under the HCI smoking regimes were 23.7% and 22.9% respectively. This is due to the fact that formaldehyde showed the highest CV values for reproducibility among the constituents. Thus, in order to set realistic and robust confidence intervals, it is very important to take into account the variations associated with cigarette manufacturing and measurement within and between laboratories.

A Survey of Nicotine Yields in Small Cigar Smoke: Influence of Cigar Design and Smoking Regimens.

Although the popularity of small cigar brands that resemble cigarettes, including both little cigars (LC) and filtered cigars (FC), has been on the rise, little is known about the delivery of nicotine from these products. Our objective was to determine the nicotine yields of small cigars in comparison to cigarettes. Nicotine yields from LC, FC, and 3R4F and 1R6F research cigarettes were determined from mainstream smoke generated on a smoking machine under the International Organization of Standardization (ISO) and Canadian Intense (CI) methods. Market characteristics (price and package label) and physical features (filter ventilation, product weight and filter weight, product length, and diameter) were also determined for eight brands of small cigars. Nicotine yields in small cigars averaged 1.24 and 3.49 mg/unit on ISO and CI regimens, respectively, compared with 0.73 and 2.35 mg/unit, respectively, for the research cigarettes. Nicotine yields per puff were similar between small cigars and cigarettes. We also found that FC did not differ from LC in nicotine yields. FC and LC differ from each other in many physical design features (unit weight, filter weight, and filter length), but are similar in others (unit length, diameter, and filter ventilation). Nicotine delivery from small cigars is similar to or greater than that from cigarettes. Thus, for future research and regulatory purposes, standard definitions need to be developed for small cigars, and FC and LC should be evaluated as separate entities. Small cigars are similar to cigarettes in their design and use. Although nicotine yields per puff were similar between products, small cigars delivered substantially higher amounts of nicotine per unit than cigarettes. These findings support the growing body of evidence to justify regulating all small cigars, including LC and FC in a similar fashion as cigarettes.

International Organization of Standardization (ISO) and Cambridge Filter Test (CFT) Smoking Regimen Data Comparisons in Tobacco Product Marketing Applications.

We investigated the differences in TNCO (tar, nicotine, and carbon monoxide) smoke yields generated under the International Organization of Standardization (ISO) and Federal Trade Commission (FTC) Cambridge Filter Test (CFT) smoking regimens. Twenty-nine commercial cigarette products from the US marketplace were acquired in 2015 and tested by measuring the TNCO smoke yields generated under these 2 nonintense smoking regimens. Data obtained demonstrated a linear relationship between the TNCO yields produced under the 2 smoking regimens (R2 > 0.99). TNCO yields produced by each product were higher under the CFT smoking regimen than the ISO smoking regimen. We found that tar, nicotine, and carbon monoxide yields were consistently 10% to 13% higher under the CFT smoking regimen than under the ISO smoking regimen. This strong correlation indicates that the 2 smoking regimens can be used to apply a correlation correction to CFT TNCO data and allow its comparison to ISO TNCO data in tobacco product marketing applications.