TY - JOUR
AU1 - PharmD, Bartosz Koszowski, PhD,
AU2 - PhD, Meridith Hill Thanner,
AU3 - PhD, Wallace B Pickworth,
AU4 - PhD, Kenneth M Taylor,
AU5 - PhD, Lynn C Hull,
AU6 - PhD, Megan J Schroeder,
AB - Abstract Introduction Cigars are combusted tobacco products consisting of filler, binder, and wrapper, which are derived from tobacco. Despite the abundance of literature on the composition of traditional combusted cigarettes, research is limited on the physical and chemical properties of cigars. Therefore, research on cigar properties may be useful to better understand their health impact. Methods In this study, twenty large cigar and cigarillo products were characterized for physical properties (ie, weight, length, and diameter), filler nicotine content, and tobacco pH. Tobacco pH was used to calculate free nicotine content, free nicotine concentration, and percent free nicotine for all cigars using the Henderson–Hasselbach equation. An additional analysis was performed on a second batch of two large cigar and two cigarillo brands to determine within-brand consistency. All analyses were performed in triplicate. Results The initial analysis of the twenty cigars showed that cigars exhibited wide variation in product size and nicotine content, although tobacco pH was similar across cigars. Furthermore, in the two large cigar and cigarillo brands analyzed a second time, there was considerable within-brand variance in nicotine content and concentration between the first and second analyses. Conclusions While only a small sample of commercially-available cigars was analyzed, our data suggest there is wide variability in nicotine content and some physical properties in the domestic cigar market. The data may help to inform potential future regulatory decisions related to these products. Implications This study reveals some of the challenges to experimental cigar research and illustrates the need to characterize cigar products (eg, nicotine and tobacco content) before use in clinical studies. Additional studies and characterization of the physical and chemical properties of cigars may be useful to further understand these products’ toxicity, abuse potential, and public health impact. Introduction The 2009 Family Smoking Prevention and Tobacco Control Act1 granted FDA authority to regulate all tobacco products, with immediate jurisdiction over cigarettes, cigarette tobacco, roll your own tobacco, and smokeless tobacco. In May 2016, this jurisdiction was extended to all tobacco products, including cigars.2 This authority over cigar products is particularly important due to documented changes in cigar use patterns over the past decade. While cigarette smoking rates declined substantially from 2000 to 2011, cigar consumption more than doubled during the same period.3,4 A wide variety and number of cigar products are sold in the US marketplace, including large cigars, cigarillos, and little cigars, which differ in size, filler, flavor, and design features.5 Although no universal definition or legal and regulatory distinctions for the different subcategories currently exist, large cigars and cigarillos differ from little cigars predominantly in that they contain more tobacco filler and have binders and wrappers that are prepared from reconstituted tobacco and tobacco leaf. Little cigars are manufactured similarly to cigarettes, typically do not contain a binder, and use a cigarette paper-based wrapper that contains air-cured tobacco pieces, extracts, or remnants. Although there is no accepted approach to define cigars based on design features, the US Department of the Treasury and the US Federal Trade Commission categorize cigars based on weight.6 The currently available studies on cigar product characteristics were published more than a decade ago and may not represent the cigar products that are presently marketed. While previous work has documented that nicotine content, tobacco weight, and tobacco pH varies among and within cigar product categories,7 no studies to date characterize current cigar products for both physical and nicotine properties. Differences in physical characteristics and tobacco pH, for example, may affect user smoking topography, and thus the amount of nicotine to which cigar smokers are exposed. Furthermore, because unprotonated (“free”) nicotine is more readily absorbed into biologic tissues than the protonated form,8 tobacco pH may be an important factor in the rate of nicotine absorption and, therefore, a product’s addiction potential.9 While several studies have reported that cigar tobacco pH10,7 is more alkaline than cigarette tobacco, no recent reports have been published on large cigars or cigarillos. A better understanding of these relationships is important for further clinical research and interpretations. In the current study, nicotine content (total and free), tobacco pH, and physical characteristics were determined for ten commercial large cigars and ten cigarillos. The study’s aim was to understand the variability of cigar characteristics, a critical aspect in conducting and interpreting clinical study results. Methods Cigars Ten domestic large cigars and ten domestic cigarillos were selected and purchased in August 2015 based on national 2014 Nielsen Market Share ratings indicating products with the greatest market share, and subsequent regional availability in the Baltimore, Maryland area. Cigar classification as large cigar or cigarillo was based on product labeling. Secondary analyses on two large cigar and two cigarillo products were subsequently conducted in January 2016 on a different batch of products, purchased at a later date, to determine within-brand, between-batch variability. All products were stored in their original packaging at ambient temperature after purchase until analysis. Free nicotine content, free nicotine concentration, and percent free nicotine were calculated for each cigar based on nicotine content/concentration and tobacco pH according to the Henderson–Hasselbach equation with a pKa of 8.02 for nicotine. Physical and Nicotine Measurements All cigar characterization analyses (ie, physical properties, nicotine content, and tobacco pH) were performed by Enthalpy Analytical, Inc. (Richmond, VA). All analytical methods used to characterize the cigars have been validated and are accredited to ISO 17025:2005. To allow for comparisons, 24 hours prior to analysis, all cigars were conditioned by placement in a drying oven to regulate temperature to 22°C (+/− 1 degree) and humidity to 65% (+/− 5%) which is consistent with ISO 3401. Physical Properties To determine length, each cigar was measured from the butt side of the cigar to the end. Cigar diameter was measured 15 mm from the mouth end to avoid measurement at the cigar’s tapered end. Both measures were taken using a certified ruler and recorded in millimeters to the nearest 0.5 mm. Cigars were weighed on a certified and calibrated analytical balance and recorded in grams to the nearest 0.0001 g, with both individual and average weights reported. Where applicable, cigars were weighed with and without filters; the filter was removed prior to nicotine and pH analyses. To remove the filter, cigars were pinched at the tobacco-filter joint to separate the filter. If the wrapper tore or any of the tobacco components remained adhered to the filter component, the cigar was discarded and not used for testing. Nicotine and Tobacco pH Following the length, diameter, and weight measurements, the cigar tobacco was ground, at room temperature, in preparation for the nicotine and pH analyses. The tobacco filler, binder, and wrapper components of the cigars and cigarillos were processed as a single composite sample using a ball mill grinder. Alkaloids were extracted from a sample of 250 mg of tobacco with 4 mL aqueous 5N NaOH and 40 mL CH3OH containing quinoline as the internal standard. After shaking for 30 minutes, the sample was centrifuged, and then directly analyzed by gas chromatography–mass spectrometry (GC–MS) using electron-impact ionization (Agilent GC-MSD, SIM; selected ions: nicotine m/z 84 and 162, and quinoline m/z 129 were monitored). The alkaloids present in tobacco samples were quantified using an internal standard. The linear range was 4–360 μg/mL. The limit of detection and limit of quantification for nicotine were 1.2 and 4 μg/mL respectively. Nicotine concentration was calculated based on product weight. The pH of tobacco filler was determined by taking a 2 g sample of the ground tobacco of the entire cigar product (wrapper and filler) and combining it with 20 mL of degassed high performance liquid chromatography grade water. This sample was placed on an orbital shaker for 30 minutes and then incubated in the dark for 60 minutes. pH was measured using an electronic pH meter equipped with a glass electrode and then evaluated at specified time intervals until a stable reading (≤10% variance) was obtained. Quality Control and Statistical Analyses For each cigar product, nicotine analyses were run in triplicate with individual data values reported as well as the average, standard deviation, and relative standard deviation for the three observations. For this study, the nicotine analysis was monitored with KY 3R4F tobacco analyzed “as is” and spiked at a known concentration to establish the percent recovery. Recovery values had an acceptance range of ±20%. The pH analysis was also verified using the KY 3R4F tobacco. For each analytical run, a calibration curve was analyzed for each batch of samples and an independently prepared quality control sample was analyzed with each group of approximately ten samples. Acceptance criteria for quality control runs were ±10% of expected values. For each variable, an arithmetic mean with standard deviation was calculated for each cigar product tested. To compare differences between the 2015 and 2016 product batches, absolute percent differences were calculated. Due to the small sample size, statistical comparisons between products were not performed. Results The physical properties and nicotine content of the 10 large cigars and 10 cigarillos are presented in Table 1. Table 1. Physical and Nicotine Characterization of Large Cigars and Cigarillos   Cigar name  Price per cigar [$]  Physical characterization  Nicotine characterization  Weight (with wrapper) [g]  Length [mm]  Diameter [mm]  Nicotine content [mg/cigar]  Nicotine concentration [mg/g tobacco]  Tobacco pH  Free Ncotine [%]  Free nicotine [mg/g tobacco]  Free nicotine [mg/cigar]  Mean (Standard deviation)  Calculateda  Large Cigars  Antonio Y Cleopatra Dark Natural  1.27  6.39 (0.74)  157 (2)  12.70 (0.50)  74.00 (1.80)  11.6 (0.30)  6.37 (0.02)  2.19  0.25  1.62  Backwoods Original  0.82  2.89 (0.16)  106 (6)  9.05 (1.28)  28.80 (0.80)  9.96 (0.28)  6.60 (0.01)  3.66  0.36  1.05  Blunt Ville Natural Deluxe  1.00  2.68 (0.31)  144 (2)  9.40 (0.50)  18.10 (0.20)  6.76 (0.07)  7.43 (0.01)  20.45  1.38  3.70  Dutch Masters Palma  2.25  9.14 (0.44)  144 (1)  16.60 (0.70)  99.30 (4.00)  10.90 (0.40)  6.30 (0.01)  1.87  0.20  1.86  Garcia Y Vega Presidente  1.12  7.53 (0.54)  153 (1)  15.10 (0.60)  82.00 (1.30)  10.90 (0.20)  6.50 (0.03)  2.93  0.32  2.40  Hav-a-Tampa Jewels Original (with filter)  0.66  3.83 (0.32)  122 (1)  10.20 (0.40)  46.10 (1.10)  20.40 (0.50)  5.88 (0.01)  0.72  0.15  0.33  Phillies Blunt  1.64  6.96 (0.36)  125 (1)  14.80 (0.60)  51.60 (0.50)  7.42 (0.07)  6.71 (0.01)  4.67  0.35  2.41  Romeo Y Julieta 1875 Churchill  5.25  17.60 (0.10)  177 (1)  19.00 (1.70)  505.00 (8.00)  28.60 (0.40)  6.17 (0.02)  1.39  0.40  7.03  Swisher Sweets Perfecto  0.68  6.97 (0.37)  128 (1)  15.00 (0.70)  51.30 (0.70)  7.37 (0.10)  6.59 (0.03)  3.58  0.26  1.84  White Owl New Yorker  0.90  7.63 (0.61)  144 (1)  15.20 (0.40)  60.60 (1.30)  7.95 (0.17)  6.72 (0.02)  4.77  0.38  2.89  Mean (Standard Deviation)  1.66 (1.35)  7.16 (4.26)  140 (20)  13.71 (3.27)  101.68 (143.74)  12.19 (6.98)  6.53 (0.41)  4.63 (5.70)  0.41 (0.35)  2.51 (1.84)  Cigarillos  Dutch Master’s Green  1.25  2.99 (0.28)  112 (1)  11.10 (1.00)  22.90 (0.10)  7.66 (0.02)  6.37 (0.01)  2.19  0.17  0.50  Garcia Y Vega Whiffs Natural  1.44  1.64 (0.10)  93.50 (0.50)  8.70 (0.47)  19.40 (0.20)  11.80 (0.10)  6.15 (0.01)  1.33  0.16  0.26  Good Times Straight Natural  0.35  3.04 (0.34)  107 (1)  10.80 (0.40)  36.40 (1.50)  12.00 (0.50)  6.48 (0.03)  2.80  0.34  1.02  Middleton’s Black & Mild (with filter)  1.28  4.24 (0.19)  128 (1)  9.65 (0.49)  25.50 (0.80)  7.89 (0.26)  5.34 (0.02)  0.21  0.02  0.05  Phillies Natural Brown  0.86  3.13 (0.28)  113 (0)  10.50 (0.50)  22.90 (0.40)  7.33 (0.12)  6.45 (0.02)  2.62  0.19  0.60  Royal Comfort Black  0.70  2.84 (0.22)  107 (1)  10.60 (0.50)  26.20 (1.00)  9.22 (0.34)  6.71 (0.02)  4.67  0.43  1.22  Swisher Diamonds  0.50  2.57 (0.10)  109 (1)  11.50 (0.50)  28.70 (0.00)  11.20 (0.00)  6.26 (0.01)  1.71  0.19  0.49  Swisher Sweets Original  0.75  2.66 (0.08)  110 (1)  10.50 (0.60)  25.50 (0.50)  9.59 (0.18)  6.32 (0.03)  1.96  0.19  0.50  White Owl Silver  0.75  2.54 (0.15)  111 (1)  10.20 (0.40)  27.40 (0.20)  10.80 (0.10)  6.39 (0.01)  2.29  0.25  0.63  Zig Zag Straight Up  0.70  2.90 (0.16)  113 (1)  10.90 (0.60)  14.00 (0.50)  4.84 (0.17)  7.23 (0.03)  13.95  0.68  1.95  Mean (Standard Deviation)  0.86 (0.35)  2.86 (0.64)  110 (8)  10.45 (0.79)  24.89 (5.89)  9.19 (2.44)  6.39 (0.49)  3.37 (3.89)  0.26 (0.18)  0.72 (0.55)    Cigar name  Price per cigar [$]  Physical characterization  Nicotine characterization  Weight (with wrapper) [g]  Length [mm]  Diameter [mm]  Nicotine content [mg/cigar]  Nicotine concentration [mg/g tobacco]  Tobacco pH  Free Ncotine [%]  Free nicotine [mg/g tobacco]  Free nicotine [mg/cigar]  Mean (Standard deviation)  Calculateda  Large Cigars  Antonio Y Cleopatra Dark Natural  1.27  6.39 (0.74)  157 (2)  12.70 (0.50)  74.00 (1.80)  11.6 (0.30)  6.37 (0.02)  2.19  0.25  1.62  Backwoods Original  0.82  2.89 (0.16)  106 (6)  9.05 (1.28)  28.80 (0.80)  9.96 (0.28)  6.60 (0.01)  3.66  0.36  1.05  Blunt Ville Natural Deluxe  1.00  2.68 (0.31)  144 (2)  9.40 (0.50)  18.10 (0.20)  6.76 (0.07)  7.43 (0.01)  20.45  1.38  3.70  Dutch Masters Palma  2.25  9.14 (0.44)  144 (1)  16.60 (0.70)  99.30 (4.00)  10.90 (0.40)  6.30 (0.01)  1.87  0.20  1.86  Garcia Y Vega Presidente  1.12  7.53 (0.54)  153 (1)  15.10 (0.60)  82.00 (1.30)  10.90 (0.20)  6.50 (0.03)  2.93  0.32  2.40  Hav-a-Tampa Jewels Original (with filter)  0.66  3.83 (0.32)  122 (1)  10.20 (0.40)  46.10 (1.10)  20.40 (0.50)  5.88 (0.01)  0.72  0.15  0.33  Phillies Blunt  1.64  6.96 (0.36)  125 (1)  14.80 (0.60)  51.60 (0.50)  7.42 (0.07)  6.71 (0.01)  4.67  0.35  2.41  Romeo Y Julieta 1875 Churchill  5.25  17.60 (0.10)  177 (1)  19.00 (1.70)  505.00 (8.00)  28.60 (0.40)  6.17 (0.02)  1.39  0.40  7.03  Swisher Sweets Perfecto  0.68  6.97 (0.37)  128 (1)  15.00 (0.70)  51.30 (0.70)  7.37 (0.10)  6.59 (0.03)  3.58  0.26  1.84  White Owl New Yorker  0.90  7.63 (0.61)  144 (1)  15.20 (0.40)  60.60 (1.30)  7.95 (0.17)  6.72 (0.02)  4.77  0.38  2.89  Mean (Standard Deviation)  1.66 (1.35)  7.16 (4.26)  140 (20)  13.71 (3.27)  101.68 (143.74)  12.19 (6.98)  6.53 (0.41)  4.63 (5.70)  0.41 (0.35)  2.51 (1.84)  Cigarillos  Dutch Master’s Green  1.25  2.99 (0.28)  112 (1)  11.10 (1.00)  22.90 (0.10)  7.66 (0.02)  6.37 (0.01)  2.19  0.17  0.50  Garcia Y Vega Whiffs Natural  1.44  1.64 (0.10)  93.50 (0.50)  8.70 (0.47)  19.40 (0.20)  11.80 (0.10)  6.15 (0.01)  1.33  0.16  0.26  Good Times Straight Natural  0.35  3.04 (0.34)  107 (1)  10.80 (0.40)  36.40 (1.50)  12.00 (0.50)  6.48 (0.03)  2.80  0.34  1.02  Middleton’s Black & Mild (with filter)  1.28  4.24 (0.19)  128 (1)  9.65 (0.49)  25.50 (0.80)  7.89 (0.26)  5.34 (0.02)  0.21  0.02  0.05  Phillies Natural Brown  0.86  3.13 (0.28)  113 (0)  10.50 (0.50)  22.90 (0.40)  7.33 (0.12)  6.45 (0.02)  2.62  0.19  0.60  Royal Comfort Black  0.70  2.84 (0.22)  107 (1)  10.60 (0.50)  26.20 (1.00)  9.22 (0.34)  6.71 (0.02)  4.67  0.43  1.22  Swisher Diamonds  0.50  2.57 (0.10)  109 (1)  11.50 (0.50)  28.70 (0.00)  11.20 (0.00)  6.26 (0.01)  1.71  0.19  0.49  Swisher Sweets Original  0.75  2.66 (0.08)  110 (1)  10.50 (0.60)  25.50 (0.50)  9.59 (0.18)  6.32 (0.03)  1.96  0.19  0.50  White Owl Silver  0.75  2.54 (0.15)  111 (1)  10.20 (0.40)  27.40 (0.20)  10.80 (0.10)  6.39 (0.01)  2.29  0.25  0.63  Zig Zag Straight Up  0.70  2.90 (0.16)  113 (1)  10.90 (0.60)  14.00 (0.50)  4.84 (0.17)  7.23 (0.03)  13.95  0.68  1.95  Mean (Standard Deviation)  0.86 (0.35)  2.86 (0.64)  110 (8)  10.45 (0.79)  24.89 (5.89)  9.19 (2.44)  6.39 (0.49)  3.37 (3.89)  0.26 (0.18)  0.72 (0.55)  Initial cigar purchase in August 2015; follow-up purchase for re-analysis in January 2016; Bolded rows indicate products that were re-analyzed. avalues calculated based on measured nicotine/pH in tobacco using the Henderson–Hasselbalch equation. View Large Physical Characteristics Large Cigars The weights of sampled large cigars ranged from 2.68 g (Blunt Ville Natural Deluxe) to 17.6 g (Romeo Y Julieta 1875 Churchill); length ranged from 106 mm (Backwoods Original) to 177 mm (Romeo Y Julieta 1875 Churchill). Large cigar diameters ranged from 9.05 mm (Backwoods Original) to 19 mm (Romeo Y Julieta 1875 Churchill). Cigarillos The weights of sampled cigarillos ranged from 1.64 g (Garcia Y Vega Whiffs Natural) to 4.24 g (Middleton’s Black & Mild); length ranged from 93.5 mm (Garcia Y Vega Whiffs Natural) to 128 mm (Middleton’s Black & Mild). Cigarillo diameters ranged from 8.70 mm (Garcia Y Vega Whiffs Natural) to 11.5 mm (Swisher Diamonds). Nicotine Content Large Cigars The nicotine content in large cigars ranged from 18.1 mg/cigar (Blunt Ville Natural Deluxe) to 505 mg/cigar (Romeo Y Julieta 1875 Churchill); nicotine concentration ranged from 6.76 mg/g (Blunt Ville Natural Deluxe) to 28.6 mg/g tobacco (Romeo Y Julieta 1875 Churchill). The tobacco pH for large cigars ranged from 5.88 (Hav-a-Tampa Jewels Original) to 7.43 (Blunt Ville Natural Deluxe). Cigarillos The nicotine content in sampled cigarillos ranged from 14.0 mg/cigar (Zig Zag Straight Up) to 36.4 mg/cigar (Good Times Straight Natural); nicotine concentration ranged from 4.84 mg/g (Zig Zag Straight Up) to 12.0 mg/g tobacco (Good Times Straight Natural). The tobacco pH for cigarillos ranged from 5.34 (Middleton’s Black & Mild) to 7.23 (Zig Zag Straight Up). Secondary Product Sampling and Analysis Two large cigars (Dutch Masters Palma and White Owl New Yorker) and two cigarillos (Middleton’s Black & Mild and Royal Comfort Black) were purchased again in 2016 and analyzed as previously described to assess possible differences between product batches. Across two production batches, all cigar physical characteristics differed by less than 10%, except for the Dutch Masters Palma product, which exhibited a 12.7% change in weight (Figure 1A) and the Middleton Black & Mild product, which exhibited a 10% change in diameter (data not shown). Despite consistency in physical properties, there were substantial differences in nicotine content and concentration, particularly for the large cigars (Figure 1B and C). For example, a 32.6% and 36.7% change in nicotine content was found for the Dutch Masters Palma and White Owl New Yorker products, respectively. Tobacco pH remained similar across batches (Figure 1D). Due to changes in nicotine content and concentration, percent free nicotine differed by 16%–45% (data not shown); the largest differences were observed in the large cigar products. Figure 1. View largeDownload slide Consistency within products (differences between first and second purchased batch of two large cigars and two cigarillos) for weight (Panel A), nicotine content and concentration (Panel B and C), and tobacco pH (Panel D). Figure 1. View largeDownload slide Consistency within products (differences between first and second purchased batch of two large cigars and two cigarillos) for weight (Panel A), nicotine content and concentration (Panel B and C), and tobacco pH (Panel D). Discussion In the present study, 10 large cigars and 10 cigarillos (based on US market share) were surveyed to assess their physical characteristics, nicotine content, and tobacco pH. Wide variations in product size and nicotine content were found, although the pH was similar across all cigars. When secondary analyses of four products were conducted to assess the consistency of measured variables across product batches, there was considerable variation in the nicotine content and concentration. As seen here and in a previous study by Henningfield et al.,7 domestic cigars vary widely in their size and nicotine content. Unlike cigarettes, which have a great deal of between-brand uniformity, the large cigars and cigarillos in our study have widely variable weights (1.6–17.6 g), lengths (94–177 mm), and nicotine content (14–99 mg). The variability of tobacco and nicotine content in cigars complicates comparisons of use behavior (eg, products used per day), nicotine addiction, and toxicant exposure among cigar smokers. Furthermore, cigars vary in flavor,11 style, type of tobacco in the filler and wrapper, and ability to be adulterated.12 Consequently, simple descriptions of “cigars” or “cigar smokers” are ambiguous and may lead to confusion and/or inaccurate conclusions. In our study, the nicotine concentration for cigar products varied widely (~5–29 mg/g tobacco), but was similar to the nicotine concentrations of major US cigarette brands (13–26 mg/g tobacco).13 However, because cigarettes contain less tobacco (<1 g) than cigars, total nicotine exposure may be higher from cigars. Nicotine is a weak base and, as such, its ionization in aqueous media depends on the concentration of hydrogen ions (ie, pH).14 In this study, the aqueous pH of large cigars ranged from 6.17 to 7.43; cigarillo pH ranged from 5.34 to 7.23. This range in pH is similar to that reported by Henningfield et al.7 and the 1998 NCI Cigar Monograph.12 Furthermore, since nicotine is a weak base, the aqueous pH affects the amount of nicotine in the unionized free base form. The free base form of nicotine crosses biological membranes more easily than the ionized form.14 Our study suggests that the relatively alkaline cigar tobacco may support nicotine dermal absorption through the lips and fingers, and potentially augment pulmonary and buccal absorption from smoke. Even though the aqueous pH of suspended ground tobacco product does not necessarily reflect mainstream smoke pH15 (the main vehicle of pulmonary nicotine delivery from combustible tobacco products), the relative alkalinity of cigar tobacco and/or smoke may explain why some cigar smokers are less likely to inhale mainstream smoke than cigarette smokers.12 Currently, there are no regulatory criteria that define terminology for specific cigar types. To illustrate, some products in our study are labelled as cigarillos but are larger than some products labeled as large cigars, and some large cigars have the physical characteristics of cigarillos (eg, Middleton’s Black & Mild [4.24 g; categorized as a cigarillo] vs. Blunt Ville Natural Deluxe [2.68 g; categorized as a large cigar]). In addition, cigar size does not necessarily correlate with nicotine or free nicotine content. For example, two cigarillo products, Zig Zag Straight Up and Royal Comfort Black, have less tobacco weight than most of the tested large cigar products, but also have the greatest amount of free nicotine on a per mass of tobacco basis. These study results illustrate the wide variation in product size and nicotine content within the domestic cigar market. Because cigar size and tobacco weight do not necessarily correspond to the amount of free nicotine, a basic analysis of cigar products may be essential before cigar use in clinical studies. Additionally, consumers smoking the same brand of cigar may unintentionally be exposed to varying doses of nicotine and potentially other smoke constituents. Establishing criteria to differentiate large cigars, cigarillos, and little cigars into mutually exclusive classes is complex, but may be beneficial for research and regulatory efforts as well as appropriate product labelling for consumers. Study Limitations These analyses were performed on a limited number of cigar products, and therefore our results may not be representative of all cigars available in the US market. Furthermore, free base nicotine calculations based on tobacco pH measurements may fundamentally differ from the tobacco smoke pH generated from these tobacco products. Thus, the free nicotine calculations should be interpreted with caution. Additionally, the reported within product variations may not apply to all other cigar products. Moreover, small sample size limited our ability to perform statistical comparisons within and between products. Funding Research supported by a contract awarded to Battelle by the Food and Drug Administration (Center for Tobacco Products). IDIQ/TO#: HHSF223201310/030I_HHSF22301004T. Declaration of Interests None declared. Acknowledgments Appreciation to Enver Holder-Hayes and Deborah Neveleff, The US Food and Drug Administration, Office of Science, Center for Tobacco Products for their contributions to the manuscript. Appreciation to Carson Smith (Battelle) and Jacek Domagala (intern to Battelle from Notre Dame of Maryland University) for editorial support. Disclaimer: This publication represents the views of the author(s) and does not represent FDA/CTP position or policy. LCH and MJS contributed equally to this work. References 1. United States Congress. Family Smoking Prevention and Tobacco Control Act. Public Law. 2009. 111– 131. 2. 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TI - Nicotine Content and Physical Properties of Large Cigars and Cigarillos in the United States
JF - Nicotine and Tobacco Research
DO - 10.1093/ntr/ntx054
DA - 2018-03-01
UR - https://www.deepdyve.com/lp/oxford-university-press/nicotine-content-and-physical-properties-of-large-cigars-and-7UT3ZJ4tMV
SP - 393
EP - 398
VL - 20
IS - 3
DP - DeepDyve
ER -