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

Abstract

Introduction

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.

Methods

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.

Results

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).

Conclusions

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.

Implications

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.

Introduction

Nicotine is a plant alkaloid that is responsible for the addictive properties of tobacco products.^1,2 Combustible tobacco products are the deadliest forms of nicotine delivery systems, with cigarettes being the most widely used in the United States.³ The 2009 Family Smoking Prevention and Tobacco Control Act imposed several marketing, packaging, and tax restrictions on cigarettes, including making annual payments to states, a ban on cigarettes containing characterizing flavors (except menthol) and a ban on sale of cigarettes in packages less than 20 units per pack.⁴ Cigars are the second most popular combustible tobacco products, free from the restrictions imposed on cigarettes.^5,6 In the United States, an estimated 12.4 million people (5.2%), including middle and high school students, are cigar smokers according to the 2013 data.⁷ Cigarettes differ from cigars primarily by their wrapping paper with cigarettes defined as a “roll of tobacco wrapped in paper” and cigars as a “roll of tobacco wrapped in leaf tobacco or in a substance that contains tobacco” (The Cigarette Labeling and Advertising Act of 1965). As a combustible tobacco product, cigars are not a safe alternative to cigarettes and cause similar devastating health effects, such as addictiveness, cancers, and lung and heart diseases.^6,8,9

In addition to the wrapping paper, cigars are distinguished from cigarettes in that they are sold in a wide variety of shapes, sizes, flavors, filtration, and packaging and are subject to different marketing strategies and tax classifications. Cigars have been classified into a number of subtypes including large cigars, cigarillos, filtered cigars (FC), and little cigars (LC).⁶ To date, product weight has been the main variable taken into account in these classifications.¹⁰ LC and FC are both considered “small cigars” that are similar to cigarettes in size and having filters. Although the two classifications are often used interchangeably and the products have many similarities (ie, have filter, are wrapped in tobacco, and similar length and diameter), there are a number of important differences. For example, federally, a cigar is classified as a LC if it weighs less than 3 pounds for 1000 sticks (less than 1.36 g per unit).¹⁰ To further add to the confusion, companies themselves classify their products and sometimes even switch product category for tax purposes (eg, Djarum clove cigar and Winchester cigar).^11,12 Many manufacturers converted their LC to FC simply by adding additional weight to the product (bringing the total weight over 1.36 g per unit) to obtain a price advantage in response to the 2009 federal excise tax increase on LC.^13,14 Thus, due to the absence of standard definitions, misleading messages from the tobacco industry, miss-categorization of products by smokers,^15,16 and inconsistent classification in research studies, the scientific and public health literature on these products is difficult to interpret. For this paper, we have used the term small cigars to encompass both LC and FC.

Small cigars have also been called brown cigarettes and pseudo-cigarettes.⁵ They resemble cigarettes in their shape, and size, are predominantly filtered, have filter ventilation, are machine-made, and usually sold in 20 units per pack. Small cigars can be sold in a wide variety of characterizing flavors banned in cigarettes sold in the United States. Flavors appeal to youth and novice smokers because the flavorings alter the taste, smell, and other sensory attributes of the harsh smoke.^17–19 Also, small cigars appeal to cost-conscious smokers because they are taxed lower than cigarettes.²⁰ Typical price for a pack of Marlboro cigarettes is US $6.57 compared with US $1.65 for Dean’s small cigar in South Central Pennsylvania area. Small cigars resemble cigarettes so much that 42% of smokers identified them as cigarettes.¹⁵ In fact, to address this concern, in 2016, the Food and Drug Administration (FDA) issued warning letters to four manufacturers (Swisher International Inc, Cheyenne International LLC, Prime Time International Co, and Southern Cross Tobacco Company Inc) warning them that their products meet the definition of cigarettes in the Tobacco Control Act because they are likely to be offered to, or purchased by, consumers as cigarettes based on their overall presentation, appearance, packaging, and labeling.²¹ Small cigars are often smoked and inhaled similarly to cigarettes.^22,23 A majority of small cigar smokers (60%) are former or current dual cigarette users.^24,25 Alarmingly, many tobacco users perceive small cigars to be less addictive and harmful compared with cigarettes.^24,26

Despite the physical and usage similarity between small cigars and cigarettes, only a few studies have examined small cigar products and smoke characteristics.^27–33 In a recent study, a large range (10.3–19.1 mg/g) was found in the nicotine content of small cigar tobacco, but, on average, concentrations (12.6 mg/g) were lower than those in cigarettes (19.2 mg/g).³¹ Up-to-date data on nicotine yield in mainstream smoke collected under different standardized smoking regimens are available for commercial cigarettes^34–36 but not for cigars currently marketed in the United States. Thus, the main aim of this study was to measure nicotine in the mainstream smoke from a convenience sample of small cigars under the two most common smoking regimens: International Organization of Standardization (ISO) and Canadian Intense (CI) in order to compare nicotine yields with those from cigarettes. These two smoking regimens were selected based on research that most cigar users also smoke cigarettes,^24,25,37,38 and on the similarity of smoking topography and nicotine exposure in dual users of both products.^22,23 We also examined the effects of product characteristics such as tobacco weight and filter ventilation on nicotine yields. Product surveillance of this type is of particular importance as the small cigar market may shift in near future in anticipation of upcoming changes due to the FDA’s new deeming rule over all cigars.³⁹

Methods

Cigarette and Small Cigar Selection

The 3R4F and 1R6F research cigarettes were obtained from the University of Kentucky (Lexington, KY, USA) in 2014 and 2016, respectively. These two cigarettes were chosen because 3R4F is the most widely used research cigarette in the literature, whereas 1R6F is newly developed to better reflect products currently on the market. All the commercial small cigars were purchased locally (Dauphin and Lebanon Counties, PA, USA) in 2015–2017. We attempted to procure a sampling of all of the full flavor/regular/classic styles of small cigars available in our area from convenience stores, gas stations, and food and drug stores based on the package resemblance to cigarette packs, package labels, or availability in 20 units per pack. A total of eight brands of small cigars that fit these criteria were obtained, a number of which have been identified as popular brands across the United States^40,41 (Figure 1 and Table 1). Djarum Clove Cigars was the only brand that was sold as 12 units per pack. Some of the cigars were labeled as “little cigars; LC” and some as “filtered cigars; FC.” Dean’s Cigar and Cheyenne were labeled as “cigar.” LC and FC were classified by self-identification based on the label given on the product. We considered the two products that were not classified as either LC or FC (ie, Dean’s and Cheyenne) as FC based on weight (>1.36 g). These classifications were further confirmed by the lack of a Pennsylvania Tax Stamp⁴² on the bottom of the pack. All the tobacco products were stored in their original packaging long term at −20°C in airtight plastic bags.

Figure 1.

Photograph of the cigarettes and small cigars used in the study: (1)1R6F, (2) 3R4F, (3) Captain Black Sweets, (4) Cheyenne Full Flavor 100s, (5) Criss Cross Original, (6) Dean’s Cigars Full Flavor 100s, (7) Djarum Black Clove Cigar, (8) Swisher Sweets Regular cigar, (9) Talon Sweet Original, and (10) Winchester Original Blend.

Table 1.

Market and Physical Characteristics of Small Cigars Used in the Study

	Market Characteristics		Physical Characteristics
Brand	Product labela	Price per packb ($)	Vent Totalc (%)	Unit weightd (mg/unit)	Filter weighte (mg/cig)	Weight w/o filterf (mg/cig)	Unit lengthg (mm)	Filter lengthh (mm)	Unit diameteri (mm)
1R6F	Research	N/A	33	865.9 (16.1)	206.8 (1.9)	659.1 (15.1)	83.3 (0.4)	27.1 (0.7)	7.83 (0.06)
3R4F	Research	N/A	38	1005.6 (24.4)	225.1 (5.8)	780.3 (19.2)	84.5 (0.2)	26.7 (0.6)	7.80 (0.10)
Captain Black Sweets	LC	6.97	18	1109.7 (32.7)	203.0 (7.5)	906.6 (25.1)	98.9 (0.4)	27.6 (0.4)	7.83 (0.06)
Cheyenne Full Flavor 100s	C	1.59	23	1813.7 (90.4)	524.7 (11.8)	1288.9 (79.2)	99.4 (0.4)	30.0 (0.5)	7.87 (0.06)
Criss Cross Original	FC	1.65	28	1768.8 (38.8)	528.8 (6.8)	1240.0 (34.6)	119.9 (0.2)	30.0 (0)	7.80 (0.10)
Dean’s Cigars Full Flavor 100s	C	1.59	3	1773.0 (45.5)	539.7 (12.4)	1233.3 (32.1)	99.1 (0.3)	30.1 (1.0)	7.83 (0.06)
Djarum Black Clove Cigar	FC	6.49	9	1405.1 (36.4)	161.8 (0.3)	1243.3 (37.8)	89.5 (0.4)	24.7 (0.6)	7.73 (0.06)
Swisher Sweets Regular cigar	LC	7.99	10	1179.7 (33.8)	209.1 (2.2)	970.0 (36.0)	100.1 (0.3)	27.1 (0.2)	7.73 (0.15)
Talon Sweet Original	FC	4.07	18	1335.1 (40.6)	315.1 (15.8)	1020.0 (26.4)	99.5 (0.2)	27.0 (1.0)	8.83 (0.06)
Winchester Original Blend	LC	8.57	18	957.9 (6.2)	174.6 (0.5)	783.3 (5.7)	83.1 (0.2)	23.3 (0.6)	7.83 (0.06)

^aLC = Little Cigar; FC = Filtered cigar; C = Cigar. For all analyses, Dean’s and Cheyenne was subgrouped into the FC category. All little cigars were purchased as 20 per pack, except Djarum Black (12 per pack).

^bIncluding federal and state tax, excluding PA state sales tax.

^cValues are mean, n = 5.

^d–iValues are mean (SD), n = 3.

Materials

All chemicals were analytical grade and used as supplied. Heptadecane and nicotine were from Sigma-Aldrich (St. Louis, MO, USA), methanol from Fisher Scientific (Pittsburgh, PA, USA), and Cambridge filter pads (CFPs) from Performance Systematix Inc (Grand Rapids, MI, USA).

Determination of Physical Features and Filter Ventilation

Total filter ventilation (%) of the products were measured at the Centers For Disease Control and Prevention (CDC), Atlanta, USA as described in a previous study.³⁴ All other product features were measured at Pennsylvania State University College of Medicine. Calipers were used to measure unit length, rod length, filter length, and diameter. Products were weighed with and without filters on a calibrated analytical scale to the nearest 0.0001 g. Similar to cigarettes, some tipping paper remained on most of the cigars (except Djarum) after cutting off the filter for analysis.

Mainstream Smoke Generation

There are no validated CORESTA/ISO methods for conditioning and smoke generation for small cigars. Thus, cigarette conditioning and smoking protocols were followed for all small cigars, as in other studies.^27,29,33,43 The cigarettes or cigars were conditioned for testing by removing them from cold storage and placing them in a constant humidity chamber (60% relative humidity, 22°C) following ISO 3402:1999⁴⁴, for at least 48 hours before smoking. Mainstream smoke was generated by a single-port smoking machine (Human Puff Profile Cigarette Smoking Machine [CSM-HPP], CH Technologies, NJ, USA). One product was smoked at a time to the marked length of the filter overwrap (tipping) plus 3 mm under the International Organization of Standardization (ISO 3308:2012)⁴⁵ standard smoking regimen (35 mL puff volume, 60-second puff interval, 2-second duration, and no filter vents blocked) and Canada Intense (CI T-115: 1999)⁴⁶ smoking regimen (55 mL puff volume, 2-second duration, 30-second puff interval, and filter vents blocked with clear tape).

Determination of Nicotine Yield and Total Particulate Matter

Total nicotine from mainstream smoke was trapped onto CFPs. Nicotine was extracted following ISO 10315:2013⁴⁷ from the CFP by using 20 mL methanol, and hepatadecane was used as an internal standard. Nicotine was analyzed by GC/FID using an HP 5890 gas chromatograph with separation on an Agilent CP Wax 52 CB column (30 m × 0.25 mm × 0.25 µm) using helium as the carrier gas with a flow rate of 1.2 mL/min. The injector and detector temperatures were held at 240°C and 280°C, respectively. The initial column temperature was 100°C, held for one minute, then heated to 240°C, and held for 10 minutes before returning to initial conditions. Total particulate matter was determined following ISO 4387:2008⁴⁸ by weighing the CFPs before and after smoking product on a calibrated analytical scale to the nearest 0.0001 g and rounding off to the nearest mg.

Statistical Analysis

Statistical analyses comparing cigarettes with cigars, and evaluating correlations between characteristics and nicotine yield, were performed using Microsoft Excel. To assess the relationship between physical design features and nicotine yields, an unadjusted linear regression or scatterplot was used to obtain the R-squared value to be assessed for correlation. When comparing LC characteristics with FC characteristics, an independent two-sample t-test was used to evaluate statistical significance.

Results

Products Price

In the South Central Pennsylvania area, the price per pack (including federal and state tax, excluding state sales tax) ranged from US $1.59 (8 cents per Cheyenne cigar and Dean’s cigar) to US $8.57 (43 cents per Winchester cigar) (Table 1). The average price for the small cigar brands purchased for this study was US $4.86. When subgrouped, a pack of FC cost significantly (p = .01) less (average US $3.07) compared with LC (average US $7.84), and compared with US $6.57 for a commercial cigarette (Marlboro Silver).

Physical Characteristics

We determined filter ventilation, product weight and length, and with and without filters, for the noted number of replicates for each brand (Table 1). We decided to examine filter ventilation after noticing obvious holes in the filter for some of the small cigar brands. The total filter ventilation ranged from 3% (Dean’s) to 28% (Criss Cross), with no statistical difference between the FC and LC. The mean ± SD unit weight of all small cigars was 1417 ± 333 mg, ranging from 960 mg (Winchester) to 1810 mg (Cheyenne), with FC (1620 ± 229 mg) weighing 50% more than LC (1080 ± 113 mg) (p = .01). The cigars were also weighed after filters were removed to obtain the weight of the filler tobacco and wrapping sheet. Without the filter, cigars weighed 1080 ± 190 mg, with Winchester being the lightest (780 mg) and Cheyenne the heaviest (1290 mg) and FC (1200 ± 105 mg) weighing more (p = .005) than LC (890 ± 94 mg) (p = .005). Also, the filter weight for FC (413 ± 169 mg) was >twofold greater than for LC (196 ± 18 mg) (p = .001).

We also measured product length and length of the filters. The overall length of cigars was 98.7 ± 10.5 mm per unit and did not differ between FC (101.4 ± 11 mm) and LC (94 ± 9 mm). Meanwhile, the filter length of FC (28.4 ± 2.5 mm) was significantly higher than LC (26.0 ± 2.3 mm) (p = .02). FC did not differ from LC in diameter (FC = 8 mm, LC = 7.8 mm). Thus, overall, FC and LC differ in some (unit weight, filter weight, and filter length), but not all (unit length, diameter, and filter ventilation) design features.

Yields Under ISO and CI

Overall, the eight cigar brands were machine smoked on a linear smoking machine along with two research cigarettes (3R4F and 1R6F) for analysis of nicotine yields under the ISO and CI regimen (Table 2). Large variation was observed in the number of puffs taken by the different cigars to reach 3 mm from the filter overwrap. The cigars took 10–23 puffs on the ISO method and 8–24 puffs on the CI method. For cigarettes, puff count, in general, increased on the CI regimen, but for cigars, no change was observed. When subgrouped, FC took significantly more puffs than LC on the ISO method (19 vs. 12, p = .01) and on the CI method (19 vs. 11, p = .006).

Table 2.

Smoking Yields of Small Cigars Under the International Organization of Standardization and Canadian Intense Protocol

	Smoking yields under ISO protocol per unita				Smoking yields under CI protocol per unitb
Brand	Puff count	TPM (mg)	Nicotine (mg)	Nicotine (mg/puff)	Puff count	TPM (mg)	Nicotine (mg)	Nicotine (mg/puff)
1R6F	8.0 (0.1)	8.6 (2.4)	0.73 (0.03)	0.09 (0.001)	8.4 (0.8)	22.7 (1.9)	2.34 (0.31)	0.28 (0.05)
3R4F	9.0 (0.2)	8.5 (0.9)	0.74 (0.09)	0.08 (0.01)	10.7 (0.82)	21.0 (2.5)	2.38 (0.18)	0.22 (0.02)
Captain Black Sweets	11.8 (0.5)	14.5 (0.7)	0.98 (0.25)	0.08 (0.02)	11.0 (1.4)	38.6 (2.2)	2.88 (0.24)	0.27 (0.06)
Cheyenne Full Flavor 100s	16.2 (0.5)	16.0 (1.0)	0.89 (0.32)	0.05 (0.02)	16.0 (0.01)	37.4 (2.9)	2.87 (0.24)	0.18 (0.02)
Criss Cross Original	23.0 (1.0)	20.9 (1.1)	1.48 (0.10)	0.06 (0.00)	24.0 (0.0)	64.5 (3.2)	4.91 (0.97)	0.20 (0.04)
Dean’s Cigars Full Flavor 100s	18.3 (1.3)	17.0 (1.1)	0.96 (0.07)	0.05 (0.00)	17.0 (0.0)	33.9 (3.54)	1.85 (0.18)	0.11 (0.01)
Djarum Black Clove Cigar	21.0 (0.0)	37.7 (1.5)	2.57 (0.23)	0.12 (0.01)	19.7 (2.1)	102.6 (4.9)	6.15 (0.58)	0.35 (0.04)
Swisher Sweets Regular cigar	15.4 (1.1)	12.8 (1.6)	1.03 (0.15)	0.07 (0.01)	12.5 (0.7)	31.4 (1.5)	2.90 (0.16)	0.23 (0.03)
Talon Sweet Original	17.0 (1.4)	15.8 (0.6)	1.29 (0.20)	0.08 (0.01)	18.5 (0.7)	42.7 (2.9)	4.32 (0.02)	0.23 (0.01)
Winchester Original Blend	10.0 (0.01)	10.6 (0.4)	0.77 (0.13)	0.08 (0.01)	8.5 (0.6)	28.5 (3.6)	2.07 (0.35)	0.25 (0.02)

ISO = International Organization of Standardization, Canadian Intense = CI.

^aValues are mean (SD), n = 3–7.

^bValues are mean (SD), n = 2–4.

We found that under the ISO method, the mean nicotine yield was 1.24 mg per cigar ranging from 0.76 mg per cigar (Winchester) to 2.56 mg per cigar (Djarum). Interestingly, there was no statistical difference between FC nicotine yields and LC nicotine yields. Nicotine yield under the CI method was also obtained with a mean of 3.49 mg per cigar and ranging from 1.85 mg per cigar (Winchester) to 6.15 mg per cigar (Djarum). Thus, our results show that, among the brands, nicotine yields varied 3.3-fold on both the ISO and CI methods with Winchester being the lowest and Djarum the highest. This nicotine yields were between 42% (ISO) and 62% (CI) higher than that of commercial cigarettes reported previously (Table 3)^34–36 and 48% (CI) and 70% (ISO) higher than the research cigarettes in our study. Cheyenne showed the most variability in nicotine yield on the ISO method (CV = 36%), whereas Criss Cross showed the most variability on the CI method (CV = 20%). There were no statistical differences between the nicotine yields comparing FC with LC. When the differences in puff count are taken into account, nicotine yields per puff averaged 0.07 mg (range: 0.05 mg from Cheyenne and Dean’s to 0.12 mg from Djarum) under the ISO method and 0.23 mg (range: 0.11 mg from Dean’s to 0.35 mg from Djarum) under the CI method. On a per puff basis, nicotine yield was similar in research cigarettes (mean = 0.08 mg under the ISO method and 0.25 mg under the CI method) as in small cigars.

Table 3.

Summary Statistics Comparing Commercial Cigarettes With Small Cigars

		Commercial cigarettes (reported from the literature)	Small cigars (based on data from this study)
Nicotine yield ISO (mg/unit)	Mean	0.87a	1.24
	Range	0.1–2.2	0.76–2.56
Nicotine yield CI (mg/unit)	Mean	2.13b	3.49
	Range	1.32–4.92	1.85–6.15
Puff count ISO	Median	8.0a	16.6
	Range	6.0–11.4	10.0–23.0
Puff count CI	Median	9.2b	16.5
	Range	7.3–12.1	8.5–24.0

^aData obtained from Ref.³⁴, 50 cigarette brands tested, product range: 1.1–17.0 mg tar per cigarette. 1.6–17.3 mg CO per cigarette.

^bData obtained from Ref.³⁶, 61 cigarette brands tested, product range: 23.8–58.0 mg tar per cigarette. 19.3–53.2 mg CO per cigarette.

Nicotine yields among the different brand varieties were strongly correlated (r² = 0.83) between the ISO and CI smoking regimens. Nicotine yield was strongly correlated with total particulate matter (r² = 0.93 for ISO method, r² = 0.82 for CI method) and less so with puff number (r² = 0.44 for ISO method, r² = 0.50 for CI method). No correlations were found for nicotine yield with filter ventilation (r² = 0.03 for ISO method, r² = 0.03 for CI method), cigar weight (r² = 0.004 for ISO method, r² = 0.02 for CI method), tobacco filler and wrapper weight (r² = 0.17 for ISO method, r² = 0.17 for CI method), or cigar length (r² = 0.00 for ISO method, r² = 0.05 for CI method).

Discussion

Small cigars resemble cigarettes in packaging, design (size, filter, burn time, tobacco pH), and usage characteristics.^5,9,23 A convenience sample of eight cigar brands were machine smoked under the standardized ISO and CI methods, and comparisons were made to commercial cigarettes (Table 3). Under FDA’s new deeming rule, ingredient reporting goes into effect on August 8, 2017 and harmful and potentially harmful constituent (HPHCs) reporting goes into effect on August 8, 2019.⁴⁹ In the absence of machine-smoking protocols specific for small cigars, manufacturers will likely have to report nicotine and other HPHCs measured under the current cigarette smoking ISO and CI protocols. Besides, in dual users of Winchester LC and cigarettes, puff topographies were similar for cigarettes and LCs (10 puffs of 41.5 mL, 2-second duration, and 20 seconds between puffs).^18,19 Overall, we found that cigars deliver an average of 1.24 and 3.49 mg nicotine per unit on the ISO and CI machine-smoking regimens, respectively. Of note, Winchester LC, which had the lowest nicotine delivery, has been the most commonly used brand in research studied to date.^22,23,50 It is also of concern that Djarum, which has the highest nicotine delivery, is a highly popular brand with estimated 6.7 million units being sold in the United States in 2012.¹¹

Our results are consistent with observations made by others on the design characteristics of small cigars.³² Similar to cigarettes, small cigar filter vents are positioned such that they can influence yields when machine smoked and be unintentionally or intentionally be blocked by the smoker. We found that ventilation ranged from 3%–28% across products, which is much less compared with the range found in commercial cigarettes (0.1%–82%).²⁹ As observed previously,⁵¹ we found that for some brands (Cheyenne, Criss Cross, and Dean’s), there appeared to be additional tobacco in the rod and material added to the filters to increase their weight (up to an additional 0.50 g) in a likely intentional attempt to evade taxes levied on the lower weight products. The lower price of cigars is appealing to many smokers. Nationwide, small cigars (US $3.82 average price) are 37% cheaper than cigarettes (US $5.58 average price) based on 2011–2013 data.²⁰ Overall, as reported earlier, the classification based solely on product weight reported by the manufacturers enables FC to be nontaxable and thus cheaper.⁴²

Perhaps due to strategic marketing by the tobacco industry, there is a perception that, similar to premium cigars, small cigar smoke is commonly not inhaled and is, thus, less harmful to the lungs.⁶ This was apparent from an internal industry document which states that “small cigars have increasingly acquired some of the characteristics of cigarettes and are known to be smoked by significant numbers of former cigarette smokers (who may from habit smoke and inhale in the same way), Cigar Group (CG) should seek to develop both products and strategies which will emphasize the traditional distinction between cigars and cigarettes. Only in this way can CG preserve a significant presence in the medium–large segment where benefits might be expected should the Authorities decide to emphasize the possible hazards associated with small cigars, particularly when smoked in the same way as cigarettes.”⁵² However, scientific research studies show that tobacco pH is similar for small cigars and cigarettes, as is the nicotine boost and carbon monoxide exposures in users of these products.^53,54 In this study, we were able to examine some of the product characteristics that can affect nicotine delivery from small cigars. When the nicotine yield was calculated taking the large variation of puff count into consideration, the average nicotine yield of small cigars was 0.07 mg per puff (ISO) and 0.23 mg per puff (CI), which is very similar to nicotine yield of research cigarettes (mean = 0.08 mg per puff on ISO and 0.25 mg per puff on CI method). This is of importance because the higher the nicotine per puff, the greater the nicotine impact is felt by smokers.⁵⁵ However, nicotine addiction is complex, related not only to the dose and speed of nicotine absorption but also to other chemicals in smoke that alter addictiveness and sensory effects of smoke.⁵⁶ Surprisingly, our data also indicate that unlike cigarettes,^34,54 nicotine yield for cigar brands did not correlate to product filter ventilation, unit weight, unit length, or tobacco weight.

Our study has some limitations. We were not able to find some popular small cigars brands (eg, Prime Time, Santa Fe, Smoker’s Choice, and 305’s)^40,41 in the South Central Pennsylvania area, limiting our analysis. Further, we did not have the capability to know if the price differences noted in the small cigars were due to some cigars being generic brands versus premium brands because such data could not be found in the literature. The nicotine content of small cigar tobacco has a large range (10.3–19.1 mg/g), of which 33% has been shown to be available in mainstream smoke.⁵³ The nicotine content of the small cigars, not measured in this study, would significantly influence nicotine yields. Also, nicotine yields were determined only for research cigarettes (Table 2) and not commercial cigarettes in this study. However, the nicotine yields obtained for the research cigarettes are very consistent with modern commercial cigarettes previously reported in the literature (Table 3), suggesting that the research cigarettes can serve as surrogates. The nicotine yields obtained by machine smoking do not necessarily reflect all possible nicotine exposures.⁵⁷ People adjust their smoking behavior in order to obtain the desired dose of nicotine⁵⁸ for which future smoking behavior studies in participants with different LC and FC products that differ in nicotine are necessary. Also, a study has found that major design characteristics were similar in the flavored and nonflavored versions of small cigars.³² But, future studies are needed to determine nicotine yields for within brand variations based on potential product characteristics such as flavor additives and year of tobacco growing and processing. We were also unable to assess some other relevant physical and design features (nicotine content of filler and wrapper, filter composition and design, tobacco blend and packing density, and additives) that might influence nicotine yield. Finally, in this study, we determined total nicotine yields without looking at differences based on protonation states of nicotine.

The FC as a subgroup did not differ from the LC in their nicotine yield on either smoking method. Unfortunately, studies that have examined FC and LC separately are lacking. In fact, FC are often grouped with cigarillos and large cigars. The tobacco companies appear to be exploiting this loophole in classification not only for a tax advantage, but also to potentially make research findings difficult to generalize and interpret. As mentioned in a tobacco industry document, “it must be recognized that small cigars with cigarette-like characteristics are vulnerable to attack from informed medical opinion, and may have escaped only because sales are still small in relation to total cigarette sales. Cigar Group should therefore develop contingency plans which would place HW (heavy weight) in an advantageous position, in higher weight segments, in the event of such an attack.”⁵² Research into trends in patterns of use, demographics, marketing, toxicity, abuse potential, and public health impact of FC and LC as a separate category of cigars is warranted in all future studies.

Nicotine dependence contributes to harm directly (eg, by increasing toxic exposure) or indirectly (eg, by increasing the amount and persistence of use).⁵⁹ Mandating a reduction in nicotine content of cigarettes to nonaddictive levels is the foundation for a number of harm reduction approach strategies currently under consideration.¹ Also, dual cigarette and cigar users have been shown to have greater tobacco dependence symptoms than exclusive cigarette smokers based on higher CPD, shorter time to first tobacco use after waking, and greater likelihood of craving and withdrawal symptoms.⁶⁰ Thus, based on our data combined with other studies, all of the small cigars studied were capable of delivering sufficient amounts of nicotine to create and maintain dependence. The FDA published the final deeming rule on May 10, 2016 bringing all tobacco products, including all types of cigars, under its regulatory authority.³⁹ Cigar or tobacco manufacturers already have a history of adapting their products according to taxation regimens in order to maintain sales. A potential product standard to reduce nicotine content in combustible tobacco products down to levels that would be minimally addictive would clearly need to include cigars as well as other combusted tobacco such as cigarettes. We hope that this study can help inform the FDA for future regulatory decisions on small cigars.

Funding

This work was supported in part by the National Institute on Drug Abuse of the National Institutes of Health and the Center for Tobacco Products of the US Food and Drug Administration (under Award Number P50-DA-036107). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Food and Drug Administration.

Author Contributions

The manuscript was written through contributions of all authors. All authors have given approval to the final version of the manuscript.

Declaration of Interests

JF has done paid consulting for pharmaceutical companies involved in producing smoking cessation medications including GSK, Pfizer, Novartis, J&J, and Cypress Bioscience and has received a research grant and study drug from Pfizer (not relating to cigarette emissions or free radical measurement).