The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) asked the National Academies of Sciences, Engineering, and Medicine (the National Academies) to examine the evidence on the patterns of use and health effects of “premium”1 cigars compared to other tobacco products, identify research needs, and make prioritized recommendations for future federally funded research on premium cigars (see Box 1-2 in Chapter 1 for the full statement of task). The committee also addressed research questions provided by FDA, NIH, and other stakeholders, including examining the state of marketing and perceptions of premium cigars (see Appendix A).
INTRODUCTION AND DEFINITIONS
The early to mid-1990s saw a large surge in U.S. cigar consumption: 5 billion cigars in 1997. Premium cigar consumption increased approximately 250 percent from 1993 to 1997 and 90 percent from 1996 to 1997. These trends did not apply to all tobacco products, as cigarette consump-
1 Note that quotations are used at first occurrence of the term “premium” in each chapter, as there is no formally agreed-upon definition of what constitutes a premium cigar, and different entities might use this term differently. See later in this Summary and Chapter 1 for more information. In addition, when the terms “cigar(s)” or “cigars in general” are used in this report, they refer to all cigar types (filtered cigars, little cigars, cigarillos, and large/traditional cigars [which include premium cigars]). When discussing a specific cigar type, the type is noted in text.
tion decreased 2 percent in 1993–1997. Premium cigars, however, make up a small percent of the total U.S. cigar market. With these dramatic increases in cigar smoking, the National Cancer Institute (NCI) undertook a comprehensive review of available knowledge about cigars in 1998—the only one to date. The resulting monograph (Cigars: Health Effects and Trends) made several recommendations for research; however, they have largely not been addressed, and many of the identified information gaps persist. This report provides a comprehensive update to that report for health effects, marketing, and perceptions of premium cigars, and patterns of use for all cigar types.
There is no single, consistent definition of premium cigars accepted by FDA, industry, courts, and the public. Consequently, there is no clear distinction between premium and large nonpremium cigars or even among other cigar types. The lack of a formal, accepted definition makes research challenging, and few published studies specifically focus on premium cigars. The marketplace is diverse, with many different types of cigars, including little/filtered cigars, cigarillos, large cigars, and premium cigars. Box S-1 provides what are largely considered common characteristics of the different cigar types, and Figure S-1 provides examples of what these products generally look like.
Premium cigars do have a different pattern of use than other cigar products and, therefore, different resulting health effects. However, they are not inherently less risky than other cigar products. All cigars contain harmful and potentially harmful constituents,2 and the extent to which they negatively affect health largely depends on how they are used (e.g., frequency and duration of use, pattern of inhalation).
The Family Smoking Prevention and Tobacco Control Act3 (commonly known as the Tobacco Control Act) of 2009 established FDA as the principal federal regulatory authority for the manufacture, distribution, and marketing of tobacco products. This authority was applied to cigarettes and to cigarette tobacco, roll-your-own, and smokeless tobacco. The statute permitted FDA to issue regulations “deeming” other types of tobacco products subject to restrictions and regulation under the Fed-
2 Harmful or potentially harmful constituents is the FDA regulatory term for chemicals or chemical compounds in tobacco products or tobacco smoke that cause or could cause harm to smokers and nonsmokers.
3 Public Law 111–31.
eral Food, Drug, and Cosmetic Act (FD&C Act).4 In 2014, FDA proposed two alternatives for the scope of the deeming provisions: Option 1 (all products meeting the statutory definition of “tobacco product” would be deemed) and Option 2 (same as Option 1, but excluding premium cigars). In 2016, FDA adopted Option 1 and finalized a rule to broaden its regulatory authority to include all products meeting the statutory definition
4 21 U.S.C. 301.
of a tobacco product,5 including cigars. FDA concluded that this option would more comprehensively protect the public’s health, as it noted that the evidence was insufficient to justify excluding premium cigars from the final deeming rule and therefore regulation.
However, in March 2018, FDA issued a call for additional information and comments not previously submitted for consideration for the deeming rule. This advanced notice of proposed rulemaking sought information on the definition, use patterns, and public health effects of premium cigars to further inform FDA’s regulatory actions on such cigars. In August 2020, FDA stated that the comments received did not provide sufficient evidence to answer questions about how premium cigar characteristics and patterns of use affect health outcomes and if they do so differently than other tobacco products. Premium cigars have been the subject of legal and regulatory efforts for the past decade. In June 2021, FDA withdrew its entry for information request on premium cigars from the Unified Agenda of Regulatory and Deregulatory Actions, pending review of this report. Several court cases are ongoing regarding cigars and premium cigars involving FDA. Members of Congress in both chambers have introduced legislation since 2011 to exclude premium cigars from FDA regulation; none of the bills have passed the chamber of Congress in which they were introduced.
The committee organized its work in four focus areas: characteristics of cigars, patterns of use, marketing and perceptions, and health effects (see Figure S-2). Figure S-2 highlights how patterns of premium cigar use are influenced by cigar characteristics (e.g., nicotine level, pH, addiction potential), marketing, and user perceptions. Premium cigar marketing is impacted by characteristics of the product itself and how the product is described (e.g., handmade, artisanal, premium) and, in turn, how consumers perceive the product, which directly influences how they intend to use it. Consumers’ reactions to marketing campaigns and/or their perceptions about premium cigars may influence how premium cigar companies characterize their products. The resulting patterns of use lead to varying levels of toxic exposures from smoking premium cigars (or being exposed to secondhand smoke) based on use, ending with health outcomes.
5 Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines “tobacco product” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”
Given the heterogeneity of the research and the varied topics that the committee was tasked with reviewing, it adapted its approach to reviewing the literature and assessing the evidence for each focus area. Box S-2 describes its evidence framework to assess the strength of the evidence throughout the report.
A systematic literature search was conducted (see Appendix B) to identify publications on premium cigars. Because the term “premium” has not been used systematically, searches considered cigars more generally. The committee’s approach was informed by published guidelines for conducting systematic reviews and approaches taken by prior National Academies committees.
Early in its work, the committee noted the very limited literature available on premium cigars specifically. With no agreed-upon definition of premium cigars, the literature is inconsistent regarding which brands are considered premium, and many publications do not distinguish premium from other large cigars. To guide its work, the committee developed a working definition of premium cigars (see Box S-1 and Chapter 1).
Because of the paucity of literature on premium cigars, studies of large/traditional cigars (which include premium), cigars overall (including filtered cigars/little cigars and cigarillos), and other combustible tobacco products were included based on committee members’ assessment of the relevance and potential generalizability of the findings to premium cigars. The committee also relied heavily on biological mechanisms and plausibility in its framework, particularly to assess health effects. The committee extrapolated data from other tobacco products when the data was strong and in the absence of any important threats to validity. In addition, the committee commissioned several analyses to further inform its work (see Appendixes C, D, F, and G).
Based on previous reviews, the committee developed standardized language to categorize the strength of the evidence. Box S-2 presents the categories and describes the types of evidence that correspond to the committee’s confidence in each conclusion category. Conclusive evidence implies that observed associations between premium cigar use and a given outcome are very unlikely to change in the face of new evidence, whereas other categories progressively represent less available (or conflicting) evidence. Conclusive, strongly suggestive, and moderately suggestive evidence describe a direction of effect (e.g., increased or decreased risk of a health outcome), whereas topics with insufficient or no available evidence do not imply a direction. The level of evidence does not indicate the magnitude or importance of the effect. The committee used the framework as a guide and included expert judgment in evaluating individual studies and in the bodies of evidence. The report provides findings6 on patterns of use, and conclusions on product characteristics, marketing and perceptions, and health effects.
FINDINGS AND CONCLUSIONS
Characteristics of Cigars
Vast amounts of data, much of it recent, exist on toxic and carcinogenic constituents of cigar tobacco and smoke demonstrating that all analyzed toxicant levels are similar or higher than those found in cigarette tobacco and smoke, compared per unit of tobacco. These data clearly demonstrate that cigars could be as dangerous as or more dangerous than cigarettes, with respect to toxicant and carcinogen exposure per unit consumed. Despite only limited data on premium cigars, it is reasonable to expect that the results of analyses of tobacco and smoke would not substantially differ from other cigar types because premium cigars’ tobacco and pyrolysis conditions are similar. Based on laboratory studies using validated analytical methods and a variety of smoking conditions, including human smoking topography conditions, the available data demonstrate that exposure of premium cigar users to toxic and carcinogenic constituents of smoke will be qualitatively similar to the exposure of users to constituents of other combustible tobacco products. The relationship between tobacco pH and smoke pH remains unclear, and smoke analysis in general can be challenging. However, two laboratory studies have shown cigar smoke
6 A finding is a statement of the evidence, whereas a conclusion is an inference, interpretation, or generalization drawn from the evidence.
pH becoming more alkaline from early to last puffs, which would result in more unprotonated nicotine and therefore more oral nicotine absorption.
Conclusion 2-1: There is conclusive evidence that the addictive, toxic, and carcinogenic constituents of cigar tobacco in general are the same as those present in cigarette tobacco. There is strongly suggestive evidence that constituents of premium cigar tobacco are similar to constituents of other cigars because all tobacco contains nicotine, carcinogenic tobacco-specific nitrosamines, metals, and precursors to toxic and carcinogenic compounds formed during the combustion process.
Conclusion 2-2: There is conclusive evidence that the toxicants and carcinogens in cigar smoke in general are qualitatively the same as those in cigarette smoke. There is no reason to believe that toxicants and carcinogens in premium cigar smoke are any different from those in other types of cigars. Additionally, it is likely that the total toxic and carcinogenic constituent yields will increase with the mass of tobacco filler in the cigar.
Conclusion 2-3: There is strongly suggestive evidence that there is a wide variety of pH levels of tobacco used in cigars overall; however, higher pH has been noted in premium cigar tobacco than for other cigar types. While there is insufficient evidence on the pH of premium cigar smoke, the pH of large cigar smoke is generally higher than cigarette smoke, which can decrease depth of inhalation and increase nicotine absorption through the oral mucosa. There is insufficient evidence on the relationship between the pH of premium cigar tobacco and smoke.
Based on the measurement of urinary biomarkers of nicotine and toxicants and carcinogens in the large National Health and Nutrition Examination Survey (NHANES) and the Population Assessment of Tobacco and Health (PATH) and several smaller controlled clinical studies examining different products, such as small and large cigars, cigar users are exposed to significant amounts of nicotine and harmful and potentially harmful constituents. While levels of some urinary biomarkers were higher in every day exclusive cigarette smokers, the PATH study found that, for other biomarkers, concentrations in every day exclusive traditional cigar smokers were comparable to those of every day exclusive cigarette smokers. This indicates similar exposure and uptake of nicotine, toxicants, and carcinogens. Concentrations of biomarkers were also higher than in never-tobacco users.
Conclusion 2-4: There is conclusive evidence that cigar smokers in general are exposed to significant amounts of nicotine and numerous harmful and potentially harmful constituents.
Inhalation patterns and the resulting exposure to nicotine and harmful and potentially harmful smoke constituents have not been studied directly in premium cigar users. However, based on the measurement of inhalation patterns among users of large cigars and studies that examined the effect of inhalation patterns on exposure to nicotine and toxicants from conventional cigarettes, the available data strongly suggest that inhalation patterns will be important determinants of exposure in premium cigar users, too. Although data from experimental studies that objectively measured puffing patterns in large cigar users who also smoke conventional cigarettes (dual users) are limited, they are consistent with self-reported inhalation patterns of cigar smokers who used to smoke cigarettes. The body of evidence suggests that, compared to those who only smoke cigars, dual users of cigars and cigarettes are more prone to smoking cigars with a greater intensity and therefore, inhaling the smoke more deeply.
Conclusion 2-5: There is strongly suggestive evidence that the inhalation patterns of cigar smokers in general significantly affect their exposure to nicotine and harmful and potentially harmful constituents. At present, the extent to which premium cigar users who do not inhale have systemic exposure to nicotine and harmful and potentially harmful constituents remains unknown. It is likely that smokers of premium cigars who concurrently smoke cigarettes or smoked cigarettes in the past inhale more smoke compared to exclusive users of premium cigars.
PATTERNS OF USE
Despite a paucity of data on the patterns of use of premium cigars specifically, based on the available published literature and work commissioned by the committee (see Appendixes C and D), the committee identified the following key findings:7
Finding 3-1: Large, machine-produced cigars have been the dominant cigar type for much of the last century. Total cigar consumption began declining in the mid-1970s and reached its lowest level in 1993, when promotion of premium cigars reversed overall consumption trends for all cigar types. Since the release of the NCI’s 1998 monograph on cigars, overall cigar consumption has increased every year, with a total increase of 145 percent from 1998 to 2020.
7 In findings 3-1 through 3-10 “premium cigar user(s)” are those reporting use for at least 1 of the past 30 days.
Finding 3-2: Premium cigars are consistently a small, stable percent of the U.S. cigar market.
Finding 3-3: About 1 percent of the U.S. adult population smokes premium cigars, a frequency that has remained stable over time.
Finding 3-4: Cigarettes remain the most commonly used combustible tobacco product among adults in the United States. The prevalence of cigarette smoking among adults in 2018–2019 was 16.4 percent compared to 0.7 percent for premium cigars, 0.5 percent for nonpremium cigars, 1.4 percent for cigarillos, and 0.8 percent for filtered cigars.
Finding 3-5: The majority of premium cigar users are male, white, with higher income and education levels compared to those who smoke cigarillos, little filtered cigars, or cigarettes. Premium cigar users are on average 7–10 years older than those who smoke cigarillos or little filtered cigars. Premium cigar use is less common among youth, and only 0.6 percent of those who reported smoking a premium cigar brand in the past 30 days were under the age of 18. Premium cigar use is also less common among women, non-Hispanic Black people, and people with less than a high school education.
Finding 3-6: The frequency and intensity of smoking is lower for premium cigars compared to other types of cigars and cigarettes. Only about 5 percent of premium cigar users smoke these daily, whereas 22 percent of nonpremium cigar users, 19 percent of cigarillo users, 40 percent of filtered cigar users, and 76 percent of cigarette users smoke those products daily. The median number of cigars or cigarettes smoked per day is about 0.1 for premium cigars, 0.2 for nonpremium cigars, 0.3 for cigarillos, 1.0 for filtered cigars, and 10 for cigarettes.8
Finding 3-7: Premium cigar users are less likely to smoke cigarettes or other cigar types concurrently than other cigar type users. Dual use with cigarettes was highest for filtered cigar users (~70 percent), followed by cigarillo users (~60 percent) and nonpremium cigar users (~50 percent), and lowest for premium cigar users (~26 percent).
8 The median was calculated consistent with the methods used by Corey et al. (2018): respondents reporting smoking less than one cigar per day on the days smoked were assigned as 0.5 cigars per day.
Finding 3-8: Premium cigar users are more likely to be never or former cigarette smokers than users of other cigar products. They are also more likely than the general population to smoke cigarettes.
Finding 3-9: The prevalence of alcohol dependence among those who smoke premium cigars is similar to those who smoke nonpremium cigars or cigarettes. The prevalence of cannabis and illicit drug dependence among those who smoke premium cigars is lower than those who smoke nonpremium cigars or cigarettes. However, the prevalence of alcohol, cannabis, and illicit drug dependence among those who smoke premium cigars is higher than for those who do not use any tobacco products.
Finding 3-10: Population Assessment of Tobacco and Health Study analyses suggest that about three-quarters of exclusive premium cigar users continued smoking premium cigars in the following year. Among exclusive premium cigar users in Wave 1 (2013–2014), slightly more than half remained as exclusive premium cigar users in Wave 5 (2018–2019). About 35 percent discontinued use of cigars and cigarettes by Wave 5. Less than 5 percent became cigarette smokers (exclusive or dual with premium or nonpremium cigars) by Wave 5. Additionally, exclusive premium cigar users who smoked infrequently (i.e., less than 6 days in the past 30 days) were more likely to discontinue use within a year compared to those who smoked more frequently.
MARKETING AND PERCEPTIONS
Cigar Aficionado, the first magazine to specifically promote premium cigars as a lifestyle, was associated with the rapid increase in premium cigar sales and consumption in the early 1990s. Along with other cigar lifestyle magazines, it continues to promote premium cigars. Despite the 1998 NCI monograph’s recommendations, data on overall cigar marketing expenditures have been limited, as are published data on marketing expenditures of premium cigars through traditional channels (e.g., direct mail, e-mail). Although the committee found it difficult to access marketing data (for both branded and non-branded marketing) and found few published studies, marketing of premium cigars still occurs. Based on the committee’s primary data collection, it is evident that cigars are marketed on the Internet and social media platforms, but only one published study reported the extent to which premium cigars are marketed in these ways. Evidence indicates that premium cigars are marketed through direct mail advertisements, although the magnitude of this type of marketing is
unknown because tracking data are not readily accessible. Based on its review, the committee concludes:
Conclusion 4-1: Based on the committee’s primary data collection, there is conclusive evidence that third-party cigar retailers use direct-to-consumer methods to market premium cigars using similar strategies as the nonpremium cigar industry.
Conclusion 4-2: Based on the committee’s primary data collection, there is conclusive evidence that premium cigar companies use lifestyle magazines and festivals to promote premium cigars. Some of these marketing strategies, such as sponsoring music festivals and promoting their products with an urban lifestyle and hip-hop and rock music, may appeal to young people.
Conclusion 4-3: Based on the committee’s primary data collection, there is conclusive evidence that premium cigar companies have online and social media presences not captured by traditional methods of tracking marketing expenditures.
Conclusion 4-4: Based on the 1998 NCI monograph on cigars, subsequent publications, the committee’s primary data collection, and consistent with research on the “premiumization” of tobacco products that purport better quality and less harm, there is conclusive evidence that premium cigars are advertised and promoted as less harmful than other tobacco products and as having benefits that outweigh their adverse health effects. Premium cigars are also marketed as an integral component of a successful, luxurious lifestyle, used at upscale social events, and by influential celebrities and individuals.
Conclusion 4-5: There is strongly suggestive evidence from survey data that consumers of premium cigars who buy in person typically purchase their cigars from cigar bars or smoke/tobacco specialty shops or outlet stores, whereas nonpremium large traditional cigar users typically purchase their cigars at convenience stores/gas stations. A lower proportion of premium cigar users buy their cigars in person than nonpremium large traditional cigar users. Data from online cigar retailers show that a large proportion of premium cigar sales occur online, though this is not directly captured in current surveys of cigar users.
Conclusion 4-6: There is no research that examines whether consumers distinguish premium cigars from large cigars or other cigar types, consumers’ knowledge of premium cigars, or what defines premium cigars.
Conclusion 4-7: There is strongly suggestive evidence that the U.S. population perceives cigar products overall to be harmful and addictive. However, there is no research that examines the knowledge of the specific health effects of premium cigars.
Conclusion 4-8: There is strongly suggestive evidence from prospective studies that lower perceived harm and addictiveness of cigars in general is associated with cigar use behavior, including current use in adults and initiation in youth.
The potential adverse health effects of premium cigars need to be viewed in the context of the harms of smoking combusted tobacco broadly. Cigarette smoking is the most common form of combusted tobacco use, and its health effects are well established, including increased overall mortality, cardiovascular disease, chronic obstructive lung disease, cancers, susceptibility to respiratory infection, periodontal disease, and other diseases. The toxicants generated by burning tobacco are generally similar across tobacco types. The extent of inhalation and frequency and duration of use are major factors in determining whether tobacco smoking will cause disease.
Assessing the health effects of premium cigars (including secondhand smoke) included reviewing biological plausibility; reviewing the chemical nature of the tobacco leaf and emissions from premium cigars and how these compare to other combusted tobacco products; reviewing the evidence for extent of inhalation of premium cigar smoke, including biomarkers of exposure that might establish levels of systemic exposure; and researching the epidemiology of particular diseases in relation to cigar use. Because the epidemiology on premium cigar use is quite limited, the committee examined cigar use in general, with a particular focus on inhalation, frequency, and duration. These data were considered as a whole to assess specific disease risks from premium cigar use. The committee was unable to compare risks among various cigar types.
Conclusions 5-1 and 5-2 are based on the known chemical characteristics of combustible tobacco products, including cigars, and biological mechanisms by which constituents of combustible tobacco products are processed (in animals and humans). While studies on cigars may include premium cigars, they do not distinguish premium from other cigar types. However, given the conclusive data on tobacco products, including cigars in general, and the absence of any important threats to validity, the committee extrapolated these findings to premium cigars.
Conclusion 5-1: There is conclusive evidence that smoke from cigars in general, including premium cigar smoke, contains many hazardous and potentially hazardous constituents, capable of causing cardiovascular disease, lung disease, cancer, and multiple other negative health effects.
Conclusion 5-2: There is conclusive evidence that the chemical nature of emissions from cigars in general, including premium cigars, are similar to those of cigarette smoke. There is strong biological plausibility that exposure to these chemicals will cause disease. Thus, if cigar smoke is inhaled and cigars are smoked regularly, the risks are likely to be qualitatively similar to those of cigarette smoking.
Tobacco smoking is associated with increased risk of mortality, cardiovascular disease, respiratory disease, cancer, and other adverse health outcomes. Health risk associated with tobacco use, including use of premium cigars, may be determined by smoking behaviors, including frequency, intensity, duration, and depth of inhalation. No epidemiologic studies have examined the association of premium cigars with health outcomes; however, several have examined the health effects of cigar use in general, which may include premium cigars. Based on the findings from epidemiologic studies evaluating the health effects of cigar use in general, biological plausibility, the absence of any important threats to validity, generalizability of study inferences, and the smoking behaviors of premium cigar users, the committee concludes:
Conclusion 5-3: There is strongly suggestive evidence that the health risks of premium cigar use (overall mortality; cardiovascular disease; lung, bladder, and head/neck cancer; chronic obstructive pulmonary disease; and periodontal disease) depend on frequency, intensity, duration of use, and depth of inhalation.
Conclusion 5-4: There is insufficient evidence to determine if occasional or nondaily exclusive cigar use in general is associated with increased health risks.
Conclusion 5-5: There is strongly suggestive evidence that health consequences of premium cigar smoking overall are likely to be less than those smoking other types of cigars because the majority of premium cigar smokers are nondaily or occasional users and because they are less likely to inhale the smoke.
Conclusion 5-6: There is strongly suggestive evidence that many of the health risks of daily exclusive cigar use in general (overall mortality; car
diovascular disease; lung, bladder, and head/neck cancer; chronic obstructive pulmonary disease; and periodontal disease) are significantly higher than those of never-smokers and lower than those of daily cigarette smokers.
Conclusion 5-7: There is moderately suggestive evidence that the health risks among primary cigar users in general (those who were never established cigarette users) are generally lower than among secondary cigar users (those who were former users of cigarettes) because secondary cigar users may be more likely to inhale the smoke. Likewise, concurrent users of premium cigars and other combustible tobacco products would experience greater health risks than those smoking only premium cigars.
Conclusion 5-8: There is insufficient evidence to draw conclusions on the health effects of premium cigars on
Despite a lack of direct evidence on the potential health effects of flavored premium cigars (as added flavors are excluded in most definitions of premium cigars), based on the extensive literature on the effects of flavors on other types of cigars and other tobacco products, evidence suggests that adding characterizing flavors (not inherent to the tobacco itself) would have important implications for premium cigars’ impact on public health. Based on the findings from flavored cigars in general and other flavored tobacco products, and biological plausibility, no important threats to validity, and generalizability of study inferences, the committee concludes:
Conclusion 5-9: Based on the extensive literature on the effects of flavors on cigars and other tobacco products, there is moderately suggestive evidence that adding characterizing flavors (that is, flavors added to the product that are not inherent to the tobacco itself) to premium cigars could result in a greater appeal to nonusers and lead to more frequent use with potentially increased nicotine intake, increased addiction potential, and increased exposure to harmful and potentially harmful constituents present in premium cigar smoke.
Studies are limited on premium cigar secondhand smoke; nonetheless, it seems clear that concentrations of secondhand cigar smoke in
general can be similar to or greater than that from cigarettes. The emission rates appear to be lower for cigars, but cigars are smoked for much longer periods. It is likely that the health effects of indoor premium cigar and cigarette smoking would be similar for a similar duration and intensity of exposure. Evidence is lacking about the extent of secondhand exposure to premium cigar smoke.
Conclusion 5-10: There is sufficient evidence that premium cigars generate considerable levels of secondhand smoke; however, there are insufficient data on the health risks associated specifically with exposure to premium cigar secondhand smoke. It is plausible that since the constituents emitted from premium cigars are similar to constituents from other tobacco products, the health risk might be the same, but the extent of secondhand premium cigar exposure is unknown.
Premium cigars, like other cigar products, provide the sensations and stimuli shown to be important to the dependence potential of tobacco products (e.g., hand-to-mouth movements, taste, smells, airway sensations). Per this report’s definition, they lack characterizing flavors, which are known to increase the addictiveness of other tobacco products. Some research indicates that nonpremium cigars, particularly large cigars that are similar in size and other characteristics (no filter), might have nicotine levels similar to other cigar products and potentially conventional cigarettes. A strong biological plausibility exists that premium cigars possess the features (i.e., rate/amount of nicotine delivery, pleasant stimuli) liable to make them as addictive as other tobacco products with known addiction potential (e.g., smokeless tobacco).
Conclusion 5-11: There is moderately suggestive evidence to support the biological plausibility that regular cigar smoking in general can be addictive. It is likely that this is also true for premium cigar smoking, based on nicotine delivery characteristics, abuse liability studies, and epidemiological data. The magnitude of premium cigar dependence appears to be less than that of cigarette smoking and smokeless tobacco use dependence. The extent of addiction is likely to depend on the patterns of use.
After reviewing the varied definitions of premium cigars used by different entities and the chemical constituents of cigar products, the committee concluded that there is no material difference between products typically considered premium cigars and other cigar types in terms of harmful or potentially harmful constituents. Based on available data,
however, a meaningful difference does exist in how products typically considered premium are currently used (e.g., how often they are smoked, depth of inhalation, user demographics). The committee notes that there is a difference between a tobacco product being inherently harmful due to its constituent makeup, which generally stays consistent, and patterns of use, which change over time. However, the committee was not tasked with providing guidance on whether premium cigars should be considered separately from other cigar types for research or for regulatory purposes.
Premium cigars comprise a small share of the market compared to other cigar types. Evidence suggests that they are less likely to be used by youth, and most users smoke them only occasionally. However, it is important to continue to monitor premium cigar use, as these patterns could change. For example, changes in regulation that could affect one or more tobacco categories, shifts in consumer awareness or perceptions, changes in prices or taxes of one or more tobacco products, or social shifts could result in a preference for premium cigars and influence patterns of premium cigar use. Therefore, it is important to have a greater understanding of premium cigars’ physical characteristics, patterns of use, user perceptions, tobacco industry marketing strategies, and health effects, over time, to inform regulatory decisions.
The committee identified nine priority recommendations that the federal government should support to advance the field. Chapter 6 describes the criteria that the committee considered to specify its research recommendations.
Definition of Premium Cigars and Other Cigar Types
This report repeatedly points to the lack of formal definitions for not only premium cigars but also other cigar types, which has significantly hindered cigar research.
Recommendation 1: The Food and Drug Administration, in consultation with other federal agencies, should develop formal categories and definitions for cigars to be used for research to ensure consistency among studies.
These definitions could likely also be used for regulatory purposes. It should be noted that many cigars considered premium weigh considerably more than 6 pounds per 1,000 units. Since this weight threshold is used in many definitions of premium cigars, the weight criterion merits
re-examination, as it might need to be increased to be consistent with the current marketplace (e.g., other cigar types also commonly meet this weight threshold). Experience with other tobacco products (e.g., e-cigarettes) has demonstrated that as definitions are delineated, new products arise that no longer fit into existing definitions. In addition, tobacco products are also sometimes altered to meet the definition or category of another product. Therefore, in addition to standardizing definitions for research, product design criteria (e.g., length, weight, circumference, tobacco weight, tobacco type, flavors, filters) should also be identified and reported consistently in all research studies so that as products evolve, they can still be characterized and compared.
Strategic Planning and Data Collection
The 1998 NCI monograph identified significant gaps in data on cigar use and evaluation and made recommendations for improvement. No coordinated federal surveillance and evaluation infrastructure has since been established to support regular monitoring and tracking related to different cigar types. To conduct research on premium cigars and compare among cigar types, infrastructure to gather relevant data for cigars overall is needed.
Recommendation 2: The Department of Health and Human Services, in partnership with the Alcohol and Tobacco Tax and Trade Bureau and the Federal Trade Commission (FTC), should implement a strategic plan to develop surveillance and evaluation systems that regularly monitor patterns of use, product characteristics, and related knowledge and perceptions by cigar type. These systems should also measure exposure to cigar smoke; track health outcomes; monitor tobacco industry marketing and promotion strategies; track sales and marketing expenditures; track cigar prices by cigar type; make data available; and define other indicators of monitoring to inform public health research and practice. These efforts should include but are not limited to
- Agreed-upon definitions of each cigar type (see Recommendation 1), and
- Development of annual FTC sales and marketing expenditure reports on all cigar product types, as is done for cigarettes, smokeless tobacco, and electronic cigarettes.
This recommendation will likely require funding from Congress. A similar infrastructure is already in place for cigarettes. Parts of this recom-
mendation could be implemented in the short term—for example, item b, which calls for annual FTC sales and marketing expenditure reports.
Available data to classify study participants based on type of cigar use has been on relatively recent use (e.g., past 30 days), which may underestimate the total number of users. Collecting data on the environments in which premium cigars are smoked (e.g., homes, cigar lounges, outdoors), including by whom and smoking duration, will allow researchers to determine the real-life exposures to secondhand smoke, an area with a paucity of data. Given the potential seasonal and geographic variation in premium cigar use, including paradata (administrative data about the survey) in publicly available datasets could facilitate a better understanding of such variations and their implications for interpreting prevalence estimates.
Recommendation 3: The Department of Health and Human Services should ensure that the tobacco research it supports, including surveys such as the Population Assessment of Tobacco and Health Study, the Tobacco Use Supplement to the Current Population Survey, and the National Survey on Drug Use and Health:
- Measures ever use, ever regular use, and past 12-month use to better capture lifetime use of each type of cigar product.
- Asks participants about use of premium cigars, employing commonly used terminology (e.g., “Have you ever smoked premium cigars?”) in addition to asking about brands used.
- Asks participants about self-reported inhalation patterns, how cigars are typically smoked (e.g., in one session or partial/relighting), and where cigars are smoked (e.g., indoors at home) to assess secondhand smoke exposure.
- Includes paradata (administrative data about the survey), such as survey date and geographic location in publicly available datasets to improve understanding of patterns of use and/or exposure.
Most studies on health effects do not distinguish premium from nonpremium cigars. Cigar use in these studies may include premium cigars and other large cigars, little cigars, or cigarillos. Studies that distinguish premium from nonpremium cigar use would better isolate the health effects of premium cigar smoking. In addition, data on premium cigar use shows that co-use with alcohol is more likely than any other substance (e.g., co-use of cannabis was low). Co-use of alcohol with tobacco products is directly related to cancer risk.
Recommendation 4: The Food and Drug Administration (FDA), the National Institutes of Health, and other federal agencies should ensure that the research they support on the associations between cigar, including premium cigar, use and health effects
- Reports the frequency of use, duration, intensity, cumulative exposure, pattern of inhalation, and the number of years smoking cigars to inform potential dose–response relationship and modifying factors (e.g., co-use of alcohol, cannabis, and other substances);
- Distinguishes primary, secondary, and dual use cigar smokers;
- Examines co-use of alcohol and premium cigars;
- Estimates the associations between cigar use and specific lung cancer histological types;
- Includes questions on the type of cigar, including premium cigars, separated from large cigars and other cigar types; and
- Uses the definitions of cigar types provided by FDA (see Recommendation 1).
Additional Priority Recommendations
Methods are available to analyze harmful and potentially harmful constituents in premium cigar tobacco, but developing standardized conditions for quantifying the components of premium cigar smoke and executing studies on these components are a research priority.
Recommendation 5: To improve knowledge of premium cigar characteristics, the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and other federal agencies should support
- The development of reproducible methods for machine smoking of premium cigars;
- Laboratory studies to measure nicotine, toxicants, and carcinogens in tobacco and smoke emitted from premium cigars;
- Studies to assess how the pH of premium cigar smoke affects puff topography and extent of inhalation;
- Comparative biomarker studies, both of toxicant exposure and of potential harm, in smokers of premium, large, and other cigar type smokers;
- Studies that precisely measure “real-life” puff topography and patterns of use;
- Studies that systematically evaluate how various premium cigar characteristics (e.g., size, shape, type of tobacco, added flavoring, sugar content, moisture, smoke pH) affect puffing topography; and
- Observational studies to assess patterns and intensity of secondhand smoke exposure to premium cigar smoke.
Marketing and Risk Perceptions
Because promotional activities can increase cigar consumption, normalize cigar use, and decrease barriers to cigar use among new users (including youth and young adults, women, racialized and ethnic populations, and sexual and gender minority groups), and given the lack of research in this area for premium cigars, the committee recommends:
Recommendation 6: The Food and Drug Administration (FDA), the National Institutes of Health (NIH), and other federal agencies should conduct or fund research to determine the unique type of marketing, advertising, and promotional practices used by companies that manufacture, distribute, and sell premium cigars. FDA, NIH, and other federal agencies should also identify strategies for tracking these activities, especially those that may appeal to youth.
See Chapter 6 for specific related research needs—for example, studies on various environmental (e.g., print and online media and social media platforms, social events, bars, lounges) and interpersonal channels (e.g., industry representatives, peers, online users) used to promote premium cigars.
Little is known about the addiction potential of premium cigars and how it compares to other cigar types. Premium cigars may have nicotine levels similar to (or higher than) other cigar products and conventional cigarettes because they contain more tobacco. In addition, premium cigar and non-flavored cigar products may have similar sensorimotor characteristics that contribute to addiction potential (see Chapter 5). For these reasons, the conceptual and biological plausibility that premium cigars can be addiction-promoting products cannot be ruled out, given a sufficient level of exposure. However, more research is needed.
Recommendation 7: The Food and Drug Administration (FDA), the National Institutes of Health, and other federal agencies should support research that
- Provides data on the level of dependence in relation to patterns of premium and other cigar type use;
- Measures dependence on cigars and other tobacco products in dual and/or poly-tobacco users;
- Compares dependence on large cigars with flavors to dependence on premium cigars (which, by definition in this report, do not include flavors); and
- Studies the impact on dependence of reduced nicotine content in cigars, per proposed FDA policy to reduce nicotine to 0.4 mg/g for all cigarettes, to make them minimally addictive.
Regarding item d, FDA has issued an advance notice of proposed rulemaking that would require tobacco companies to lower the nicotine content in all cigarettes sold to levels at which they are no longer addictive. If this regulation progresses and all cigars are excluded, or other cigar types are included but premium cigars are excluded, premium cigars would provide an alternative source of nicotine for cigarette and cigar smokers.
The literature has significant gaps about the health effects of large and premium cigars on specific populations; however, additional research is a high priority in certain areas.
Recommendation 8: The Food and Drug Administration, the National Institutes of Health, and other federal agencies should support research on the comparative health effects of cigar types, including premium cigars, in priority populations (as needed based on prevalence and trends), including
- Women, racialized and ethnic populations, sexual and gender minority groups, adolescents/young adults, and during pregnancy, including studies on the impact on nondaily users of cigars;
- People with vascular disease, including assessments of their cardiovascular risk, as this population would be especially vulnerable to the adverse effects of acute short-term smoke exposure;
- People with respiratory diseases, such as chronic obstructive pulmonary disease and asthma;
- Cancer survivors; and
- People with occupational exposures to premium cigars (e.g., in cigar lounges, manufacturing).
Consumer Perceptions and Knowledge
Beliefs such as risk perceptions are central to numerous health behavior theories and have been the focus of decades of tobacco research. Risk perceptions are also often the targets of interventions to prevent and reduce tobacco use, such as required health warning labels on tobacco packaging/marketing and mass media campaigns designed to raise awareness. However, no research examines whether consumers distinguish premium cigars from large cigars or other cigar types, consumers’ knowledge of what premium cigars are, what defines premium cigars, or knowledge on the health effects of premium cigars specifically.
Recommendation 9: The Food and Drug Administration, the National Institutes of Health, and other federal agencies should support research to assess consumer knowledge and awareness of premium cigars in the U.S. population. Specifically, these studies should
- Develop and implement specific measures that capture awareness of premium cigars as a tobacco product category, perceived risks and benefits of using premium cigars, and knowledge of the risks of premium cigar use; and
- Gather data regarding consumer knowledge about different cigar types and how, why, and where people start, continue, and discontinue using premium cigars (including perceived benefits and harms).
While research on premium cigars is largely lacking, the committee drew conclusions in many areas based on studies on other cigar types, biological plausibility, and the absence of important threats to validity. Therefore, the committee identified nine research priorities directed to federal agencies to expand the evidence base for premium cigars and cigars in general. If implemented, the committee’s recommendations will result in a better understanding of premium cigar use, marketing practices, and health effects over time.