Regulatory Context

The FDA Center for Tobacco Products (CTP) is responsible for regulating tobacco products. The Family Smoking Prevention and Tobacco Control Act⁴ (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 regulatory authority was applied to cigarettes and to cigarette tobacco, roll-your-own, and smokeless tobaccos (Apelberg, 2021). The statute permitted FDA to issue regulations “deeming” other types of tobacco products subject to restrictions and regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act).⁵

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, except premium cigars would be excluded) (FDA, 2016). In 2016, FDA adopted Option 1 after concluding that deeming all cigars would more comprehensively protect the public's health. FDA noted that the evidence was insufficient to justify excluding premium cigars from the final deeming rule and therefore regulation. The finalized rule broadened FDA's regulatory authority to include all products meeting the statutory definition of a tobacco product,⁶ including cigars (FDA, 2016)⁷ and established restrictions on newly deemed tobacco products for the protection of public health, including requiring health warnings on packaging and in advertisements.

However, in March 2018, FDA issued a call for additional information and comments not previously submitted for consideration for the deeming rule (FDA, 2018). 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 them. 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 whether they do so differently than do other tobacco products (FDA, 2021). As described later in this chapter, in early 2021, FDA and the National Institutes of Health (NIH) asked the National Academies of Sciences, Engineering, and Medicine (National Academies) to form a committee to explore the available literature on the health effects and patterns of use of premium cigars. 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 (FDA, 2021).

Litigation

In 2016, the Cigar Association of America, International Premium Cigar and Pipe Retailers Association, and Cigar Rights of America (trade associations and advocates for premium cigar manufacturers, retailers, and consumers) filed a lawsuit⁸ against FDA, contesting the deeming rule and its application to cigars and pipe tobacco (i.e., Option 1 in the deeming rule). The lawsuit alleged that the enforcement of premarket review of premium cigars would be costly, making FDA's issuance of the deeming rule “arbitrary and capricious” in violation of the Administrative Procedure Act (APA); requiring industry to pay “user fees” is an illegal tax, also in violation of APA; imposing user fees on cigar manufacturers but not e-cigarette manufacturers is “contrary to [the] constitutional right” to due process protected by the Fifth Amendment, a violation of APA; FDA's cost analysis did not properly quantify the rule's costs or identify significantly less costly alternatives to the rule, a violation of the Regulatory Flexibility Act; and FDA's decision to regulate all cigars rather than exempting premium cigars is also “arbitrary and capricious” (PHLC, n.d.).

Litigation is ongoing. For example, in August 2020, a ruling from the U.S. District Court for the District of Columbia prohibited FDA from enforcing the premarket authorization requirement for premium cigars (part of the Tobacco Control Act) until it develops a streamlined substantial equivalence process for premium cigars (FDA, 2020; PHLC, n.d.). Requirements for warnings on cigar packages have also been suspended (FDA, 2020; PHLC, n.d.).

In July 2021, the Washington, DC, Court of Appeals rejected an appeal filed in May 2021 by three cigar trade organizations challenging a previous decision made by the DC District Court, which legally validates FDA's requirements for substantial equivalence and upholds the 2007 predicate date for cigars.⁹

Congressional Bills

Members of Congress in both chambers have introduced legislation several times to exclude premium cigars from FDA regulation. Most recently, a bill sponsored by Rep. Kathy Castor (D-FL-14), with both Democratic and Republican cosponsors, was introduced in June 2021 to exclude “traditional and premium cigars” from FDA regulation.¹⁰ A similar version of the bill sponsored by Senator Marco Rubio (R-FL) was introduced in February 2021.¹¹ Members of Congress have introduced previous iterations of the same bill since 2011, none of which have passed the chamber of Congress in which they were introduced (Nagy, 2016).

Cigar Use in the United States

Historically, premium cigars in the United States are imported (NCI, 1998). Nicaragua, the Dominican Republic, and Honduras are currently the three largest producers (Savona, 2021). Recent data suggests that premium cigar use may be increasing, given that the United States imported more than 171 million premium cigars from January to May 2021, which is a 73 percent increase from the same months in 2020. However, as noted, premium cigars make up a small percentage of the U.S. cigar market. Alcohol and Tobacco Tax and Trade Bureau data suggest that the percentage of the cigar market sales that may be premium ranged from 1.5 to 3.0 percent between 2010 and 2020 (see Chapters 3 and 4).

Robust data on premium cigar use are scarce, given the lack of a single, consistent definition, absence of survey questions that assess premium cigar use, and lack of studies directly measuring consumer perceptions (see Chapter 4). However, some information about prevalence of premium cigar use has been published with data from the Population Assessment of Tobacco and Health (PATH)¹² Study and the National Survey on Drug Use and Health (NSDUH);¹³ the committee commissioned additional analyses of these datasets (see Appendixes C and D). In 2019, 3.6 percent of adults in the United States smoked at least one type of cigar; the majority of cigar users are men (Cornelius et al., 2020; Jeon and Mok, 2022). A 2021 analysis of PATH data shows that the majority of adult premium cigar users were non-Hispanic White people (Jeon and Mok, 2022). Additionally, premium cigar users tend to be older, male, and more affluent than users of other tobacco products. An analysis of PATH Wave 1 data found the past 30-day prevalence of premium cigars to be 0.7 percent among adults in 2013–2014 (Corey et al., 2018); the prevalence of current established premium cigar users was also 0.7 percent in a commissioned analysis of PATH Wave 4 (2016–2017) data (Jeon and Mok, 2022). The authors also found a median of 1.7 days of cigar smoking in the past 30 days among premium cigar users (Corey et al., 2018). See Chapter 3 and Appendixes C and D for more information on premium cigar patterns of use and demographics.

Although data on premium cigar use in youth is sparse, cigar smoking overall in this group declined significantly from 2011 to 2018. However, cigars were the most common combustible tobacco product in 2020 (3.5 percent of middle and high school youth reported smoking cigars in the past 30 days, exceeding levels of past 30-day cigarette smoking) (Gentzke et al., 2019, 2020). Cigar use was higher in Black middle and high school students in 2020 than for any other tobacco product (Gentzke et al., 2019). Additionally, data from the 2020 Monitoring the Future survey¹⁴ show that 1.5 and 1.2 percent of eighth and tenth grade students, respectively, reported smoking large cigars in the past 30 days (Gentzke et al., 2019). Past-month cigar use in the 2019 NSDUH was higher among people aged 18–25 (7.7 percent) than 12–17 (1.4 percent) and 26+ (4.0 percent) (Miech et al., 2021; SAMHSA, 2020). Past 30-day use of premium cigars, however, was very uncommon (0.1 percent) in those under age 18 in a commissioned analysis of NSDUH data from 2010 to 2019 (Bover Manderski et al., 2022).

Health Effects

Studies have shown that cigar smoking and inhalation of cigar smoke are associated with a variety of negative health outcomes, including coronary heart disease, certain forms of cancer (e.g., of the oral cavity, esophagus, larynx, and lungs), and all-cause mortality (Apelberg, 2021; Bover Manderski et al., 2022; Chang et al., 2015; NCI, 1998; Rostron et al., 2019). An estimated 9,000 deaths per year among U.S. adults aged 35+ are attributed to regular cigar smoking (Nonnemaker et al., 2014). The physical characteristics of cigars affect users' interactions with them and subsequently influence their health effects. For example, most cigars contain more tobacco than cigarettes and can be smoked for longer (NCI, 1998). Due to the incomplete combustion of tobacco in cigars, the smoke is composed of many of the same carcinogenic compounds found in cigarette smoke (NCI, 1998). The pH of premium cigars may affect inhalation patterns, which in turn affects exposure to cigar tobacco and smoke constituents and influence health outcomes. Premium cigar pH is generally more alkaline than that of cigarette smoke, hindering but not preventing inhalation when smoking cigars (NCI, 1998). In an alkaline pH, more nicotine is in the unprotonated form, which is readily absorbed by the oral mucosa but also results in harsher smoke, which is more difficult to inhale (see Chapters 2 and 5).

“Premium Cigar” Definition for the Purposes of This Report

Federal regulations define a cigar as “any roll of tobacco wrapped in leaf tobacco or in any substance containing tobacco.”¹⁵ Cigars come in many different types, including large traditional cigars (premium and nonpremium), cigarillos, and little cigars;¹⁶ products vary widely in size, shape, components (e.g., filters, flavors), cost, and packaging. Despite the wide variety, no universally accepted classification system exists, which creates challenges for research, policy, and regulation. For federal tax purposes, a distinction is made between large and small cigars.¹⁷ The Department of Treasury defines small cigars as weighing no more than 3 pounds per 1,000 cigars (less than or equal to 1.36 grams per cigar) and large cigars as weighing more than this amount. Additionally, for taxation purposes, large cigars, which include a wide array of sizes, including cigarillos, are reported in two groups: those with a pretax value below $763.222 per 1,000 and those above; these groupings correspond with federal excise tax structures. Prior to 2003, these two groups were referred to as Class A–G and Class H cigars, respectively. While these designations are no longer used, it is important to note that the cigar industry has referred to premium cigars as “Class H,” although all Class H cigars may not be premium under some definitions (i.e., they could be machine made) (Hoyt, 2008). In the NCI Monograph on Cigars, Hoffman and Hoffman (1998) classify cigars into four groups (see Table 1-1). This classification system is useful because it illustrates the extent of the cigar marketplace. Compared to “small” or “little” cigars, premium cigars are larger and heavier, are handmade, and do not use filters or tips.

The lack of standardization in the cigar market, combined with the wide range of products, presents challenges for operationally defining premium cigars. Existing definitions do have commonalities, such as the wrapper composition and filler type (see the Chapter 1 Annex, which lists various definitions). Consequently, different definitions have been used by state agencies, federal entities, the tobacco industry and associated organizations, courts, and researchers. The seven most common premium cigar attributes are listed in Box 1-3.

BOX 1-3

Most Common Premium Cigar Attributes.

With the exception of price, the first six attributes are consistent with the definition used in FDA's 2014 advance notice of proposed rulemaking for deeming tobacco products and in the August 2020 U.S. District Court ruling, so the cigar industry and FDA (FDA, 2016, 2020) generally accept this definition. None of these characteristics by themselves are a sufficient attribute for defining a premium cigar; all need to be considered together. The first three attributes (handmade, filler type, and wrapper composition) are nearly universally accepted, dating back to the NCI Monograph (and likely further), as features that distinguish premium and nonpremium cigars. While weight is not as commonly referred to in definitions and not intrinsic to being premium, the cut point of 6 pounds per 1,000 is the weight most commonly used, including by FDA. Therefore, it is part of the definition in this report so as to include a minimum weight threshold; however, the majority of premium cigars weigh more—sometimes double this weight or more (see Chapter 2 and Appendix F). Filters or tips and flavoring are quite common in the mass-produced cigar marketplace but rare in the premium market; these attributes also assist in differentiation. Lastly, price is important to consider for a few reasons. First, as noted, it is relevant for taxation, and the industry has historically considered premium cigars to fall into the now defunct Class H. Second, the committee acknowledges consumers' understanding of “premium” may vary (marketing experts define “premium” products as those that cost more, with at least 20 percent more than the average given as an example) (NielsenIQ, 2016). Third, researchers have used price (i.e., $2) to discriminate between large and premium cigars in the absence of other information (Corey et al., 2018). Last, and perhaps most importantly, price likely serves as a proxy for the first three attributes (handmade, filler type, and wrapper composition) in Box 1-3; a handmade cigar with long-leaf filler and a whole leaf wrap is more expensive to produce. Setting a threshold for price is challenging, as it can be impacted by local, state, and federal taxation and manipulated by the industry. Therefore, price is not formally considered as part of the committee's definition but may be useful when information is lacking on the other six attributes.

For the literature review and this report, the committee is referring to the six attributes in Box 1-3 to define premium cigars, unless noted otherwise. As stated, the committee was not tasked with providing a recommendation for a regulatory definition of a premium cigar, and therefore the definition of premium cigars used by the committee is for the purpose of this report only. While other stakeholders may adopt or adapt this definition for other purposes, additional factors might need to be considered. For example, the tobacco industry has altered its products so that they no longer fit existing regulatory definitions (or now meet the definition of a different tobacco product), and this factor was not a major consideration for the committee. As noted, the price of tobacco products can also be manipulated by the tobacco industry. See Recommendation 1 in Chapter 6 for additional considerations on this topic, including considerations of the weight criterion used in many definitions and the need to potentially increase the weight threshold.

Study Process

The 1998 NCI monograph is the only comprehensive review on cigars (all types)—it included a review of product characteristics, marketing, health effects, and research needs (NCI, 1998). While several review articles have examined specific aspects of cigar use since then, these look at just one aspect (e.g., a specific health effect) or review just one type of cigar (e.g., marketing of cigarillos). Therefore, the committee used the 1998 NCI report as a starting point for its review and has updated many aspects of it.

To conduct its review, the committee gathered information in a variety of ways. It held four information-gathering sessions between March and May 2021 (agendas are available in Appendix H; all meetings were virtual) on a range of topics, including tobacco science, tobacco control policy, cigar industry perspectives, health effects of cigars, and tobacco data. In addition, the committee held a public comment session to solicit feedback on the preliminary research questions provided to the committee by FDA and NIH (see next paragraph). It held deliberative meetings and received public submissions of materials for its consideration throughout the course of the study.¹⁸ Its online activity page also provided information to the public about its work and facilitated communication with the public.¹⁹

As noted, FDA and NIH provided a list of preliminary research questions and asked that the committee solicit input from stakeholders on the preliminary list to guide its literature review. The final determination of specific questions to be answered was the responsibility of the committee, which took into account the preliminary list and feedback received via public meetings and written comments. That final list is available in Appendix A.

Given the paucity of data available on premium cigars, the committee commissioned several analyses to further inform its work: two papers on the patterns of use of premium and other cigars, one with 10 years of NSDUH data (2010–2019) and one with PATH data from Waves 1–5 (2013–2019; see Appendixes C and D), a paper with data on cigar weight, length, and nicotine content from a convenience sample of different brands and cigar types (see Appendix F), and a paper with geographic information system mapping analysis to map the locations of premium cigar retailers and overlay retailer density with demographic measures by census tract using data provided by the Premium Cigar Association (to gain a better sense of where premium cigar retailers and lounges are located; see Appendix G). The committee also conducted a social media environmental scan and a content analysis of three popular cigar lifestyle magazines; social media and magazine content were examined to understand marketing content (see Chapter 4).

Four work groups were formed to refine the research questions, incorporate public comments, and undertake the literature reviews. These work groups were organized by the topics of product characteristics, patterns of use, psychosocial factors, and health effects. Committee members reviewed each article identified through the literature search (see Appendix B) to assess the content, relevance, study methodology, and quality. The overall body of literature for each research question was assessed, and research gaps and measurement issues were identified. The committee then prioritized the research and measurement needs and provided recommendations for future research (see Chapter 6).

Evidence Review

The statement of task charges the committee with conducting a “comprehensive and systematic assessment and review of the scientific literature” of the health effects related to the use of premium cigars (see Box 1-2). It was also asked to review patterns of use and other factors related to premium cigars (see Appendix A for the research questions). Given the heterogeneity of the research and varied topics that the committee had to review, it created a formalized framework to assess the strength of the evidence (see the sections later in this chapter).

A systematic literature search was conducted (see Appendix B for search terms, years, databases, and journals) to identify publications on premium cigars. Because “premium” has not been used systematically, searches considered cigars more generally. Reviews were identified for all combustible tobacco products for comparison to premium cigars (whereas individual articles were summarized for large/traditional and premium cigars and other cigar types as needed). The committee's approach was informed by published guidelines for conducting systematic reviews and the approaches taken by prior National Academies committees (CRD, 2009; Higgins, 2021; IOM, 2011, 2012, 2016; NASEM, 2017, 2018; NRC, 2014; OHAT, 2019; Whiting et al., 2016). However, early in its work, the committee noted the very limited literature available on premium cigars specifically and lack of agreed-upon definition, no agreement by consumers on the nature of the product they use, and therefore of consistency regarding which brands are considered “premium” in the literature. Moreover, many publications do not distinguish “premium” from other large cigars.²⁰ For many of its conclusions, the committee extrapolated data from other tobacco products, cigars in general, or large/traditional cigars overall (which include premium) when the data was strong and there were no important threats to validity. In addition, the study types varied considerably (e.g., laboratory, epidemiologic and toxicologic studies, and surveys). The committee adjusted its approach and framework accordingly. Notably, its approach incorporated major attributes of systematic reviews. It systematically located, screened, and selected studies (including using multiple databases and systematically collecting data); evaluated individual studies for strengths and limitations; and synthesized findings into an assessment of the overall body of literature. Note that for patterns of use, the committee included only findings (no conclusions).²¹

Because of the paucity of literature on premium cigars specifically, studies of large, traditional cigars, cigars overall, and occasionally other combustible tobacco products were included based on committee members' assessment of the relevance and potential generalizability of those studies' findings to premium cigars.

Given the limited data, the committee relied heavily on biological mechanisms and plausibility in its framework, particularly for health effects. As noted in Chapter 2, despite differences between premium cigars and traditional large cigars, many similarities also exist, and therefore information from large traditional cigars and sometimes other types of cigars can be relevant. This section includes an overview of the committee's methods for identifying, reviewing, and assessing the literature, which is followed by its approach to assessing causality and integrating data from human, animal, in vitro, and laboratory studies and the framework developed to describe the strength of the evidence informing its conclusions.

Literature Review and Quality Assessment

Causality

Little to no direct empirical evidence exists evaluating the health effects of premium cigars specifically. Despite a general consensus that high-quality epidemiological studies supported by strong toxicology and other mechanistic biological evidence provide the strongest basis for firm inferences regarding causality, these studies do not exist for premium cigars in isolation (and, in large part, studies also do not differentiate between large/traditional cigars and other types). With only a few exceptions, the epidemiological literature is extremely limited, and even where it is stronger, it does not address the etiology of chronic diseases. In other cases, there is simply no credible epidemiological research on premium or large cigars.

Given this challenge, the committee drew upon knowledge of the health effects of some constituents of the emissions from cigars and other combustible tobacco products, as this provides one relevant line of indirect evidence. Another important source of evidence is toxicology studies with implications for the biological mechanisms of premium cigars. The certainty, magnitude, and health relevance of these pathways bear on their value for making causal inferences (NASEM, 2018). For example, in vivo animal evidence may be more pertinent to inferences regarding human health effects than in vitro findings are. Nevertheless, the toxicological and mechanistic literature provides evidence supporting the plausibility of various mechanisms by which premium cigar exposure influences health (NASEM, 2018).

As noted in NASEM (2018), “tying these diverse threads of indirectly relevant evidence together to draw a summary conclusion is necessarily somewhat subjective, bringing together the knowledge and judgment of the committee as a whole to reach consensus.” To provide comparable inferences across the full array of health concerns, the committee reviewed and modified approaches used in other National Academies reports and published guidelines on evidence synthesis (e.g., IOM, 2012; NASEM, 2017, 2018; NRC, 2007, 2014) to reach conclusions based on human evidence, animal evidence, laboratory studies, and their integration.

Causal Pathways

Figure 1-1 presents a simplified schematic of the pathway from premium cigars to health outcomes. Individual health effects are, of course, based on individual level (e.g., frequency, duration) of use. Patterns of premium cigar use are impacted by cigar characteristics (e.g., nicotine level, pH, addiction potential), its marketing, and the user's risk and benefit perceptions. Marketing is also impacted by characteristics of the product itself and how the product is described (e.g., handmade, artisanal, premium; see Chapter 4 for more on this topic) and, in turn, the way that consumers perceive the product, which directly influences how they intend to use it. Product perceptions are informed by both the marketing of and trial with the product. Consumers' reactions to marketing campaigns and/or their perceptions about premium cigars may influence how premium cigar companies characterize their products (e.g., addictive potential, the role of pH on users' smoking experience). Although the committee's statement of task does not specifically request a review of marketing and perceptions, they are inextricably linked to patterns of use (these topics are also included in the research questions). The resulting patterns of use lead to varying levels of toxic exposures from smoking premium cigars (or from secondhand smoke), ending with health outcomes. Note that other factors could be included in this framework (e.g., social factors such as social networks); however, the framework focuses on the factors described in this report. Because the committee primarily focused on distal health outcomes, evidence on the effects of premium cigars for these outcomes is most relevant to assessing premium cigar health effects. In the absence of high-quality epidemiological evidence on these outcomes, the committee drew upon biologic and mechanistic evidence, which have documented and well-known health effects.

Evidence Synthesis—Health Effects

The committee's assessment of data aimed to establish causation between premium cigars and a given health end point, not merely a statistical association. However, in the absence of high-quality epidemiological studies of the health effects of premium cigar use specifically, the committee took into account several considerations to draw causal inferences from the evidence available (as was done in NASEM, 2018). These considerations rely on criteria typically used to interpret and establish causation based on epidemiological data and are adapted from the approach taken in the 2014 Surgeon General's report on smoking and health (e.g., strength of the association, consistency, specificity, biological gradient) (HHS, 2014; Hill, 1965). Evidence from multiple epidemiological studies would provide the strongest evidence of a consistent effect (NASEM, 2018).

The committee looked for coherence across the body of evidence. For example, the committee draws analogies from other combustible tobacco products, such as other cigars and cigarettes. The committee also uses animal, in vitro, and laboratory data and evidence on intermediate outcomes to establish the biological plausibility of a hypothesized disease pathway.

Conclusions

Informed by reports of previous Institute of Medicine and National Academies committees (IOM, 2012, 2016; NASEM, 2017, 2018) and the U.S. Preventive Services Task Force (USPSTF, 2018), the committee developed standardized language to categorize the strength of the evidence described in its conclusions. Box 1-4 presents the categories and describes the types of evidence that correspond to the committee's confidence in each category. Conclusive evidence implies that observed associations between premium cigar use and a given outcome are very unlikely to change with new evidence, whereas other categories provide progressively less evidence. Conclusive, strongly suggestive, and moderately suggestive evidence describe a direction of effect (e.g., increased or decreased risk of a health outcome); topics with insufficient or no available evidence cannot imply a direction. The level of evidence does not indicate the effect's size, magnitude, or importance. The framework is a guide, and expert judgment—in the evaluation of individual studies and in bodies of evidence—was involved.

BOX 1-4

Evidence Framework.

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