Premium Cigars Patterns of Use, Marketing, and Health Effects (2022) / Chapter Skim
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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]
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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.
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. b Most premium cigars currently on the market weigh much more than this threshold, and cigars in other categories sometimes weigh this much as well (see Appendix F)
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.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)
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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.
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, 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.
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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.
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8 PREMIUM CIGARS: PATTERNS OF USE, MARKETING, AND HEALTH EFFECTS BOX S-2 Evidence Framework Description* • Conclusive evidence implies that observed associa tions between premium cigar use and a given out come are very unlikely to change with new evidence, Level of whereas other categories provide progressively less Confidence evidence.
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* For all categories, the evidence includes, when appropriate, literature on nonpremium cigars.
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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.
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At present, the extent to which premium cigar users who do not inhale have sys temic exposure to nicotine and harmful and potentially harmful constitu ents 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.
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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)
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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 depen dence among those who smoke premium cigars is lower than those who smoke nonpremium cigars or cigarettes. However, the preva lence 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.
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Premium cigars are also marketed as an integral component of a successful, luxuri ous 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.
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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.
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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)
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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.
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The extent of addiction is likely to depend on the patterns of use. PRIORITY RESEARCH 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.
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High-Priority 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 consul tation with other federal agencies, should develop formal categories and definitions for cigars to be used for research to ensure consis tency among studies.
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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 Ser vices, in partnership with the Alcohol and Tobacco Tax and Trade Bureau and the Federal Trade Commission (FTC)
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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.
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. Additional Priority Recommendations Product Characteristics 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.
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used to promote premium cigars. Addiction Potential Little is known about the addiction potential of premium cigars and how it compares to other cigar types.
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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.
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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.
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