Premium Cigars Patterns of Use, Marketing, and Health Effects (2022) / Chapter Skim
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1 Context and Methods
1 Context and Methods
Pages 27-49
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From page 27... ...
These trends did not apply to all tobacco products, as cigarette consumption decreased 2 percent in 1993–1997. Premium cigars, however, make up a small percentage of the total U.S.
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From page 28... ...
. Despite no formal definitions of these cigar types, Box 1-1 provides what are largely considered common characteristics (see the definitions section later in this chapter for more on premium cigars and Chapter 2 for a detailed description of cigar types)
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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)
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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 whether they do so differently than do other tobacco products (FDA, 2021)
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. 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.
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From page 32... ...
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)
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From page 33... ...
. THE COMMITTEE'S CHARGE FDA and NIH asked the Health and Medicine Division of the National Academies to examine the available evidence on the patterns of use and health effects of premium cigars compared to other tobacco products and to identify research needs and make prioritized recommendations for future federally funded research on premium cigars.
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From page 34... ...
those who use other tobacco products (including demographic characteristics, tobacco use status, and factors that influence potential use) Based on the literature review and information National Academies and FDA have collected on premium cigars, the multidisciplinary committee convened by National Academies will make prioritized recommendations for future federally funded research on premium cigars.
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From page 35... ...
The seven most common premium cigar attributes are listed in Box 1-3. 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.
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From page 36... ...
High price (e.g., $7–$12 per cigar) As discussed in this chapter, the committee used criteria 1–6 to differentiate pre mium cigars from other cigar types, unless noted otherwise (a premium cigar would meet all six criteria)
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From page 37... ...
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.
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, 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 18 Publicaccess materials can be requested from PARO@nas.edu.
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From page 39... ...
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)
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.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.
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From page 41... ...
However, as noted later in this section, no studies of the health effects of premium cigars specifically were identified, so the committee relied on health effects and toxicology studies of other cigar types (including overall and large/traditional cigars, which could include premium cigars) and biologic plausibility.
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From page 42... ...
Nevertheless, the toxicological and mechanistic literature provides evidence supporting the plausibility of various mechanisms by which premium cigar exposure influences health (NASEM, 2018)
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; 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.
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, patterns of use of premium cigars and other cigar types (Chapter 3) , marketing and perceptions of cigar products (Chapter 4)
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• The categorizations for each conclusion are based on the committee's overall assessment of the body of evidence. The available evidence (including biologic plausibility when appropriate here and in the next categories)
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From page 46... ...
and their chemical constituents, the committee identified no material difference between products typically considered premium cigars and other cigar types in terms of harmful or potentially harmful constituents (see Chapter 2)
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2016. Deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act; restrictions on the sale and distribution of tobacco products and required warning statements for tobacco products.
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From page 48... ...
Paper Commissioned by the Committee on Patterns of Use and Health Effects of "Premium Cigars" and Priority Research (Appendix C)
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From page 49... ...
2021. Strong year for premium cigars continues.
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