Appendix A
Research Questions
The Center for Tobacco Products of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) (the report sponsors) submitted draft research questions to guide the literature review for this report. The committee statement of task (see Chapter 1) states that the draft research questions are subject to further input from stakeholders. To gather this input, the draft questions were posted to the committee website and public comments were accepted through May 6, 2021.1 The preliminary list of questions from FDA and NIH is available on the project website.2 The committee also held a public comment session for individuals and organizations to provide verbal feedback and asked for input from relevant organizations during one of its information-gathering meetings.3 Based on this feedback, the committee updated the research questions and used those questions to guide its review of the literature. The final list of questions is below, organized by topic. While none of the preliminary questions were removed, some were combined or expanded. Notably, many of the comments submitted by stakeholders suggested questions regarding marketing and user perceptions of premium cigars. Given the connection between marketing and user perceptions (see Chapter 1 and
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1 All written comments submitted to the committee are available in the project public access file and from PARO@nas.edu.
2 See https://www.nationalacademies.org/event/04-20-2021/docs/DE4A7B81359B6E0C08B06CACEE9033DF81528523E951 (accessed November 11, 2021).
3 See https://www.nationalacademies.org/event/04-20-2021/health-effects-and-patternsof-use-of-premium-cigars-meeting-2-part-2.
Figure 1-1), the committee added several questions in this category. The committee also added to the questions on product characteristics, patterns of use, and health effects based on the input received. However, not all stakeholder suggestions were added—given the limited time for the committee’s review, the committee focused on the suggestions that were most salient to its charge. As noted throughout this report, there is a paucity of data published on “premium”4 cigars, which limited the committee’s review for many of these questions.
CIGAR PRODUCT CHARACTERISTICS
- What is the impact of different manufacturing processes on cigars (e.g., selection and curing of leaves)?
- Are the chemical constituents present in cigarette smoke similar to those that are found in premium cigars or other cigars?
- How would the addition of flavors to premium cigars alter the smoke’s harmful and potentially harmful constituent (HPHC) profile?
- What is known about use characteristics among users of premium cigars in terms of depth of inhalation?
- Due to the varying sizes of cigars, what is the most accurate way to measure exposure/emissions to HPHCs? And, what are best practices for HPHC testing in premium cigars?
CIGAR PATTERNS OF USE
- How does the cigar market break down into the various cigar types, by sales? How has the market changed in recent years? What are contributing factors to the changes?
- What is the range of retail prices for premium cigars? What are the reported prices that people pay for premium cigars? How many cigars do people usually buy at a time?
- What is known about the demographic and socioeconomic characteristics of users of premium cigars? What are the characteristics of users in terms of age, gender, race, ethnicity, educational attainment, and income?
- What is known about use characteristics among users of premium cigars in terms of quantity of cigars used and frequency of use? How
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4 Note that quotations are used at the first occurrence of the term “premium” in each section of the report, as there is no formally agreed upon definition of what constitutes a premium cigar, and different entities might use this term differently. See Chapter 1 for more information.
- What is known about the use of premium cigars among different populations, such as youth, racial and ethnic minorities, individuals of low socioeconomic status, pregnant people, people with disabilities, lesbian, gay, bisexual, transgender, and queer or questioning people, and people with mental illness?
- How are the demographic and socioeconomic characteristics of users of premium cigars similar to or different from characteristics of users of other cigar types and other tobacco products?
- What is known about co-use of premium cigars and other tobacco products? How do those who use premium cigars only (mono-product) differ from users of premium cigars in conjunction with (dual use) other cigar subtypes and/or other tobacco products in terms of age, gender, race, ethnicity, educational attainment, income, frequency of use, and use of other addictive substances?
- Regarding use of cigar products with other tobacco products, what are the impacts on risk trajectories for youth and young adult tobacco users?
- How and where do premium cigar users obtain these products? Does use vary by season?
- Where do youth and young people obtain cigars (online mail-order sites, other retailers, or other sources)?
- What is known about premium cigar smokers who want to or have quit using premium cigars? Are they more or less likely to quit than users of other cigar types and other tobacco products? What methods do they use to quit?
- How does current premium cigar use influence initiation or continued use of other tobacco products?
- Do consumers use premium cigars as a cessation mechanism from other tobacco products?
are these characteristics similar to or different from those of users of other cigar subtypes?
CIGAR MARKETING AND RISK PERCEPTIONS
- How do the perceived benefits and harms of premium cigars differ from those of other cigar subtypes or other tobacco products?
- Are risk perceptions associated with different patterns of use (e.g., initiation of premium cigar use, greater use, dual use, or sustained use)?
- How do perceptions of premium cigars vary by sociodemographic groups by sex, age, sexual orientation, race and ethnicity, geographic location, income level, and education level?
- Is knowledge of the various constituents of premium cigars associated with different patterns of use (e.g., initiation of premium cigar use, greater use, dual use, or sustained use)?
- Are there particular features of premium cigars, either with the product itself or in the way the products are packaged and/or marketed, that would be considered appealing or unappealing to youth?
- What is the impact of coupons and price floors on premium cigar use? What types of discounts and price promotions are applied to premium cigars?
- Is product marketing of premium cigars associated with different patterns of use (e.g., initiation of premium cigar use, greater use, dual use, or sustained use)?
- What is the impact on use behaviors of celebrity endorsements? Is celebrity endorsement associated with different patterns of use (e.g., initiation of premium cigar use, greater use, dual use, or sustained use)?
- What is the impact on use behaviors of social influencers? Do social media icons influence different patterns of use (e.g., initiation of premium cigar use, greater use, dual use, or sustained use)?
HEALTH EFFECTS OF CIGARS
- What are the acute and long-term health effects of premium cigar use in terms of circulatory, respiratory, oropharyngeal, cancer, and other health outcomes? How are these health effects similar to or different from health effects of other cigar subtypes and other combustible tobacco products?
- What are the short- and long-term health effects (cancer and noncancer) of secondary and tertiary exposure to “premium” cigar smoke? How do these differ from the short- and long-term effects of secondary exposure to other subtypes of cigars and to other tobacco products? How do these differ by subgroups (e.g., youth vs. adults)?
- How do the health effects of premium cigar use vary by the following factors? Inhalation; frequency and intensity of use; unique features of premium cigars (such as the construction process); amount of smoke inhaled; population subgroups and/or demographic characteristics of those who use them; concurrent use of other tobacco products; pre-existing medical conditions; other factors.
- What are the adverse health effects of exposure to harmful and potentially harmful constituents, including nicotine, tobacco-specific nitrosamines, volatile organic compounds, and polyaromatic hydrocarbons?
- How much of the emissions of premium cigars become secondhand smoke? Is it the same as cigarettes?
- Do the chemical constituents in premium cigars pose similar hazards as cigarettes? Other cigar types?
- Are there unique chemicals/toxicants that are delivered to nonusers who are exposed to premium cigar smoke versus smoke from other cigar subtypes?
- Will a multi-product user be exposed to a different HPHC smoke profile or different health impacts compared to a solely premium cigar user?
- How does the pharmacokinetics of nicotine in premium cigars compare to other cigar subtypes and to other tobacco products?
- How does the addition of flavors alter the smoke’s harmful and potentially harmful constituent profile? How does the addition of flavors affect the health effects of premium cigars?
- Are the health effects of premium cigars different for dual users, past users of other products, etc.?
- What is known about the characteristics of premium cigars that cause people to start using them and continue using them? How are those characteristics similar to or different from characteristics of other cigar subtypes and other tobacco products?
- What is known about the abuse or addiction potential associated with premium cigars? Do premium cigars pose different addiction or abuse potential than other tobacco products, and, if so, what is the source of that differential risk? Are differences or similarities due to products themselves or how they are used, how people initiated, or other reasons?
- What is known about the subjective effects of premium cigar users after prescribed and ad libitum smoking regimens (e.g., dependence, withdrawal, liking)? How do these results compare to other cigar subtypes and to other tobacco products?
- What are best practices in quantifying the long-term health risks of premium cigar use and secondary exposure to premium cigar smoking?
- Are there specific biomarkers and clinical end points that should be used to assess the health effects of premium cigar use? If so, what clinical end points should be used to assess the impact of premium cigar smoke on user health? How do biomarkers and clinical end points associated with premium cigar use compare to use of other cigar subtypes?
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