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2 Tobacco Control Landscape
Pages 31-62

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From page 31...
... . The environment in which tobacco products are used and sold is complex and evolving, and requires working across multiple sectors and understanding an intricate web of stakeholders including a diverse user population, largely addicted to tobacco products.
From page 32...
... Tobacco is viewed as a wicked problem because of the often contradictory goals of stakeholders that give rise to uncertainty and because of the addictive nature of tobacco products. Five years ago, FDA was given an unprecedented opportunity to regulate tobacco, but the complex nature of tobacco control remains an impediment to clear-cut and effective policy implementation.
From page 33...
... Food and Drug Administration; HHS = U.S. Department of Health and Human Services; NGO = nongovernmental organization; PH = public health; TTB = Alcohol and Tobacco Tax and Trade Bureau.
From page 34...
... 34 Perceived importance to focus on other health programs Government – willingness to legislate – tobacco control Economics + – + + Tobacco Tax Government Government + + taxes revenues income from from smokers tobacco taxes regulation + + Government funding Government of tobacco control Protobacco Antitobacco awareness of constituencies constituencies Tobacco research tobacco health risk + + + + + + + + + + + + + + Funding for tobacco health + Researchers' + research Funding for tobacco Antismoking Health care costs awareness of control programs legislation tobacco health risk + + Tobacco + + Smokers control – Public awareness of tobacco programs Tobacco control + + health risk programs Tobacco + Individual – + revenues Fraction of people + smoking People behavior starting + + smoking Tobacco + People quitting Health insurers' + + smoking + coverage of tobacco industry Trend in tobacco – + quitting costs company revenues – Smoking as a social norm + + – + – + Tobacco marketing Pressure on tobacco activities Tobacco products + – + availability companies to Tobacco reduce marketing growers – activities FIGURE 2-2  Complex tobacco landscape. NOTE: This figure is not drawn to scale, nor is any meaning implied by the relative sizes of elements within the figure.
From page 35...
... . As tobacco products continue to be introduced, FDA and other members of the tobacco control community face evolving challenges and uncertainty.
From page 36...
... The Smoke Free Alternatives Trade Association, for example, engages lobbyists at the federal and state levels to block potentially threatening legislation related to vapor products and aims to reinforce the distinctions between vapor and tobacco products and their two respective industries (SFATA, 2015)
From page 37...
... . Whatever the reason for using tobacco products, many of these smokers are likely to become addicted, specifically to nicotine.
From page 38...
... ) broad authority to regulate the manufacturing, marketing, and sale of tobacco products, including cigarettes, cigarette tobacco, "roll-your-own" tobacco, and smokeless tobacco products (see Box 2-1 for highlights from the Tobacco Control Act)
From page 39...
... : • Registration and inspection of tobacco companies --  equiring owners and operators of tobacco companies to regis R ter annually and be subject to inspection every 2 years by FDA • Standards for tobacco products --  llowing FDA to require standards for tobacco products (e.g., A tar and nicotine levels) as appropriate to protect public health 9 The Tobacco Control Act user fee program will generate more than $4.5 billion in user fees over 9 years (2009–2018)
From page 40...
... 11 When a manufacturer obtains a marketing order, the manufacturer has complied with the requirements under the FD&C Act to bring its product to market. While FDA may issue a marketing order for a tobacco product to be marketed, the order does not necessarily mean that the tobacco product is safe or "approved" (FDA, 2015b; Miner, 2012)
From page 41...
... Although not explicitly stated in the Tobacco Control Act, FDA may develop and disseminate public education campaigns that inform the public ­ about the dangers of tobacco products. In February 2014, FDA launched nationally its first youth tobacco prevention campaign, called "The Real Cost," across multiple media platforms, including television, radio, print, and online (FDA, 2015a)
From page 42...
... It prohibits, with certain exceptions, state and local requirements that are different from, or in addition to, requirements under the provisions of the FD&C Act relating to specified areas.14 New tobacco products  The Tobacco Control Act defines a tobacco product as any product "made or derived from tobacco" that is not a drug, device, or combination product. In April 2014, FDA proposed to deem all products that meet the definition of a tobacco product to be subject to the FD&C Act, as amended by the Tobacco Control Act (HHS, 2014a)
From page 43...
... . 16 The Substance Abuse and Mental Health Services Administration oversees implementation of the Synar Amendment, which requires states to have laws in place prohibiting the sale and distribution of tobacco products to minors, and the enforcement of those laws.
From page 44...
... . The Tobacco Control Act permits state and local governments to: • E  xpand the current requirements of the Tobacco Control Act that limit advertisements for cigarettes and smokeless tobacco to black and-white text to apply to advertisements for cigars and other tobacco products as well • P  rohibit the display of "power walls" of cigarette packages at retail outlets • L  imit the number and size of tobacco advertisements at retail outlets • R  equire that tobacco products (and advertisements)
From page 45...
... Multiple tribes now produce, market, and sell tobacco products and view the manufacturing and sales of tax-free tobacco products as a revenue opportunity, a benefit to tribal economic development, and, perhaps most importantly, an exercised right of their sovereign statuses. State excise taxes do not apply to cigarettes sold to tribal members on tribal land (Samuel et al., 2012)
From page 46...
... For example, the reasons that people initiate the use of tobacco products (e.g., social influence) are often different from their reasons for continuing to use the products (e.g., addiction)
From page 47...
... . Concept Definition Intrapersonal Level Individual characteristics that influence behavior, such as knowledge, attitudes, beliefs, and personality traits Interpersonal Level Interpersonal processes and primary groups, including family, friends, and peers that provide social identity, support, and role definition Community Level Institutional Factors Rules, regulations, policies, and informal structures, which may constrain or promote recommended behaviors Community Factors Social networks and norms, or standards, which exist as formal or informal among individuals, groups, and organizations Public Policy Local, state, and federal policies and laws that regulate or support healthy actions and practices for disease prevention, early detection, control, and management FIGURE 2-3  An ecological perspective: Levels of influence.
From page 48...
... For example, social norms about tobacco use in a particular school can alter peer influence in that school, which in turn will affect the initiation of tobacco use among the youth in that school. Alternately, variables can moderate (i.e., change)
From page 49...
... . The use of tobacco products among older siblings is also a predictive factor in youth tobacco use (HHS, 2012)
From page 50...
... This context, in turn, is influenced by macro-level interventions, such as various tobacco policies (e.g., increased taxes on tobacco products) and communication campaigns (e.g., social marketing)
From page 51...
... often moderate the impact of intrapersonal, interpersonal, and macro-level determinants described above and the speed with which individuals progress through these stages of tobacco use. One caveat is that the majority of empirical research to date has been specific to cigarette smoking, so that there is limited etiologic research available concerning the developmental processes and pathways of initiation for other tobacco products.
From page 52...
... These aggregate population models have been very useful in determining the overall magnitude of the tobacco epidemic and its likely trajectory; however, given the increased complexity of the tobacco use landscape, it is becoming evident that policy makers need to better understand and model explicitly the essential social- and individual-level processes of tobacco use behavior (e.g., the mechanisms of initiation, cessation, and relapse) in order to anticipate as accurately as possible the effects of policy interventions.
From page 53...
... Examples include models of how the development of new tobacco products disrupt existing industry and retailer practices or models of community-level policies at the point of sale that are designed to affect retailer behavior (e.g., advertising)
From page 54...
... , so the modeling decision to focus on a specific policy question versus initiation or cessation needs to discussed early in model conceptualization. This section outlines the conditions in which an ABM could be useful to inform tobacco control policy.
From page 55...
... 2014. Tobacco product use among adults -- United States, 2012–2013.
From page 56...
... 2014. Tobacco products: FDA spending and new product review time frames (GAO-14-508T)
From page 57...
... Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.
From page 58...
... Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.
From page 59...
... 2012. Information technology, tools, tobacco products, and public health.
From page 60...
... . TPSAC (Tobacco Products Scientific Advisory Committee)
From page 61...
... Nicotine & Tobacco Research 12(7)


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