The study of the relationship between tobacco use and health problems has a long history. The classic papers by Doll and colleagues began to appear in 1950, with the first prospective study linking cigarette smoking and lung cancer published in 1954 (Doll and Hill, 1954), following up on many cross-sectional studies. A number of other important studies added to the growing evidence base about the health risks of smoking (e.g., Cornfield et al., 1959; Dorn, 1959; Hammond and Horn, 1958; Wynder and Graham, 1950). A seminal report, Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service,1 was published in 1964, and since that time Surgeons General have released 32 other reports on a variety of topics related to tobacco use (HHS, 2014).
Smoking rates in the United States have declined substantially since 1965 when the prevalence of current cigarette smoking was approximately 42 percent (HHS, 2014). Furthermore, it has recently been estimated that tobacco control policies in the United States since 1965 have led to 8 million fewer premature deaths and have extended the mean life span by 19 to 20 years per death postponed, corresponding to an increment of about 2 years in life expectancy at age 40 (Holford et al., 2014). However, tobacco use continues to have major public health implications: While the prevalence of current cigarette smoking among U.S. adults declined from 24.7 percent in 1997 to 17.8 percent in 2013 (NCHS, 2014), more than 42
1 This report is often referred to as the first Surgeon General’s report on smoking; however, the authors were actually a nongovernmental advisory committee to the Surgeon General.
million American adults still smoke, leading to about 480,000 premature deaths each year (HHS, 2014).
According to the most recent results from an annual survey of adolescents in grades 8, 10, and 12, American teens are smoking less than ever before (Johnston et al., 2014). Smoking in this age group peaked in 1996–1997 before beginning a fairly steady and substantial decline that continued through the mid-2000s (HHS, 2014). In 2013 the number of adolescents who reported having smoked in the previous 30 days had decreased from peak levels seen in the mid-1990s by 79 percent in grade 8, 70 percent in grade 10, and 56 percent in grade 12 (Johnston et al., 2014). Other surveys show similar trends (Kann et al., 2014; SAMHSA, 2013). While tremendous strides have been made, each day more than 3,000 adolescents try their first cigarette, and, if current trends continue, 5.6 million adolescents alive today in the United States are likely to die prematurely of smoking-related illness (HHS, 2014).
Tobacco use by young adults (those between 18 and 24 years of age) also poses serious concerns. While nearly 90 percent of people who have ever smoked daily first tried a cigarette before 19 years of age, the fact that another 9.4 percent tried their first cigarette before the age of 26 should not be overlooked (see Table 2-8 in Chapter 2). Additionally, only 54 percent of daily smokers are smoking daily before age 18, but 85 percent are doing so by age 21, and 94 percent before age 25 (see Table 2-8 in Chapter 2). These data strongly suggest that if someone is not a regular tobacco user by 25 years of age, it is highly unlikely they will become one.
Data from 2012 show that current cigarette use among adults was highest among persons ages 21 to 25 years (34.1 percent) (SAMHSA, 2013). Certain emerging patterns of tobacco use among young adults are also of concern, including an increase in the number of young adults who smoke lightly (fewer than five cigarettes per day) or intermittently (nondaily) (Fagan and Rigotti, 2009; Pierce et al., 2009) but do not consider themselves “smokers” (Leas et al., 2014). There has also been a very recent increase in the use of other tobacco products, such as electronic cigarettes and hookahs, among college students (HHS, 2012; Johnston et al., 2014).
Research suggests that brain and psychosocial development continues past the age of 18 years (IOM and NRC, 2014), the age of legal tobacco purchase in the United States. The self-regulatory system matures gradually, beginning in pre-adolescence and continuing through young adulthood (Steinberg, 2012). High-risk behaviors, including tobacco use, are generally more common in adolescents and young adults than in older adults. Additionally, the tobacco industry, prohibited from marketing to those younger
than 18 years of age, has for decades targeted marketing and promotional activities to young adults (Sepe et al., 2002). The convergence of the neurobiological factors and the tobacco use epidemiology reinforces the importance of preventing young adults, in addition to children and adolescents, from becoming tobacco users.
Neither the prevalence of cigarette smoking nor the use of other tobacco products is evenly distributed in the population; rather, both are more heavily concentrated in certain population subgroups than in others. Over time in the United States, cigarette smoking has become more and more concentrated in lower socioeconomic groups defined by few years of schooling and lower income (Fagan et al., 2007). Smoking prevalence also varies across racial and ethnic groups, with the highest prevalence among American Indians and Alaskan natives and the lowest among Asian Americans (Fagan et al., 2007).
Sexual orientation is also strongly associated with the prevalence of current smoking. Smoking prevalence is much higher among sexual minorities than in the population as a whole (Lee et al., 2009; Ryan et al., 2001). The prevalence of smoking among persons with a history of mental illness is approximately double the prevalence in the general population (Lasser et al., 2000). This increased likelihood of smoking in those with a history of mental illness is not limited to one or a few psychiatric diagnoses but rather is a cross-cutting association that applies to psychiatric diagnoses across the board (Lasser et al., 2000). Historically, the prevalence of smoking has been higher among active duty military personnel (Bray et al., 2006) and veterans of the military (Brown, 2010) than in the general population. There is evidence that this disparity is diminishing in the veteran population (Hamlett-Berry et al., 2013).
The release of the 1964 report on smoking and health spurred our current tobacco control activities, and efforts increased dramatically beginning in the 1990s. In the early 1990s tobacco control advocates and policy makers focused on preventing children from initiating tobacco use. Congress included an important policy lever, known as the Synar Amendment to the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act,2 aimed at decreasing youth access to tobacco. The Synar program re-
2 ADAMHA Reorganization Act of 1992, Public Law 102-321, 102nd Cong. (July 10, 1992).
quires states to have laws in place prohibiting the sale and distribution of tobacco products to persons under the age of 18 and to enforce those laws effectively (SAMHSA, 2014). Failure to meet these requirements may result in a state losing 40 percent of its substance abuse prevention and treatment block grant. The Synar program is described in detail in Chapter 5.
In 1994 a committee convened by the Institute of Medicine (IOM) released the report Growing Up Tobacco Free (IOM, 1994). The report called for a comprehensive youth-oriented tobacco control strategy. The strategy included Congress establishing a regulatory program for tobacco products within an appropriate agency of the Public Health Service. In 1995 the commissioner of the Food and Drug Administration (FDA), Dr. David Kessler, famously declared smoking a “pediatric disease” because “nicotine addiction begins when most tobacco users are teen-agers” (Hilts, 1995). In 1996 FDA issued a final rule prohibiting the sale of cigarettes and smokeless tobacco to any person under age 18 and imposing restrictions on the marketing, labeling, and advertising of tobacco products (HHS, 1996). While this 1996 rule was invalidated in 2000 by a Supreme Court decision ruling that FDA did not have the authority to regulate tobacco products,3 it was specifically incorporated in the Family Smoking Prevention and Tobacco Control Act of 20094 (hereafter referred to as the Tobacco Control Act).
The Master Settlement Agreement of 1998 (MSA) resulted from settlements between the attorneys general of 46 states and the 4 largest tobacco manufacturers (NAAG, 1998). The MSA required the companies to make annual payments to the states as compensation for some of the medical costs of caring for people with smoking-related diseases; to curtail or end certain tobacco marketing practices; and to dissolve tobacco industry organizations. The MSA also called for the establishment of a national foundation, which led to the creation of the American Legacy Foundation, a nonprofit tobacco control research and education organization known for its early and aggressive media campaigns about the dangers of tobacco use.
The child-focused strategy, although not universally embraced (Craig and Boris, 2007; Glantz, 1996), galvanized attention and resources, and significant successes followed. For example, the proportion of students in grades 9 through 12 who had used tobacco products in the past 30 days (including cigarettes, smokeless tobacco products, and cigars) decreased 46.1 percent between 1997 and 2011, from 43.4 percent to 23.4 percent (CDC, 2012b). This remarkable progress sprung from a number of well-established policy levers: increased state and federal excise taxes, compre-
3FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 120 S. Ct. 1291, 146 L. Ed. 2d 121 (2000).
4 Family Smoking Prevention and Tobacco Control Act of 2009, Public Law 111-31, 111th Cong. (June 22, 2009).
hensive state tobacco control programs, smoke-free policies that help to denormalize smoking behavior and to decrease secondhand smoke exposure, national and local media campaigns to alert children and adolescents to the dangers of tobacco use and to de-glamorize the behavior, promotion of cessation strategies, school-based programs, and surveillance and evaluation.
Today, most tobacco control programs are administered at the state and local levels. States fund their tobacco control programs through a variety of revenue streams, including state general funds, federal government funding, tobacco industry settlement payments, cigarette excise taxes, and funding from nonprofit organizations. The Office on Smoking and Health at the Centers for Disease Control and Prevention (CDC) compiles and publishes an evidence-based guide to help states plan and establish effective tobacco control programs (CDC, 2014). CDC recommends that state programs be funded at $10.53 per person in the state population. While most states spend significantly less than that (CDC, 2012a), funding for state tobacco control programs has nonetheless been shown to be associated with decreases in adolescent and young adult smoking (Farrelly et al., 2013, 2014).
The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act to grant FDA broad authority over tobacco products administered by a newly created Center for Tobacco Products (CTP) funded with user fees paid by the tobacco industry. The Tobacco Control Act directed FDA to, among other things, issue regulations to restrict cigarette and smokeless tobacco retail sales to youth and restrict tobacco product advertising and marketing to youth. (See Box 1-1 for a summary of the major components of the Tobacco Control Act.) On the other hand, the act specifically prohibits FDA from taking certain actions, including reducing nicotine levels in tobacco products to zero, requiring a prescription to purchase tobacco products, banning the face-to-face sale of tobacco products in any one specific category retail environment, banning specific classes of tobacco products, and establishing a minimum age of sale of tobacco products higher than 18 years of age.5 The Tobacco Control Act did, however, direct FDA to convene a panel of experts to conduct a study on “the public health implications of raising the minimum age to purchase tobacco products” and to submit a report to Congress on the issue.
5 Family Smoking Prevention and Tobacco Control Act of 2009, Public Law 111-31 § 906, 111th Cong. (June 22, 2009).
Key Components of the Family Smoking Prevention and Tobacco Control Act of 2009
What the Tobacco Control Act does
Restricts cigarettes and smokeless tobacco retail sales to youth by directing FDA to issue regulations which, among other things:
- Require proof of age to purchase these tobacco products—the federal minimum age to purchase is 18—Sec. 102
- Require face-to-face sales, with certain exemptions for vending machines and self-service displays in adult-only facilities—Sec. 102
- Ban the sale of packages of fewer than 20 cigarettes—Sec. 102
Restricts tobacco product advertising and marketing to youth by directing FDA to issue regulations which, among other things:
- Limit color and design of packaging and advertisements, including audiovisual advertisements—Sec. 102 (However, implementation of this provision is uncertain due to pending litigation. See Discount Tobacco City & Lottery v. USA, formerly Commonwealth Brands v. FDA.)
- Ban tobacco product sponsorship of sporting or entertainment events under the brand name of cigarettes or smokeless tobacco—Sec.102
- Ban free samples of cigarettes and brand-name non-tobacco promotional items—Sec. 102
Note: Among its many provisions, the Tobacco Control Act required FDA to reissue its 1996 final regulations aimed at restricting the sale and distribution of cigarette and smokeless tobacco products—Sec. 102
The Tobacco Control Act specifically
Requires bigger, more prominent warning labels for cigarettes and smokeless tobacco products:
However, the implementation date of more prominent warning labels for cigarettes is uncertain, due to ongoing proceedings in the case of R. J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, No. 11-1482 (D.D.C.), on appeal, No. 11-5332 (D.C.Cir.).
Gives FDA authority over, among other things:
- Registration and inspection of tobacco companies—Sec. 905 of the FDCA
- Standards for tobacco products—Sec. 907 of the FDCA
- “Premarket Review” of new tobacco products—Sec. 910 and 905 of the FDCA
- “Modified risk” products—Sec. 911 of the FDCA
- Enforcement action plan for advertising and promotion restrictions—Sec. 105
The Tobacco Control Act also requires
- Tobacco industry must disclose research on the health, toxicological, behavioral, or physiologic effects of tobacco use—Sec. 904 of the FDCA
- Tobacco industry must disclose information on ingredients and constituents in tobacco products, and must notify FDA of any changes—Sec. 904 of the FDCA
How FDA oversees the implementation of the Tobacco Control Act
Among other things, FDA:
- Established the Center for Tobacco Products to implement the Tobacco Control Act—Sec. 901 of the FDCA
- Established the Tobacco Products Scientific Advisory Committee to provide advice, information, and recommendations to FDA—Sec. 917 of the FDCA
- Assesses user fees on tobacco product manufacturers and importers based on their market share. The fees are used to fund FDA activities related to the regulation of tobacco products—Sec. 919 of the FDCA
- Reports to Congress on how best to encourage companies to develop innovative products that help people stop smoking—Sec. 918 of the FDCA • Issues regulations and conducts inspections to investigate illicit trade in tobacco products—Sec. 920 of the FDCA
- Convenes a panel of experts to study the public health implications of raising the minimum age to purchase tobacco products—Sec. 104
Limits on FDA’s authority:
- Ban certain specified classes of tobacco products—Sec. 907 of the FDCA
- Require the reduction of nicotine yields to zero—Sec. 907 of the FDCA
- Require prescriptions to purchase tobacco products—Sec. 906 of the FDCA
- Ban face-to-face tobacco sales in any particular category of retail outlet—Sec. 906 of the FDCA
The Tobacco Control Act preserves the authority of state, local, and tribal governments to regulate tobacco products in certain specific respects. It also prohibits, with certain exceptions, state and local requirements that are different from, or in addition to, requirements under the provisions of the FDCA relating to specified areas.
SOURCE: FDA, 2014.
In August 2013 FDA contracted with the IOM to convene a committee to:
- Examine existing literature on tobacco use initiation, and
- Use modeling and other methods, as appropriate, to predict the likely public health outcomes of raising the minimum age for purchase of tobacco products to 21 years and 25 years.
The resulting Committee on the Public Health Implications of Raising the Minimum Age for Purchasing Tobacco Products comprises experts in public health law, epidemiology of tobacco use and tobacco risks, adolescent and young adult development, risk behaviors and perceptions, public health policy and practice, and public policy modeling. (See Appendix F for the biographical sketches of committee members.) The committee met five times, including holding a public workshop. (See Appendix E for the agendas of public meetings.)
At its first meeting, a representative of CTP discussed the charge with the committee. During that discussion, CTP urged the committee to include in its analysis the impact of raising the minimum age to 19, 21, and 25 years of age and the committee has done so. CTP also encouraged the committee to conceive broadly the definition of “public health impact.” As described in future chapters, the committee assessed the effects of possible policy changes on tobacco initiation, prevalence, morbidity, and mortality. However, because the charge is limited to public health implications, the committee did not analyze the overall economic impact of raising the minimum age.
Because the Tobacco Control Act refers to both minimum age for purchase6 and minimum age for sale,7 there is some ambiguity regarding the scope of the legal restriction the committee has been instructed to assess. The committee interpreted its charge to focus on the minimum age of legal access to tobacco products (MLA) in the context of the body of youth access laws and enforcement policies currently in place across the country. As will be discussed at length in this report, these laws and policies vary considerably, not only in the scope of the conduct that is prohibited but also in the prescribed penalties for violations. What all of the laws and policies have in common, however, is a focus on curtailing retail access to tobacco products by underage persons, with little, if any, emphasis on punishing
6 Id. § 104.
7 Id. § 906.
the underage users of tobacco products themselves. As requested by CTP, the committee has made no recommendations on whether the MLA should be raised. The report is limited to findings and conclusions bearing on the public health implications of raising the MLA as well as a review of relevant policy considerations.
As the reader will see, there exists an abundance of relevant data on adolescent tobacco use, risks of tobacco use, effects of youth access restrictions and their enforcement, and adolescent and young adult brain and psychosocial development. However, there are many important unknowns, including a rapidly changing landscape of tobacco products. The recent increase in the use of electronic nicotine delivery systems and hookahs by adolescents and young adults could have a substantial effect on the use of cigarettes and other combustible tobacco products, but it is too early to make informed predictions about these effects.
Additionally, there is no direct empirical evidence on the effects on adolescent and young adult tobacco use of raising the MLA above 18 years of age. Four states have an MLA of 19 years, but the effect of setting the age at 19 has not been studied. Several small jurisdictions in Massachusetts have raised the MLA above 18 years, but, again, the effect of doing so has not been evaluated. New York City raised the MLA to 21 years as of May 2014, but insufficient time has passed to study its effect. In the absence of pertinent studies of the effect of raising the MLA for tobacco, the committee drew on the relevant bodies of literature on adolescent and young adult development, the epidemiology of tobacco use, enforcement of youth access restrictions, studies of the effect of raising the minimum legal drinking age for alcohol, and the effects of other tobacco control policies to estimate the likely effects of raising the MLA for tobacco on initiation of tobacco use and the health consequences of that level of tobacco use.
The charge to the committee specifically includes the use of modeling. Simulation modeling is the primary tool used to assess the potential outcomes, benefits, and costs of public health and policy interventions (Feuer et al., 2004; Habbema et al., 2006; NRC, 1994; Thompson and Graham, 1996). Models complement traditional statistical and epidemiological approaches, and they translate and synthesize available evidence into an integrated framework to assist with decision making. Notable examples of the application of simulation models in non-tobacco public health policy include pandemic preparedness (Halloran et al., 2008), the design of optimal vaccination strategies (Elbasha et al., 2009; Kim and Goldie, 2008; Kim et al., 2009; Thompson, 2013; Thompson et al., 2015; Van de Velde et al., 2012), cocaine use simulations (Caulkins et al., 2007; Rydell and
Everingham, 1994), and the assessment of effective cancer screening strategies (de Koning et al., 2014; Knudsen et al., 2007; Mandelblatt et al., 2009; Zauber et al., 2008). Some guidelines exist to support the development of policy models in some domains, and generally they suggest that comparing and contrasting the predictions from different models can enhance the validity of the conclusions and allow for the exploration of a wider range of assumptions and of potential policy and health outcomes (Caro et al., 2012; Eddy et al., 2012; Habbema et al., 2006; Mandelblatt et al., 2009; Weinstein et al., 2003; WHO, 2008; Zauber et al., 2008).
To date, tobacco control simulation models have focused primarily on cigarette smoking and have provided estimates of the impact of current policies (program evaluation), forecasts of their future effects (status quo projections), and assessments of the possible effects of new policies (Ahmad, 2005a,b; HHS, 2014; Holford et al., 2014; Levy et al., 2005, 2010, 2012; Mendez and Warner, 2000; Mendez et al., 2013; NCI, 2007; Warner and Mendez, 2012). Reports from the U.S. government have highlighted the important insights of these models (HHS, 2014; NCI, 2007).
For this report, the committee commissioned the use of two established cigarette smoking macro-simulation models to complement its conclusions about the effects of a change in the MLA on tobacco initiation by providing quantitative estimates of how the likely effects on initiation would affect future smoking prevalence and select measures of smoking-related morbidity and mortality. The models are the Cancer Intervention and Surveillance Modeling Network (CISNET)8 smoking population model and the SimSmoke model. Both models simulate annual age-specific smoking prevalence and smoking-attributable mortality. In addition, CISNET models the variation in smoking patterns by birth cohort and can account for the effects of smoking intensity. SimSmoke models the effects of important tobacco control policies and supports the simulation of maternal and child health outcomes. While increasing the MLA is currently the purview of states and localities, the models project the effects of a policy change on the United States as a whole and cannot take into consideration important differences across the country that could influence the magnitude of the effect of raising the MLA in states or localities.
8 CISNET is a consortium of National Cancer Institute–sponsored investigators who use statistical modeling to improve the understanding of cancer control interventions in prevention, screening, and treatment and also their effects on population trends in incidence and mortality. As noted, for simplicity, the committee uses CISNET to refer both to the consortium as well as to the CISNET smoking population model used in this report.
The next five chapters provide foundational material on tobacco use patterns (Chapter 2), brain and psychosocial development in adolescents and young adults (Chapter 3), health effects of tobacco use (Chapter 4), the current legal landscape regarding minimum age laws and the enforcement of youth access restrictions (Chapter 5), and the effectiveness of youth access restrictions (Chapter 6). The committee’s conclusions regarding the likely impact of raising the MLA on initiation and prevalence of tobacco use are set forth in Chapter 7 and the conclusions on the likely impact of raising the MLA on morbidity and mortality are found in Chapter 8. The report concludes with a discussion of the considerations for policy makers. The details of the models used can be found in Appendix D, along with comprehensive results.
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