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Report to Congress on th e Study on Raising the Minimum Age to Purchase Tobacco Products Department of Health and Human Services Food and Drug Administration Date St ephen M. Ostroff, M.D. Ac ting Commissioner of Food and Drugs Executive Summary The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize the Food and Drug Administration (FDA or the Agency) to regulate the manufacture, marketing, distribution, and sale of regulated tobacco products and protect the public from the harmful effects of tobacco product use. The Tobacco Control Act was enacted in 2009 and required the Agency to establish the Center for Tobacco Products (CTP or the Center) to implement the new law. The Tobacco Control Act gave FDA immediate authority to regulate cigarettes, cigarette tobacco, roll-your- own tobacco, and smokeless tobacco as well as the authority to regulate additional tobacco products by issuing a regulation. The Tobacco Control Act also obligated FDA to convene an expert panel to study the public health implications of raising the minimum age to purchase tobacco products. The Agency contracted with the Institute of Medicine (IOM) in 2013 t o convene a committee to examine existing literature on tobacco use initiation and to use modelin g and other methods as appropriate, to predict the likely public health outcomes of raising t he minimum age to purchase tobacco products to 21 years and 25 year s. The Committee w as empanelled on February 4, and April 10, 2014, with 13 experts in public health la w, epidemiology relating to tobacco use and risks, adolescent and young adult development, ri sk behaviors and perceptions, public health policy and practice, and public policy modelin g. I OM released a report to FDA and the public in March 201 5. This report provides a summary a nd discussion of the results of that expert panel, pursuant to the requirement s of Section 104(1) and (2) of the Tobacco Control Act. Table of Contents Background 4 Public Health Significance 4 Institute of Medicine Study Process 6 Summary of IOM's Findings 7 Conclusion 9 Background The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to regulate the manufacture, marketing, distribution, and sale of regulated tobacco products and protect the public from the harmful effects of tobacco product use. The Tobacco Control Act was enacted by Congress in 2009 and required FDA to establish the Center for Tobacco Products (CTP or the Center) to implement the new law. The law required FDA to regulate tobacco within a different context than the one used to regulate other products in FDA, such as pharmaceuticals and medical devices, because tobacco is inherently harmful when used as intended. This new context is one that takes into consideration the impact of tobacco products on the health of the public as a whole, including users and nonusers, which has been referred to as the "public health standard." In addition, the law required FDA to re-issue, with certain exceptions, the "1996 Rule" (21 CFR Part 1140), which includes, among other important provisions, a minimum age of 18 years old to purchase cigarettes and smokeless tobacco products. Other areas of the law outline FDA’s authority to regulate new products as well as those products currently on the market. The Tobacco Control Act also requires FDA to report to Congress on various aspects of its work at specific intervals. This report addresses the requirement in Section 104(1) and (2) of the Tobacco Control Act. Section 104 (1) and (2) states: The Secretary of Health and Human Services shall (1) convene an expert panel to conduct a study on the public health implications of raising the minimum age to purchase tobacco products; and (2) not later than 5 years after the date of enactment of this Act, submit a repor t to the Congress on the results of such study. 1 In response to the this requirement, the Agency contracted with the Institute of Medicine (IOM) to convene an expert panel to study the public health implications of raising the minimum age to purchase tobacco products. This report is a summary and discussion of th e IOM study, which IOM published on March 12, 2015, and is available at http://www.iom.edu/Reports/2015 /TobaccoMinimumAgeReport.aspx. Public Health Significance There is more than 50 years of research demonstrating that tobacco products are dangerous and that use of these products causes serious health issues such as cancer, heart disease, lung diseases, premature births and other conditions. Cigarettes alone kill more than 480,000 Americans every year.2 The use of these products is especially dangerous for children due to th e impact of nicotine and smoke exposure on their growth and development as well as the risk that Family Smoking Prevention and Tobacco Control Act, Section 104(1) and (2). The Health Consequences of S moking - 50 Years of Progress: A Report of the Surgeon General 2014 many may become long-terms users due to the addictiveness of the products. Research has found that virtually all new users of tobacco products are under the age of 3 0. Youth general ly start buying tobacco products as they become more regular user s. Fifty-four percent of smoke rs, who ever had smoked daily, started smoking daily before age 18, 85 percent before age 21, and 97 percent before age 26 . 3 Thus restricting access during this critical transition period has the potential to reduce the prevalence of daily use.4 Congress has acknowledged that the lack of legal and regulatory authority by the federal government and states prior to enactment of the Tobacco Control Act contributed to the adverse public health and societal issues created by tobacco use. This was especially evident in the increased use of traditional (cigarettes) and novel (electronic cigarettes, hookah, etc.) tobacc o products by young people. In recent years, a greater proportion of first cigarette use is occurring among young adults. 5, 6. In addition, older adolescence and young adulthood is often the time of transition to daily us e. Because of this continued initiation in young adulthood, the prevalence of tobacco use is hig hest among young adults (compared to adolescents and older adults). The 2014 Report of the Surgeon General on the Health Consequences of Smoking, predicted that, at the current rate of smoking, 5.6 million Americans currently under the age of 18 will die p rematurely from a smoking-related illness. T he report also acknowledged that since the first S urgeon General' s Report on tobacco in 19 64, more than 20 million Americans have died from sm oking-related illnesses .7 Wh ile smoking rates have declined,8 estimates of premature deaths a ssociated with smoking have increased because of additional diseases found to be causally related to smoking. Smoking-related illnesses affect not only people who smoke, but also those exposed to second-hand smoke.9 In addition to the issue of tobacco smoke exposure, young people are at an additional risk due to nicotine exposure. The literature demonstrates that exposure to nicotine has an adverse effect on the brain during adolescence, a critical time of development. This has lifelong implications. 10 3 Institute of Medicine. (2014). Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products. Retrieved on March 25, 20 15 from http://www.iom.edu/Reports/20 15/TobaccoMinimumAgeReport.aspx 4 DiFranza JR, Savageau JA, Fletcher KE. Enforcement of underage sales laws as a predictor of daily smoking among adolescents -a national study. BMC Public Health. 2009; 9:107. 5 Substance Abuse and Mental Health Services Administration (SAMHSA). Re sults from the 2004 National Survey on Drug Use an d Health : Detailed Tables. Rockville, MD: U. S. De partment of Health and Hu man Services, Substance Ab use and Mental He alth Services Ad ministration. Office of A pplied Studies; 2005. http://media.samhsa.gov/data/NSDUH/2k4nsduh/2k4tabs/Sect4seTabs 1 to50.h tm #tab4.25d. Accessed January 5, 2016. 6 Substance Abuse and Mental Health Services Adminis tration (SAMHSA). Results from the 2014 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: U.S. Depa rtment of Health and Human Services, Substance Abuse and Mental Healt h Services Administration, Center for Behavioral Health Statistics and Quality; 2015. http://www.sa mhsa. gov/data/sitesldefaul t/tiles/ SDUH-DetTabs20 14/NSDUH-DetTabs20 14.pdf. Accessed January 5, 2016. 7 The Health Consequences of Smoking- 50 Years of Progress: A Report of the Surgeon General 20 14 8 Ibid. 9 Ibid. 10 Ibid. The Tobacco Control Act provides FDA with broad authority to regulate the manufacture, sale, and distribution of regulated tobacco products. However, the law also includes some limitations on the agency' s authority. This includes provisions prohibiting FDA from banning face-to-face sales of any tobacco product by a specific category of retail outlets, as well as those that preven t FDA from raising the minimum age of sale of tobacco products above 18 years of age. 11 Institute of Medicine Study Process In August 2013, the Agency contracted with the Institute of Medicine (IOM) to convene a committee to: 1. examine existing literature on tobacco use initiation; and 2. 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. IOM is a part of the National Academies, which includes the National Academies of Sciences, the National Academy of Engineering, and the National Research Council . These group s comprise a 140 year old institution that has provided objective and scientific opinions and advic e to the nation in various capacities . The members of the National Academies organizations a re professionals in various scientific fields, who are called upon to provide their expertise to objectively answer rigorous scientific question s. The primary financial sponsors of the Natio nal Academies research are fede ral agencies, states, and foundatio ns. The National Academies h ave processes in place to ensure that financial sponsors of a National Academies study hav e no influence on the study process and the results. When studies are commissioned by agencies, IOM employs the National Academies' four-stage study process, which includes: Defining the Study, Committee Selection Approval, Committee W ork (public meetings, information gathering, deliberations, and drafting the report), and Report R eview. T his is a standard format for all studies conducted by any organization within the N ational Academies. The IOM Committee on the Public Health Implications of Raising the Minimum Age for Purchasing Tobacco Products was assembled to address these tasks and was comprised of experts in public health Jaw, epidemiology relating to tobacco use and risks, adolescent and young adult development, risk behaviors and perceptions, public health policy and practice, and public policy modeling. For approximately a year and a half, this group examined the tasks above within the context of the body of literature that includes current youth access laws an d enforcement policies in states and localities. Summary of IOM's Findings The review and evaluation by IOM yielded seven conclusions, which were provided in the Summary of the Report. It did not issue any recommendations to the Agency. 11 FD&C Act, Section 906(d)(3)(ii). Conclusion 1: Increasing the minimum age of legal access to tobacco products will likely prevent or delay initiation of tobacco use by adolescents and young adults. 12 The Committee based this conclusion on the scientific evidence regarding the increased vulnerability to nicotine addiction by adolescent and young adults that use tobacco products due to the immature biology of the brain during this stage of life. As a person ages and the brain matures, there is a diminishing effect of the addictive properties of nicotine; therefore, a perso n that is older at the time ofinitiation13 is less likely to become addicted after initiation. Conclusion 2: Although changes in the minimum age of legal access to tobacco products will directly pertain to individuals who are age I 8 or older, the largest proportionate reduction in the initiation of tobacco use will likely occur among adolescents of ages 15 to 17 years. 14 Conclusion 3: The impact of raising the minimum age of legal access to tobacco products to 2 1 on the initiation of tobacco use will likely be substantially higher than raising it to 19, but t he added effect of raising the minimum age beyond 21 to age 25 will likely be considera bly smaller. 15 The premise for the Committee's Conclusions 2 and 3 is their finding that access to tobacco p roducts is primarily based on social networks. A dolescents are less likely to have peers and a ssociates over the age of 21. 16 A further restriction to age 25 would increase the impact more as they are even less likely to have adults aged 25 in their social networks. 17 Using these social constructs, the Committee concluded that the higher the minimum legal age, the greatest effect would be on initiation rates for adolescents aged 15 to 17 years. However, significant reductions in use would also be seen among younger adolescents and among young adults aged 18-21. Conclusion 4: Based on the modeling, raising the minimum age of legal access to tobacco products, particularly to ages 21 and 25, will likely lead to substantial reductions in smoking prevalence. 18 12 Institute of Medicine. (2014). Public Health Implications of Raising the Minimum Age of Legal Access to T obacco Products. Retrieved on March 25, 2015 from http: //www. iom.edu/Reports/20 15/TobaccoMinimumAgeReport.aspx 13 Initiation is defined as having smoked 100 cigarettes. This definition is taken from the National Health Interview Su rvey (NHIS). 14 Institute of Medicine. (2014). Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products. Retrieved on March 25, 2015 from http://www. iom.edu/Reports/2015/TobaccoMinimumAgeReport.aspx 15 Ibid. 16 Ibid. 17 Ibid. 18 Ibid. The Committee used two tobacco simulation models to illustrate Conclusion 4: SimSmoke and the Cancer Intervention and Surveillance Modeling Network (CISNET) smoking population model. Although the models have different assumptions; the results are similar and show the same trajectory. W ith the current federal minimum legal age of 18, both models predict a red uction in smoking prevalence between 20 15 and 21 00 in the United States. The models fur ther predict that raising the minimum legal age to 19 y ears, 21 year s, or 25 years will reduce prev alence still further due to greater reductions in initiation. Both models estimate that raising the minimum legal age will lead to greater decreases in smoking prevalence above and beyond the current expected continued decreases in prevalence as follows 19: Minimum Legal Age of Access Expected Additional Decrease in Smoking Prevalence 19 years 3% 2 1 years 12% 25 years 16% Conclusion 5: Based on the modeling, raising the minimum age of legal access to tobacco products will likely lead to substantial reductions in smoking-related mortality. 20 The modeling analysis by the Committee suggests that raising the minimum legal age could lead to remarkable reductions in smoking-attributed death and disability over time, and that these impacts would be more immediate for younger generations (those born 2000-20 19), as they w ould be impacted by the change in minimum legal age most immediately. Th e models took in to consideration the total number of years of life lost (YLL) as well as the number of deaths av erted by birth cohorts. Th e CISNET Yale Lung Cancer Model was used in concert with the CI SNET smoking population model to further illustrate the number of lung cancer deaths that wo uld be averted at each minimum legal age interval. 21 Th e total number of deaths saved would b e greater with a higher minimum age, but that incremental increase is greater going from age 18 t o age 21. F or example, the cumulative number of deaths prevented (from the more conservative model) when the minimum age is increased from 18 to 21 is 250,000; increasing from 21 -25 adds another 80,000 additional deaths prevented. Conclusion 6: Based on a review of the literature, raising the minimum age of legal access t o tobacco products will likely immediately improve the health of adolescents and young adults by reducing the number of those with smoking-caused diminished health stat us. As the initial bi rth cohorts affected by the policy change age into adultho od, the benefits of the reductions o f the intermediate and long-term adverse health effects will also begin to mani fest. Raisin g the minimum age of legal access to tobacco products will also likely reduce exposure to secondhand 19 Ibid. 20 Ibid. 21 Ibid. smoke and the prevalence of other tobacco products, further reducing their associated adverse health effects, both immediately and over time. 22 Conclusion 7: Based on a review of the literature and on the modeling, an increase in the minimum age of legal access to tobacco products will likely improve maternal, fetal, and infan t outcomes by reducing the likelihood of maternal and paternal smoking. 23 In Conclusions 6 and 7, the Committee noted that as this generation matures into adulthood, the likelihood that they will begin smoking will be reduced if the minimum legal age of access is increased. This reduction in smoking initiation will lead to improved health outcomes over time. A generation of fewer smokers, who will become parents, naturally leads to improved health outcomes for pregnant women, infants, and children, particularly those who would be at risk for cigarette smoke exposure directly or via secondhand delivery.24 The SimSmoke model was used to predict the effects of raising the minimum legal age on the incidence of pre-term births, lo w birth-weight, and SIDS . These data demonstrate that with an increase of the minimum legal ag e, immediate reductions in pre-term births, low birth-weight, and SIDS would be realized. An increase in the minimum legal age will likely prevent or delay initiation by youth and young adults, which would lead to a reduction in the prevalence of tobacco use in general. A reduction in the prevalence of tobacco use contributes to immediate population health benefits, especiall y for those that would have used tobacco or would have been exposed to the smoke . Those tha t would benefit most from a change in the minimum legal age are those adolescents who woul d have initiated smoking well before 18 years of age. 25 Some of the known adverse health effe cts due to cigarette smoking include nicotine addiction, respiratory and cardiac problems, as well as multiple forms of can cer. Delayed initiation of tobacco use would delay the onset of any immediate health effects until later in life, which would allow individuals to be healthier during their most active and productive years o f life. This would reduce lost productivity in the workforce due to smoking-related illnesses as well as contribute to a reduction in heal th care costs for smoking-related illnesses. Conclusion Adolescents are particularly vulnerable to the adverse health effects of tobacco use, including nicotine exposure, which often leads to nicotine addiction and long-term use of tobacco products . This has life-long implications, including development of preventable and chronic smoki ng related illnesses, which cause suffering and reduced productivity due to illness and prematu re death. In lieu of federal action, states and localities have begun to explore and enact changes in their laws regarding the minimum legal age to purchase tobacco products. Since the passage of the Tobacco Control Act, ten states have either raised the minimum legal age of purchase for 22 Ibid. 23 Ibid. 24 Ibid. 25 Ibid. tobacco entirely or have local laws that raise the age to either 19 or 21. The findings of this IOM r eport will be useful to federal, state, and local policy makers that have the authority to raise the mi nimum legal age of purchase of tobacco products to reduce tobacco use initiation by A merica's youth. APPENDIX A COMMITTEE ON THE PUBLIC HEALTH IMPLICATIONS OF RAISING THE MINIMUM AGE FOR PURCHASING TOBACCO PRODUCTS RICHARD J. BONNIE (Chair), Harrison Foundation Professor of Medicine and Law, Professor of P sychiatry and Neurobehavioral Sciences, Director of the Institute of Law, Psychiatry, and Public P olicy, University of Virginia ANTHONY J. ALBERG, Blatt Ness Distinguished Endowed Chair in Oncology, Professor, Public Health Sciences, Interim Director of Hollings Cancer Center, Medical University of South Carolina REGINA BENJAMIN, NOLA.com/ Times Picayune Endowed Chair in Public Health Sciences, Xavier Un iversity, New Orleans JONATHAN CAULKINS, Professor, Operations Research and Public Health Policy, Heinz College of Public Policy and Management , Operations Research Department, Carnegie Mellon University BONNIE HALPERN-FELSHER, Professor, Department of Pediatrics, Director of Research, Associate Director of Adolescent Medicine Fellowship Program, Division of Adolescent Medicine, Stanford University SWANNIE JETT, Executive Director, Florida Department of Health in Seminole County HARLAN JUSTER, Director, Bureau of Tobacco Control, New York State Department of Health JONATHAN D. KLEIN, Associate Executive Director, Julius B. Richmond Center of Excellence for C hildren and Secondhand Smoke, American Academy of Pediatrics PAULA M. LANTZ, Professor and Chair, Department of Health Policy and Management, Milken I nstitute School of Public Health, The George Washington University ROBIN MERMELSTEIN, Director of the Institute for Health Research and Policy, Professor of Psychology, Clinical Professor of Community Health Sciences, School of Public Health, Institute f or Health Research and Policy, University of Illinois, Chicago RAFAEL MEZA, Assistant Professor, Department of Epidemiology, University of Michigan PATRICK O'MALLEY, Research Professor, Institute for Social Research, University of Michigan KIMBERLY THOMPSON, Professor of Preventive Medicine and Global Health, University of Central Fl orida College of Medicine, President, Kid Risk, Inc.