The Case and Context for “The Real Cost” Campaign

Discussion of how the creation of the Center for Tobacco Products at the U.S. Food and Drug Administration, youth trends in cigarette smoking, and effectiveness of mass media interventions served as the foundation for the development of “The Real Cost” youth smoking prevention media campaign. The success of the campaign demonstrates that a comprehensive regulatory approach that includes public education can reduce the public health burden of tobacco use.Supplement informationThis article is part of a supplement entitled Fifth Anniversary Retrospective of “The Real Cost,” the Food and Drug Administration's Historic Youth Smoking Prevention Media Campaign, which is sponsored by the U.S. Food and Drug Administration. Discussion of how the creation of the Center for Tobacco Products at the U.S. Food and Drug Administration, youth trends in cigarette smoking, and effectiveness of mass media interventions served as the foundation for the development of “The Real Cost” youth smoking prevention media campaign. The success of the campaign demonstrates that a comprehensive regulatory approach that includes public education can reduce the public health burden of tobacco use. This article is part of a supplement entitled Fifth Anniversary Retrospective of “The Real Cost,” the Food and Drug Administration's Historic Youth Smoking Prevention Media Campaign, which is sponsored by the U.S. Food and Drug Administration. The passage of the Family Smoking Prevention and Tobacco Control Act1Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31 (2009).Google Scholar in 2009 ushered in a new era for tobacco control. Significant progress was made in reducing the devastating consequences of tobacco use through state and local tobacco control policies, national and state-level public education campaigns, and changing social norms.2HHSThe Health Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon General. HHS, CDC, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA2014Google Scholar However, the creation of the Center for Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA) offered an unprecedented opportunity to reduce the death and disease caused by products that are highly addictive and part of the social fabric for many Americans. CTP's mission is “to protect Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others.” A key phrase within this statement, and found throughout the Tobacco Control Act, is “especially young people.” Tobacco cessation is notoriously difficult,2HHSThe Health Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon General. HHS, CDC, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA2014Google Scholar so preventing smoking initiation and the nicotine addiction that often follows is an intervention with large long-term benefits for public health. While components of the new Center focused on developing scientific, regulatory, compliance, enforcement, and management strategies and infrastructure to support the implementation of the Tobacco Control Act, the Center's leadership and its Office of Health Communication and Education considered the role of public education vital to fulfilling the Center's mission to reduce the enormous public health burden of tobacco use. CTP's investment in campaigns directly supports the Center's regulatory actions and overall mission. In addition, campaigns are necessary to ensure FDA regulation does not lead consumers to mistakenly believe that tobacco products are safe.3Zeller M Hatsukami D The Strategic Dialogue on Tobacco Harm Reduction: a vision and blueprint for action in the U.S.Tob Control. 2009; 18: 324-332https://doi.org/10.1136/tc.2008.027318Crossref PubMed Scopus (172) Google Scholar Public education campaigns that entail informing consumers about the risks of tobacco products contribute to carrying out these authorities by further disseminating health risk information and by helping ensure tobacco users and nonusers have a better understanding of the health risks. The Center's sustainable, multi-year investments in youth tobacco prevention media campaigns mark a historic first for the federal government, and CTP's efforts are intended to dramatically increase the number of youth who do not start using tobacco products, which will result in lasting public health benefits. Although the total investment is significant, it is expected that campaign costs will be recovered over time as the public's health improves, thereby saving society billions in medical costs4MacMonegle AJ Nonnemaker J Duke JC et al.Cost-effectiveness analysis of The Real Cost campaign's effect on smoking prevention.Am J Prev Med. 2018; 55: 319-325Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar as new generations of youth and young adults decide to never use tobacco and more adults resolve to quit. An examination of young people and smoking finds that the pediatric epidemic of tobacco use has been well established.5HHSPreventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General. HHS, CDC, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA2012Google Scholar Cigarette smoking is almost always initiated and established during adolescence, often well before the legal age to purchase cigarettes. About 2,000 youth under age 18 years smoke their first cigarette every day in the U.S., and more than 300 kids become daily smokers.6U.S. Substance Abuse and Mental Health Services Administration. 2017 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: SAMHSA; 2018. https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.pdf. Accessed January 3, 2019.Google Scholar Further, close to 90% of established adult smokers smoked their first cigarette by age 18 years.2HHSThe Health Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon General. HHS, CDC, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA2014Google Scholar Beyond the increased risk of lifelong nicotine addiction, the 2012 Surgeon General's report on youth and young adult tobacco use details other serious health consequences of smoking as a young person, including reduced lung function, reduced lung growth, early abdominal aortic atherosclerosis, coronary artery atherosclerosis, DNA damage that can lead to cancer, and wheezing severe enough to be diagnosed as asthma.5HHSPreventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General. HHS, CDC, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA2012Google Scholar Preventing youth cigarette smoking requires an in-depth understanding of the unique risk factors facing young people. A review of the literature by FDA's campaign research and evaluation contractor, RTI International, found that young people are at a critical juncture as they move from the adolescent stage of their lives to becoming young adults and may change existing behaviors and develop new lifelong behaviors during this time.7Emmons KM Wechsler H Dowdall G Abraham M Predictors of smoking among U.S. college students.Am J Public Health. 1998; 88: 104-107https://doi.org/10.2105/AJPH.88.1.104Crossref PubMed Scopus (146) Google Scholar, 8Wechsler H Rigotti NA Gledhill-Hoyt J Lee H Increased levels of cigarette use among college students: a cause for national concern.JAMA. 1998; 280: 1673-1678https://doi.org/10.1001/jama.280.19.1673Crossref PubMed Scopus (342) Google Scholar If these new behaviors are negative—such as experimenting with cigarettes—they may influence the long-term ability to reduce preventable diseases and premature death—resulting in a lost opportunity to establish positive health behaviors consistent with a healthy lifestyle. The human brain also continues developing well into late adolescence or early adulthood, making young people more susceptible to social and environmental influences to use tobacco than older adults.5HHSPreventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General. HHS, CDC, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA2012Google Scholar Adolescent brains also may be more sensitive to the reinforcing effects of nicotine in combination with other chemicals found in tobacco products, which may increase youth susceptibility to nicotine addiction.9National Institute on Drug Abuse. Tobacco, nicotine, and e-cigarettes. www.drugabuse.gov/publications/research-reports/tobacco-nicotine-e-cigarettes. Updated January 2018. Accessed February 22, 2018.Google Scholar In fact, studies of adolescent smokers show that symptoms of addiction, such as withdrawal, craving for tobacco, and failed attempts at quitting, can appear within the first weeks of tobacco use,10Ursprung WW DiFranza JR The loss of autonomy over smoking in relation to lifetime cigarette consumption.Addict Behav. 2010; 35: 14-18https://doi.org/10.1016/j.addbeh.2009.08.001Crossref PubMed Scopus (35) Google Scholar, 11DiFranza JR Hooked from the first cigarette.Sci Am. 2008; 298: 82-87https://doi.org/10.1038/scientificamerican0508-82Crossref PubMed Scopus (44) Google Scholar, 12Doubeni CA Reed G DiFranza JR Early course of nicotine dependence in adolescent smokers.Pediatrics. 2010; 125: 1127-1133https://doi.org/10.1542/peds.2009-0238Crossref PubMed Scopus (102) Google Scholar making early intervention critical. In 2012, CTP began considering the development of a youth smoking prevention media campaign. With support from RTI International, CTP first assessed the recent history of youth tobacco use using data from sources such as the National Youth Tobacco Survey, the Youth Risk Behavior Surveillance System, the Monitoring the Future study, and the National Survey on Drug Use and Health. Although there was a steady decline in overall high school youth cigarette smoking over time—from 36.4% in 1997 to 18.1% in 2011—the rate reduction had slowed.13CDC. Trends in the prevalence of tobacco use national YRBS: 1991-2015. Atlanta, GA: CDC. https://www.cdc.gov/healthyyouth/data/yrbs/pdf/trends/2015_us_tobacco_trend_yrbs.pdf. Accessed December 3, 2018.Google Scholar, 14Kann L McManus T Harris WA et al.Youth risk behavior surveillance—United States, 2015.MMWR Morb Mortal Wkly Rep. 2016; 65: 1-180https://doi.org/10.15585/mmwr.ss6506a1PubMed Google Scholar The data also showed that the majority of youth who engaged in cigarette smoking behavior were “experimenters,” meaning they had smoked less than 99 cigarettes in their lifetime. Secondary analysis of 2012 National Youth Tobacco Survey data and 2012 U.S. Census population estimates found that about 21% of adolescents aged 12–17 years—roughly 5 million youth—reported having smoked between one puff and 99 cigarettes in their lifetime.15U.S. Census BureauAnnual estimates of the resident population by single year of age and sex for the United States: April 1, 2010 to July 1, 20121. U.S. Census Bureau, Washington, DC2013Google Scholar, 16CDC, U.S. Food and Drug Administration. Total at-risk experimenters and susceptible non-trier estimates: 2012 NYTS dataset and codebook. Atlanta, GA: HHS, CDC. www.cdc.gov/tobacco/data_statistics/surveys/nyts/. Updated October 1, 2015. Accessed February 23, 2018.Google Scholar About 22% of youth aged 12–17 years had never smoked but were open to smoking. Less than 4% of youth reported having smoked more than 100 cigarettes in their lifetime and on at least 1 of the past 30 days.16CDC, U.S. Food and Drug Administration. Total at-risk experimenters and susceptible non-trier estimates: 2012 NYTS dataset and codebook. Atlanta, GA: HHS, CDC. www.cdc.gov/tobacco/data_statistics/surveys/nyts/. Updated October 1, 2015. Accessed February 23, 2018.Google Scholar With more than 10 million youth at risk for or already experimenting with cigarette smoking,15U.S. Census BureauAnnual estimates of the resident population by single year of age and sex for the United States: April 1, 2010 to July 1, 20121. U.S. Census Bureau, Washington, DC2013Google Scholar, 16CDC, U.S. Food and Drug Administration. Total at-risk experimenters and susceptible non-trier estimates: 2012 NYTS dataset and codebook. Atlanta, GA: HHS, CDC. www.cdc.gov/tobacco/data_statistics/surveys/nyts/. Updated October 1, 2015. Accessed February 23, 2018.Google Scholar the data presented an opportunity to disrupt the trajectory of adolescent cigarette experimentation to daily smoking. Decades of declining youth smoking rates made the task of reducing youth tobacco use prevalence harder than ever. In addition to a smaller target audience, years of successful smoking prevention efforts also suggested that youth who smoked, or experimented with smoking, did so in spite of the efforts that led so many of their peers to remain smoke free. The power of mass media interventions to reduce youth cigarette smoking is well established. Evidence from controlled field experiments and population studies shows that mass media campaigns designed to discourage tobacco use can change attitudes about tobacco use and reduce smoking prevalence.17Biener L Ji M Gilpin EA Albers AB The impact of emotional tone, message, and broadcast parameters in youth anti-smoking advertisements.J Health Commun. 2004; 9: 259-274https://doi.org/10.1080/10810730490447084Crossref PubMed Scopus (144) Google Scholar, 18Brinn MP Carson KV Esterman AJ Chang AB Smith BJ Mass media interventions for preventing smoking in young people.Cochrane Database Syst Rev. 2010; CD001006https://doi.org/10.1002/14651858.CD001006.pub2PubMed Google Scholar, 19Davis KC Farrelly MC Messeri P Duke J The impact of national smoking prevention campaigns on tobacco related beliefs, intentions to smoke and smoking initiation: results from a longitudinal survey of youth in the United States.Int J Environ Res Public Health. 2009; 6: 722-740https://doi.org/10.3390/ijerph6020722Crossref PubMed Scopus (35) Google Scholar, 20National Cancer Institute. The Role of the Media in Promoting and Reducing Tobacco Use. Tobacco Control Monograph No. 19. Bethesda, MD: HHS, NIH, National Cancer Institute. NIH Pub. No. 07-6242, June 2008.Google Scholar In the years since CTP first began developing FDA's landmark youth smoking prevention media campaign, “The Real Cost,” the evidence has only continued to grow, and now includes the successful outcomes from “The Real Cost” evaluation.21Farrelly MC Duke JC Nonnemaker J et al.Association between The Real Cost media campaign and smoking initiation among youths—United States, 2014–2016.MMWR Morb Mortal Wkly Rep. 2017; 66: 47-50https://doi.org/10.15585/mmwr.mm6602a2Crossref PubMed Scopus (91) Google Scholar A number of youth tobacco prevention media campaigns have been proven effective, but perhaps the most directly relevant campaign is truth®. In 2000, the American Legacy Foundation launched truth®, a national campaign to discourage tobacco use among youth, with funding from the Master Settlement Agreement. An evaluation of the campaign, which uses health effects of smoking with graphic images and reveals tobacco industry marketing practices, found it was associated with significant declines in youth smoking prevalence.22Farrelly MC Davis KC Haviland ML Messeri P Healton CG Evidence of a dose-response relationship between “truth” antismoking ads and youth smoking prevalence.Am J Public Health. 2005; 95: 425-431https://doi.org/10.2105/AJPH.2004.049692Crossref PubMed Scopus (403) Google Scholar This evaluation also demonstrated a dose–response relationship between exposure to the truth® campaign and youth smoking, with higher levels of exposure being related to lower prevalence of youth smoking.22Farrelly MC Davis KC Haviland ML Messeri P Healton CG Evidence of a dose-response relationship between “truth” antismoking ads and youth smoking prevalence.Am J Public Health. 2005; 95: 425-431https://doi.org/10.2105/AJPH.2004.049692Crossref PubMed Scopus (403) Google Scholar Other relevant prevention campaigns include those from Florida and Massachusetts that occurred within the context of multifaceted tobacco control programs. In Florida, smoking prevalence declined by nearly 5 percentage points during the first 2 years of the campaign, whereas Massachusetts’ campaign slowed progression to established smoking within the first 4 years.23Siegel M Biener L The impact of an antismoking media campaign on progression to established smoking: results of a longitudinal youth study.Am J Public Health. 2000; 90: 380-386https://doi.org/10.2105/AJPH.90.3.380Crossref PubMed Scopus (206) Google Scholar The evidence for successful campaigns also suggests campaign funding must be sufficient to expose a significant portion of the target population to tested messages a significant number of times over a significant period of time to elicit the intended changes in behavior.2HHSThe Health Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon General. HHS, CDC, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA2014Google Scholar Understanding the opportunity at hand to further reduce youth initiation through a sustained and adequately funded smoking prevention campaign, CTP developed the capacity and framework necessary to develop, implement, and determine the effectiveness of “The Real Cost” campaign. Designed with the state of the science for campaigns in mind, CTP created a cadre of internal and external teams with expertise in market research, campaign development and implementation, and outcome evaluation. CTP's campaign framework utilized market research, best practices, exploratory research, and summaries of the available evidence. It included a rigorous formative research process to further understand target audiences and to qualitatively and quantitatively test messages and materials to ensure they resonated with intended audiences. “The Real Cost” was rigorously evaluated to measure changes in knowledge, attitudes, beliefs, and behaviors. CTP also conducted an extensive review of academic research, including a large study of youth by the University of Pennsylvania's Annenberg School for Communication, which identified promising tobacco prevention message themes tied to CTP's regulatory authority and mission,24Brennan E Gibson L Momjian A Hornik RC Identifying potential target beliefs for a youth-focused smoking prevention mass media campaign: final findings and recommendations for 13–17 year old non-smokers. CECCR Working Paper Series. Penn's Center of Excellence in Cancer Communication Research, Annenberg School for Communication, University of Pennsylvania, Philadelphia, PA2013Google Scholar which served as the messaging pillars for “The Real Cost”:•Loss of Control/Addiction: Intention to smoke is reduced when youth understand that tobacco use leads to the loss of control/independence due to addiction (e.g., If I smoke I will be… controlled by smoking).•Dangerous Chemicals: Intention to smoke is reduced when youth understand that there are dangerous chemicals in tobacco smoke also found in other known products (e.g., If I smoke I will inhale… ammonia, which is also found in many household cleaners).•Health Consequences: Intention to smoke is reduced when youth understand that tobacco use leads to cosmetic health effects (e.g., If I smoke I will… get wrinkles). It was within this framework and with the support of leaders within the Center, FDA, and HHS that CTP embarked on the development, implementation, and evaluation of “The Real Cost” campaign—a first-of-its-kind federal campaign to prevent youth from smoking. The results have been overwhelmingly positive. “The Real Cost” prevented nearly 350,000 U.S. youths aged 11–18 years from initiating smoking from February 2014 to March 2016,21Farrelly MC Duke JC Nonnemaker J et al.Association between The Real Cost media campaign and smoking initiation among youths—United States, 2014–2016.MMWR Morb Mortal Wkly Rep. 2017; 66: 47-50https://doi.org/10.15585/mmwr.mm6602a2Crossref PubMed Scopus (91) Google Scholar further adding to the substantial evidence that mass media campaigns can be an effective intervention for protecting public health. Additional papers within this journal supplement provide detail on the target audience segmentation, message development, and media planning. The success of “The Real Cost” demonstrates that achieving CTP's overall mission to reduce the enormous public health burden of tobacco use requires a comprehensive regulatory approach that includes public education that communicates the harms of cigarette smoking. Publication of this article was supported by the Center for Tobacco Products at the U.S. Food and Drug Administration (FDA). This publication represents the views of the author and does not represent FDA position or policy. The author to and and for their leadership and and the campaign for “The Real were reported by the author of this This article is part of a supplement entitled Fifth Anniversary Retrospective of “The Real Cost,” the Food and Drug Administration's Historic Youth Smoking Prevention Media Campaign, which is sponsored by the U.S. Food and Drug Administration.