Achieving Public Health Impact: Health Communication Research to Inform Tobacco Regulatory Science.

Health communication research applies communication science to develop generalizable knowledge capable of improving the health and well-being of individuals and communities. But to what extent does the knowledge generated by the health communication field actually achieve public health impact? To answer this question, we discuss the application of health communication science and research within a tobacco regulatory science framework. We describe three areas in which health communication research funded by the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) contributed to 1) youth tobacco prevention campaigns, 2) cigarette health warnings, and 3) regulation of labeling, advertising, and marketing claims. These examples demonstrate how communication regulatory science achieves public health impact in the real world by informing national policies, regulatory actions, and public health practice.

Evaluating The Real Cost Digital and Social Media Campaign: Longitudinal Effects of Campaign Exposure on E-cigarette Beliefs.

INTRODUCTION: Over the past decade, youth e-cigarette use has risen exponentially. At the same time, digital media use increased markedly while the use of traditional broadcast TV declined. In response, the U.S. Food and Drug Administration's The Real Cost public education campaign shifted to communicating the harms of e-cigarette via primarily digital and social platforms. This study evaluated longitudinal associations between exposure to campaign advertisements and changes in campaign-specific beliefs among US youth. METHODS: A nationally representative longitudinal cohort of youth (aged 11-16 years at baseline) was surveyed five times. Building on earlier work, we analyzed data from the last three waves (April-July 2020; January-April 2021; and August-October 2021; N = 2625). We assessed self-reported exposure to six ads and agreement with 11 beliefs that were each targeted by one or more ads. Eleven weighted panel regression models assessed whether ad exposure predicted changes in campaign-specific beliefs over time. RESULTS: We observed significant associations between ad exposure and increases in at least one campaign-specific belief for five of the six ads. Across the 11 beliefs, we observed associations between increased exposure and increases in 6 beliefs related to e-cigarettes and toxic metals, lung damage, dangerous ingredients, anxiety, cigarette use, and disappointing important people. CONCLUSIONS: We found evidence that self-reported exposure to this digital and social media campaign was successful at influencing youth, providing support for the effectiveness of the campaign's adaption to address youth's changes in tobacco and media use habits. IMPLICATIONS: The Food and Drug Administration's The Real Cost public education campaign educates youth about the dangers of e-cigarette use. This study evaluates longitudinal associations between exposure to The Real Cost's advertisements and changes in campaign-specific beliefs among youth. Considering evolving trends in youth media consumption, the campaign adapted its media approach to increase delivery across digital and social media platforms. Our findings indicate that the campaign reached its intended audience and increased youth beliefs around the harm of e-cigarettes and the consequences of e-cigarette use, offering evidence for the effectiveness of digital and social media youth prevention efforts within a fragmented digital environment.

The FDA's Diverse and Dynamic Activities in the Social and Behavioral Sciences: Advancing and Supporting Health Equity.

The U.S. encompasses a heterogenous mix of people and health disparities exist for various subpopulations, such as minorities, women, people with limited English proficiency, those with low socioeconomic status, and other underserved groups. Differences in health outcomes arise in part due to inequalities and injustices rooted in biological, social, and structural factors. Because the origins of health disparities are multifactorial, the approaches to reduce, or even eliminate them, must be multifactorial as well. The social and behavioral sciences are well poised to address the myriad and complex factors that affect health outcomes, including those at the individual level (eg, individuals' behaviors, attitudes, and beliefs), the neighborhood level (eg, housing), the community level (eg, cultural values and norms), and the policy level (eg, public policies that influence healthcare funding and access to healthcare resources and educational materials). In addition, the social and behavioral sciences (1) help equip government agencies with the perspectives and tools needed to promote health equity and (2) contribute to rigorous, evidence-based solutions for public health issues, such as disparities found in childhood vaccination rates, childhood obesity, tobacco use, and access to health information technology. The FDA, in particular, actively conducts social and behavioral sciences research to guide the Agency's efforts to advance and support health equity.

E-cigarette susceptibility among U.S. middle and high school students: National Youth Tobacco Survey Data Trend Analysis, 2014-2018.

Youth e-cigarette use has rapidly increased in the last few years. Susceptibility is a validated measure associated with future tobacco use. We examined trends in e-cigarette susceptibility across five years (2014-2018) of the National Youth Tobacco Survey among youth e-cigarette never users. We observed increases in overall e-cigarette susceptibility from 2014 to 2016 and decreases from 2016 to 2018. Generally, sociodemographic variables were not associated with trend effects; however, there was an interaction between linear trends with both race/ethnicity and other tobacco product (OTP) use. The percentage of youth who were susceptible to using e-cigarettes ranged from 32.9% in 2014 to 33.2% in 2018 with a high of 36.7% in 2016. We also examined the prevalence of e-cigarette susceptibility by race/ethnicity, sex, school level, OTP use, and e-cigarette harm perception. E-cigarette susceptibility was associated with race, school level, OTP ever use, and e-cigarette harm perceptions. Hispanic youth, those in high school, and OTP ever users were more likely to be susceptible to e-cigarette use compared to their counterparts across all years. E-cigarette susceptibility was most prevalent among those who perceived e-cigarettes to pose "no harm" in 2014 and "little harm" in 2018 when compared to other item response options in 2014 and 2018, respectively. This study is the first to document trends in e-cigarette susceptibility among youth. Understanding antecedents of e-cigarette use and identifying youth subgroups vulnerable to e-cigarette use is valuable to developing effective prevention efforts. Disclaimer: The findings and conclusions in this publication are those of the authors and do not necessarily represent the official position of the Food and Drug Administration or the Centers for Disease Control and Prevention.

Influence of Warning Statements on Understanding of the Negative Health Consequences of Smoking.

INTRODUCTION: Pursuant to the Tobacco Control Act (TCA), the US Food and Drug Administration (FDA) is developing new cigarette health warnings to convey the negative health consequences of cigarette smoking. AIMS AND METHODS: This study assessed which of 15 revised warning statements (10 on topics similar to TCA statements and 5 on other topics) promoted greater understanding of cigarette smoking risks relative to TCA statements. In February 2018, adolescent and adult smokers and adolescents susceptible to smoking (n = 2505) completed an online experiment. Control condition participants viewed TCA statements; treatment condition participants viewed combinations of TCA and revised statements. Analyses compared revised statements to TCA statements on the same health topic or to randomly selected TCA statements if there were no statements on the same topic. RESULTS: Relative to TCA statements, 12 of 15 revised statements were more likely to be considered new information, and 12 resulted in more self-reported learning. Three revised statements made participants think more about health risks than TCA statements; the reverse was true for one revised statement. Participants rated most TCA and revised statements as moderately believable and informative. Seven revised statements were found to be less believable and factual, and one revised statement more believable and factual. Treatment condition participants correctly selected more smoking-related health conditions than control condition participants (13.79 versus 12.42 of 25). CONCLUSIONS: Findings suggest that revised statements can promote greater understanding of cigarette smoking risks. Results informed FDA's selection of warning text that was paired with images for testing in a follow-up study. IMPLICATIONS: The US FDA may adjust the text of the cigarette warning statements provided in the TCA if the revised statements promote greater public understanding of the negative health consequences of cigarette smoking. Most of the revised warning statements tested were more likely to be considered new information and resulted in more self-reported learning compared with paired TCA statements, providing support for using revised statements as part of cigarette health warnings. These results informed the development of pictorial cigarette warnings by FDA that were tested in a follow-up study and included in a proposed rule.

Impact of Pictorial Cigarette Warnings Compared With Surgeon General's Warnings on Understanding of the Negative Health Consequences of Smoking.

INTRODUCTION: The Family Smoking Prevention and Tobacco Control Act requires cigarette packages and advertisements to bear health warnings with "color graphics depicting the negative health consequences of smoking." AIMS AND METHODS: This study assessed whether new US Food and Drug Administration developed pictorial cigarette warnings (PCW) increased understanding of smoking-related risks relative to the current Surgeon General's (SG) warnings. In March-May 2019, adolescent and adult smokers and nonsmokers participated in an online experiment with three sessions completed over approximately 2 weeks. Participants viewed 1 of 16 PCW (treatment conditions) or an SG warning (control) on mock cigarette packages and advertisements. Measures assessed whether warnings provided new information, induced thinking about risks, changed smoking-related health beliefs, and were accurately recalled, among other outcomes. RESULTS: The majority of PCW (≥13 conditions) resulted in greater learning of new information, higher self-reported learning, and greater reports of thinking about smoking risks; they were viewed as more informative, understandable, and attention-drawing compared with the control condition. Most participants believed the warning were factual, although 8 PCW were perceived as less factual than the control. There were changes toward more agreement with health beliefs for 11 PCW between Sessions 1 and 2 and 7 PCW between Sessions 1 and 3. Participants in all treatment conditions were more likely than control condition participants to correctly recall the warning. Across outcomes, PCW related to addiction, death, and quitting did not perform as well as other PCW. CONCLUSIONS: Many of the PCW tested increased understanding of the risks associated with cigarette smoking relative to current SG warnings. IMPLICATIONS: The Tobacco Control Act requires cigarette packages and advertisements to bear PCW depicting the negative health consequences of smoking. This study tested whether any of 16 newly proposed PCW increased understanding of smoking-related risks relative to existing SG warnings. Results suggest that most PCW tested, particularly those related to less widely known health effects, resulted in greater learning of new information, higher self-reported learning, and greater reports of thinking about smoking risks compared with SG warnings. These results, along with other factors, informed the US Food and Drug Administration's selection of proposed PCW.

Association between free tobacco product sample receipt and tobacco use in youth and adults in the PATH Study, 2014-2016.

Tobacco companies have distributed free samples of tobacco products in the past. While prior studies have found a relationship between various marketing strategies and tobacco use, no study has assessed the prevalence of free sample receipt or the relationship between receipt and subsequent tobacco use. We analyze three waves of Population Assessment of Tobacco and Health (PATH) Study data to provide the first nationally representative prevalence estimates of free tobacco product receipt among US youth and adults in 2014 to 2016. This analysis also examines the relationship between free tobacco product receipt and ever, past 30-day, and new tobacco use one year later. The prevalence of free sample receipt in the US population in 2014-2016 was 0.8% for any tobacco product but 1.6% for ENDS/e-liquid in adults, and 0.5% for any tobacco product but 1.05% for ENDS/e-liquid in youth. Free sample receipt was higher among vulnerable subgroups. Receipt of free tobacco product samples was associated with tobacco use status using cross-sectional data in youth and adults, as well as one year later in youth. Receipt of a free ENDS or e-liquid sample was associated with any tobacco and ENDS use status using cross-sectional data in youth and adults. After these data were collected, the US Food and Drug Administration broadened the ban on distributing free samples to include all tobacco products except smokeless tobacco in adult-only facilities. Our findings support limiting free samples to further prevent youth access to tobacco products.

Adult Use of and Transitions From Nicotine and Non-nicotine-Containing E-cigarettes: Data From the Population Assessment of Tobacco and Health (PATH) Study, 2013-2016.

INTRODUCTION: Studies largely focus on nicotine-containing e-cigarettes (NiCE) though non-nicotine-containing e-cigarettes (NoCE) exist; NoCE prevalence and patterns of use are largely unknown. This study examines self-reported prevalence and patterns of NiCE/NoCE use. METHODS: We analyzed adult (18+ years) data from the Population Assessment of Tobacco and Health (PATH) study from Wave 1 (2013-2014, n = 32,320), Wave 2 (2014-2015, n = 28,632), and Wave 3 (2015-2016, n = 28,148). We test associations between Wave 1 self-reported current NoCE/NiCE use status and demographic characteristics and assess the proportion of self-reported current NoCE/NiCE users at Wave 1 or Wave 2 who continue to use NoCE or NiCE, switch to NiCE or NoCE, discontinue e-cigarette use, switch to use other nicotine products (ONP), or add ONP use 1 year later (i.e., at Wave 2 or 3). RESULTS: Maintaining the same self-reported NiCE/NoCE and ONP use status 1 year later was the most common use pattern between waves. However, 15.65% of exclusive NoCE users in Wave 2 transitioned to NoCE plus nicotine product use in Wave 3. Also, some exclusive NoCE users transitioned to exclusive NiCE use (17.77% Waves 1-2; 11.55% Waves 2-3). DISCUSSION: Some exclusive NoCE users transitioned to NiCE or added nicotine product use, suggesting there may be other factors (e.g., familiarity with using an aerosolizing device) in addition to the presence of nicotine in influencing initiation or sustained use of nicotine products. IMPLICATIONS: Studies largely focus on nicotine-containing e-cigarettes (NiCE) though non-nicotine-containing e-cigarettes (NoCE) exist; this study adds to the literature by describing demographic characteristics and tobacco use of adult self-reported NoCE users. In addition, the study examines transitions in self-reported NoCE/NiCE use, revealing that some exclusive NoCE users transition to other nicotine product use 1 year later.