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

Abstract

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.

Health communication research applies communication science to develop generalizable knowledge capable of improving the health and well-being of individuals and communities. The field continues to grow at a rapid pace (Dang et al., 2021; Makkizadeh & Ebrahimi, 2022). But to what extent does the knowledge generated by the health communication field actually achieve impact?

Posing this question immediately raises the question of what we mean by “impact.” In the current article, we define impact as producing research that influences policies, regulatory actions, or practices that directly or indirectly affect behaviors in service of public health. Given that health communication resulting from such policies, actions, or practices aims to change behavior by modifying causes of behavior, we consider changes in such causal mediators—including improvements in knowledge, beliefs, attitudes, and intentions—as evidence of impact.

Historically, translating research into evidence-based policies and public health practice has been more limited than we might expect. Some research findings may not find their way into policies or practice, and in cases where the gap between research and application is bridged, it may take 15 or more years for that research to influence evidence-based policies or practice (Melnyk, 2021; Morris et al., 2011).

Moreover, research translation is often much more challenging than expected (Gentry et al., 2020), as researchers encounter barriers such as the lack of conduits for new knowledge to reach practitioners and the lack of research-based programs to fit into real-world circumstances, among others. Given challenges in research translation and application, there has been an increased focus on how we can meaningfully translate research findings into practice (Glasgow & Emmons, 2007). This has included the emergence of entirely new fields such as dissemination and implementation research (Tabak et al., 2012).

In the current article, we discuss how the application of health communication science and research within a regulatory science framework can translate to public health impact in the real world. We describe three areas in which health communication research funded by the United States (U.S.) Food and Drug Administration (FDA) Center for Tobacco Products (CTP) directly informed public health policies, regulatory actions, and public health practice. The three areas we discuss are 1) youth tobacco prevention campaigns, 2) cigarette health warnings, and 3) regulation of labeling, advertising, and marketing claims. Before discussing these areas, we begin with the origins of the regulatory science model.

Family Smoking Prevention and Tobacco Control Act

The inception of this federal tobacco regulatory science model began in 2009, when Congress passed a groundbreaking law – the Family Smoking Prevention and Tobacco Control Act (FSPTCA) – which granted the FDA authority to regulate the manufacture, distribution, and marketing of all commercial tobacco products in the U.S. (Family Smoking Prevention and Tobacco Control Act, 2009). Under the FSPTCA, the FDA was given the authority to regulate cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, as well as the authority to extend its jurisdiction to other tobacco products deemed through subsequent rulemaking. In 2016, the FDA’s Deeming Rule extended its tobacco regulatory authorities to other products meeting the definition of a tobacco product, including but not limited to cigars, waterpipe tobacco, and e-cigarettes (U.S. Food and Drug Administration, 2021). In March of 2022, Congress passed legislation that extended the FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine (Consolidated Appropriations Act, 2022).

Tobacco is the only product regulated by the FDA that causes disease, disability, and death when used as intended. As such, regulation of tobacco products is not guided by the usual FDA “safe and effective” standard (i.e., there is no safe tobacco product), but by public health standards that consider risks and benefits to the population as a whole. The FDA CTP’s overarching public health goals are to 1) prevent people from starting to use tobacco products, 2) encourage current tobacco users to quit, and 3) decrease the harms of tobacco product use. FDA-funded tobacco regulatory research, which includes NIH administered FDA-funded research (Ashley & Backinger, 2012), advances these public health goals by informing FDA actions and filling in knowledge gaps needed to regulate products in a dynamic and changing marketplace.

Tobacco regulatory science is a distinct scientific discipline that “serves as the critical bridge between tobacco products and public health by enabling the FDA to assess various products’ inherent risks and how they are used, and regulate them accordingly” (Ashley et al., 2014, p. 1046). Communication regulatory science is communication research that uses validated techniques, tools, and models to inform regulatory actions that promote optimal communication outcomes and benefit the public (Noar et al., 2019).

Communication regulatory studies often culminate in the highest quality studies, as such work may inform national policies, actions, and practices. The primary goal of the research is to inform communications used in regulatory actions, whereas the advancement of theory and generalizable knowledge are secondary aims of the inquiry (Ashley et al., 2014). Said another way, applying health communication research in a tobacco regulatory science framework inherently builds in translation, as the research questions necessitate intentional planning to inform and bolster the regulatory authorities of the FDA and what is needed to advance an action as a basis for inquiry. Regulatory science research in health communication has also made major contributions to generalizable knowledge in extant areas of inquiry, such as tobacco advertising and marketing, health warnings, processing of risk information, and behavior change messages and campaigns, among other areas (Noar et al., 2019).

Health Communication Research Informs FDA CTP Communication Work

Regulation of tobacco products by the FDA CTP involves a number of activities relevant to communication and marketing. We discuss three instances where health communication research has played a significant role in the FDA CTP’s real-world communication policies, actions, and practices: 1) youth tobacco prevention campaigns, 2) cigarette health warnings, and 3) regulations of labeling, advertising, and marketing claims (Table 1).

Table 1.

Examples of FDA CTP Actions, Health Communication Research Evidence, and Public Health Impact

Topic	Action	Evidence Base	Public Health Impact
Youth tobacco prevention campaigns	FDA launches The Real Cost youth smoking prevention campaign in 20141	Loss of control/addiction, harmful ingredients, and physical (cosmetic) effects shown to be among the most promising themes for cigarette smoking prevention campaigns for youth	The campaign reaches its target audiences, with ad awareness reaching more than 90% of susceptible non-triers and experimenters. By 2016, the campaign is estimated to have had prevented up to 587,000 youths aged 11–19 from initiating cigarette smoking.
Cigarette health warnings	FDA finalizes a rule for nine pictorial warnings in June of 2011; after litigation prevents their implementation, FDA proposes and finalizes a new set of pictorial warnings in March of 20202	Extant studies show pictorial warnings to outperform text-only warnings on a large series of outcomes; studies specific to FDA warnings show them to increase public understanding of smoking harms and motivate quitting smoking	FDA finalizes a rule for pictorial cigarettes warnings in 2011 and again in 2020. A modeling study shows that pictorial warnings would have substantial public health impact over the next 50 years once implemented in US.
Labeling, advertising, and marketing claims	FDA sends warning letters to Santa Fe Natural Tobacco Company in 2015 warning them about misleading marketing claims used to promote their Natural American Spirits (NAS) cigarettes3	Studies show that cigarettes marketed as “natural,” “organic,” and “additive free” are perceived as less harmful by smokers compared to other cigarettes	In 2017, Santa Fe Natural Tobacco Company ceases using the terms “additive-free” and “natural” in their marketing of NAS cigarettes. They continue to use “natural” in their brand name, however.

Note. FDA CTP = Food and Drug Administration Center for Tobacco Products.

¹Visual example of Real Cost ad platforms: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0144827

²Visual example of 2020 pictorial warnings: https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements

³Visual example of Natural American spirits advertising before changes made: https://tobacco.stanford.edu/cigarette/img9007/

Youth Tobacco Prevention Campaigns

CTP’s mission includes “educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others” (U. S. Food & Drug Administration, 2023a, np). Public education efforts are vital to comprehensive tobacco control by informing the public about the risks of tobacco products and ensuring that FDA regulation does not lead consumers to mistakenly believe that tobacco products are safe (Brubach, 2019; Zeller et al., 2009). Mass media campaigns are a public education approach with demonstrated success in preventing tobacco initiation and disrupting progression to established tobacco use (Centers for Disease Control and Prevention, 2014).

Evidence Base

The FDA CTP’s tobacco public education campaigns are informed by insights and experiences accumulated through decades of health communication research focusing on campaign development, implementation, and evaluation (Atkin & Rice, 2013; Hornik, 2002). For illustration, we focus on two lines of work that have played central roles in the development of the FDA’s youth tobacco prevention campaign, The Real Cost.

A defining feature of communication regulatory science research is the rigorous use of validated tools and techniques to provide decisional support to CTP communication activities. To identify target beliefs for campaign messaging, The Real Cost has relied on an empirical approach developed by Hornik and colleagues for guidance (Hornik & Woolf, 1999). According to this approach, promising beliefs for a campaign should 1) show strong associations with the behavior (or intention) of interest, 2) have room to move (i.e., not be universally agreed upon in the target population), and 3) be movable by persuasive messaging. Using this approach, a team at the University of Pennsylvania conducted a systematic analysis of youth beliefs regarding cigarette smoking and identified three message pillars for The Real Cost cigarette prevention campaign: loss of control/addiction, harmful ingredients, and physical (cosmetic) effects (Brennan et al., 2017). These message pillars have guided The Real Cost since its inception and contributed centrally to the campaign’s success.

Another communication research tool widely used in The Real Cost is the construct and measurement of perceived message effectiveness (PME). There is broad evidence in support of PME’s validity and utility as a metric of potential message impact in campaign research (Cappella, 2018; Ma et al., 2023; Noar et al., 2020). The Real Cost has consistently used PME to pre-test campaign messages before releasing them into the market (Crosby et al., 2019; Zhao et al., 2016). PME has also been included in evaluation surveys to track message performance in the field (e.g., Duke et al., 2015). Over the years, the FDA campaigns have incorporated elements of some new developments in PME research in its formative work, such as new PME measures and testing protocols (e.g., Kim & Cappella, 2019; Ma et al., 2023). The accumulated evidence at the FDA has also contributed valuable data to the PME literature on important theoretical questions (e.g., Zhao et al., 2022).

The FDA CTP’s The Real Cost public education campaign has relied heavily on health communication research to guide campaign development and implementation as described above. These tobacco regulatory research efforts have provided a critical evidence base for campaign decision-making.

Public Health Impact

The Real Cost cigarette prevention campaign was launched in 2014 with the aim to prevent cigarette smoking among at-risk youth ages 12 to 17, defined as youth who have never smoked but are susceptible to initiation (i.e., susceptible non-triers) or have experimented with smoking but have not yet established regular smoking (i.e., experimenters). With extensive media buys, the campaign quickly reached its target audiences, with ad awareness reaching 90.5% and 94.6% among susceptible non-triers and experimenters, respectively, only months after campaign launch (Duke et al., 2015). Youth reported favorable PME ratings of campaign advertising (Duke et al., 2015) and campaign exposure was associated with positive changes in campaign-targeted beliefs after a year or so in the field (Duke et al., 2018).

By 2016, researchers estimated the campaign had prevented up to 587,000 youths aged 11–19 from initiating cigarette smoking nationwide (Duke et al., 2019), saving the country $53 billion in costs associated with medical care, lost wages, and increased disability (U.S. Food and Drug Administration, 2023b). In 2018, campaign messaging expanded to address the harms of e-cigarettes in response to the rapid rise in youth use (Zeller, 2019). Recent findings from a nationally representative longitudinal cohort study (MacMonegle et al., in press) showed that the campaign reached its intended audience (75% of youth were aware of at least one ad by the final survey wave) and that exposure to The Real Cost e-cigarette prevention ads increased youth beliefs about the harms of e-cigarette use. Also, a randomized clinical trial of The Real Cost e-cigarette prevention ads found that they reduce adolescents’ susceptibility to vaping (Noar et al., 2022). In addition to preventing youth tobacco use and reduced societal costs, health resources and materials born from these evidence-based strategies engender and strengthen public health practice by researchers, policymakers, and practitioners (UNC Lineberger Comprehensive Cancer Center, n.d.; U.S. Food & Drug Administration, n.d.).

Cigarette Health Warnings

The FSPTCA amended Section 4 of the Federal Cigarette Labeling and Advertising Act to require cigarette packages and advertisements to bear health warnings, consisting of one of nine textual warning statements accompanied by color graphics depicting the negative consequences of smoking. The FDA has taken significant steps to develop and implement such warnings. The FDA finalized a rule in June of 2011 for nationwide implementation of nine pictorial cigarette warnings on all cigarette packages and advertising. The warnings used the nine statements named in the FSPTCA and paired them with images selected through an empirical study (Nonnemaker et al., 2015). However, legal challenges resulted in the warnings being ruled unconstitutional (R. J. Reynolds Tobacco Co. v. United States Food & Drug Administration, 2012). Given this setback, the FDA conducted a series of studies and developed a new set of warnings (Pepper et al., 2020a, 2020b), publishing a final rule in March of 2020. This new set of 11 warnings used different text and images than the earlier proposed warnings, with a particular focus on lesser-known health risks of smoking (Pepper et al., 2020a, 2020b). Legal challenges from the tobacco industry (R. J. Reynolds Tobacco Co. v. United States Food & Drug Administration, 2020) have resulted in the rule being set aside, effective Dec 7, 2022.

Evidence Base

Research has demonstrated that the four text-only, Surgeon General’s warnings currently on the side of cigarette packs are seldom noticed by smokers (Borland et al., 2009). As indicated above, the FDA conducted research to determine the most impactful images to pair with the nine textual warning statements (Nonnemaker et al., 2015), and the resulting pictorial health warnings were included in the 2011 rule. In addition, the FDA funded studies on those nine pictorial warnings, building a robust knowledge base on pictorial cigarette warnings in the U.S.

Studies indicated that the nine pictorial warnings developed by the FDA for the 2011 rule were perceived as significantly more effective in motivating quitting smoking and convincing youth not to smoke than text-only warnings (Byrne et al., 2015; Hammond et al., 2013). They appear to have similar effects across both the general population and subgroups of various race, education, and income levels (Cantrell et al., 2013; Gibson et al., 2015). The pictorial warnings were more likely to attract attention compared to text-only warnings (McQueen et al., 2015) and they increased heavy smokers’ intentions to quit smoking (Blanton et al., 2014). Moreover, the FDA’s pictorial warnings increased smoking quit attempts compared to the Surgeon General’s text-only warnings in a large randomized controlled trial (Brewer et al., 2016).

Although the nine pictorial cigarette warnings in the 2011 rule were not implemented, these and other studies funded by the FDA provided strong scientific evidence for the impact of pictorial warnings across a series of outcomes (Noar, Hall, et al., 2016). Findings from the field of communication regulatory science were instrumental in informing the final rule that was issued by the FDA in March of 2020 by demonstrating that cigarette health warnings are effective in promoting greater public understanding of the negative health consequences of cigarette smoking.

Public Health Impact

The robust scientific knowledge base built upon the health communication research on cigarette health warnings supported the FDA’s ability to promulgate final rules in 2011 and 2020 to require cigarette health warnings on cigarette packages and advertisements pursuant to section 201 of the FSPTCA. Due to the legal challenges, the effect of pictorial cigarette health warnings on U.S. cigarette packages and advertisements on consumer understanding in the U.S. has yet to be realized. However, internationally more than 130 countries and jurisdictions have implemented pictorial warnings (Canadian Cancer Society, 2021), and two systematic reviews of observational studies show large impacts of stronger health warnings. For instance, after countries implemented stronger warnings – typically pictorial warnings – increases in attention, thinking about the risks of smoking, and foregoing cigarettes were observed when compared to before implementation (Noar et al., 2017). Studies have also revealed increases in knowledge about the health risks of smoking, increases in smoking quit attempts, and reductions in smoking prevalence when comparing after to before implementation periods (Noar, Francis, et al., 2016). A modeling study simulated what the impact of pictorial warnings would be once implemented in the U.S. (Levy et al., 2017). The study found that pictorial warnings would produce a relative reduction in smoking prevalence by 5% in the short term and 10% over the long term. In addition, the study found that such warnings would prevent more than 650,000 deaths, 46,000 low birth weight babies, 73,000 pre-term births, and 1,000 cases of sudden infant death syndrome over the next 50 years.

A robust body of regulatory health communication science evidence supports the final rule issued by the FDA in March of 2020 and demonstrates that cigarette health warnings are effective in promoting greater public understanding of the negative health consequences of cigarette smoking. Findings show that pictorial cigarette warnings increase attention to warning messages (Borland et al., 2009; Hammond et al., 2006; Thrasher et al., 2007), increase the likelihood that consumers will read, recall, and understand the warnings (Evans et al., 2015; McQueen et al., 2015), and increase knowledge of the negative health consequences of smoking (Acharya et al., 2016; Hammond, 2011; Hammond et al., 2006; White et al., 2008). Thus, the potential public health impact of implementing pictorial warnings in the U.S. is substantial.

Regulation of Labeling, Advertising, and Marketing Claims

The FDA has the authority to regulate the content of product labeling, advertising, and marketing to ensure that it is neither false, misleading, misbranded, nor adulterated. Additionally, under provisions of section 911 of the FD&C Act, only products with an FDA modified risk granted order can be marketed with claims of with risk modification (e.g., claims that it reduces disease risk) or exposure modification (e.g., claims that it reduces exposure to harmful constituents). To enforce these standards, the FDA may take regulatory actions such as issuing warning letters, imposing fines, or seeking court orders to stop certain activities. The FDA has issued warning letters to firms marketing products that make modified risk claims without having an FDA order in effect which renders the tobacco product to be adulterated under section 902(8) of the FD&C Act (U.S. Food and Drug Administration, 2023c). Additionally, the FDA has issued a number of warning letters for the use of claims or descriptions on product labeling or advertising that may mislead consumers by suggesting reduced harm or risk in using a tobacco product.

Evidence Base

A substantial body of evidence indicates that tobacco products bearing deceptive and misleading labels and descriptions are perceived as less harmful than those without such misrepresentations. According to a systematic review (Morgan et al., 2017), cigarettes labeled as “additive-free” are perceived as less addictive, particularly by adolescents, and are thought by smokers to contain no nicotine. Research has also demonstrated that claims of cigarettes being “organic,” “natural,” or “additive-free” mislead people by reducing perceived harm of cigarettes compared to those labeled as “regular” and “light” (Baig et al., 2019). As one example, in 2015 the FDA sent warning letters to Santa Fe Natural Tobacco Company (SFNTC), the maker of Natural American Spirit (NAS) cigarettes, warning them against the use of deceptive terms such as “additive-free” and “natural” on their product packaging and in their marketing materials (Lewis et al., 2020). The branding of NAS cigarettes prominently features an image of a Native American smoking a pipe, and the term “natural” is highly visible on each cigarette package. Research indicated that the descriptor “100% additive-free” had significant impact on reducing the perceived harm of NAS cigarettes (Pearson et al., 2016). Consistent with this, findings from Wave 1 (2013–2014) data from the Population Assessment of Tobacco and Health (PATH) survey showed that a large portion of US adult NAS smokers – ranging from 50% and 70%, depending on their usual sub-brand – indicated that NAS cigarettes posed less risk to their health than regular cigarettes, despite disclaimers stating that “no additives in our tobacco does NOT mean a safer cigarette” (Leas et al., 2017). After receiving warning letters from the FDA, SFNTC agreed to eliminate the terms “additive-free” and “natural” from their marketing claims for NAS cigarettes in 2017.

Specific to products that bear modified risk claims, research shows that exposure to modified risk claims (e.g., statements that the product has lower harm than cigarettes or that the product leads to lower exposure to chemicals than cigarettes) leads to lower perceived risk (El-Toukhy et al., 2018; O’Brien et al., 2022) and lower perceived exposure to chemical constituents (El-Toukhy et al., 2018). Additionally, exposure to modified risk claims may produce halo effects such that consumers generalize benefits not described in the specific claim (Seidenberg et al., 2021). These findings highlight the real potential for products with unauthorized modified risk claims to mislead consumers.

Public Health Impact

As of December 2023, the FDA has issued more than 600 warning letters to firms for manufacturing, selling, or distributing products found to be violative of the FD&C Act. An experimental study exploring the potential effectiveness of removing the terms “additive-free” and “natural” found that it reduced misconceptions about the addictiveness of NAS cigarettes (Gratale et al., 2019).

Additionally, the FDA has issued 16 modified risk granted orders for smokeless tobacco products, cigarettes, and heated tobacco products (U.S. Food & Drug Administration, 2023d). As previously discussed, products with unauthorized modified risk claims may mislead consumers into thinking that product use will lead to reduced risk, resulting in consumers switching to a tobacco product that does not confer benefits over other tobacco products (and may, in some cases, lead to greater harm). As the body of regulatory communication evidence grows, findings on the impact of product labeling and descriptors on consumer understanding and perceptions can continue to inform potential FDA regulatory actions.

Conclusion

The communication field is dedicated to an understanding of communication processes and effects. As an applied sub-field, health communication seeks to advance such scholarship in a health context, yet its potential can only fully be realized when research findings are translated in ways that achieve public health impact. In this article, we have discussed the application of health communication science and research within a tobacco regulatory science framework, an important model for bridging the research-practice gap.

We have described three areas in which health communication research funded by the FDA CTP directly informed public health policies, actions, and practices of the FDA. These real-world applications represent key areas of health communication inquiry that have applicability to behavioral contexts beyond tobacco, including communication campaigns, health warnings, and regulation of marketing claims. The work reviewed here and the regulatory science model provide examples of how health communication research and science can result in public health impact in the real world that invites translation to other health communication contexts.

Looking to the future, a crucial priority in tobacco regulatory science is reducing tobacco-related health disparities and the subsequent health consequences of those disparities, a long-standing issue in tobacco prevention and control (Simmons et al., 2016). The FDA CTP is moving forward with actions intended to reduce health disparities in tobacco use and its associated harm, including proposing product standards that will prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (except tobacco) in cigars (U.S. Food and Drug Administration, 2022a). The FDA also announced their intent to propose a product standard that would reduce the nicotine levels in cigarettes and other combustible products to minimally or non-addictive levels (U.S. Food and Drug Administration, 2022b). Thus, communication regulatory research can and should be leveraged to support these and other efforts to bolster effective policies, actions, and practices, and ultimately improve public health.