Managing a policy paradox? Responses to textual warning labels on E-cigarette advertisements among U.S. national samples of youth overall and adults who smoke or vape.

CONTEXT: Current use and potential future uptake of e-cigarettes among youth remain public health concerns in the U.S., even as people who smoke combustible cigarettes could benefit from switching completely to e-cigarettes. The U.S. Food and Drug Administration (FDA) is considering alternative warning messages, but warnings that discourage youth from use may also deter people who smoke from switching. This study tests ten pre-registered hypotheses on effects of warning messages with national samples of youth overall and adults who smoke and/or vape. METHODS: NORC recruited 1639 adults (ages 18+) who smoke, vape, or use both products, from their probability-sampled AmeriSpeak Panel and augmented their AmeriSpeak Teen Panel with Lucid's nonprobability opt-in panel to recruit 1217 youth (ages 14-17) to participate in a web-based survey experiment. We randomly assigned respondents to view one of five warning label conditions and respond to measures of their e-cigarette risk beliefs, willingness to use e-cigarettes, and (among people who smoke or vape) considerations to quit these products. FINDINGS: Relative to the current FDA warning about nicotine, warning messages about the harms of e-cigarette use for youth brain development did not influence risk beliefs or reduce willingness to use these products among youth. Brain development warning messages did increase beliefs about these harms among adults but did not increase quit considerations among people who vape, relative to the FDA warning. Warning messages with information about chemical constituents of vaping products and the harm of these chemicals produced higher e-cigarette quit considerations than did the FDA warning among adults who vape. CONCLUSION: Potential alternative warning label messages were largely ineffective relative to the current FDA warning about nicotine, though limited evidence suggests some potential for chemical + harm messaging to encourage people who use both e-cigarettes and cigarettes to consider quitting both.

Examining Perceptions of Uncertain Language in Potential E-Cigarette Warning Labels: Results from 16 Focus Groups with Adult Tobacco Users and Youth.

E-cigarette use among youth presents a public health risk. Yet, cigarette smokers who substantially reduce their smoking or switch completely from traditional combustible cigarettes could benefit. As science about e-cigarettes is continually emerging, any potential warnings are likely to contain uncertain language. Hedged verbiage may impact decision making. To assess reactions, we conducted 16 online focus groups; 8 with youth (n = 32, grouped by gender and by vaping experience) and 8 with adult tobacco users (n = 37, grouped by smokers, dual users of e-cigarettes and cigarettes, and former smokers who switched to e-cigarettes). Each focus group viewed and discussed 8 potential warnings messages. We conducted an inductive thematic analysis of the reactions to warning messages that contain uncertain language. Respondents' reactions were often negative, but varied based on specific usages of uncertainty, existing beliefs about uncertainty in law and science, and smoking/vaping use patterns that supported the use of uncertainty related to e-cigarettes. Many youth (and some adults) believed that uncertain language enabled audiences to minimize the likelihood of harm or interpreted it as meaning there are both healthy and unhealthy e-cigarettes. This qualitative study provides evidence that the use of types of uncertain language, the frequency of that use, and/or the selection of particular words in warnings, might not achieve the intended public health aims of increasing understanding of risk, deterring youth uptake, and/or facilitating a substantial switch from cigarettes. The use of certain types of uncertain language appears to have significant potential to bring unintended consequences. Suggestions for research and policy are included.

Perceived threat and fear responses to e-cigarette warning label messages: Results from 16 focus groups with U.S. youth and adults.

AIMS: A warning on e-cigarette packaging is one way the U.S. government can inform the public of known harms of e-cigarette use. Currently, the only required warning on these products is: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This exploratory study aims to inform potential future investigations and FDA decisions regarding alternative warnings that may generate fear in addition to being intentionally informational. METHOD: Data were obtained from responses by 16 online focus groups with adult (N = 47, age range = 18-64) and youth (N = 32, age range 14-16) participants with various smoking and vaping experiences. We showed each focus group a set of hypothetical e-cigarette warning labels to determine how they respond to currently existing public statements that communicate information on the toxicity of ingredients in e-cigarettes, potential health risks, addiction to nicotine, and the uncertainty of the science regarding health effects of using these products. The focus group interviews were audio recorded and transcribed. Transcripts were subjected to a multiphase coding process to identify common response themes. Codes derived from the Extended Parallel Processing Model were then applied to understand impact of potentially fear-inducing language by warning category and age group. RESULTS: For adults, all warnings-except those about addiction-gave rise to spontaneous danger control (intended) responses, such as quit intentions. Warnings highlighting cognitive and uncertain effects may be particularly promising for adult consumers of tobacco products because both gengerated danger control and response efficacy without evidence of fear control. However, responses also suggest that warnings risk discouraging some adults who use combustible cigarettes from transitioning to e-cigarettes for harm reduction. For youth, while evidence of response efficacy and danger control emerged among youth exposed to messages in all warning categories but one-addiction-unproductive reactions indicative of fear control were also prevalent among youth respondent across most warning types. On average, youth were more skeptical than adults about the harms of using e-cigarettes. POLICY IMPLICATIONS: Implications of study findings for the development of future effective e-cigarette warning messages are explored.

Challenges in communicating the benefits of switching from cigarettes to e-cigarettes: Responses from eight adult focus groups with varying smoking experience.

This study explored the effectiveness of nuanced messages, described in our study as warnings, that seek to convey the potential benefits of switching from cigarettes to e-cigarettes for adults. The messages were designed to convey the potentially complex idea that e-cigarettes are likely less harmful than combustible cigarettes but that e-cigarettes still present a risk. Eight adult focus groups (N = 37) with varying smoking profiles responded to a set of messages that are used by government agencies and non-government organizations to convey the benefits of switching and ongoing risk associated with e-cigarette use. Results indicate that a suggestion of health benefits from exclusive use of e-cigarettes was met with skepticism from users of e-cigarettes and combustible cigarettes, and generated confusion about what these benefits were. Messages suggesting that individuals who have switched to e-cigarettes should not switch back to combustible cigarettes elicited the strongest statements of doubt and mistrust among focus group participants, regardless of smoking status. Participants representing all smoking profiles agreed with the message suggesting that switching from combustible cigarettes to e-cigarettes still exposes the user to ongoing health risks. Our focus group discussions suggest that adult smokers may not interpret nuanced messages about harm reduction in a way that will encourage switching behavior.

Should Graphic Warning Labels Proposed for Cigarette Packages Sold in the United States Mention the Food and Drug Administration?

INTRODUCTION: Under the US Family Smoking Prevention and Tobacco Control Act, the US Food and Drug Administration (FDA) has the authority to implement graphic warning labels (GWLs) on cigarette packages. Neither the original labels proposed by the FDA nor the revised labels include a source to indicate sponsorship of the warnings. This study tests the potential impact of adding a sponsor to the content of GWLs. METHODS: We recruited adult smokers (N = 245) and middle-school youth (N = 242) from low-income areas in the Northeastern US. We randomly assigned participants to view one of three versions of the original FDA-proposed warning labels in a between-subjects experiment: no sponsor, "US Food and Drug Administration," or "American Cancer Society" sponsor. We tested the effect of varying sponsorship on source attribution and source credibility. RESULTS: Compared to unsponsored labels, FDA sponsorship increased source attributions that the FDA sponsored the labels among both middle-school, largely nonsmoking youth and adult smokers. However, sponsorship had no effect on source credibility among either population. CONCLUSIONS: We found no evidence that adding FDA as the source is likely to boost source credibility judgments, at least in the short term; though doing so would not appear to have adverse effects on credibility judgments. As such, our data are largely consistent with the Tobacco Control Act's provisions that allow, but do not require, FDA sponsorship on the labels. IMPLICATIONS: This study addresses the FDA's regulatory efforts by informing the possible design and content of future cigarette warning labels. Our results do not offer compelling evidence that adding the FDA name on GWLs will directly increase source credibility. Future work may test more explicit FDA source labeling and continue to examine the credibility of tobacco message content among high-priority populations.

Testing the Effects of Certain versus Hypothetical Language in Health Risk Messages.

This paper tests how the certainty or hypotheticality conveyed through language can be harnessed to enhance the effectiveness of targeted messaging about health risks. We conducted two experiments with adult smokers (n = 317) and middle school youth (n = 321) from low-income communities in the context of pictorial cigarette warning labels. We manipulated hypotheticality of risk through verb modality: 1. non-modal (present tense, e.g., smoking causes cancer), and modal/hypothetical (2. may, 3. can, and 4. will). For adult smokers, definitive (present tense) wording led to greater health risk beliefs, compared to hypothetical wording, among adult males but not females. For youth, contrary to what might seem intuitive, the more hypothetical may verb modality was more effective than the present tense language in promoting health risk beliefs. Among youth, greater health risk beliefs were also associated with reduced susceptibility to use cigarettes. No differences in negative affect by hypotheticality of language were found for either population. We discuss these findings in relation to the theoretical implications for the concept of hypotheticality and the application of construal level theory to strategic health communication.

Independent or synergistic? Effects of varying size and using pictorial images in tobacco health warning labels.

INTRODUCTION: Legal challenges have blocked the implementation of large, pictorial health warning labels (HWLs) in the U.S. In light of future legal questions the U.S. Food and Drug Administration may face in proposing alternative HWLs, we examined whether less restrictive HWL versions on the front of packs-smaller HWLs and/or text-only HWLs that do not include pictorial imagery-may be sufficient to promote cognitive and affective outcomes associated with smoking cessation. METHODS: We recruited low-income smokers in two separate experiments through field-based recruitment methods (Study 1, N = 497) or Amazon Mechanical Turk (MTurk) (Study 2, N = 495). In both studies, we randomly assigned participants to a no-HWL control condition or one of four HWL conditions in a 2 (pictorial vs. text-only) × 2 (50% vs. 30% size) between-subjects design. RESULTS: Relative to text-only HWLs, pictorial HWLs increased negative affect but not risk belief acceptance, cognitive elaboration about smoking harms, or quit intentions. The 50% HWLs increased quit intentions relative to the control condition in both studies. The 50% HWLs also outperformed the 30% HWLs in promoting quit intentions in Study 2. Subsequent analyses revealed that this effect in Study 2 may have been driven by the 50% HWLs strengthening the relationship between risk-related thoughts and intentions, although there was no evidence for this pattern in Study 1. We found no evidence for interaction effects between the pictorial and size manipulations. CONCLUSIONS: Our findings suggest that 50% HWLs, whether pictorial or text-only, can encourage low-income smokers to consider quitting under some conditions.

Effects of Varying Color, Imagery, and Text of Cigarette Package Warning Labels among Socioeconomically Disadvantaged Middle School Youth and Adult Smokers.

The U.S. Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) of 2009 paved the way for the Food and Drug Administration (FDA) to propose nine different graphic warning labels (GWLs) intended for prominent placement on the front and back of cigarette packs and on cigarette advertisements. Those GWLs were adjudicated as unconstitutional on the ground that they unnecessarily infringed tobacco companies' free speech without sufficiently advancing the government's public health interests. This study examines whether less extensive alternatives to the original full-color GWLs, including black-and-white GWLs and text-only options, have similar or divergent effects on visual attention, negative affect, and health risk beliefs. We used a mobile media research lab to conduct a randomized experiment with two populations residing in socioeconomically disadvantaged communities: biochemically confirmed adult smokers (N = 313) and middle school youth (N = 340). Results indicate that full-color GWLs capture attention for longer than black-and-white GWLs among both youth and adult smokers. Among adults, packages with GWLs (in either color or black-and-white) engendered more negative affect than those with text-only labels, while text-only produced greater negative affect than the packages with brand imagery only. Among youth, GWLs and text-only labels produced comparable levels of negative affect, albeit more so than brand imagery. We thus offer mixed findings related to the claim that a less extensive alternative could satisfy the government's compelling public health interest to reduce cigarette smoking rates.

Testing competing explanations for graphic warning label effects among adult smokers and non-smoking youth.

RATIONALE: The United States courts have blocked the implementation of graphic warning labels on cigarette packages (GWLs). This decision was based, in part, on the premise that GWLs are unnecessarily emotional and are meant to scare rather than inform consumers about smoking's health effects. However, research in judgment and decision-making suggests these relationships are more complex. OBJECTIVE: In this article, we draw on several theoretical frameworks that lead to competing hypotheses about the relationships between negative affect, health risk beliefs, and quit intentions (among adult smokers) or susceptibility to start smoking (among non-smoking youth). METHOD: We tested these competing mediation models using data from two experiments with two populations each-adult smokers (Ns = 313 and 238) and primarily non-smoking middle-school youth (Ns = 340 and 237). Using mobile recruitment methods, we focused specifically on individuals from socioeconomically disadvantaged communities in rural and urban areas of the Northeastern United States. RESULTS: The best fitting model across all four datasets was one in which label-induced negative affect (a) directly predicted intentions/susceptibility but also (b) indirectly predicted intentions/susceptibility via risk beliefs. Although mediation analyses did not demonstrate significant serial mediation effects of label exposure on intentions/susceptibility through negative affect then risk beliefs, there was some evidence that label exposure indirectly promoted adults' quit intentions through negative affect. Additionally, negative affect consistently mediated the indirect effect of label exposure on strengthened risk beliefs among adults and youth. CONCLUSIONS: These results speak to the importance of negative affect in directly motivating adult smokers' quit intentions but also serving an informational function, directing adult smokers and non-smoking youth to accept the health risks of smoking.

Effects of 30% and 50% Cigarette Pack Graphic Warning Labels on Visual Attention, Negative Affect, Quit Intentions, and Smoking Susceptibility among Disadvantaged Populations in the United States.

Introduction: Though the WHO Framework Convention for Tobacco Control (FCTC) calls for the implementation of large graphic warning labels (GWLs) on cigarette boxes, the courts have blocked the implementation of 50% labels in the United States. We conducted an experiment to explore whether changing the size of GWLs is associated with changes in visual attention, negative affect, risk beliefs, and behavioral intentions. Method: We recruited adult smokers (N = 238) and middle-school youth (N = 237) throughout the state of New York in May 2016. We randomly assigned participants to one of three between-subject conditions (no GWL [control], 30% GWL, 50% GWL). Results: Adult and youth participants looked at the GWLs longer when the GWL covered 50% versus 30% of the pack's front. Increasing GWL size from 30% to 50% did not influence negative affect or risk beliefs, though both GWL sizes increased negative affect relative to the no-GWL control group. Exposure to 50% GWLs increased adult smokers' intentions to quit compared to no-GWL, but smokers exposed to 30% GWLs did not differ from control. There were no differences between 50% GWLs, 30% GWLs, and control on youth smoking susceptibility. Conclusions: Findings provide some evidence of the benefits of a 50% versus 30% GWL covering the front of the pack for adult smokers and at-risk youth from socioeconomically disadvantaged backgrounds-though not on all outcomes. Implications: This research shows that 30% GWLs on cigarette packages increase negative affect relative to packages without front-of-package GWLs. Larger GWLs on cigarette packages (50% vs. 30%) increase visual attention to the warning and its pictorial content among low-SES smokers and at-risk youth but do not further increase negative affect. A 50% GWL increased adults' quit intention compared to no GWL at all, but we were underpowered to detect modest differences in quit intentions between a 50% and 30% GWL. Future work should thus continue to explore the boundary conditions under which relatively larger GWLs influence cognitive, affective, and behavioral outcomes.

BioPortal: ontologies and integrated data resources at the click of a mouse.

Biomedical ontologies provide essential domain knowledge to drive data integration, information retrieval, data annotation, natural-language processing and decision support. BioPortal (http://bioportal.bioontology.org) is an open repository of biomedical ontologies that provides access via Web services and Web browsers to ontologies developed in OWL, RDF, OBO format and Protégé frames. BioPortal functionality includes the ability to browse, search and visualize ontologies. The Web interface also facilitates community-based participation in the evaluation and evolution of ontology content by providing features to add notes to ontology terms, mappings between terms and ontology reviews based on criteria such as usability, domain coverage, quality of content, and documentation and support. BioPortal also enables integrated search of biomedical data resources such as the Gene Expression Omnibus (GEO), ClinicalTrials.gov, and ArrayExpress, through the annotation and indexing of these resources with ontologies in BioPortal. Thus, BioPortal not only provides investigators, clinicians, and developers 'one-stop shopping' to programmatically access biomedical ontologies, but also provides support to integrate data from a variety of biomedical resources.