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.

Combining Inserts With Warning Labels on Cigarette Packs to Promote Smoking Cessation: A 2-Week Randomized Trial.

BACKGROUND: Cigarette pack inserts with messages on cessation benefits and advice are a promising labeling policy that may help promote smoking cessation. PURPOSE: To assess insert effects, with and without accompanying pictorial health warning labels(HWLs), on hypothesized psychosocial and behavioral outcomes. METHODS: We conducted a 2 × 2 between-subject randomized trial (inserts with efficacy messages vs. no inserts; large pictorial HWLs vs. small text HWLs), with 367 adults who smoked at least 10 cigarettes a day. Participants received a 14-day supply of their preferred cigarettes with packs modified to reflect their experimental condition. Over 2 weeks, we surveyed participants approximately 4-5 times a day during their smoking sessions, querying feelings about smoking, level of worry about harms from smoking, self-efficacy to cut down on cigarettes, self-efficacy to quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported their perceived susceptibility to smoking harms and, for the last 24 hr, their frequency of thinking about smoking harms and cessation benefits, conversations about smoking cessation or harms, and foregoing or stubbing out cigarettes before they finished smoking. Mixed-effects ordinal and logistic models were estimated to evaluate differences between groups. RESULTS: Participants whose packs included inserts were more likely than those whose packs did not include inserts to report foregoing or stubbing out of cigarettes (OR = 2.39, 95% CI = 1.36, 4.20). Otherwise, no statistically significant associations were found between labeling conditions and outcomes. CONCLUSIONS: This study provides some evidence, albeit limited, that pack inserts with efficacy messages can promote behaviors that predict smoking cessation attempts.

Cigarette pack inserts (small leaflets inside packs) with messages about quitting benefits and tips to quit may promote smoking cessation. We randomly assigned 367 adult smokers to one of four groups: control group with small health warning labels (HWLs) on the side of packs; inserts with cessation messages and small HWLs; large picture HWLs showing health effects from smoking; inserts and large picture HWLs. Participants received a 14-day supply of their preferred cigarettes in packs that reflected their assigned group. Over 2 weeks, we surveyed participants 4­5 times a day during times when they smoked, asking their feelings about smoking and smoking-related harms, confidence to reduce cigarettes and quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported on the prior 24 hr: how often they thought about smoking harms and cessation benefits; conversations about smoking cessation or harms; and foregoing or stubbing out cigarettes before they finished smoking. People whose packs had inserts (with or without picture HWLs) were more likely than those whose packs did not include inserts (control group or picture HWLs only) to report foregoing or stubbing out of cigarettes. This study provides some evidence that inserts with cessation messages may promote smoking cessation.

Recruitment Methods, Inclusion, and Successful Participation in a Longitudinal Clinical Trial Using Ecological Momentary Assessment.

Underrepresentation of historically marginalized populations in clinical trials continues to threaten the validity of health intervention research. Evidence supports the merits of intercept and other proactive forms of recruitment for achieving more equitable representation. However, researchers also report lower retention and adherence to protocols among these populations, particularly in longitudinal studies. Few studies have compared recruitment methods for longitudinal randomized trials testing health interventions, with even fewer having done so for trials involving ecological momentary assessment (EMA). As intervention research integrates EMA and other data collection approaches requiring substantial participant effort, it is critical to better understand the effectiveness and implications of strategies to improve the representativeness of health research. This secondary data analysis compared outcomes of proactive and reactive recruitment strategies (mobile lab intercepts and internet/flyer advertising, respectively) in study inclusion, task completion, and retention within a 14-day randomized controlled trial that used EMA to evaluate cigarette package health messages. Proactive recruitment resulted in higher proportions of participants with low income and education, limited health literacy, and of diverse racial/ethnic makeup. However, this recruitment method also resulted in lower task completion, especially in the second week of the trial period, and lower retention, although group differences were not explained by participant sociodemographic characteristics targeted by inclusion efforts. We conclude that proactive recruitment via intercepts is an effective strategy for health intervention research that aims to include stakeholders from historically marginalized groups but that researchers and funders must recognize these methods require additional resources, considerations, and capacity to address non-trivial challenges to successful participation.

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.

Evaluating Cigarette Pack Insert Messages with Tips to Quit.

Objectives: Canada is the only country that currently uses cigarette pack inserts to communicate health messages to smokers, including tips to quit. Messages about strategies for quitting smoking are also central to the US Food and Drug Administration's (FDA) Every Try Counts (ETC) campaign. This study assessed US smokers' responses to Canadian and ETC-based messages formatted for pack inserts. Methods: US adult smokers (N = 524) were recruited from an online consumer panel and rated 8 insert messages: 4 based on Canadian inserts and 4 based on ETC. Participants randomly viewed each message accompanied by an image of either a person or a symbolic representation of the topic. Participants rated the perceived effectiveness (PE) of each message. Paired t-tests were used to assess mean differences in PE across topics, image types, and quit intentions. Results: ETC messages were consistently rated as more effective than Canadian messages regardless of quit intentions. Image types did not significantly influence PE. Conclusions: Messages from ETC are perceived as more effective than messages used in Canada. The FDA has the authority to communicate with smokers through inserts and should consider adopting inserts to promote smoking cessation.

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.