Importance

The inclusion of graphic warning labels (GWLs) on cigarette packs is recommended for tobacco control but has not yet been implemented in the US. It is unknown whether and to what extent the inclusion of GWLs on cigarette packs affects smokers' willingness to display the packs in public.

Objective

To determine whether the inclusion of GWLs on cigarette packs affects pack-hiding behavior among smokers in social settings.

Design, setting, and participants

This community-based randomized clinical trial assessed smokers' real-world experience of using cigarettes repackaged to include GWLs (GWL packs) compared with standard US packs and blank packs over a 3-month intervention period with 12 months of follow-up between September 6, 2016, and December 3, 2019. The study included 357 participants aged 21 to 65 years from San Diego County, California, who smoked 5 or more cigarettes per day, were not actively planning to quit smoking, were not pregnant, and had no unstable medical conditions. Participants purchased and received cigarette packs through the study website.

Interventions

During the 1-month run-in period, participants received their usual US cigarette packs. During the 3-month intervention period, participants were randomized to receive GWL packs (study-manufactured packs with 3 rotating images under license from the Commonwealth of Australia; GWL pack group), blank packs (study-manufactured packs devoid of industry marketing imagery; blank pack group), or standard US packs (US pack group).

Main outcomes and measures

Pack hiding was queried daily (with participants reporting behavior within the last 4 hours) and weekly via interactive text messages during the 1-month run-in and intervention periods. Self-reported smoking behavior was biochemically validated.

Results

Among 357 enrolled participants, the mean (SD) age was 39.3 (11.8) years; 195 participants (54.6%) were female, 40 (11.2%) were Hispanic, 243 (68.1%) were non-Hispanic White, and 74 (20.7%) were of other non-Hispanic races (including American Indian or Alaska Native, Asian or Pacific Islander, Black or African American, or multiracial). A total of 18 987 cigarette packs were purchased and delivered during the run-in and intervention periods. Daily querying showed that the inclusion of GWLs on cigarette packs increased the percentage of smokers who hid their packs at least some of the time from 41.3% (95% CI, 39.6%-43.0%) during the run-in period to 57.1% (95% CI, 55.9%-58.1%) by the end of the intervention period. In the postintervention period, returning to standard US packs reduced pack-hiding behavior to the levels observed during the run-in period. Pack hiding remained at run-in levels for both the blank pack group (35.2%; 95% CI, 33.6%-36.8%) and the US pack group (41.4%; 95% CI, 39.7%-43.1%]) throughout the study. Although even participants in the GWL group with the lowest prestudy tendency to conceal score (ie, 1) had a mean (SE) probability of pack hiding during the intervention of 0.84 (0.02), this group's probability of pack hiding decreased to a mean (SE) of 0.43 (0.03) after intervention. When social reactions to packs were queried at the end of the study, the modal response from participants in the GWL pack group was observers' aversive reactions to the packs, whereas the modal response from participants in the blank pack group was observers' positive interest in the study. Neither smoking prevalence nor consumption differed by group at any point in the study.

Conclusions and relevance

In this randomized clinical trial, receiving cigarettes in GWL packs vs blank packs increased pack-hiding behavior in social settings, which may be associated with aversive reactions from observers. However, 12-month smoking behavior did not change.

Trial registration

ClinicalTrials.gov Identifier: NCT02676193.

Importance

The US Food and Drug Administration's implementation of graphic warning labels (GWLs) on cigarette packs is under challenge in US courts.

Objective

To determine whether GWLs can affect US smokers' perceptions about their cigarettes or health consequences and changes in smoking behavior.

Design, setting, and participants

This study was a randomized clinical trial of the effect of a 3-month, real-world experience of cigarettes with GWL packaging. Community recruitment was done from September 2016 through December 2019 of daily smokers from San Diego, California, aged 21 to 65 years, who were not ready to quit. Participants were randomized to purchase and receive cigarettes in 1 of 3 pack designs: GWL, blank, or standard US pack. Data analysis was performed from July 2020 to February 2021.

Interventions

The study manufactured GWL cigarette packs (3 versions with Australian-licensed images) and packs devoid of marketing. For 3 months, participants purchased GWL, blank, or standard US pack cigarettes that were delivered to their home.

Main outcomes and measures

Smoking-related cognitions and behavior were queried by daily and weekly interactive text messages. Smoking behavior was self-reported before and after the intervention by 96% of randomized participants and was biochemically validated on a subsample.

Results

The study sample included 357 participants (195 women [54.6%]; mean [SD] age, 39.5 [11.9] years); 116 were randomized to the standard US pack group, 118 were randomized to the GWL pack group, and 125 were randomized to the blank pack group. Over the 3 months, participants who received the GWL packs had reduced positive perceptions of recent cigarettes smoked compared with participants who received the branded US pack (mean difference, -0.46 SD; 95% CI, -0.73 SD to -0.20 SD; P < .001). Health concerns increased in all groups, with a significant increase in the GWL group vs the US pack group (mean difference, 0.35 SD; 95% CI, 0.09 SD to 0.62 SD; P = .002). Quitting cognitions increased in all study groups, with a peak mean change of 0.60 SD for GWL participants vs 0.34 SD for US pack participants (mean difference, 0.55 SD; 95% CI, 0.28 SD to 0.81 SD; P < .001). GWL participants had slightly more cigarette abstinence periods per week than the US pack group, but the difference was not significant (adjusted odds ratio, 1.06; 95% CI, 0.99 to 1.13). At 3 months, there was no between-group difference in any smoking behavior. The blank pack group was similar to the US pack group on all measures.

Conclusions and relevance

These findings suggest that the introduction of GWL packs appears to decrease positive perceptions of cigarettes and increase quitting cognitions in the short term. However, additional complementary tobacco control strategies may be necessary for GWL packs to be associated with reduced smoking behavior.

Trial registration

ClinicalTrials.gov Identifier: NCT02676193.

Background

The US lags behind >120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers.

Method

To investigate the "real-world" impact of GWLs in US smokers, we are conducting a randomized trial involving a 3-month intervention and 8-month follow-up. The study recruited California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1) Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack. Throughout the 3-month intervention, participants purchased study-packaged cigarettes and reported daily cognitions and behavior through ecological momentary assessments. We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.

Results

The trial enrolled 359 participants (average age 39 years; average cigarette consumption half a pack/day). The 3 study groups were balanced on age, gender, race-ethnicity, education and income (17% low income) as well as on smoking related variables.

Conclusions

This 3-month real-world randomized trial will test the effect of repackaging cigarettes from standard US packs to GWL plain packs on smokers' perceptions of the risks of smoking, their perception of the appeal of their cigarettes, and on their smoking behavior.

Objective

To identify whether three types of cigarette pack designs, including three versions of graphic warning label (GWL) plain packs, one GWL absent and branding absent pack (blank) and the smoker's own GWL absent and branding present pack (US), elicit different valence, type and levels of affect.

Design

US daily smokers (n=324) were asked to handle each of the five pack types and 'think aloud' their reactions. To avoid a muted familiarity response, exposure to their own US pack followed exposure to at least one GWL plain pack. Reactions were scored on a reactivity scale (-3 to +3) and the text was coded for speech polarity (-1 to +1) and emotive word frequency.

Results

Reactivity scores had excellent inter-rater reliability (agreement ≥86%; intraclass correlation coefficient ≥0.89) and were correlated with speech polarity (r=0.21-0.37, p<0.001). When considering their US pack, approximately two-thirds of smokers had a low (31.5%) to medium (34.6%) positive response (reactivity=1.29; polarity=0.14) with expressed feelings of joy and trust. Blank packaging prompted a largely (65.4%) neutral response (reactivity=0.03; polarity=0.00). The gangrenous foot GWL provoked mostly medium (46.9%) to high (48.1%) negative responses (reactivity=-2.44; polarity=-0.20), followed by neonatal baby (reactivity=-1.85; polarity=-0.10) and throat cancer (reactivity=-1.76; polarity=-0.08) warnings. GWLs varied in their elicitation of disgust, anger, fear and sadness.

Conclusion

Initial reactions to GWL packs, a blank pack, and smokers' current US pack reflected negative, neutral, and positive affect, respectively. Different versions of the GWL pack elicited different levels and types of immediate negative affect.