Examination of Voluntary Compliance with New FDA Cigar Warning Label Requirements Olivia A. Wackowski, PhD, MPH Marin Kurti, PhD Kevin R.J. Schroth, JD Cristine D. Delnevo, PhD, MPH Objectives: The US Food and Drug Administration (FDA) issued new requirements to strengthen and increase the size of cigar warnings. Although these requirements were challenged in court by the cigar industry, and later struck down, cigar manufacturers had the option of voluntarily complying during the injunction. In this study, we examined voluntary warning compliance on a sample of discarded cigar wrappers. Methods: Warnings were examined on a sample of 1352 discarded cigar wrappers and packs obtained from 15 census tracts in Oakland, California in February 2019. Warnings were coded for new requirement compliance (ie, sized at 30% or more on front and back of pack). Results: Overall, 67.3% of wrappers displayed compliant warnings – other wrappers had smaller warnings only on the front (30.6%), only on the back (1.5%) or no warning (0.4%). Cigar warning placement was significantly associated with brand (p < .01), cigar type (p < .01), and unit size (p < .01). The prevalence of warning compliance was at least 90% for 6 brands but ranged from 0% to 65% for others. Compliance was lowest for cigarillos (62.1%) and packs of 3 (27.6%). Conclusions: Strengthening cigar warnings can help increase their ef- fectiveness, but cigar manufacturers may not voluntarily implement changes fully. Continued surveillance and renewed regulatory efforts are warranted. Key words: cigars; cigarillos; warning labels; tobacco policy Tob Regul Sci.™ 2020;6(6):379-383 DOI: doi.org/10.18001/TRS.6.6.1 obacco warning labels are important tools a set of manufacturers who were parties to a 2000 for communicating product risks to con- agreement with the US Federal Trade Commis- sumers, but are conditional on being sion.3 The new Deeming Rule requirements are Tnoticed.1 In the United States (US), the 2016 significant given that population studies examining Deeming Rule gave the US Food and Drug Ad- the impact of policies strengthening cigarette text ministration (FDA) the authority to regulate cigars warnings in other countries (including increases in and to strengthen the prominence of cigar warning size and prominence) have found increases in re- labels, effective August 10, 2018.2 These regula- ports of noticing and looking closely at warnings tions required that warnings be displayed on the following these warning improvements.1 front and back of cigar packs and occupy at least However, cigar industry groups filed multiple 30% of these areas.2 Prior to this time, cigar warn- lawsuits challenging the Deeming Rule’s new cigar ings were not required by law and smaller warnings warning requirements.4,5 Enforcement of the rule (with font size based on pack surface area, not a was initially delayed, and then, in July 2020, an standard minimum percentage of pack display size) appellate court struck down the rule, finding that were displayed only on the front of cigar packs by the FDA failed to provide evidence about the pub- Olivia A. Wackowski, Associate Professor, Rutgers Center for Tobacco Studies, Rutgers University, New Brunswick, NJ, United States. Marin Kurti, Assistant Professor, Department of Sociology, Anthropology, Criminology and Social Work, Eastern Connecticut State University, Willimantic, CT, United States. Kevin R.J. Schroth, Associate Professor, Rutgers Center for Tobacco Studies, Rutgers University, New Brunswick, NJ, United States. Cristine D. Delnevo, Professor, Rutgers Center for Tobacco Studies, Rutgers University, New Brunswick, NJ, United States. Correspondence Dr Wackowski; [email protected] Tob Regul Sci.™ 2020;6(6):379-383 379 Examination of Voluntary Compliance with New FDA Cigar Warning Label Requirements lic health impact of the warnings on cigar smoking (0.4%) (Table 1). prevalence among cigar smokers and nonsmokers.5 Cigar warning placement was significantly asso- Whereas the lawsuit was pending, the FDA noted ciated with brand (p < .01), cigar type (p < .01), that cigar manufacturers were free to comply with and unit size (p < .01) (Table 1). The prevalence of the warning rule voluntarily.2 Strengthening cigar warning compliance was at least 90% for 6 brands warnings is important, particularly given the dis- (Swisher Sweets, Good Times, Show, Game Leaf, OG proportionate use of cigars by young people and Woods, Phillies) but ranged from 0% to 65% for minorities.6,7 In this study, which took place while others. Warning compliance ranged from 20% to the lawsuit was pending, we examined the presence 100% for brands manufactured by parties of the of cigar warning labels on a sample of cigar packs 2000 FTC agreement (Table 1). By cigar type and and wrappers collected in 15 neighborhoods in unit sizes, compliance was lowest for cigarillos Oakland, California (US). (62.1%) and packs of 3 (27.6%). METHODS Conclusions We collected data in February 2019 as part of a Cigar warning labels present opportunities to in- broader littered wrapper study measuring flavored form consumers about the risks of these products; product availability following a flavored tobacco however, research suggests tobacco warnings are ban in Oakland, California. We collected 1501 more likely to be noticed and attended to when discarded cigar wrappers in a random sample of they are larger and more prominent.1,9 This study 15 census tracts in Oakland stratified by neigh- found that although some cigar brands moved to- borhood race/ethnicity. Details of tract selection wards adopting new Deeming Rule requirements are described elsewhere.8 Members of the research to increase the size and placement of cigar warn- team collected all cigar wrappers present on the ings, other brands stalled or lagged behind in the streets and sidewalks of selected tracts (excluding absence of warning enforcement and given the un- those in trash cans, parks and private residences). certainty presented by pending lawsuits. Collection took place between 7:00 AM and 5:00 Findings are consistent with other cigar research PM on weekdays. findings varying warning label displays on cigar After collection, cigar wrappers were cleaned, industry-sponsored social media sites in 2019,10 photographed and coded for brand name, cigar as well as previous studies on e-cigarettes that also type, unit size, and warning display (including lo- found the use of voluntary warnings on e-cigarette cation and size). We double coded a portion of the packaging and advertising was variable ahead of sample (10%, N = 150) and had good inter-rater new Deeming Rule regulations requiring and agreement – pack unit size (k = 0.90), cigar type (k standardizing these warnings.11,12 If the FDA is- = 0.69), warning label size and placement (front sues a new rule requiring cigar warnings, efforts to of pack: k = 0.88, back of pack: k = 0.88). We ex- strengthen those warnings may benefit from addi- cluded 149 single cellophane cigar wrappers from tional research on cigar warning label effectiveness, analysis (largely from the brand Black & Mild) be- as limited cigar warning specific research exists to cause we could not accurately assess the warning la- date.13 bels of their potential original packaging (ie, these Study limitations include analysis of a conve- were single wrapped cigars which may have been nience sample of discarded cigar packs and wrap- packaged in multi-unit count boxes that carried pers in one geographic location. Thus, data may warning labels). not be representative of a broader set of brands. However, it is worth noting that the products in RESULTS our sample were clearly ones used by consumers Overall, 67.3% of wrappers displayed warnings because they were collected as discarded wrap- compliant with Deeming Rule regulations (ie, on pers. Also, our data were collected at one point in front and back, sized at 30% or more) – other time, approximately 6 months after the intended wrappers had smaller warnings only on the front Deeming Rule effective date for warnings. As such, (30.6%), only on the back (1.5%), or no warning our findings may not be representative of volun- 380 Wackowski et al Table 1 Percentage of Cigar Wrappers with Different Warning Label Sizes and Placement, by Cigar Brand, Type and Unit Size (N = 1352) Front and Front Only Back Only No Back Less than Less than Placement 30% or More 30% 30% Brands /(Manufacturer) Percentage Percentage Percentage Percentage Swisher Sweets (N = 401)/ (Swisher Intl)a 90.7 9.2 0 0 Backwoods (N = 343) / (Altadis)a 65 34.4 0.6 0 Dutch Masters (N = 179) / (Altadis)a 20.1 79.9 0 0 Good Times (N = 96) / (Good Times USA) 95.8 1.1 3.1 0 SHOW (N = 80) / (Show Cigars Inc) 91.3 8.8 0 0 Game Leaf (N = 79) / (Swedish Match)a 94.9 3.8 1.3 0 Splitarillos (N = 65) / Trendsetttah, Inc) 0 100 0 0 XXL Royal Blunts (N = 22) / (Altadis)a 50 0 50 0 Fronto Leaf (N = 15) / (Hot Skull Inc) 0 100 0 0 Zig Zag (N = 13) / National Tobacco Co.) 30.7 69.2 0 0 OG Woods (N = 9) / (Good Times USA) 100 0 0 0 Nomad (N = 7) / (Ezra Zion) 0 100 0 0 Phillies (N = 6) / (Altadis)a 100 0 0 0 High Hemp (N = 6) / (High Hemp Co) 0 16.7 0 83.3 Other (N = 31) 58.1 25.8 12.9 3.2 Product Type Percentage Percentage Percentage Percentage Cigarillo (N = 694) 62.1 36.4 0.6 0.86 Large Cigar (N = 520) 74.1 25.6 0.4 0 Blunt Wrap (N = 134) 67.9 20.9 11.2 0 Filtered Cigars (N = 4) 100 0 0 0 Unit Size % % % % 1 (N = 292) 60.9 38.7 0.3 0.0 2 (N = 862) 73.1 24.7 1.5 0.7 3 (N = 94) 27.6 70.2 2.1 0 4 (N = 3) 66.7 0 33.3 0 5 (N = 98) 73.5 22.5 4.1 0 20 (N = 3) 100.0 0 0 0 Total (N = 1352) 67.3 30.6 1.5 0.4 Note.