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IntroductionRemoval of tobacco industry branding from cigarette packs may reduce their appeal. Adding graphic warning labels (GWLs) should enhance this effect. We investigate whether willingness to pay for various packaging designs changes after 3 months' use of: (1) US branded packs without GWLs (US), (2) non-branded packs without GWLs (Blank), and (3) rotating non-branded packs with GWLs (gangrene; throat cancer; neonatal baby) covering >75% of pack (GWL).MethodsCalifornian adult daily smokers not planning to quit (n=287; 56% female; mean age=39.6) completed a discrete choice purchase task before and after 3 months' experience using one of three packaging options. Conjoint analysis and pre-post modelling evaluated the change in importance of pack attributes and willingness to pay for US, Blank or GWL (blindness; teeth; gangrene) pack designs.ResultsPrice determined ~70% of purchase choices, while pack design determined ~22%. Irrespective of intervention arm, US packaging generated appeal valuations compared with Blank packaging, while GWLs consistently provoked strong aversive valuations at baseline and follow-up. Compared with the US pack arm, using GWL packs for 3 months decreased willingness to pay for US packaging (β=-$0.38, 95% CI -0.76 to 0.00). Wear-out effects were detected in the discount needed to willingly purchase the gangrene-GWL pack (β=$0.49, 95% CI 0.16 to 0.82) and Blank pack (β=$0.42, 95% CI 0.09 to 0.74) but not for GWLs (blindness, teeth) not used in trial.ConclusionCompared with US branded packs, the negative valuation of non-branded GWL packs attenuates with even 3 months' use but does not generalise to non-used GWLs. This suggests that GWLs should be regularly refreshed. The appeal valuation of industry imagery suggests that the US plan to retain such imagery on packs may ameliorate the effect of GWLs.

OBJECTIVE: Plain packaging and graphic warning labels are two regulatory strategies that may impact cigarette risk beliefs and reduce consumption, but data are needed to better understand how smokers respond to such regulations. METHODS: Adult, daily, Marlboro non-menthol smokers (Red [n = 141] or Gold [n = 43]) completed a mixed factorial randomized trial. Participants smoked their usual cigarettes during baseline (5-days) and were randomized to receive cigarette packs with a warning label manipulation (graphic vs. text-only). Within each warning label condition, participants completed three within-subjects pack color manipulations (red, gold, plain), each lasting 15 days. Participants were blinded to the fact that all packs contained their usual cigarettes. Mixed-effects models examined between- and within-subject differences on risk beliefs, product perceptions, and smoking behavior. RESULTS: Warning type and package color did not impact cigarette consumption or subjective ratings. However, use increased in all conditions (2.59-3.59 cigarettes per day) relative to baseline. While smokers largely held correct risk beliefs at baseline (Mean = 6.02, SE = 0.17, Range:0-8), the cumulative number of incorrect or uncertain cigarette risk beliefs increased from baseline in all pack color manipulations in the text (IRR range = 1.70-2.16) and graphic (IRR range = 1.31-1.70) warning conditions. Across all pack color periods, those in the graphic (vs. text) warning condition had reduced odds of reporting their study cigarettes as safer than regular cigarettes (OR range = 0.22-0.32). CONCLUSIONS: Pack color modification may increase uncertainty about several key cigarette risk beliefs, though graphic warnings may attenuate these effects. Regulatory agencies could consider supporting policy changes with information campaigns to maximize public knowledge. TRIAL REGISTRATION: November 25, 2014; Registration number: NCT02301351.

ObjectiveTo 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.DesignUS 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.ResultsReactivity 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

IntroductionGraphic warning labels on cigarette packaging are mandated in 118 countries and are under consideration in the USA. We propose an appeal-aversion assessment tool to help regulators choose among graphic packaging options.MethodsAfter familiarisation with different cigarette packaging, adult daily smokers (n=338) from San Diego, California, USA completed a discrete choice appeal-aversion purchasing task and provided information on nicotine dependence and sociodemographics (2017-2019). The conjoint analysis estimated the importance and price utility for product attributes (ie, packaging, price, tobacco origin and quitline number). The price premiums that smokers would be willing to pay to avoid purchasing graphic packaging were calculated.ResultsAmong purchase determinants, the price was the most important attribute (65.5%), followed by packaging design (27.1%). Compared with blank packaging without marketing, branded industry packs had appeal valuations (US$0.54; 95% CI: US$0.44 to US$0.65), whereas graphic warning packs had aversion valuations that varied with the salience of the image (blindness=-US$2.53, 95% CI: -US$2.76 to -US$2.31; teeth damage=-US$2.90, 95% CI: -US$3.17 to -US$2.63; and gangrenous foot=-US$3.70, 95% CI: -US$4.01 to -US$3.39). The aversion was such that 46.2% of participants were willing to pay a 50+% premium over their current cigarette price to have their branded packs rather than a graphic pack. These appeal-aversion valuations were moderated by sex, income and nicotine dependence (p

IntroductionGraphic warning labels on cigarette packaging are mandated in 118 countries and are under consideration in the USA. We propose an appeal-aversion assessment tool to help regulators choose among graphic packaging options.MethodsAfter familiarisation with different cigarette packaging, adult daily smokers (n=338) from San Diego, California, USA completed a discrete choice appeal-aversion purchasing task and provided information on nicotine dependence and sociodemographics (2017-2019). The conjoint analysis estimated the importance and price utility for product attributes (ie, packaging, price, tobacco origin and quitline number). The price premiums that smokers would be willing to pay to avoid purchasing graphic packaging were calculated.ResultsAmong purchase determinants, the price was the most important attribute (65.5%), followed by packaging design (27.1%). Compared with blank packaging without marketing, branded industry packs had appeal valuations (US$0.54; 95% CI: US$0.44 to US$0.65), whereas graphic warning packs had aversion valuations that varied with the salience of the image (blindness=-US$2.53, 95% CI: -US$2.76 to -US$2.31; teeth damage=-US$2.90, 95% CI: -US$3.17 to -US$2.63; and gangrenous foot=-US$3.70, 95% CI: -US$4.01 to -US$3.39). The aversion was such that 46.2% of participants were willing to pay a 50+% premium over their current cigarette price to have their branded packs rather than a graphic pack. These appeal-aversion valuations were moderated by sex, income and nicotine dependence (p

IntroductionGraphic warning labels on cigarette packaging are mandated in 118 countries and are under consideration in the USA. We propose an appeal-aversion assessment tool to help regulators choose among graphic packaging options.MethodsAfter familiarisation with different cigarette packaging, adult daily smokers (n=338) from San Diego, California, USA completed a discrete choice appeal-aversion purchasing task and provided information on nicotine dependence and sociodemographics (2017-2019). The conjoint analysis estimated the importance and price utility for product attributes (ie, packaging, price, tobacco origin and quitline number). The price premiums that smokers would be willing to pay to avoid purchasing graphic packaging were calculated.ResultsAmong purchase determinants, the price was the most important attribute (65.5%), followed by packaging design (27.1%). Compared with blank packaging without marketing, branded industry packs had appeal valuations (US$0.54; 95% CI: US$0.44 to US$0.65), whereas graphic warning packs had aversion valuations that varied with the salience of the image (blindness=-US$2.53, 95% CI: -US$2.76 to -US$2.31; teeth damage=-US$2.90, 95% CI: -US$3.17 to -US$2.63; and gangrenous foot=-US$3.70, 95% CI: -US$4.01 to -US$3.39). The aversion was such that 46.2% of participants were willing to pay a 50+% premium over their current cigarette price to have their branded packs rather than a graphic pack. These appeal-aversion valuations were moderated by sex, income and nicotine dependence (p

BackgroundCigarette packs are a form of advertising that distributes brand information wherever smokers go. In the 21st century, tobacco companies began using onserts on cigarette packs to communicate new advertising messages to smokers.MethodsWe reviewed tobacco industry documents dated 1926 to 2017 to identify how the tobacco industry developed and used onserts in marketing and to serve the industry's political and legal objectives.ResultsOnserts added to cigarette packs became a more cost-effective way for brands to market in the year 2000. Manufacturers then began studying them, finding that new messages were appealing, while repeated messages were ignored. By 2005, tobacco companies were using onserts to effectively communicate about new tobacco products and packaging changes. They also used repeated 'corporate responsibility' messages that were, according to the industry's own research, likely to be ignored.ConclusionsTobacco companies have expanded on cigarette pack-based advertising. Twenty-first century onserts simultaneously seek to increase sales using materials that are novel, attractive and provide independent value, while undercutting public health messages about the risks of tobacco use using materials that repeat over time and are comparatively unattractive. Health authorities can use this industry research to mandate onserts to communicate effective health messages.

BackgroundCigarette packs are a form of advertising that distributes brand information wherever smokers go. In the 21st century, tobacco companies began using onserts on cigarette packs to communicate new advertising messages to smokers.MethodsWe reviewed tobacco industry documents dated 1926 to 2017 to identify how the tobacco industry developed and used onserts in marketing and to serve the industry's political and legal objectives.ResultsOnserts added to cigarette packs became a more cost-effective way for brands to market in the year 2000. Manufacturers then began studying them, finding that new messages were appealing, while repeated messages were ignored. By 2005, tobacco companies were using onserts to effectively communicate about new tobacco products and packaging changes. They also used repeated 'corporate responsibility' messages that were, according to the industry's own research, likely to be ignored.ConclusionsTobacco companies have expanded on cigarette pack-based advertising. Twenty-first century onserts simultaneously seek to increase sales using materials that are novel, attractive and provide independent value, while undercutting public health messages about the risks of tobacco use using materials that repeat over time and are comparatively unattractive. Health authorities can use this industry research to mandate onserts to communicate effective health messages.

Background/aimsThe aim of this investigation was to identify which design elements on Natural American Spirit packs are salient to (i.e., noticed by) U.S. adult smokers and what meanings smokers derive from these elements.MethodWe conducted a secondary analysis of qualitative data from a study of cigarette packaging design. U.S. adult smokers ( n = 33) from all nine census regions participated in six telephone-based focus groups in March 2017. We used constant comparison analysis to identify key themes.ResultsFour themes were identified, two focused on salient design elements and two focused on design element meanings. The themes of "bright and flashy color" and "the American Indian logo" were identified as key design elements, while the themes of "healthy and safer" and "targeting at-risk smokers" were identified as meanings smokers derived from design elements.ConclusionsPack design elements influence smokers' perceptions about reduced health risk of Natural American Spirit cigarettes and may be especially dangerous to vulnerable populations, including young adults and American Indians. Findings from this study suggest that the banning of text descriptors may not be enough to address misconceptions about "healthier" cigarettes.

ObjectiveTo analyse the tobacco industry's strategy of using trade and investment agreements to prevent the global diffusion of standardised packaging (SP) of tobacco products.MethodsReview of tobacco industry documents, relevant government documents and media items. The data were triangulated and thematically analysed.ResultsInternal tobacco industry documents reveal that during the early 1990s, tobacco companies developed a multipronged trade strategy to prevent the global diffusion of progressive tobacco packaging and labelling proposals, including SP. This strategy consisted of (1) framing the health issue in terms of trade and investment, (2) detailing alleged legal violations concerning trade barriers, intellectual property and investment rights, (3) threatening legal suits and reputational damage, and (4) garnering third-party support. These efforts helped delay SP until 2010 when Australia became the first country to reintroduce SP proposals, followed by governments in the UK and New Zealand in 2012, Ireland in 2013 and France in 2014. Review of government documents and media sources in each of the five countries indicate the industry continues to employ this multipronged strategy throughout the SP policy's progression. Although this strategy is tailored towards each domestic context, the overall tobacco industry's trade strategy remains consistently focused on shifting the attention away from public health and towards the realm of trade and investment with more corporate-friendly allies.ConclusionGovernments seeking to implement SP need to be prepared to resist and counter the industry's multipronged trade strategy by avoiding trade diversions, exposing false industry legal and reputational claims, and monitoring third-party support.

This study examines how health advocates and the Australian government responded to international commercial pressure during the implementation of tobacco standardised packaging (SP) as a measure to reduce non-communicable diseases (NCDs). Relevant government and NGO documents, and media items were reviewed. Policymakers and health advocates (n = 19) in Australia were interviewed. In 2009, Australia's National Health Taskforce recommended SP, which the Australian government announced in April 2010. In response, tobacco companies threatened the government with litigation in both domestic and international courts, claiming that SP would violate their investment and intellectual property rights. However, these legal threats were unsuccessful in forcing the government to withdrawal the SP proposal. Tobacco companies legally challenged SP, but as of February 2018 failed with each legal challenge. The political success of enacting and implementing SP against international commercial pressure was supported by legal preparation and support, and a whole-of-government approach. The Australian SP case illustrates how, against international commercial opposition, governments can build and maintain political and official support to enact and implement progressive public health measures to reduce NCDs.

BackgroundBeginning in the 1960s in the USA and globally since 1998, tobacco companies have beenaggressively promoting heated tobacco products (HTP). In 2016, Philip Morris International (PMI) applied to the US Food and Drug Administration (FDA) seeking authorisation to market their IQOS HTP system and flavoured 'HeatSticks' in the USA as a modified-risk tobacco product (MRTP).MethodsWe systematically evaluated the publicly available data PMI submitted to FDA in its MRTP application to determine whether PMI's IQOS product meets the US Tobacco Control Act's standard for MRTP claims. We examined whether PMI provided sufficient data showing tobacco users will not initiate with IQOS, that youth will not misperceive the MRTP-related claims being made concerning IQOS, and how youth perceive health risks associated with IQOS.ResultsPMI's own studies failed to provide evidence that youth, including non-users and former users, will not find IQOS appealing, will not initiate use of IQOS and will not perceive these products as risk-free. Further, PMI did not refer to independent studies conducted among adolescents which could influence their conclusions. Finally, their studies suffered from design and implementation flaws and cannot be relied on to support the proffered claims.ConclusionPMI's own data and available evidence from scientific studies conducted independent of the tobacco industry regarding how novel tobacco products are currently being marketed suggest that introduction of IQOS will result in adolescent and young adult non-users initiating tobacco use with IQOS and could also increase poly-use of IQOS along with other tobacco products.

BackgroundBeginning in the 1960s in the USA and globally since 1998, tobacco companies have beenaggressively promoting heated tobacco products (HTP). In 2016, Philip Morris International (PMI) applied to the US Food and Drug Administration (FDA) seeking authorisation to market their IQOS HTP system and flavoured 'HeatSticks' in the USA as a modified-risk tobacco product (MRTP).MethodsWe systematically evaluated the publicly available data PMI submitted to FDA in its MRTP application to determine whether PMI's IQOS product meets the US Tobacco Control Act's standard for MRTP claims. We examined whether PMI provided sufficient data showing tobacco users will not initiate with IQOS, that youth will not misperceive the MRTP-related claims being made concerning IQOS, and how youth perceive health risks associated with IQOS.ResultsPMI's own studies failed to provide evidence that youth, including non-users and former users, will not find IQOS appealing, will not initiate use of IQOS and will not perceive these products as risk-free. Further, PMI did not refer to independent studies conducted among adolescents which could influence their conclusions. Finally, their studies suffered from design and implementation flaws and cannot be relied on to support the proffered claims.ConclusionPMI's own data and available evidence from scientific studies conducted independent of the tobacco industry regarding how novel tobacco products are currently being marketed suggest that introduction of IQOS will result in adolescent and young adult non-users initiating tobacco use with IQOS and could also increase poly-use of IQOS along with other tobacco products.

BackgroundOver two-thirds of Natural American Spirit (NAS) smokers believe their cigarettes might be 'less harmful', but toxicological evidence does not support this belief. We assessed whether standardised packaging could reduce the possibility of erroneous inferences of 'safety' drawn from NAS cigarette packaging.MethodsUS adult smokers (n=909) were recruited to a between-subject survey experiment (3 brands×3 packaging/labelling styles) through Amazon Mechanical Turk and rated their perception of whether a randomly assigned cigarette package conveyed that the brand was 'safer' on a three-item scale (Cronbach's α=0.92). We assessed whether NAS packs were rated higher on the 'implied safety' scale than two other brands and estimated the effect that plain packaging (ie, all branding replaced with a drab dark brown colour) and Australian-like packaging (ie, all branding replaced with a drab dark brown colour and a graphic image and text on 75% of the pack surface) had on perceptions of the NAS cigarette package.ResultsSmokers' ratings of the standard NAS pack on the implied safety scale (mean=4.6; SD=2.9) were 1.9 times (P

BACKGROUND:Over two-thirds of Natural American Spirit (NAS) smokers believe their cigarettes might be 'less harmful', but toxicological evidence does not support this belief. We assessed whether standardised packaging could reduce the possibility of erroneous inferences of 'safety' drawn from NAS cigarette packaging. METHODS:US adult smokers (n=909) were recruited to a between-subject survey experiment (3 brands×3 packaging/labelling styles) through Amazon Mechanical Turk and rated their perception of whether a randomly assigned cigarette package conveyed that the brand was 'safer' on a three-item scale (Cronbach's α=0.92). We assessed whether NAS packs were rated higher on the 'implied safety' scale than two other brands and estimated the effect that plain packaging (ie, all branding replaced with a drab dark brown colour) and Australian-like packaging (ie, all branding replaced with a drab dark brown colour and a graphic image and text on 75% of the pack surface) had on perceptions of the NAS cigarette package. RESULTS:Smokers' ratings of the standard NAS pack on the implied safety scale (mean=4.6; SD=2.9) were 1.9 times (P

IntroductionPrior to the US Food and Drug Administration's (FDA) regulation of electronic cigarettes and warning statements related to nicotine addiction, there was no critical examination of manufacturer/distributor voluntary practices that could potentially inform FDA actions aimed to protect consumers. This study examined the content of warning statements and safety characteristics of electronic cigarette liquid bottles using a national sample.MethodsResearch staff randomly selected four electronic cigarette liquid manufacturers/distributors from four US geographic regions. Staff documented the characteristics of product packaging and content of warning statements on 147 electronic cigarette liquids (0-30 mg/ml of nicotine) purchased online from 16 manufacturers/distributors in April of 2016.ResultsData showed that 97.9% of the electronic cigarette liquid bottles included a warning statement, most of which focused on nicotine exposure rather than health. Only 22.4% of bottles used a warning statement that indicated the product "contained nicotine." Of bottles that advertised a nicotine-based concentration of 12 mg/ml, 26% had a warning statements stated that the product "contains nicotine." None of the statements that indicated that the product "contained nicotine" stated that nicotine was "addictive." All bottles had a safety cap and 12% were in plastic shrink-wrap. Fifty-six percent of the websites had a minimum age requirement barrier that prevented under-aged persons from entering.ConclusionsMost manufacturers/distributors printed a warning statement on electronic cigarette liquid bottles, but avoided warning consumers about the presence and the addictiveness of nicotine. Studies are needed to examine manufacturer/distributor modifications to product packaging and how packaging affects consumer behaviors.ImplicationsThese data can inform future FDA requirements related to the packaging and advertising of e-cigarette liquids; regulation related to the content of warning statements, including exposure warning statements, which are not currently mandated; and requirements on websites or language on packaging to help manufacturers adhere to the minimum age of purchase regulation. The data can also be used to help FDA develop additional guidance on the framing of statements on packaging that helps consumers make informed decisions about purchasing the product or protecting young people from use or unintentional exposure to the product.

Although smoking declines in the United States, the prevalence of male adolescent smokeless tobacco (ST; moist snuff and chewing tobacco) use remains unchanged. ST product characteristics, such as flavoring, packaging, and branding, could influence adolescents' ST initiation and continued use. This qualitative study examines the potential role of product characteristics in shaping ST-related perceptions and behaviors among rural adolescent males. Semi-structured individual interviews were conducted at three California rural high schools. ST users were asked about their experiences and perceptions related to product characteristics. Interviews were transcribed, coded, and analyzed using a general inductive approach. Participants associated flavored ST with appealing non-tobacco products, such as chewing gum and alcohol. Availability of different varieties and flavors stimulated interest and curiosity in sampling or switching between ST products. Time-limited promotional flavors and packaging also enhanced product appeal. Adolescent ST users preferred certain brands based on perceived brand features and perceived nicotine content, associating higher-strength brands as better suited for experienced ST users. Brand preferences frequently reflected perceived ST brand popularity within peer groups. Based on these observations, potential ST regulation and health education campaigns to address misconceptions about ST characteristics could influence adolescents' ST-related perceptions and reduce ST use among this vulnerable population.

BackgroundThe shipment of human islets (IE) from processing centers to distant laboratories is beneficial for both research and clinical applications. The maintenance of islet viability and function in transit is critically important. Gas-permeable silicone rubber membrane (SRM) vessels reduce the risk of hypoxia-induced death or dysfunction during high-density islet culture or shipment. SRM vessels may offer additional advantages: they are cost-effective (fewer flasks, less labor needed), safer (lower contamination risk), and simpler (culture vessel can also be used for shipment).MethodIE were isolated from two manufacturing centers and shipped in 10-cm(2) surface area SRM vessels in temperature- and pressure-controlled containers to a distant center after at least 2 days of culture (n = 6). Three conditions were examined: low density (LD), high density (HD), and a microcentrifuge tube negative control (NC). LD was designed to mimic the standard culture density for IE preparations (200 IE/cm(2)), while HD was designed to have a 20-fold higher tissue density, which would enable the culture of an entire human isolation in 1-3 vessels. Upon receipt, islets were assessed for viability (measured by oxygen consumption rate normalized to DNA content [OCR/DNA)]), quantity (measured by DNA), and, when possible, potency and function (measured by dynamic glucose-stimulated insulin secretion measurements and transplants in immunodeficient B6 Rag(+/-) mice). Postshipment OCR/DNA was not reduced in HD vs LD and was substantially reduced in the NC condition. HD islets exhibited normal function postshipment. Based on the data, we conclude that entire islet isolations (up to 400,000 IE) may be shipped using a single, larger SRM vessel with no negative effect on viability and ex vivo and in vivo function.

In its graphic warning label regulations on cigarette packages, the Food and Drug Administration severely discounts the benefits of reduced smoking because of the lost "pleasure" smokers experience when they stop smoking; this is quantified as lost "consumer surplus." Consumer surplus is grounded in rational choice theory. However, empirical evidence from psychological cognitive science and behavioral economics demonstrates that the assumptions of rational choice are inconsistent with complex multidimensional decisions, particularly smoking. Rational choice does not account for the roles of emotions, misperceptions, optimistic bias, regret, and cognitive inefficiency that are germane to smoking, particularly because most smokers begin smoking in their youth. Continued application of a consumer surplus discount will undermine sensible policies to reduce tobacco use and other policies to promote public health.

In its graphic warning label regulations on cigarette packages, the Food and Drug Administration severely discounts the benefits of reduced smoking because of the lost "pleasure" smokers experience when they stop smoking; this is quantified as lost "consumer surplus." Consumer surplus is grounded in rational choice theory. However, empirical evidence from psychological cognitive science and behavioral economics demonstrates that the assumptions of rational choice are inconsistent with complex multidimensional decisions, particularly smoking. Rational choice does not account for the roles of emotions, misperceptions, optimistic bias, regret, and cognitive inefficiency that are germane to smoking, particularly because most smokers begin smoking in their youth. Continued application of a consumer surplus discount will undermine sensible policies to reduce tobacco use and other policies to promote public health.