Introduction of standardised packaging and availability of illicit cigarettes: a difference-in-difference analysis of European Union survey data 2015-2018.

Standardised packaging of tobacco products is intended to reduce the appeal of smoking, but the tobacco industry claims this increases illicit trade. We examined the percentage of people reporting being offered illicit cigarettes before and after full implementation of standardised packaging in the UK, Ireland and France and compared this to other European Union countries. Reported ever illicit cigarette exposure fell from 19.8% to 18.1% between 2015 and 2018 in the three countries fully implementing the policy, and from 19.6% to 17.0% in control countries (p for difference=0.320). Standardised packaging does not appear to increase the availability of illicit cigarettes.

Health and Economic Impact of Health Warnings and Plain Tobacco Packaging in Seven Latin American Countries: Results of a Simulation Model.

INTRODUCTION: The burden of disease attributable to tobacco use in Latin America is very high. Our objective was to evaluate the 10-year potential impact of current legislation related to cigarette packaging and warnings and expected effects of moving to a higher level of strategies implementing cigarette plain packaging on health and cost outcomes in Argentina, Bolivia, Brazil, Chile, Colombia, Mexico, and Peru, using a microsimulation model. AIMS AND METHODS: We used a probabilistic state-transition microsimulation model, considering natural history, costs, and quality of life losses associated with main tobacco-related diseases. We followed up individuals in hypothetical cohorts and calculated health outcomes annually to obtain aggregated long-term population health outcomes and costs. We performed a literature review to estimate effects and analyzed studies and information from ministries, relevant organizations, and national surveys. We calibrated the model comparing the predicted disease-specific mortality rates with local statistics. RESULTS: Current graphic warnings already in place in each country could avert, during 10 years, 69 369 deaths and 638 295 disease events, adding 1.2 million years of healthy life and saving USD 5.3 billion in the seven countries. If these countries implemented plain packaging strategies, additional 155 857 premature deaths and 4 133 858 events could be averted, adding 4.1 million healthy years of life and saving USD 13.6 billion in direct health care expenses of diseases attributable to smoking. CONCLUSIONS: Latin American countries should not delay the implementation of this strategy that will alleviate part of the enormous health and financial burden that tobacco poses on their economies and health care systems. IMPLICATIONS: Tobacco smoking is the single most preventable and premature mortality cause in the world. The Framework Convention on Tobacco Control, supported by the World Health Organization, introduced a package of evidence-based measures for tobacco control. This study adds evidence on the potential health effects and savings of implementing cigarette plain packaging in countries representing almost 80% of the Latin American population; findings are valuable resources for policy makers in the region.

Flavor Capsule Variants' Performance in a "Dark Market": Implications for Standardized Packaging.

BACKGROUND: By increasing excise taxes, eliminating tobacco marketing, and requiring standardized (plain) packaging of tobacco products, governments internationally have reduced smoking's allure. Yet product innovations, such as flavor capsule variants (FCVs), remain unregulated and may appeal to non-smokers. We examined the growth of FCVs in a country with a progressive policy environment. METHODS: Each year, New Zealand tobacco companies must provide details of the number of cigarette sticks released for each brand and variant to the Ministry of Health. We used this information to analyze FCVs' performance for British American Tobacco (BAT) and Philip Morris International (PMI), which account for a large proportion of New Zealand tobacco sales. We report the quantity released of each variant and share of parent brand portfolio, and examine growth patterns within the premium, everyday, and value market subsections. RESULTS: BAT introduced FCVs in 2012 and by 2014 offered FCVs in all market subsections; PMI introduced a Marlboro FCV in 2014. FCVs grew rapidly relative to unflavored variants and, by 2017, represented nearly 10% of BAT's product portfolio and more than 3% of PMI's product portfolio. By 2017, FCVs accounted for more than a third of the Dunhill sticks released, 14% of Holiday, and 17% of Pall Mall. CONCLUSIONS: FCVs' rapid growth may have reduced declines in the numbers of sticks released. Policy makers should disallow FCV innovations, which offer no health benefits to smokers and may instead attract non-smokers to smoking. Where timely, these regulations could be incorporated into standardized packaging policies. IMPLICATIONS: FCVs have grown quickly in countries with comprehensive tobacco marketing restrictions, which suggests tobacco companies are now focusing on novel product designs to attract new smokers. Standardized packaging regulations could address both external packaging and stick design innovations, such as FCVs; alternatively, specific regulations prohibiting FCVs may be required.

Consumer Perceptions of Cigarette Design in France: A Comparison of Regular, Slim, Pink and Plain Cigarettes.

INTRODUCTION: The cigarette, like the cigarette pack, is used by tobacco companies as a promotional tool. We explore how the cigarette could potentially be used as a dissuasive tool. METHODS: An online survey was conducted with 15-30-year-old smokers and nonsmokers (N = 998) in France to explore their perceptions of a plain cigarette (gray with no brand name) and three branded cigarettes (regular, slim, pink). Participants were randomly assigned to view the plain cigarette and either the regular, slim, or pink cigarette. They were asked to rate the cigarettes by Appeal (tastiest, highest quality, and most expensive), Harm (most dangerous and most effective for motivating people to talk about tobacco dangers), and Perceived behavioral impact (most effective to convince teenagers not to start and to motivate smokers to reduce consumption and quit). RESULTS: In comparison to the gray cigarette, each of the branded cigarettes were considered more appealing, less harmful, and more likely to motivate teenagers to start and less likely to motivate smokers to reduce consumption or quit. CONCLUSIONS: The study suggests that altering the appearance of the cigarette may reduce cigarette appeal, increase harm perceptions, and deter both young people and smokers. IMPLICATIONS: Very little research has focused on dissuasive cigarettes whereas the cigarette stick has become very important for tobacco companies for communication purposes. This is the first study to compare the effect of various branded cigarettes (regular, slim, and pink) with a plain gray cigarette on young adult smokers and nonsmokers. The findings suggest that a plain gray cigarette can reduce cigarette appeal, increase perceptions of harm, and may deter use among both smokers and nonsmokers.

Introduction of Standardized Tobacco Packaging During a 12-Month Transition Period: Findings From Small Retailers in the United Kingdom.

INTRODUCTION: Factory-made cigarettes (FMC) and roll-your-own (RYO) tobacco have had to be produced in standardized packaging since May 20, 2016 in the United Kingdom, with a minimum pack size of 20 sticks for FMC and 30 g for RYO. Manufacturers and retailers were given a 12-month transition period. METHODS: An observational study was conducted using monthly Electronic Point of Sale data from 500 small retailers in England, Scotland, and Wales, between May 2016 and May 2017. The 20 top selling tobacco products (15 FMC, 5 RYO) were monitored to observe when standardized packs were first introduced, the proportion of retailers selling each fully branded and standardized product, and the average number of monitored fully branded and standardized products sold by each retailer. The number of unique tobacco-related product codes sold by each retailer was also recorded each month. RESULTS: Eighteen of the fully branded products continued to be sold throughout the transition period and no standardized variants were sold in the first 5 months. It was not until month eleven that the average number of standardized products sold by retailers exceeded the fully branded products. The average number of unique tobacco-related product codes sold by each retailer decreased by a third over the transition period. CONCLUSIONS: Tobacco companies used the transition period to delay the removal of fully branded products and gradually introduce standardized variants. This staggered introduction may have mitigated some of the immediate intended effects of the legislation by desensitizing consumers to new pack designs. IMPLICATIONS: Evaluation research from countries which have introduced standardized packaging for tobacco products is key to help inform future implementation. This is the first study to monitor the transition from fully branded to standardized products using real-time retail data. The findings demonstrate that tobacco companies delayed the introduction of standardized products and removal of fully branded packaging. Countries seeking to introduce standardized packaging should consider what length of transition is allowed, as the protracted 12-month period in the United Kingdom appeared longer than needed to transition stockholding and may have mitigated immediate intended effects by desensitizing consumers to new pack designs.

Evidence From Qualitative Studies of Youth About the Impacts of Tobacco Control Policy on Young People in Europe: A Systematic Review.

INTRODUCTION: A range of tobacco control policies endeavor to prevent smoking uptake in young people, yet relatively little is known about how such interventions impact young people's engagement with smoking. We reviewed existing qualitative evidence on young people and smoking in Europe to assess whether, in what ways and why young people comply with, adapt to, resist, or circumvent tobacco control policies in their respective countries. METHODS: We undertook a systematic review of academic literature presenting qualitative research from Europe on smoking and young people (11-18 years), published from 2000 to 2015. Bibliographic searches (PubMed, PsycInfo, SSCI) produced 1357 records, from which 43 relevant articles were assessed for quality and 39 included in the review. RESULTS: Most studies were from the United Kingdom (27), with a small number (one or two each) from other European countries (Denmark, Sweden, Switzerland, Belgium, Cyprus, Greece, Hungary, Ireland, and Spain). Only 16 articles (11 from United Kingdom) provided any evidence about the impacts of tobacco control policies on young people's smoking. These focused on smoke-free legislation (four), age of sale laws (four), plain packaging (three), and black market tobacco (one). CONCLUSIONS: There is very little qualitative evidence exploring the impacts of tobacco control on youth smoking in Europe. To develop more effective smoking prevention policies that take account of local political, social, and cultural contexts, more qualitative research from a wider range of European countries is needed to understand how tobacco control impacts on young people's social worlds and smoking behaviors. IMPLICATIONS: Smoking is the leading cause of premature mortality in Europe. However, there is little qualitative evidence exploring the impact of tobacco control policies on young people in Europe. Most comes from the United Kingdom and focuses on a narrow range of policies. Thus, we have a limited understanding of how and in what ways tobacco control policies reach young people, their engagement with these, and how local context affects their impact. More qualitative research is needed, from a wider range of countries and on a broader range of tobacco control policies, to strengthen the evidence-base for reducing youth smoking.

The Response of Retailers in Scotland to the Standardised Packaging of Tobacco Products Regulations and Tobacco Products Directive.

INTRODUCTION: With most marketing channels prohibited, the retail environment has assumed greater importance for tobacco companies, even in markets with a ban on the open display of tobacco products. Research has yet to qualitatively explore how retailers respond to standardized packaging in a country where this has been introduced. METHODS: As part of the DISPLAY study, face-to-face interviews were conducted with 24 small retailers in Scotland between May 23 and June 26, 2017; the interviews were conducted after The Standardised Packaging of Tobacco Products Regulations and the Tobacco Products Directive were fully implemented. RESULTS: We found high retailer compliance with the legislation. With price-marked packs and packs containing less than 20 cigarettes and 30 g of rolling tobacco banned, retailers stated that this helped simplify ordering and stock management. The removal of price-marked packs also allowed them some flexibility to set their own prices, but many chose to stick closely to recommended retail price in order to remain competitive and avoid complaints from customers. In contrast to one of the tobacco industry's arguments against standardized packaging, most retailers suggested that transaction times had not increased, even though the changes had only recently come into force. CONCLUSIONS: This study challenges some of the arguments used against standardized packaging and provides an insight into the storage and pricing strategies adopted by retailers following the removal of price-marked packs. IMPLICATIONS: This study explores the response of the retailers to the introduction of standardized tobacco packaging and provides an insight into the storage and pricing strategies adopted by retailers following the removal of price-marked packs. It explores the importance of the retailer in tobacco companies' desire to maintain tobacco sales and challenges some of the arguments used against standardized packaging, such as an increase in transaction times. Countries seeking to introduce standardized packaging should monitor the experiences of retailers, preferably from preimplementation through to post implementation, to help understand how retailers respond to this policy and to inform compliance.

Difference between recommended retail price and sales price for tobacco products in independent and convenience (small) retailers before and after the introduction of standardised tobacco packaging in the UK.

AIM: Recommended retail price (RRP) is a marketing strategy used by tobacco companies to maintain competitiveness, communicate product positioning and drive sales. We explored small retailer adherence to RRP before and after the introduction of the Standardised Packaging of Tobacco Products Regulations in the UK (fully implemented on 20 May 2017) which mandated standardised packaging of cigarettes and rolling tobacco, set minimum pack/pouch sizes and prohibited price-marking. METHOD: Monthly electronic point of sale data from 500 small retailers in England, Scotland and Wales were analysed. From May 2016 to October 2017, we monitored 20 of the best-selling fully branded tobacco products (15 factory-made cigarettes, 5 rolling tobacco) and their standardised equivalents. Adherence to RRP was measured as the average difference (%) between monthly RRPs and sales prices by pack type (fully branded vs standardised), price-marking on packaging and price segment. RESULTS: The average difference between RRP and sales price increased from +0.36% above RRP (SD=0.72) in May 2016, when only fully branded packs were sold, to +1.37% in October 2017 (SD=0.30), when standardised packs were mandatory. Increases above RRP for fully branded packs increased as they were phased out, with deviation greater for non-price-marked packs and premium products. DISCUSSION: Despite tobacco companies emphasising the importance of RRP, small retailers implemented small increases above RRP as standardised packaging was introduced. Consequently, any intended price changes by tobacco companies in response to the legislation (ie, to increase affordability or brand positioning) may be confounded by retailer behaviour, and such deviation may increase consumer price sensitivity.

Standardised snus packaging reduces brand differentiation: a web-based between-subject experiment.

BACKGROUND: Perceptions of tobacco packaging may be consequential for consumption and initiation. We explored the potential effect of standardised packaging on young adults' ratings of the appeal of brands of snus (Swedish moist snuff) and on their perceptions of typical users of these brands. We were interested in both the effects on average levels of ratings and on the within-subject variability of the ratings. The latter was used as a measure of the extent to which individuals can differentiate between brands. METHODS: A sample of 625 Norwegians aged 16-30 were randomly allocated to one of three between-subject conditions: Branded Packaging, Standardised Packaging, or Standardised Packaging with Health Warnings. The participants rated 10 snus brands on measures of general appeal and on their perceptions of the typical brand user (e.g., "… is sporty and active"). RESULTS: The standardised packages (without health warnings) were not rated more negatively than the branded packages, while the standardised packages with health warnings were rated slightly more negatively than the branded packages. However, in terms of within-subject standard deviations, the variability of the brand ratings across the packages was substantially lower for standardised packaging types in comparison to branded packages. CONCLUSIONS: Even in cases where standardised tobacco packaging appears to have little overall effect on the valence of the average ratings, it can have a strong effect on the variability of the ratings. This suggests that standardised packaging can reduce the potential for brand differentiation.

Adolescents' perceptions of standardised cigarette packaging design and brand variant name post-implementation: a focus group study in Scotland.

BACKGROUND: The United Kingdom (UK) fully-implemented standardised packaging for cigarettes and rolling tobacco on 20th May 2017. We explore adolescent's awareness of, and responses to, standardised cigarette packaging in the UK after it became mandatory. METHODS: Eight focus groups were conducted in schools in Scotland with 16-17 year-olds (n = 41), between November 2017 and November 2018, to explore awareness of, and responses to, standardised cigarette packaging. Unlike in Australia, where only straight-edged flip-top cigarette packs are permitted, in the UK standardised cigarette packs can have slim designs, and different edge types (straight, rounded or bevelled) and opening styles (flip-top or shoulder box). We explored how each of these pack formats was perceived. We also explored to what extent brand variant name differentiated cigarettes sold in standardised packaging. RESULTS: Most participants were aware of standardised packaging without being shown pack stimuli. Standardised packs were considered embarrassing and off-putting, and the health warnings salient. Among the standardised packs shown, there was a preference for the slimmer pack, viewed as more discrete and the cigarettes potentially less harmful, and the shoulder box, considered cool and different. Participants were interested in some brand variant names on standardised packs (e.g. Legendary Black), particularly those they considered to imply coolness and sophistication. CONCLUSION: Adolescents consider standardised cigarette packs in the UK unappealing, and the warnings salient, two core aims of this measure. However, positive reactions to some of the standardised packs (slimmer pack, shoulder box), and variant names used, has implications for countries developing standardised packaging regulations.

Analysis of phthalate esters in two different baby care products available in United Arab Emirates.

Phthalates are used as plasticizers in a wide range of products and are known to affect the human health adversely. Hence, the present study was carried out to identify and quantify the presence of four phthalates namely dimethyl phthalate (DMP), dibutyl phthalate (DBP), and diethyl phthalate (DEP), di (2-ethylhexyl) phthalate (DEHP) in the two baby products i.e. baby oils and baby lotions. The daily exposure levels and hazard index of each phthalate were also calculated. It was an analytical study where two different brands of samples of baby oil and baby lotion each, from the date of manufacturing of 3, 10, and 20 months were collected. The extraction of phthalates from different samples was done and analyzed using HPTLC. Results showed the presence of all four phthalates, although some phthalates were not present in 3 M samples. The maximum concentration of all the phthalates was found in 20 M samples. Their concentration increased with the storage time indicating the possibility of leaching and migration of phthalates from the container into the product. The hazard indices for phthalates estimated for baby oil and baby lotion were found below 1, which denotes that the daily phthalate exposures are within the regulatory limits. It is important to consider that the exposure to phthalates can occur not only by dermal contact of these baby products but also through other routes. Hence, the study signifies the importance of phthalates concentration in such regularly used products.

Phospholipid composition of packed red blood cells and that of extracellular vesicles show a high resemblance and stability during storage.

Red blood cells (RBCs) are stored up to 35-42days at 2-6°C in blood banks. During storage, the RBC membrane is challenged by energy depletion, decreasing pH, altered cation homeostasis, and oxidative stress, leading to several biochemical and morphological changes in RBCs and to shedding of extracellular vesicles (EVs) into the storage medium. These changes are collectively known as RBC storage lesions. EVs accumulate in stored RBC concentrates and are, thus, transfused into patients. The potency of EVs as bioactive effectors is largely acknowledged, and EVs in RBC concentrates are suspected to mediate some adverse effects of transfusion. Several studies have shown accumulation of lipid raft-associated proteins in RBC EVs during storage, whereas a comprehensive phospholipidomic study on RBCs and corresponding EVs during the clinical storage period is lacking. Our mass spectrometric and chromatographic study shows that RBCs maintain their major phospholipid (PL) content well during storage despite abundant vesiculation. The phospholipidomes were largely similar between RBCs and EVs. No accumulation of raft lipids in EVs was seen, suggesting that the primary mechanism of RBC vesiculation during storage might not be raft -based. Nonetheless, a slight tendency of EV PLs for shorter acyl chains was observed.

Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States.

Introduction: Prior 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. Methods: Research 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. Results: Data 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. Conclusions: Most 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. Implications: These 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.

Standardised cigarette packaging may reduce the implied safety of Natural American Spirit cigarettes.

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 <0.001) higher than smokers' ratings of a Marlboro Red pack (mean=2.4; SD=2.3) and 1.7 times (P <0.001) higher than smokers' ratings of a Newport Menthol pack (mean=2.7; SD=2.4). These perceptions of implied safety were lower when plain packaging was used (Cohen's d=0.66; P <0.001) and much lower when Australian-like packaging was used (Cohen's d=1.56; P <0.001). CONCLUSION: The results suggest that NAS cigarette packaging conveys that its cigarettes are 'safer' and that such perceptions are lower with standardised packaging, both with and without warning images.

Can't see the woods for the trees: exploring the range and connection of tobacco industry argumentation in the 2012 UK standardised packaging consultation.

INTRODUCTION: Transnational tobacco company (TTC) submissions to the 2012 UK standardised packaging consultation are studied to examine TTC argumentation in the context of Better Regulation practices. METHODS: A content analysis was conducted of Philip Morris International and British American Tobacco submissions to the 2012 UK consultation. Industry arguments concerning expected costs and (contested) benefits of the policy were categorised into themes and frames. The inter-relationship between frames through linked arguments was mapped to analyse central arguments using an argumentation network. RESULTS: 173 arguments were identified. Arguments fell into one of five frames: ineffectiveness, negative economic consequences, harm to public health, increased crime or legal ramifications. Arguments highlighted high costs to a wide range of groups, including government, general public and other businesses. Arguments also questioned the public health benefits of standardised packaging and highlighted the potential benefits to undeserving groups. An increase in illicit trade was the most central argument and linked to the greatest variety of arguments. CONCLUSIONS: In policy-making systems characterised by mandatory impact assessments and public consultations, the wide range of cost (and contested benefits) based arguments highlights the risk of TTCs overloading policy actors and causing delays in policy adoption. Illicit trade related arguments are central to providing a rationale for these arguments, which include the claim that standardised packaging will increase health risks. The strategic importance of illicit trade arguments to industry argumentation in public consultations underlines the risks of relying on industry data relating to the scale of the illicit trade.

Impact of plain packaging of cigarettes on the risk perception of Uruguayan smokers: an experimental study.

BACKGROUND: Uruguay, a South American country of 3.4 million inhabitants that has already banned tobacco advertising, prohibited such terms as light, mild and low-tar and required graphic warnings covering 80% of cigarette packs, is considering the imposition of plain, standardised packaging. METHODS: We conducted an experimental choice-based conjoint analysis of the impact of alternative cigarette package designs on the risk perceptions of 180 adult current Uruguayan smokers. We compared plain packaging, with a standardised brand description and the dark brown background colour required on Australian cigarette packages, to two controls: the current package design with distinctive brand elements and colours; and a modified package design, with distinctive brand elements and the dark brown background colour. Graphic warnings were also varied. RESULTS: Plain packaging significantly reduced the probability of perceiving the stimulus cigarettes as less harmful in comparison to the current package design (OR 0.398, 95% CI 0.333 to 0.476, p<0.001) and the modified package design (OR 0.729, 95% CI 0.626 to 0.849, p<0.001). CONCLUSIONS: Plain packaging enhanced the perceived risk of cigarette products even in a highly regulated setting such as Uruguay. Both the elimination of distinctive brand elements and the use of Australia's dark brown background colour contributed to the observed effect.

How tobacco companies in the United Kingdom prepared for, and responded to, standardised packaging of cigarettes and rolling tobacco.

INTRODUCTION: As a result of the Standardised Packaging of Tobacco Products Regulations and Tobacco Products Directive, all packs of cigarettes (factory-made and hand-rolled) in the UK must be drab brown, display pictorial warnings on the principal display areas and contain no less than 20 cigarettes or 30 g of tobacco. The legislation was phased in between May 2016 and May 2017. Our objective was to monitor pack, brand and product changes preimplementation and postimplementation. METHODS: Our surveillance of the cigarette market involved a review of the trade press, a monthly monitor of online supermarkets and regular visits to stores, from May 2015 to June 2017. RESULTS: Before standardised packaging there were changes to the pack graphics (eg, redesigned packs and limited editions) and pack structure (eg, resealable inner foil) and the issue of a number of reusable tins. After standardised packaging, changes included newer cigarette pack sizes for some brand variants (eg, 23 and 24 packs). Changes to the branding prestandardised packaging included brand extensions, and poststandardised packaging included brand and/or variant name change, often with the inclusion of colour descriptors and brand migrations. Product changes prestandardised packaging included the introduction of novel filters (eg, filters with two flavour-changing capsules, tube filters, firmer filters and filters with granular additives). There was non-compliance with the legislation, with slim packs, which are not permitted, on sale after standardised packaging was implemented. CONCLUSIONS: Our findings highlight the need to monitor developments in markets introducing standardised packaging and have policy implications for countries considering this measure.

Observed smoking and tobacco pack display in Australian outdoor cafés 2 years after implementation of plain packaging.

Background: Implementation of tobacco plain packaging (PP) in Australia in December 2012 was associated with significant reductions in the percentage of patrons at outdoor cafés observed to be displaying tobacco packs and actively smoking, immediately post-implementation and 1 year later. This study examines whether these positive effects were sustained through to 2 years post-PP. Methods: An observational study conducted at cafés, restaurants and bars with outdoor seating in Melbourne, Australia documented the number of: patrons; patrons actively smoking; tobacco packs on display; orientation and type of displayed packs and whether or not children were present. Data were collected pre-PP (2012), early post-PP (2013), 1 year post-PP (2014) and 2 years post-PP (2015). Multilevel Poisson regressions analyzed changes in each outcome, adjusting for important covariates. Results: Overall, positive effects of PP implementation on tobacco pack display and active smoking were not fully sustained through to 2 years post-PP for the total sample. Interactions between phase and the presence of children indicated that pack display and active smoking were lower in all post-implementation phases (compared with pre-PP) at venues where children were present but not at venues where children were not present. Conclusions: Children at outdoor cafés were still being exposed to less tobacco packaging and active smoking, 2 years after implementation of the packaging changes. More regular refreshment of graphic health warnings is likely to be required to sustain these effects, and to reduce pack display behaviour at venues with no children.

[Study of the deadlines for the use after sterilization of hot-sealable bags and sheaths]. / Étude des dates limites d'utilisation après stérilisation des sachets et gaines thermoscellables.

INTRODUCTION: The choice of packaging is crucial for the sterility of a reusable medical device. The use-by dates for sterile barrier systems (SBSs) are currently determined solely on the basis of an empirical rating scale developed in 1985. The objective of our work is to validate in a scientific way this deadline for the use of SBS for heat-sealable sleeves and bags, with protective packaging. MATERIALS AND METHODS: Thirty SBSs were tested after different storage periods ; six, nine and twelve months. They contained five different types of medical devices, followed the different sterilization steps and were stored in the operating room. The SBSs have or have not been folded in order to analyze this practice in our unit as well. Various tests were carried out on the paper side of the SBS, the plastic side and the welds. RESULTS: After 6 months of storage, SBS are still sterile. After 9 and 12 months, the results are more moderate. Folding the SBS will affect the weld, regardless of the storage time. DISCUSSION: This study allowed us to extend all our expiration dates up to 6 months, to stop the habit of folding the SBS and to become aware of the importance of having a size of SBS adapted to the different devices to be packaged and lastly, to protect the ends. CONCLUSION: Each sterilization unit must carry out its own study and risk analysis because the determination of shelf life periods depends on many factors.

Quality issues with malaria rapid diagnostic test accessories and buffer packaging: findings from a 5-country private sector project in Africa.

BACKGROUND: Use of antigen-detecting malaria rapid diagnostic tests (RDTs) has increased exponentially over the last decade. WHO's Global Malaria Programme, FIND, and other collaborators have established a quality assurance scheme to guide product selection, lot verification, transport, storage, and training procedures. Recent concerns over the quality of buffer packaging and test accessories suggest a need to include these items in product assessments. This paper describes quality problems with buffer and accessories encountered in a project promoting private sector RDT use in five African countries and suggests steps to avoid or more rapidly identify and resolve such problems. METHODS: Private provider complaints about RDT buffer vials and kit accessories were collected during supervisory visits, and a standard assessment process was developed. Using 100 tests drawn from six different lots produced by two manufacturers, lab technicians visually assessed alcohol swab packaging, blood transfer device (BTD) usability, and buffer appearance, then calculated mean blood volume from 10 BTD transfers and mean buffer volume from 10 individual buffer vials. WHO guided complaint reporting and follow-up with manufacturers. RESULTS: Supervisory visits confirmed user reports of dry alcohol swabs, poorly functioning BTDs, and non-uniform volumes of buffer. Lot testing revealed further evidence of quality problems, leading one manufacturer to replace buffer vials and accessories for 40,000 RDTs. In December 2014, WHO issued an Information Notice for Users regarding variable buffer volumes in single-use vials and recommended against procurement of these products until defects were addressed. DISCUSSION: Though not necessarily comprehensive or generalizable, the findings presented here highlight the need for extending quality assessment to all malaria RDT test kit contents. Defects such as those described in this paper could reduce test accuracy and increase probability of invalid, false positive, or false negative results. Such deficiencies could undermine provider confidence in RDTs, prompting a return to presumptive treatment or reliance on poor quality microscopy. In partial response to this experience, WHO, FIND, and other project partners have developed guidance on documenting, troubleshooting, reporting, and resolving such problems when they occur.