Changes in roll-your-own tobacco and cigarette sales volume and prices before, during and after plain packaging legislation in the UK.

BACKGROUND: Plain packaging and minimum pack size legislation for tobacco products was introduced in the UK in May 2016, with a 1-year sell-off period until May 2017, during which both fully branded and plain packs of various sizes were legally available. This study investigates trends in prices of roll-your-own tobacco (RYO) before, during and after implementation of this legislation, and compares trends with those observed in the cigarette market. METHODS: We used Nielsen Scantrack data for the period from March 2013 to June 2018 to describe trends in UK inflation-adjusted prices and volumes of both RYO and cigarettes, and linear regression to estimate changes in prices associated with the introduction of plain packaging and the minimum pack sizes of 30 g RYO and 20 cigarettes. RESULTS: In contrast to a downward trend in cigarette sales volumes, RYO volumes rose throughout the study period. By the time plain packs accounted for 75% or more of sales, the average price of products sold in equivalent pack sizes had increased, relative to average prices in the year before implementation and with adjustment for tax changes, from 34.9 to 38.8 pence per gram for RYO (mean difference 4.26, 95% CI 3.99 to 4.53 pence, 12% increase), and from 38.6 to 41.13 pence for cigarettes (mean difference 2.53, 95% CI 2.24 to 2.83 pence, 7% increase) per cigarette. CONCLUSIONS: New legislation resulted in higher prices for RYO and manufactured cigarettes. However, sales volumes of RYO continued to increase throughout the study period, perhaps because RYO remains a less expensive means of smoking tobacco.

The impact of plain packaging and health warnings on consumer appeal of cannabis products.

BACKGROUND: Canada implemented 'plain packaging' regulations and rotating health warnings for cannabis products upon legalizing non-medical cannabis in October 2018. Plain packaging and health warnings are effective policy measures for reducing appeal of tobacco products; however, there is little evidence in the cannabis domain. METHODS: An experimental task was conducted as part of the online International Cannabis Policy Study. Participants aged 16-65 from Canada (n = 9987) and US states with 'legal' (n = 7376) and 'illegal' (n = 9682) recreational cannabis were randomly assigned to see one of 18 cannabis product images. Outcomes were product appeal (0 = Not at all appealing, 10 = Very appealing) and perceived youth orientation (4 age groups). A 3 (branding: full branding, brand logo only, or plain black packaging) x 2 (health warning labels: present or absent) x 3 (product type: edible gummies, cannabis oil, or pre-rolled joints) factorial design was used. RESULTS: Compared to plain packaging or a brand logo, packages with full branding were considered more appealing and more likely to be youth-oriented (p < 0.001). Products with health warnings were considered less appealing than packages without warnings (p < 0.001). Edible gummies were perceived as more appealing and more likely to be youth-oriented than pre-rolled joints and cannabis oil (p < 0.001). Additionally, edible gummies were rated as significantly more appealing by 16-18 and 19-35-year-olds than by older adults (p < 0.02 for all). CONCLUSIONS: Comprehensive health warnings and 'plain packaging' regulations may reduce the appeal of cannabis products in a legal market. The results also provide empirical evidence that edible gummies are perceived to appeal to youth.

Regulating Cannabis Manufacturing: Applying Public Health Best Practices from Tobacco Control.

State legalization and regulation of cannabis, despite continued federal illegality, is a massive shift in regulatory approach. Manufactured cannabis, including concentrates, extracts, edibles, tinctures, topicals and other products, has received less attention than more commonly used dried flower, but represents emerging regulatory challenges due to additives, potency, consumption methods, and abuse and misuse potential. In November 2017, the California Department of Public Health (CDPH) released initial cannabis manufacturing regulations as part of a new state regulatory structure. As the largest U.S. medical cannabis market (and largest legal adult use market in the world beginning in 2018), California's regulatory approach will potentially influence national and global policy. Comparing CDPH's initial regulations to tobacco control best practices reveals that, while the regulations recognize the need to protect public health, prioritizing public health over business interests requires stronger approaches to labeling, packaging, and product formulations. Based on tobacco best practices, we recommend that cannabis regulations incorporate large and proportionately sized informational labels, a prominent universal cannabis symbol, rotating and pictorial health warnings, mandatory plain packaging, a comprehensive ban on characterizing flavors and addictive additives, and strict limits on the potency of inhalable products and those easily confused with non-cannabis products.

[Current cases of falsified medicinal products within the competence of the Federal Institute for Drugs and Medical Devices (BfArM) : Case studies and extent]. / Aktuelle Fälschungsfälle bei Arzneimitteln in der Zuständigkeit des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) : Fallbeispiele und Ausmaß.

The nature of a falsification of a medicinal product can vary a lot. Therefore the means to detect them and the potential risk to patient safety can also be very different. The whole range of falsification will be described using observed cases from the Federal Institute for Drugs and Medical Devices (BfArM).Based on the relatively low number of detected cases of falsified medicines, the legal supply chain can still be regarded as safe. It has to be assumed that in the illegal supply chain, e. g. illegal internet trade, the majority of the offered medicinal products are not only falsifications due to illegal trade but because they are completely falsified. Therefore there is an especially high risk for the consumer to be harmed by medicinal products that do not fulfil the required specifications.The trend indicates that increased efforts will be necessary to keep the legal supply chain safe and to contain illegal trade with falsifications. The higher federal authorities BfArM, PEI and BVL are involved in this task by coordinating and ensuring the flow of information to the concerned authorities and stakeholders as well as informing the public. Increased efforts are also necessary due to the rising involvement of organised crime in the falsification of medicinal products. A package of measures was enacted with the Falsified Medicines Directive 2011/62/EU to protect the legal supply chain from falsified medicinal products.

[The Herceptin® case : A case of falsification of medicinal products to a greater extent]. / Der Herceptin®-Fall : Ein Fälschungsfall von Arzneimitteln größeren Ausmaßes.

Falsified medicines are a raising problem for the German drug market. The complex distribution channels across the European market facilitates the introduction of falsified and stolen medicines into the legal supply chain and may pose a risk for patients. The "Herceptin® case" from 2014 of falsified medicines of Italian origin demonstrates how complex distribution systems have been misused by criminal organizations in order to introduce stolen and thus falsified medicines via the parallel trade into the market, and which measures the authorities and the parallel-traders in the national and European network have taken to ensure patient safety. Falsified medicines will continue to be a problem in the future, so new monitoring systems have to be established and effectively used for prevention. The introduction of the EU-wide serialisation system in February 2019 is therefore intended to identify falsified drugs and to prevent the further trade as well as the expenditure to the patient. Furthermore, the maintenance and intensification of the cooperation between all EU authorities involved remains indispensable to close gateways in the distribution system for falsified medicines and to minimise the risk to the population.

New product trial, use of edibles, and unexpected highs among marijuana and hashish users in Colorado.

OBJECTIVE: This study examines the relationships between trial of new marijuana or hashish products and unexpected highs, and use of edible products and unexpected highs. METHODS: We conducted an online survey of 634 adult, past-year marijuana users in Colorado. We used logistic regression models to examine the relationship between new product trial or edible use and unexpected highs. RESULTS: In the first year that recreational marijuana was legal in Colorado, 71.4% of respondents tried a new marijuana or hashish product, and 53.6% used an edible product. Trial of new products was associated with greater odds of experiencing an unexpected high after controlling for age, gender, education, mental health status, current marijuana or hashish use, and mean amount of marijuana or hashish consumed in the past month (OR=2.13, p<0.001). Individuals who reported having used edibles had greater odds of experiencing an unexpected high, after controlling for the same set of variables (OR=1.56, p<0.05). CONCLUSION: People who try new marijuana or hashish products, or use edible marijuana or hashish products, are at greater risk for an unexpected high. It is possible that some negative outcomes associated with marijuana use and unexpected highs may be averted through a better understanding of how to use product packaging to communicate with consumers.

Labelling of electronic cigarettes: regulations and current practice.

BACKGROUND: Over the past decade e-cigarettes have established themselves in the global market. E-cigarettes triggered much interest in relation to their content and efficacy as smoking cessation tools, but less attention has been paid to users and environmental safety warnings and guidance. Several regulations have been introduced to promote their safe handling and disposal. From May 2016, liquids and cartridges will be regulated by European Community Directives (ECDs) 2001/83/EC and 93/42/EEC, or 2014/40/EU if marketed as tobacco-related products. Currently, manufacturers and distributors must abide by the Chemical (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP) or Classification, Labelling and Packaging Regulations (CLP), the latter replacing CHIP in June 2015. OBJECTIVE: In this work, the compliance of marketed e-liquids and e-cigarettes with current European Union and UK legislations is assessed. RESULTS: E-liquids and e-cigarettes (21 and 9 brands, respectively) were evaluated. Evidence of non-compliance was found in relation to the CHIP/CLP toxic (13%) and environmental (37%) pictograms, tactile warning (23%), nominal amount of solution (30%), supplier contact telephone number and address (40%). None of the evaluated e-cigarettes displayed information on the correct disposal/recycling of batteries in line with the ECD 2006/66/EC. CONCLUSIONS: More stringent enforcement of regulations is needed to ensure not only the user's safety and awareness, but also the safeguarding of the environment.

Early evidence about the predicted unintended consequences of standardised packaging of tobacco products in Australia: a cross-sectional study of the place of purchase, regular brands and use of illicit tobacco.

OBJECTIVES: To test for early evidence whether, following the standardisation of tobacco packaging, smokers in Australia were--as predicted by the tobacco industry--less likely to purchase from small mixed business retailers, more likely to purchase cheap brands imported from Asia and more likely to use illicit tobacco. DESIGN: Serial cross-sectional population telephone surveys in November 2011 (a year prior to implementation), 2012 (during roll-out) and 2013 (a year after implementation). SETTING/PARTICIPANTS: Smokers aged 18 years and over identified in an annual population survey in the Australian state of Victoria (2011: n=754; 2012: n=590; 2013: n=601). MAIN OUTCOME MEASURES: Changes between 2011 and 2013 in: proportions of current smokers who purchased their last cigarette from discount outlets such as supermarkets compared with small mixed business retail outlets; prevalence of regular use of low-cost brands imported from Asia and use of unbranded tobacco. RESULTS: The proportion of smokers purchasing from supermarkets did not increase between 2011 (65.4%) and 2013 (65.7%; p=0.98), and the percentage purchasing from small mixed business outlets did not decline (2011: 9.2%; 2012: 11.2%; p=0.32). The prevalence of low-cost Asian brands was low and did not increase between 2011 (1.1%) and 2013 (0.9%; p=0.98). The proportion reporting current use of unbranded illicit tobacco was 2.3% in 2011 and 1.9% in 2013 (p=0.46). In 2013, 2.6% of cigarette smokers reported having purchased one or more packets of cigarettes in non-compliant packaging in the past 3 months; 1.7% had purchased one or more packets from an informal seller in the past year. CONCLUSIONS: One year after implementation, this study found no evidence of the major unintended consequences concerning loss of smoker patrons from small retail outlets, flooding of the market by cheap Asian brands and use of illicit tobacco predicted by opponents of plain packaging in Australia.

Analysing compliance of cigarette packaging with the FCTC and national legislation in eight former Soviet countries.

AIM: To analyse compliance of cigarette packets with the Framework Convention on Tobacco Control (FCTC) and national legislation and the policy actions that are required in eight former Soviet Union countries. METHODS: We obtained cigarette packets of each of the 10 most smoked cigarette brands in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Moldova, Russia and Ukraine. The packets were then analysed using a standardised data collection instrument. The analysis included the placing, size and content of health warning labels and deceptive labels (eg, 'Lights'). Findings were assessed for compliance with the FCTC and national legislation. RESULTS: Health warnings were on all packets from all countries and met the FCTC minimum recommendations on size and position except Azerbaijan and Georgia. All countries used a variety of warnings except Azerbaijan. No country had pictorial health warnings, despite them being mandatory in Georgia and Moldova. All of the countries had deceptive labels despite being banned in all countries except Russia and Azerbaijan where still no such legislation exists. CONCLUSIONS: Despite progress in the use of health warning messages, gaps still remain-particularly with the use of deceptive labels. Stronger surveillance and enforcement mechanisms are required to improve compliance with the FCTC and national legislation.

Implementation of the framework convention on tobacco control in Africa: current status of legislation.

OBJECTIVE: To describe, as of July 2011, the status of tobacco control legislation in Africa in three key areas of the Framework Convention on Tobacco Control (FCTC)-(1) Protection from exposure to tobacco smoke, (2) Packaging and labelling of tobacco products, and (3) Tobacco advertising, promotion and sponsorship. METHODS: Review and analysis of tobacco control legislation in Africa, media reports, journal articles, tobacco industry documents and data published in the 2011 WHO Report on the Global Tobacco Epidemic. RESULTS: Modest progress in FCTC implementation in Africa with many countries having legislation or policies on the protection from exposure to tobacco smoke, however, only a handful of countries meet the standards of the FCTC Article 8 and its Guidelines particularly with regards to designated smoking areas. Little progress on packaging and labelling of tobacco products, with few countries having legislation meeting the minimum standards of the FCTC Article 11 and its Guidelines. Mauritius is the only African country with graphic or pictorial health warnings in place and has the largest warning labels in Africa. Slightly better progress in banning tobacco advertising, promotion and sponsorship has been shown by African countries, although the majority of legislation falls short of the standards of the FCTC Article 13 and its Guidelines. Despite their efforts, African countries' FCTC implementation at national level has not matched the strong regional commitment demonstrated during the FCTC treaty negotiations. CONCLUSION: This study highlights the need for Africa to step up efforts to adopt and implement effective tobacco control legislation that is fully compliant with the FCTC. In order to achieve this, countries should prioritise resources for capacity building for drafting strong FCTC compliant legislation, research to inform policy and boost political will, and countering the tobacco industry which is a major obstacle to FCTC implementation in Africa.

[Silica classification and labelling under REACH and CLP regulation]. / Il problema della classificazione ed etichettatura della silice cristallina alla luce del REACH e del regolamento CLP.

Following literature data the evaluation CLP classification and labelling criteria doesn't support the decision to classify respirable crystalline silica (RCS) as carcinogen and suggests to consider RCS as:--STOT (Specific Target Organ Toxicant) RE (Repeated Exposure) cat.l by inhalation in case of concentration > or = 10%--STOT RE cat. 2 by inhalation in case of concentration 1 divided by 10%--Not classifiable as dangerous for human in case of concentration < 1%.

Evolução histórica das bulas de medicamentos no Brasil: [revisão] / Historical evolution of package inserts in Brazil: [review]

No Brasil, a bula é usada como fonte de informação sobre medicamentos. O estudo desenvolveu uma análise de sua evolução histórica, procurando observar a influência do desenvolvimento científico, da globalização da informação e das diferentes políticas de saúde. Procedeu-se uma revisão retrospectiva da legislação sanitária brasileira até 1920, ano da instituição do Departamento Nacional de Saúde Pública. A análise documental sobre a evolução da regulamentação sanitária no Brasil se iniciou pela Coleção Farmácia Brasileira - Portarias Sanitárias. Na segunda etapa as normas foram pesquisadas nos portais: VISALEGIS - Legislação em Vigilância Sanitária, Portal de Legislação do Sistema de Informações do Congresso Nacional e Sistema de Legislação da Saúde - Saúde Legis. A bula tornou-se um importante veículo informativo no Brasil, passou por profundas transformações regulamentares na segunda metade do século XX. Entre 1946 e 2006 o número de itens obrigatórios aumentou e sua descrição aprofundou. Entretanto, a padronização da informação para os medicamentos com o mesmo princípio ativo não se efetivou, não obstante sua importância e apesar das diferentes iniciativas observadas nas normas legais.

In Brazil, package inserts provide key information on pharmaceuticals. The current study analyzes the evolution of package inserts and the impact on this process by scientific research and development, globalization of information, and various health policies. The study began with a retrospective review of Brazilian health legislation until 1920, the year when the National Public Health Department was created. The analysis of documents on the evolution of health regulation in Brazil began with the Brazilian Pharmaceutical Collection - Health Rulings. The second stage of the study involved a search of standards and norms in VISALEGIS: Health Surveillance Legislation, Portal for Legislation from the National Congressional Information System and the Health Legislation System. Package inserts became an important vehicle for information in the country and underwent important regulatory changes in the latter half of the 20th century. From 1946 to 2006, the number of mandatory items increased, with more in-depth description. However, the standardization of information for medicines with the same active ingredient failed to materialize, despite its importance and the various legal initiatives in this direction.

Unit-dose packaging of iron supplements and reduction of iron poisoning in young children.

BACKGROUND: Iron poisoning is a major cause of unintentional poisoning death in young children. The US Food and Drug Administration proclaimed a regulation for unit-dose packaging of iron supplements in 1997. OBJECTIVE: To determine whether the requirement for unit-dose packaging of iron supplements decreases the incidence of iron ingestion and the incidence of deaths due to iron poisoning in children younger than 6 years. METHODS: This is a preintervention-postintervention study of the US federally mandated requirement for unit-dose packaging of iron supplements. The 10 years prior to the intervention were compared with the 5 years after its promulgation. The incidences of iron ingestion and of iron poisoning deaths for children younger than 6 years were obtained from the annual reports of the American Association of Poison Control Centers (Washington, DC). RESULTS: The average number of iron ingestion calls per 1000 of all calls to poison control centers regarding children younger than 6 years decreased from 2.99 per 1000 to 1.91 per 1000 (odds ratio, 1.29 [95% confidence interval, 1.27-1.32]; P<.001). The number of deaths decreased from 29 to 1 (odds ratio, 13.56 [95% confidence interval, 1.85-99.52]; P = .03). CONCLUSIONS: These are the first data that show a decrease in the incidence of nonintentional ingestion of a specific drug by young children and a decrease in mortality from poisoning by this drug after the introduction of unit-dose packaging. There was a decrease in the incidence of iron ingestion and a dramatic decrease in the number of deaths due to iron poisoning. This validates unit-dose packaging as an effective strategy for the prevention of iron poisoning and iron poisoning deaths in young children. This highly effective intervention should be considered for other medications with a high hazard for morbidity and mortality when taken as an overdose.