1) This document discusses electronic nicotine delivery systems (ENDS), also known as electronic cigarettes, which have attracted regulatory challenges. It notes the lack of research on their harmfulness compared to cigarettes and lack of manufacturing oversight.
2) Regulatory approaches to ENDS vary between countries, with some banning them, others requiring regulatory approval as drugs/devices, and others regulating as tobacco. The document examines considerations around product harmfulness, marketing, and integrating regulatory systems for tobacco and pharmaceutical nicotine products.
3) It concludes by recommending parties carefully monitor ENDS sales and promotions, apply relevant legislation to classify and regulate them, and not refer the issue to the Article 9/10 working group due to the regulatory difficulties
The document discusses Philip Morris International's research and development efforts around reduced-risk products. It outlines four product platforms for heated tobacco products and nicotine-containing products that are undergoing development. The goals are to develop alternatives to combustible cigarettes that reduce individual health risks and population harm. PMI has invested billions in research and has over 300 scientists working to develop the scientific evidence to substantiate that the products reduce risk. Their approach involves assessing product design, chemistry, toxicology, clinical trials, and post-market monitoring to show reductions in exposure, toxicity and risk compared to conventional cigarettes.
E-Cigarette Summit Speaker: Clive BatesLindsay Fox
Regulation: when less is more
Slides from Clive Bates' presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
Presentation by Ronan Barry (chairman of the Executive Committee and Board Member, Confederation of European Community cigarette Manufacturers (CECCM)) on the occasion of the EESC hearing on Manufacture, presentation and sale of tobacco and related products (Brussels, 19 Feb 2013)
The document provides an overview of electronic cigarettes (e-cigarettes) including their background, usage, health risks, regulations, and impact on young people. It discusses how e-cigarettes were invented as a safer alternative to traditional cigarettes but still carry health risks. While most studies find e-cigarettes less harmful than smoking, they still deliver addictive nicotine and may expose users to toxic chemicals. Regulations of e-cigarettes are currently lacking at both the federal and state levels.
Presentation by Peter van der Mark (Secretary-General, European Smoking Tobacco Associations (ESTA)) on the occasion of the EESC hearing on Manufacture, presentation and sale of tobacco and related products (Brussels, 19 Feb 2013).
Electronic Cigarette Regulations: When Less is Moreecigarettesummit
Clive Bates, speaker at E-Cigarette Summit London, discusses regulations surrounding electronic cigarettes. He points out that tight regulations could harm the e-cig industry and push people back to smoking tobacco. Visit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
Little over a decade since their launch, electronic cigarettes (ECs) today represent a global
industry with sales exceeding US$6 billion last year. Yet the devices have increasingly
generated heated debate surrounding their safety, efficacy and regulatory control, while
advocates of the immediate formal use of ECs opine their usefulness in reducing the
burden of smoking-related disease – other experts urge caution until more information
and better evidence become available. Dr Robert Combes reports.
Harm Reduction, the Profit Motive and tobacco Industry Tactics - Deborah ArnottLindsay Fox
Harm reduction, the profit motive and tobacco industry tactics Why caution is necessary
Slides from Deborah Arnott's presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
The document discusses Philip Morris International's research and development efforts around reduced-risk products. It outlines four product platforms for heated tobacco products and nicotine-containing products that are undergoing development. The goals are to develop alternatives to combustible cigarettes that reduce individual health risks and population harm. PMI has invested billions in research and has over 300 scientists working to develop the scientific evidence to substantiate that the products reduce risk. Their approach involves assessing product design, chemistry, toxicology, clinical trials, and post-market monitoring to show reductions in exposure, toxicity and risk compared to conventional cigarettes.
E-Cigarette Summit Speaker: Clive BatesLindsay Fox
Regulation: when less is more
Slides from Clive Bates' presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
Presentation by Ronan Barry (chairman of the Executive Committee and Board Member, Confederation of European Community cigarette Manufacturers (CECCM)) on the occasion of the EESC hearing on Manufacture, presentation and sale of tobacco and related products (Brussels, 19 Feb 2013)
The document provides an overview of electronic cigarettes (e-cigarettes) including their background, usage, health risks, regulations, and impact on young people. It discusses how e-cigarettes were invented as a safer alternative to traditional cigarettes but still carry health risks. While most studies find e-cigarettes less harmful than smoking, they still deliver addictive nicotine and may expose users to toxic chemicals. Regulations of e-cigarettes are currently lacking at both the federal and state levels.
Presentation by Peter van der Mark (Secretary-General, European Smoking Tobacco Associations (ESTA)) on the occasion of the EESC hearing on Manufacture, presentation and sale of tobacco and related products (Brussels, 19 Feb 2013).
Electronic Cigarette Regulations: When Less is Moreecigarettesummit
Clive Bates, speaker at E-Cigarette Summit London, discusses regulations surrounding electronic cigarettes. He points out that tight regulations could harm the e-cig industry and push people back to smoking tobacco. Visit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
Little over a decade since their launch, electronic cigarettes (ECs) today represent a global
industry with sales exceeding US$6 billion last year. Yet the devices have increasingly
generated heated debate surrounding their safety, efficacy and regulatory control, while
advocates of the immediate formal use of ECs opine their usefulness in reducing the
burden of smoking-related disease – other experts urge caution until more information
and better evidence become available. Dr Robert Combes reports.
Harm Reduction, the Profit Motive and tobacco Industry Tactics - Deborah ArnottLindsay Fox
Harm reduction, the profit motive and tobacco industry tactics Why caution is necessary
Slides from Deborah Arnott's presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
The Regulation of Nicotine-Containing Products - Jeremy Mean - E-Cigarette Su...Lindsay Fox
The regulation of Nicotine-Containing Products (NCPs)
Slides from Jeremy Means' presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
Proposed Changes to How E-Cigarettes Are Regulated - Prof. Linda BauldLindsay Fox
Proposed changes to how e-cigarettes are regulated: UK and EU context
Slides from Prof. Linda Bauld's presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
E-Cigarettes a Disruptive Public Health Phenomenon - Professor Antoine FlahaultLindsay Fox
E-cigarettes are a disruptive public health phenomenon that requires consideration of ethics, risks, and the precautionary principle. The precautionary principle calls for caution in the face of uncertainty and cost-effective measures to prevent harm, even without full scientific certainty. While e-cigarettes' risks are uncertain, cigarettes definitively cause death and disease. Lack of certainty on e-cigarettes should not prevent recommending them as part of tobacco control until long-term effects are known, as they may dramatically reduce risks compared to cigarettes.
OECD, 2nd Task Force Meeting on Charting Illicit Trade - Vanessa NeumannOECD Governance
This presentation by Vanessa Neumann was made at the 2nd Task Force Meeting on Charting Illicit Trade held on 5-7 March 2014. www.oecd.org/gov/risk/charting-illicit-trade-second-task-force-meeting.htm
- Altria Inc. is the largest tobacco company in the US, with 49.8% of the market, but cigarette sales volumes have been declining 3-4% annually due to health concerns, regulations, and social factors.
- Altria operates efficiently through restructuring and has strong cash flows, but faces risks from increased taxes, regulations, and potential bans on menthol cigarettes or e-cigarettes.
- The report recommends selling Altria stock with a $44.64 price target based on stagnant earnings growth forecasts and concerns about sustaining dividend growth given debt levels and revenue declines.
Lung cancer is the leading cause of cancer death in the United States. Tobacco use accounts for at least 30% of all cancer deaths and 87% of lung cancer deaths, and increases the risk of several other cancers. Tobacco contains over 4000 chemicals, including 200 that are poisonous and 69 that cause cancer. The tobacco industry knew as early as 1953 that smoking causes health risks but launched a propaganda campaign to mislead the public and sow doubt about the science. While tobacco generates tax revenue, it costs the healthcare system far more than it contributes in taxes and causes widespread preventable disease. Banning tobacco would help public health but would also impact tobacco farmers' livelihoods, requiring support for alternative crops.
E-Cigarette Summit Speaker: Dr. Jacques Le HouezecLindsay Fox
Nicotine safety in the context of e-cigarette use and tobacco dependence
Slides from Dr. Jacques Le Houezec's presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
E-Cigarette Summit Speaker: Dr Lynne DawkinsLindsay Fox
Slides from Dr Lynne Dawkins' presentation at the E-Cigarette Summit, London November 12, 2013. Electronic Cigarettes: What are they, and are they effective?
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
The chapter discusses the legal and political environment factors that global marketers must consider. It covers international laws and agreements, the political climate in home and host countries, and terms of access such as import tariffs and quotas. The objectives are to understand the legal/political factors, describe key terms of access, and explain their importance in global marketing. Assessing the legal and political systems is vital for evaluating risks and implications for marketing decisions.
This document provides a summary by Alan Blum opposing H.R. 1108, the Family Smoking Prevention and Tobacco Control Act. It argues that [1] giving the FDA regulatory authority over tobacco would legitimize the tobacco industry and imply cigarettes are now safer; [2] the tobacco industry, especially Philip Morris, would use this bill to mislead the public and doctors; and [3] there is no evidence stronger regulation could create a safer cigarette, as proposed by Philip Morris, and it would be unethical to study. The document concludes the bill would increase smoking and hinder more effective prevention efforts.
What is wrong (and right) about the Tobacco Products Directive approach to E-...Clive Bates
These are the visual aids for my talk on the truly dreadful European Union Tobacco Products Directive as it applies to e-cigarettes, and why Totally Wicked has a legal case against it.
Regulation: why less is more... E-cigarette Summit 12 November 2013 - Clive B...Clive Bates
My presentation covering why 'less is more' when it comes to regulating low risk alternatives to cigarettes such as e-cigarettes. Too much regulation will limit appeal, increase costs, raise barriers to entry and inhibit innovation. I also urge a focus on the huge potential benefits of low-risk alternatives to smoking instead of obsession over minor or implausible risks.
Cannabis Science & Policy Summit - Day 1 - SmartCannabisSummit
This document outlines a study examining the effects of growth in legal medical marijuana markets on substance use and abuse. It describes collecting new data on registered medical marijuana patients to measure the size of legal markets over time. Variation in state supply regulations and federal enforcement are used to identify how legal market size impacts recreational marijuana use and other health outcomes like traffic accidents and mortality. Results suggest that while medical marijuana laws alone have little effect, growth in the size of the legal market increases adolescent marijuana use but reduces alcohol- and opioid-related deaths among older adults by substituting marijuana for those substances.
Slides on the current situation with global cigarette consumption and trends, and how new nicotine products could change things.
See blog at: http://www.clivebates.com/?p=2782 for more commentary.
This document summarizes recent news in the tobacco industry from December 17, 2014. It discusses the FDA taking actions on tobacco product marketing applications, a planned merger vote between Reynolds American and Lorillard, proposals to tax e-cigarettes in New Jersey, elimination of tobacco discounts for military personnel, increases in teen e-cigarette use, a measure to reduce tobacco retailers in San Francisco, and dividend declarations by Altria and Philip Morris International.
Recent developments in alcohol policy in the EU (large file)tamsin.rose
presentation on policy aspects on alcohol in Europe including issues of labelling, retail environment, marketing of alcoholic drinks aimed at women and young people
Cannabis Science & Policy Summit - Day 1 - MidgetteCannabisSummit
This document summarizes a report on marijuana legalization in Vermont. It finds that marijuana use is more prevalent in Vermont than the rest of the US. Currently, Vermont spends $800,000-$1.1 million annually prohibiting marijuana. The report discusses 12 policy alternatives to the status quo and models potential tax revenue from legalization, finding it could be in the tens of millions annually from Vermont users alone. However, regulation costs and uncertainty around impacts on substance use make projections difficult.
The UK government will regulate e-cigarettes and other nicotine containing products as medicines beginning in 2016 to ensure safety and quality. This decision aligns with proposed European regulation and manufacturers will have until 2016 to obtain licenses for their products, though they can seek licenses earlier. Regulating these products as medicines means high quality products can support smokers to reduce and quit smoking. Licensed products will be available over the counter or by prescription through the NHS and can be advertised like other medicines.
This document reviews the scientific literature on electronic cigarettes (e-cigarettes) and vaping. It finds that while vaping may be less harmful than smoking, more research is still needed to understand the health effects of vaping. Regulations of e-cigarettes are currently controversial, as they are marketed as smoking cessation tools but cannot legally be classified as such. The medical community faces the challenge of advising patients on vaping given limited evidence; while vaping is likely less dangerous than smoking, physicians worry it could perpetuate nicotine addiction. More research is needed to establish the safety of e-cigarettes and their potential as a smoking alternative or cessation method.
The document discusses identifying global tobacco control research priorities related to implementing provisions of the WHO Framework Convention on Tobacco Control (FCTC). It describes a process led by the U.S. National Cancer Institute to develop papers on priority research needs for 7 areas of the FCTC, including protection from secondhand smoke, regulating product contents and disclosures, packaging and labeling, taxation and pricing, and eliminating illicit trade. Key research priorities identified include improved exposure assessment of secondhand and thirdhand smoke, determining optimal levels for regulating toxicants in tobacco products, and evaluating the public health impacts of taxation and pricing policies on consumption.
The Regulation of Nicotine-Containing Products - Jeremy Mean - E-Cigarette Su...Lindsay Fox
The regulation of Nicotine-Containing Products (NCPs)
Slides from Jeremy Means' presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
Proposed Changes to How E-Cigarettes Are Regulated - Prof. Linda BauldLindsay Fox
Proposed changes to how e-cigarettes are regulated: UK and EU context
Slides from Prof. Linda Bauld's presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
E-Cigarettes a Disruptive Public Health Phenomenon - Professor Antoine FlahaultLindsay Fox
E-cigarettes are a disruptive public health phenomenon that requires consideration of ethics, risks, and the precautionary principle. The precautionary principle calls for caution in the face of uncertainty and cost-effective measures to prevent harm, even without full scientific certainty. While e-cigarettes' risks are uncertain, cigarettes definitively cause death and disease. Lack of certainty on e-cigarettes should not prevent recommending them as part of tobacco control until long-term effects are known, as they may dramatically reduce risks compared to cigarettes.
OECD, 2nd Task Force Meeting on Charting Illicit Trade - Vanessa NeumannOECD Governance
This presentation by Vanessa Neumann was made at the 2nd Task Force Meeting on Charting Illicit Trade held on 5-7 March 2014. www.oecd.org/gov/risk/charting-illicit-trade-second-task-force-meeting.htm
- Altria Inc. is the largest tobacco company in the US, with 49.8% of the market, but cigarette sales volumes have been declining 3-4% annually due to health concerns, regulations, and social factors.
- Altria operates efficiently through restructuring and has strong cash flows, but faces risks from increased taxes, regulations, and potential bans on menthol cigarettes or e-cigarettes.
- The report recommends selling Altria stock with a $44.64 price target based on stagnant earnings growth forecasts and concerns about sustaining dividend growth given debt levels and revenue declines.
Lung cancer is the leading cause of cancer death in the United States. Tobacco use accounts for at least 30% of all cancer deaths and 87% of lung cancer deaths, and increases the risk of several other cancers. Tobacco contains over 4000 chemicals, including 200 that are poisonous and 69 that cause cancer. The tobacco industry knew as early as 1953 that smoking causes health risks but launched a propaganda campaign to mislead the public and sow doubt about the science. While tobacco generates tax revenue, it costs the healthcare system far more than it contributes in taxes and causes widespread preventable disease. Banning tobacco would help public health but would also impact tobacco farmers' livelihoods, requiring support for alternative crops.
E-Cigarette Summit Speaker: Dr. Jacques Le HouezecLindsay Fox
Nicotine safety in the context of e-cigarette use and tobacco dependence
Slides from Dr. Jacques Le Houezec's presentation at the E-Cigarette Summit, London November 12, 2013.
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
E-Cigarette Summit Speaker: Dr Lynne DawkinsLindsay Fox
Slides from Dr Lynne Dawkins' presentation at the E-Cigarette Summit, London November 12, 2013. Electronic Cigarettes: What are they, and are they effective?
Full summary of the E-Cigarette Summit: http://ecigarettereviewed.com/e-cigarette-summit-london-summary
The chapter discusses the legal and political environment factors that global marketers must consider. It covers international laws and agreements, the political climate in home and host countries, and terms of access such as import tariffs and quotas. The objectives are to understand the legal/political factors, describe key terms of access, and explain their importance in global marketing. Assessing the legal and political systems is vital for evaluating risks and implications for marketing decisions.
This document provides a summary by Alan Blum opposing H.R. 1108, the Family Smoking Prevention and Tobacco Control Act. It argues that [1] giving the FDA regulatory authority over tobacco would legitimize the tobacco industry and imply cigarettes are now safer; [2] the tobacco industry, especially Philip Morris, would use this bill to mislead the public and doctors; and [3] there is no evidence stronger regulation could create a safer cigarette, as proposed by Philip Morris, and it would be unethical to study. The document concludes the bill would increase smoking and hinder more effective prevention efforts.
What is wrong (and right) about the Tobacco Products Directive approach to E-...Clive Bates
These are the visual aids for my talk on the truly dreadful European Union Tobacco Products Directive as it applies to e-cigarettes, and why Totally Wicked has a legal case against it.
Regulation: why less is more... E-cigarette Summit 12 November 2013 - Clive B...Clive Bates
My presentation covering why 'less is more' when it comes to regulating low risk alternatives to cigarettes such as e-cigarettes. Too much regulation will limit appeal, increase costs, raise barriers to entry and inhibit innovation. I also urge a focus on the huge potential benefits of low-risk alternatives to smoking instead of obsession over minor or implausible risks.
Cannabis Science & Policy Summit - Day 1 - SmartCannabisSummit
This document outlines a study examining the effects of growth in legal medical marijuana markets on substance use and abuse. It describes collecting new data on registered medical marijuana patients to measure the size of legal markets over time. Variation in state supply regulations and federal enforcement are used to identify how legal market size impacts recreational marijuana use and other health outcomes like traffic accidents and mortality. Results suggest that while medical marijuana laws alone have little effect, growth in the size of the legal market increases adolescent marijuana use but reduces alcohol- and opioid-related deaths among older adults by substituting marijuana for those substances.
Slides on the current situation with global cigarette consumption and trends, and how new nicotine products could change things.
See blog at: http://www.clivebates.com/?p=2782 for more commentary.
This document summarizes recent news in the tobacco industry from December 17, 2014. It discusses the FDA taking actions on tobacco product marketing applications, a planned merger vote between Reynolds American and Lorillard, proposals to tax e-cigarettes in New Jersey, elimination of tobacco discounts for military personnel, increases in teen e-cigarette use, a measure to reduce tobacco retailers in San Francisco, and dividend declarations by Altria and Philip Morris International.
Recent developments in alcohol policy in the EU (large file)tamsin.rose
presentation on policy aspects on alcohol in Europe including issues of labelling, retail environment, marketing of alcoholic drinks aimed at women and young people
Cannabis Science & Policy Summit - Day 1 - MidgetteCannabisSummit
This document summarizes a report on marijuana legalization in Vermont. It finds that marijuana use is more prevalent in Vermont than the rest of the US. Currently, Vermont spends $800,000-$1.1 million annually prohibiting marijuana. The report discusses 12 policy alternatives to the status quo and models potential tax revenue from legalization, finding it could be in the tens of millions annually from Vermont users alone. However, regulation costs and uncertainty around impacts on substance use make projections difficult.
The UK government will regulate e-cigarettes and other nicotine containing products as medicines beginning in 2016 to ensure safety and quality. This decision aligns with proposed European regulation and manufacturers will have until 2016 to obtain licenses for their products, though they can seek licenses earlier. Regulating these products as medicines means high quality products can support smokers to reduce and quit smoking. Licensed products will be available over the counter or by prescription through the NHS and can be advertised like other medicines.
This document reviews the scientific literature on electronic cigarettes (e-cigarettes) and vaping. It finds that while vaping may be less harmful than smoking, more research is still needed to understand the health effects of vaping. Regulations of e-cigarettes are currently controversial, as they are marketed as smoking cessation tools but cannot legally be classified as such. The medical community faces the challenge of advising patients on vaping given limited evidence; while vaping is likely less dangerous than smoking, physicians worry it could perpetuate nicotine addiction. More research is needed to establish the safety of e-cigarettes and their potential as a smoking alternative or cessation method.
The document discusses identifying global tobacco control research priorities related to implementing provisions of the WHO Framework Convention on Tobacco Control (FCTC). It describes a process led by the U.S. National Cancer Institute to develop papers on priority research needs for 7 areas of the FCTC, including protection from secondhand smoke, regulating product contents and disclosures, packaging and labeling, taxation and pricing, and eliminating illicit trade. Key research priorities identified include improved exposure assessment of secondhand and thirdhand smoke, determining optimal levels for regulating toxicants in tobacco products, and evaluating the public health impacts of taxation and pricing policies on consumption.
This document summarizes the WHO Framework Convention on Tobacco Control (FCTC) and its decisions around e-cigarettes. It discusses how the FCTC works, including its Conference of Parties meetings where decisions are made by consensus. At COP6 in 2012, a report on e-cigarettes was presented outlining regulatory objectives and options. The decision welcomed the report and invited parties to consider regulations, while also requesting another report on e-cigarettes for COP7 to further examine the issues. The UK's regulation of e-cigarettes is guided by decisions at the EU level.
The document summarizes key elements of the FDA regulation of tobacco, including requiring tobacco companies to disclose ingredients and research, restricting marketing appeals to youth and misleading health claims, strengthening restrictions on youth sales, informing consumers through improved warning labels and product testing standards, and regulating product contents to protect public health. It provides an overview of implementation timelines and opportunities for public input on the new regulations.
Outcome of consultation exercise mlx364 on the regulation of nicotine contain...Totally Wicked Eliquid
The UK Medicines and Healthcare products Regulatory Agency conducted a public consultation on regulating nicotine-containing products under medicines regulation. They received over 1,200 responses that generally supported regulation. However, importers and users of electronic cigarettes opposed regulation due to concerns it would immediately ban currently available products or stifle innovation. As a result, the MHRA will coordinate further scientific and market research over the next 18 months before making a final decision on regulation in Spring 2013. The research will examine nicotine levels that have pharmacological effects, actual product use, impacts on smoking cessation, and potential regulatory impacts on public health.
Professor J.F. Etter - E-Cigarette Summit 2014Neil Mclaren
Professor Jean-François Etter discusses the evolving e-cigarette and vaporizer market. He notes that major tobacco companies like Philip Morris and British American Tobacco are now major players in the e-cigarette industry through brands like iQos and Voke. Independent research on these new products is needed, as the tobacco industry's past shows a history of deception. Frameworks for managing conflicts of interest are crucial to preserve the integrity of research and public trust. Academia must thoughtfully rethink interactions with industries producing nicotine and tobacco vaporizers.
Help Repeal FDA's Deeming Regulations in First 100 Days of Trump PresidencyAndrew Rhee
The FDA states that their goal is to protect Americans from tobacco related diseases and death, but let's take a look into how the FDA may have it backwards when it comes to regulation of vapor products.
https://www.lovevapeplus.com/blogs/updates/repeal-deeming-regulation
Informe de la OMS sobre los riesgos del cigarrillo electrónicoSEMPSPH
This document summarizes a World Health Organization report on electronic nicotine delivery systems (ENDS), also known as e-cigarettes. It finds that while ENDS may help some smokers quit, they also pose various health risks and could undermine tobacco control efforts. The report examines the ENDS market growth, product design and contents, health effects of nicotine exposure, and questions around the potential for ENDS to both help smokers quit and interfere with tobacco control. It incorporates recommendations from the WHO on regulating ENDS as the evidence around their risks and benefits continues to rapidly evolve.
How e cigarettes should be regulated in uk ecig summitMatt Stan
This document summarizes a presentation on proposed changes to e-cigarette regulation in the UK and EU. It discusses the current state of e-cigarette use and harm reduction, NICE guidance supporting harm reduction approaches, and the ongoing revision of the EU Tobacco Products Directive to determine regulations for e-cigarettes. Key points addressed include evidence that cutting down smoking provides little health benefit on its own but may with nicotine replacement therapy, and NICE's recommendation that licensed nicotine products are less harmful than tobacco for harm reduction.
Bareham et al E-Cigarettes Controversies within the controversyDavid Bareham
E-cigarettes have been controversial since being introduced over 10 years ago. There are ongoing debates around their potential health risks, effectiveness for smoking cessation, appropriate regulation, and the involvement of tobacco companies. Studies have shown mixed results on whether e-cigarettes help smoking cessation and their long-term health effects are still unclear due to lack of research and conflicting reports. Various organizations and experts disagree on the appropriate regulatory approach and how the risks of e-cigarettes compare to conventional cigarettes. The controversies surrounding e-cigarettes are complex with arguments on both sides and no consensus on important issues related to public health.
How E-Cigarettes Should be Regulated - Professor Jean-François ETTER - E-Ciga...Lindsay Fox
1) E-cigarettes are mostly used by smokers and help some quit or reduce smoking. Regular use by non-smokers has not been documented. E-cigarettes are less toxic than cigarettes.
2) Regulations of e-cigarettes vary by country and are currently evolving. The document discusses potential regulations as tobacco products, medications, or consumer products.
3) Regulating e-cigarettes as medications poses several problems and may stifle innovation, give the market to big tobacco, and result in fewer smokers quitting. Consumer product regulation with additional safety standards may better balance public health and individual freedom.
The document discusses how e-cigarettes should be regulated. It presents evidence that e-cigarettes are safer than cigarettes and are used mostly by smokers to help quit smoking. It analyzes the current regulations in the US, UK, and EU and argues that regulating e-cigarettes as tobacco products or medicines would be disproportionate and could negatively impact public health goals. Instead, it advocates for regulating e-cigarettes as consumer products, with additional product standards and restrictions on youth access, similar to other consumer goods. The goal of regulation should be to balance public health benefits with limiting risks, without making e-cigarettes less competitive than cigarettes.
The document discusses Malaysia's initiatives on creating smoke-free environments including a timeline of tobacco control policies from 1973 banning smoking in cinemas to plans in 2009 to further expand smoke-free areas. It outlines the country's involvement in the WHO Framework Convention on Tobacco Control including signing and ratifying the treaty and participating in related meetings and guidelines development. Key requirements and recommendations of the WHO FCTC guidelines on protection from tobacco smoke exposure are summarized.
The Family Smoking Prevention and Tobacco Control Act of 2009 grants the FDA authority to regulate tobacco products. Key provisions include banning fruit-flavored cigarettes, graphic health warnings covering 50% of cigarette packs, limits on advertising and marketing appeals to youth. It does not preempt all state/local tobacco control laws. The act aims to reduce youth tobacco use and inform the public of health risks but was partially struck down by a Kentucky court over some marketing restrictions.
The APPH Standard: What Does it Actually Mean?Clive Bates
My presentation at the Food & Drug Law Institute Tobacco and Nicotine conference 26 October 2023. I discuss five problems with the APPH concept:
1. No means of trading off different types of benefits and detriments
2. Ignores vaping benefits to youth
3. Blind to harmful unintended consequences of marketing denial orders
4. Impossible to estimate population effects at the product level - the standard only makes sense at the category level.
5. The aggregate effect of thousands of single product PMTA determinations may create adverse effects not captured in any individual application (de fact flavour ban)
I finish with three broad proposals:
1. Assess individual risk and marketing strategy pre-market
2. Assess population effects when it is actually possible to observe them - post-market
3. Conduct a single comprehensive market assessment covering all products, including illicit trade
This document provides background information and details of proposed regulations to introduce a minimum age of sale of 18 years for nicotine inhaling products such as electronic cigarettes in England and Wales. It outlines the rationale for the regulations to protect children from nicotine addiction and potential gateway effects. The proposed regulations would make it an offence to sell nicotine inhaling products to those under 18 and extend tobacco proxy purchasing offences to e-cigarettes. Exemptions are included for medicinal nicotine products prescribed to or indicated for those under 18. Views are sought on the draft regulations and their potential impact.
Marketing, Planning, Implimentation And ControlFalade Samson
The document discusses the legal and ethical framework around the sales and promotion of tobacco and alcohol in Nigeria. It provides an overview of tobacco and alcohol consumption in Nigeria. It then discusses the key aspects of the legal and ethical framework for both tobacco and alcohol separately. For tobacco, it outlines the Tobacco Control Act and compares it to the previous 1990 Tobacco Control Decree, noting how the new Act expands restrictions. It also discusses some challenges in enforcing tobacco regulations, such as the rise of smokeless tobacco and tobacco companies' corporate social responsibility programs.
Similar to Electronic nicotine delivery_systems_brief_final (20)
2006 a space oddity – the great pluto debate science _ the guardianGeorgi Daskalov
Long known as the ninth planet, Pluto was downgraded in 2006, sparking a scientific spat that raises basic questions about how we understand the universe
The document discusses Google tools that can be used to find relevant consumer insights for RFPs, creative briefs, and content strategies. It describes YouTube Analytics, Google Consumer Surveys, Google Trends, Google Correlate, which can provide fast focus group data, test consumer insights, uncover growing and declining interests, and find related search trends. These tools allow accessing larger samples of data faster and more cost-effectively than traditional market research methods to better inform marketing strategies.
Getting cytisine licensed for use world-wide: a call to actionGeorgi Daskalov
Most tobacco users live in low and middle income countries where stop smoking medicines are unavailable or unaffordable. There is an urgent need for action by key stakeholders to get cytisine licensed worldwide so that its life-saving potential can be realised.
Evaluation of the efficacy and safety of tribulus terrestris in male sexual d...Georgi Daskalov
Evaluation of the efficacy and safety of tribulus terrestris in male sexual dysfunction – a prospective, randomized, double blinded, placebo controlled clinical trial 2015 poster
This document summarizes national trends in prescription drug expenditures in the United States for 2015 and provides projections for 2016. Key findings include:
- Total US prescription drug sales in 2015 were $419.4 billion, an 11.7% increase over 2014. Spending in clinics and non-federal hospitals increased 15.9% and 10.7%, respectively.
- Growth in overall spending was driven primarily by price increases for existing drugs (8.4%), with new drugs (2.7%) and changes in drug usage (0.5%) also contributing. Hospital spending growth was mainly from price increases, while clinic growth was mostly from increased drug usage.
- Projections estimate an 11-13%
This document discusses how pharmaceutical companies can improve clinical development and manufacturing processes through product lifecycle management (PLM). It identifies 7 key business processes for transforming R&D operations: 1) drug development program management, 2) regulatory archive management, 3) clinical trial management, 4) scale-up and commercial manufacturing, 5) quality management, 6) packaging and marketing asset management, and 7) global product registration. Implementing PLM using Oracle's solutions can deliver ROI by improving productivity, reducing time to market, and lowering development costs.
This document discusses the therapeutic index of antihistamines, which is defined as the benefit-to-risk ratio or efficacy-to-safety ratio that determines the range of doses where a drug is effective and safe. While second-generation antihistamines have similar efficacy for allergic rhinitis and urticaria, they differ in their safety profiles and therapeutic indices. Fexofenadine has one of the broadest therapeutic indices, having been shown to be effective at doses as low as 20 mg twice daily and not causing sedation or cardiac toxicity at doses as high as 690 mg twice daily. A broad therapeutic index is important considering potential drug interactions and situations where patients increase their dose in search of
Extreme trans neptunian objects and the kozai mechanismGeorgi Daskalov
This document summarizes a study examining the possibility of undiscovered planets beyond Neptune based on the discovery of extreme trans-Neptunian objects (ETNOs). The study finds:
1) There is an observational bias that most ETNOs would be discovered at declinations of -24 to 24 degrees, regardless of survey completeness.
2) The clustering of the arguments of perihelion of known ETNOs near 0 degrees cannot be explained by observational biases and suggests the influence of an unseen planetary perturber.
3) The distributions of orbital parameters of known ETNOs show clustering that resembles mean motion resonances and families influenced by planetary perturbations, providing further evidence for one or more undis
Some In Vitro/In Vivo Chemically-Induced Experimental Models of Liver Oxidati...Georgi Daskalov
This review article summarizes several experimental models used to study liver oxidative stress and injury in rats, including those induced by carbon tetrachloride, tert-butyl hydroperoxide, ethanol, paracetamol, and nicotine. The models are described as involving the generation of reactive oxygen species that cause lipid peroxidation, glutathione depletion, and damage to cellular proteins and DNA, leading to effects like increased membrane permeability and cell death. Specifically, the models examine how these compounds are metabolized to produce radicals that can induce oxidative stress in the liver and hepatocytes.
This document provides information and instructions for EEA-qualified pharmacists applying for recognition as a pharmacist in Great Britain by the General Pharmaceutical Council (GPhC). The GPhC is the regulatory body that oversees pharmacists and pharmacy technicians in Great Britain. Applicants must submit documentation including proof of qualifications, identity, nationality, registration status in their home country, and fees. Required documents include diplomas, licenses, passport, birth certificate, marriage certificate if applicable, police records, and letters from authorities confirming standing and compliance with EU directives. Photographs must be certified by a professional acquaintance. All documents may require certified English translations. The process is expected to take one month, after which eligible applicants will receive a
Pharmaceutical marketing to healthcare providers provides information on new treatment options, but it is only one of many factors that influence prescribing decisions. Surveys find clinical knowledge, patient factors, and insurance policies have greater impacts. Approximately 67% of US prescriptions are for generic drugs, much higher than other countries. While representatives provide information, prescribing is shaped more by clinical guidelines, peers, formularies, and insurers' prior authorization requirements than representative interactions.
Product lifecycle management in the pharmaceutical industryGeorgi Daskalov
Pharmaceutical companies face pressure to improve product pipelines, accelerate time to market, and improve margins on existing products, while maintaining strict regulatory compliance. A comprehensive product lifecycle management (PLM) solution can help address these challenges by providing visibility and control across the entire drug development process from discovery through commercialization. PLM focuses on leveraging research and development efforts to efficiently develop new drugs and move them through the various phases of the drug lifecycle from the different internal and external functions involved. This allows for improved collaboration and management of changes to optimize profitability throughout the drug's economic life.
The document discusses various topics related to economics, politics, and society around the world. It mentions different countries, currencies, trade agreements, and political leaders. It also references challenges and opportunities facing certain industries. However, most of the information is garbled or unclear due to the formatting and characters used.
The document discusses various topics related to economics, politics, and society around the world. It mentions different countries, currencies, trade agreements, and political leaders. It also references challenges and opportunities facing certain industries. However, most of the information is garbled or unclear due to the formatting issues.
Health-care interventions to promote and assist tobacco cessation: a review o...Georgi Daskalov
This document reviews the efficacy, effectiveness, and affordability of healthcare interventions for tobacco cessation. It finds that brief advice from healthcare workers can promote smoking cessation and is affordable globally. Telephone and text support programs and printed materials can assist with quit attempts and are globally affordable. Face-to-face behavioral support increases quit rates for cigarettes and smokeless tobacco and is affordable in middle- and high-income countries. Several medications can aid quitting when combined with behavioral support, with cytisine and nortriptyline being globally affordable. Brief advice, telephone/text support, self-help materials, cytisine, and nortriptyline are identified as globally affordable tobacco cessation interventions.
The document discusses regulations around access to and classification of medicines in the UK and Europe. It describes three categories of medicines in the UK - prescription only medicines (POM), pharmacy medicines (P), and general sales list medicines (GSL). POM medicines require a prescription, P medicines can only be sold under pharmacy supervision, and GSL medicines can be sold in any retail outlet. There has been a trend of increasing medicines moving from POM to P to GSL status, making them more accessible over the counter without a prescription. This deregulation aims to empower consumers, improve access, and reduce costs, but must balance this with safety and professional oversight.
Acute activation, desensitization and smoldering activation of human acetylch...Georgi Daskalov
This study examined the acute activation and chronic desensitization of human nicotinic acetylcholine receptors (AChRs) containing α4β2, α3β4, and α7 subunits by nicotine and other nicotinic agonists. It found that nicotine causes "smoldering activation" of α4β2 AChRs at concentrations found in smokers, but higher concentrations are needed for α3β4 and α7 AChRs. Sazetidine-A selectively activates and desensitizes the (α4β2)2β2 stoichiometry of the α4β2 AChR. The study defines the concentration ranges over which different agonists can sustain smolder
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
Assessment and Planning in Educational technology.pptxKavitha Krishnan
In an education system, it is understood that assessment is only for the students, but on the other hand, the Assessment of teachers is also an important aspect of the education system that ensures teachers are providing high-quality instruction to students. The assessment process can be used to provide feedback and support for professional development, to inform decisions about teacher retention or promotion, or to evaluate teacher effectiveness for accountability purposes.
How to Manage Your Lost Opportunities in Odoo 17 CRMCeline George
Odoo 17 CRM allows us to track why we lose sales opportunities with "Lost Reasons." This helps analyze our sales process and identify areas for improvement. Here's how to configure lost reasons in Odoo 17 CRM
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
South African Journal of Science: Writing with integrity workshop (2024)
Electronic nicotine delivery_systems_brief_final
1. Fifth Session of the Conference of the Parties to the
WHO Framework Convention on Tobacco Control, 12-17 November 2012, Seoul, South Korea
FCA Policy Briefing
Electronic Nicotine Delivery Systems (ENDS)
Introduction
ENDS, or electronic cigarettes as they are commonly called,1
are a relatively recent invention
that has attracted considerable media attention in a number of countries. These devices,
generally battery-powered, purport to deliver nicotine to the lung via vapour. (Indeed, e-
cigarette users in some countries refer to themselves as “vapers”.) The extent to which nicotine
is actually absorbed via inhalation is unclear, as is the list of other ingredients that various
brands of electronic cigarettes may contain.
As the Secretariat’s report mentions, the ENDS market is evolving rapidly, with some analysts
suggesting it could eventually rival cigarettes for market share.
ENDS have proved challenging to regulators in a number of ways:
1. They are clearly perceived by many users as being substantially less hazardous than
cigarettes, and indeed it is plausible – but unproven – that this is the case;
2. One of the attractions of electronic cigarettes appears to be their superficial
resemblance to cigarettes;
3. Manufacturers and retailers have generally not sought regulatory approval for their
products, which are often marketed via the Internet;
4. Depending on a country’s legal framework, electronic cigarettes may be considered a
tobacco product or a combination therapeutic drug/medical device, or neither.
1
Some electronic cigarettes are advertised as containing no nicotine, so the two terms are not exactly equivalent.
This document relates to item 6.5 of the provisional agenda.
FCA recommendations
• Parties should, at a minimum, carefully monitor sales and promotion of ENDS
in their respective national markets and report relevant findings to the COP;
• Parties should apply relevant legislation to ENDS with respect to regulatory
approval, place of use, taxation and other issues;
• The issue of ENDS should not be referred to the Article 9/10 working group,
but will likely need further discussion at future sessions of the COP.
2. 2
Regulatory approaches to electronic cigarettes vary, as indicated in Annex 1 to the Secretariat’s
report. To give four examples:
• Brazil’s regulatory agency, ANVISA, adopted a specific resolution2
(= regulation) in 2009
banning the sale, importation and advertisement of “any electronic device for smoking”, but
the same resolution sets out rules for the potential approval of products (such as
toxicological testing and proof of efficacy of any claims made);
• Canada’s Department of Health issued a Notice to Stakeholders indicating that market
authorization is required before importing, advertising, or selling electronic smoking
products and an advisory warning people not to use electronic cigarettes, as none have
been approved for use in Canada under the provision of the Food and Drugs Act.3
By
implication, this amounted to a classification of electronic cigarettes as unapproved
drugs/medical devices. Manufacturers of electronic cigarettes can submit an application to
the Department of Health for approval to sell in Canada, in the same way as manufacturers
of nicotine gum and lozenges had to obtain pre-market approval.
• In the UK the medicines regulator (MHRA) carried out a consultation on e-cigarettes in 2010
and decided not to ban them because it did ‘not want to see useful products removed from
the market’. Further research is underway and a final decision on whether or not to
regulate all nicotine-containing products under medicines legislation will not be made until
spring 2013. In the interim, the MHRA committed to work with the electronic cigarette
industry to develop a self regulatory code of practice to foster high standards of operation. 4
• In the United States, the courts overturned an attempt by the US Food and Drug
Administration (FDA) to regulate electronic cigarettes as drugs/medical devices. Instead,
they have been ruled tobacco products, based on US legislative provisions, and the FDA has
announced plans to regulate them on this basis.5
Considerations
1. Product harmfulness
A recent review in the journal Tobacco Control commented:
On the one hand, nicotine delivered by vapour with few known
toxicants should theoretically carry relatively low risks, particularly when
compared to cigarettes. The limited data available suggest that the
products are not likely to approach the health hazards of cigarettes.
However, on the other hand, significant concerns exist with the purity of
ingredients employed, device functionality and quality control, the ease
with which devices can be modified by users, and the general lack of
oversight in manufacturing or marketing.6
2
Resolução-RDC No 46, 28 August 2009. Available on-line at: http://tinyurl.com/8hfsn73.
3
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_53-eng.php.
4
http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON065617.
5
US Food and Drug Administration. Regulation of E-cigarettes and Other Tobacco Products. On-line at:
http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm.
6
O’Connor RJ. Non-cigarette tobacco products: what have we learnt and where are we headed? Tobacco Control 2012; 21:181-
190.
3. 3
This captures the problem well. It is very likely that ENDS are substantially less hazardous than
conventional cigarettes, and one could well imagine that a major shift from the conventional to the
electronic product would have a considerable public health benefit. On the other hand, in the
absence of testing and regulatory oversight, there is no way to know this for sure – and of course
there are various scenarios under
which electronic cigarettes could
actually increase harm to users. (e.g. if
used by non-smokers, or to prevent
quitting.)
2. Marketing
ENDS are frequently promoted via the
Internet or, in some countries, through
promotional booths (for example in
shopping centres). In some countries,
there are also extensive online “vaping”
communities7
; it is not clear whether
these groups receive funding from e-
cigarette manufacturers. Some sites
focus on reviewing particular models of
electronic cigarettes, while others have
a more political agenda, involving the
legal status of electronic cigarettes
(such as whether they can be used
where smoking is prohibited).
Advertisements for electronic cigarettes generally emphasize a number of benefits over
conventional cigarettes – such as lack of smoke odour, ability to use where smoking is prohibited
and no exposure to “harmful chemicals” for bystanders. Some advertising explicitly claims that
electronic cigarettes are less hazardous than cigarettes, or are an effective means of quitting
smoking. In the public health community, one concern about ENDS is their potential for
counteracting the denormalizing effect of tobacco-control interventions, for example, by making it
possible to “smoke” (or at least: “e-smoke”) in smoke-free areas.
Electronic cigarettes have been sold in a variety of flavours.
At present, the ENDS market is quite fragmented, with multiple small manufacturers and vendors
competing for attention. Major tobacco companies have, in the past, developed their own products
that heated rather than burnt tobacco (most notably RJR, with its Premier product, which was
launched unsuccessfully in 1988.) Several tobacco companies have signalled their intention to
launch new products of this type, possibly using existing cigarette brand names.8
In the US, in April
2012, tobacco company Lorillard purchased a US electronic cigarette company.9
7
For example: http://www.e-cigarette-forum.com, www.vapersforum.com.
8
Thompson C and Wembridge M. Big Tobacco Push for Cigarette Alternatives. Financial Times, 12 August 2012.
9
Lorillard Inc., “Lorillard, Inc. Reports First Quarter 2012 Results and Acquisition of blu ecigs” April 25, 2012.
http://investors.lorillard.com/phoenix.zhtml?c=134955&p=irol-newsArticle&ID=1687024&highlight=.
A typical web advertisement for e-cigarettes
4. 4
3. Regulatory systems
For a number of years, several observers have highlighted the need for better integration or co-
ordination of regulatory approaches to tobacco products and to pharmaceutical nicotine products.
Pharmaceutical products are subject to extensive testing, rules about allowable therapeutic claims
and various advertising and marketing restrictions. Tobacco products are generally exempt from
any health-based testing (that is, they are not required to be below a certain level of risk to be
authorized for sale); in most countries there are few regulations about location of sale; and
advertising and marketing rules vary depending on Parties’ success in implementing FCTC Article
13. It is at least arguable that governments should co-regulate these types of products, particularly
in the case of countries that have approved pharmaceutical nicotine for long-term use. For
example, in 2002, the Royal College of Physicians of London published a report calling for a unified
regulatory authority for tobacco and nicotine products.10
In the way they are designed and marketed, ENDS straddle the line between tobacco products and
pharmaceutical nicotine. They promise “safe” (or at least safer) delivery of nicotine, like nicotine
gum or patches. On the other hand, they are designed to look like cigarettes and are presented as
“recreational” products rather than medicines. To date, they have not been submitted for
regulatory approval, although that could well change as larger companies become involved in this
market segment.
The WHO Study Group on Tobacco Product Regulation recommended in 2010 that ENDS should be
“regulated as combination drugs and medical devices and not as tobacco products”.11
This may well
be the logical approach in many Parties’ legal frameworks. However, Parties may also wish to take
the opportunity to undertake a review of their regulatory structures around tobacco and nicotine
products. For example, the EU is currently in the process of revising its Tobacco Products Directive
and it is understood that regulation of e-cigarettes is one of the issues under consideration.12
a) The applicability of the WHO Framework Convention on Tobacco Control
In its report to COP4, the Article 9/10 working group invited the Conference of the Parties
to “indicate whether it agrees that electronic nicotine delivery systems are to be
considered ‘tobacco products’ and should be part of future work of the working group.”
FCA continues to recommend that the COP not take a position on the specific issue of
whether ENDS are tobacco products. As the Secretariat’s report indicates, Party practice
differs, with some Parties treating electronic cigarettes as drugs/medical devices and
others as tobacco products. As this issue is likely to be subject to litigation in a number of
Parties over the coming years, a COP finding could be unhelpful. Moreover, given rapid
developments in both technology and marketing strategies, preserving flexibility would be
prudent.
10 Royal College of Physicians of London. Protecting Smokers, Saving Lives: the case for a tobacco and nicotine regulatory
authority. 2002. On-line at: http://www.rcplondon.ac.uk/publications/protecting-smokers-saving-lives.
11 WHO Study Group on Tobacco Product Regulation. Report on the scientific basis of tobacco product regulation: third report
of a WHO study group. 2010.
12 http://www.theparliament.com/latest-news/article/newsarticle/eu-moves-towards-plain-packaging-for-tobacco-products/.
5. 5
Conclusion
FCA encourages individual Parties, at a minimum, to monitor their national markets carefully
with respect to sales and promotions of electronic nicotine delivery devices, and to provide
relevant information in their reports to the COP, particularly with respect to cross-border (e.g.
Internet-based) trade.
In accordance with their particular regulatory framework, Parties should decide whether ENDS
are classified as tobacco products or drugs/medical devices, and apply relevant legislation on
regulatory approval, place of use, taxation and other issues. Parties should also consider
whether this framework requires overhaul.
FCA recommends against referring the issue of ENDS to the Article 9/10 working group. In our
view, as we stated at COP4, regulatory difficulties surrounding electronic cigarettes have little to
do with Article 9 (which deals with the regulation of contents and emissions of tobacco
products) or with Article 10 (which deals with tobacco product disclosures).