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.
This document outlines plans for new legislation in Ireland to further regulate the sale of tobacco products and nicotine delivery systems like e-cigarettes. The goals are to reduce smoking rates, especially among youth, and create a tobacco licensing system. It discusses the health impacts of smoking and rising use of e-cigarettes. The legislation would license tobacco/e-cigarette sellers, ban certain sales methods, and set penalties for violations. Views are sought on measures to draft the new bill.
This document discusses several novel nicotine products that have entered the market, including nicotinis
(martinis with tobacco juice), nicotine lollipops, nicotine wafers, and nicotine water. It raises concerns that
unlike FDA-approved nicotine cessation products, the safety and effectiveness of these novel products is
unknown since they have not undergone necessary clinical trials and FDA approval. The document advises
tobacco users to follow the guidelines of health experts and use proven FDA-approved cessation methods
if wanting to quit.
This document discusses tobacco control and prevention policies recommended by the American College of Physicians. It provides background on the health and economic impacts of tobacco use. Key points include:
- Tobacco use is the leading preventable cause of death in the US. Comprehensive tobacco control programs are needed to reduce smoking rates.
- The FDA was given authority in 2009 to regulate tobacco, but regulation alone is not enough. States must fund tobacco control efforts and increase tobacco taxes.
- Smokeless tobacco and cigars also harm health. Secondhand smoke exposure causes illness and death in nonsmokers.
This document summarizes a review of studies on nicotine replacement therapy (NRT) for smoking cessation. The review analyzed studies comparing NRT to non-use of NRT and comparing different types and administration methods of NRT. NRT was found to significantly increase smoking cessation rates compared to non-use. Various NRT delivery methods, including patches, gum, inhalers, and nasal spray, were evaluated alone and in combination. Higher doses and longer duration of therapy generally resulted in better outcomes.
Accessories are added to surfaces and objects to make them more useful, attractive, or versatile. Accessories should be used sparingly and in a coordinated style or color scheme. During refurbishment or renovation of a property, housekeeping plays an important role in preparing rooms by removing furniture and accessories, deep cleaning, and replacing items after work is completed. When accommodating guests with disabilities, properties must provide accessible rooms, transportation, registration areas, and amenities like grab bars, appropriately sized bathrooms, and communication devices for hearing impaired guests.
Major tobacco-related-events-in-the-united-statesGeorgi Daskalov
This document provides a summary of major tobacco-related events in the United States from World War II to the 1980s. It outlines key milestones such as the first studies linking smoking to cancer in the 1950s, the 1964 Surgeon General's report that concluded smoking causes disease, restrictions on tobacco advertising and the introduction of warning labels on cigarette packs. It also discusses tobacco industry efforts to downplay health risks and market "safer" cigarettes while nicotine levels increased. The summary covers events that increased public awareness of tobacco's dangers and early policies to regulate tobacco use.
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
This document outlines plans for new legislation in Ireland to further regulate the sale of tobacco products and nicotine delivery systems like e-cigarettes. The goals are to reduce smoking rates, especially among youth, and create a tobacco licensing system. It discusses the health impacts of smoking and rising use of e-cigarettes. The legislation would license tobacco/e-cigarette sellers, ban certain sales methods, and set penalties for violations. Views are sought on measures to draft the new bill.
This document discusses several novel nicotine products that have entered the market, including nicotinis
(martinis with tobacco juice), nicotine lollipops, nicotine wafers, and nicotine water. It raises concerns that
unlike FDA-approved nicotine cessation products, the safety and effectiveness of these novel products is
unknown since they have not undergone necessary clinical trials and FDA approval. The document advises
tobacco users to follow the guidelines of health experts and use proven FDA-approved cessation methods
if wanting to quit.
This document discusses tobacco control and prevention policies recommended by the American College of Physicians. It provides background on the health and economic impacts of tobacco use. Key points include:
- Tobacco use is the leading preventable cause of death in the US. Comprehensive tobacco control programs are needed to reduce smoking rates.
- The FDA was given authority in 2009 to regulate tobacco, but regulation alone is not enough. States must fund tobacco control efforts and increase tobacco taxes.
- Smokeless tobacco and cigars also harm health. Secondhand smoke exposure causes illness and death in nonsmokers.
This document summarizes a review of studies on nicotine replacement therapy (NRT) for smoking cessation. The review analyzed studies comparing NRT to non-use of NRT and comparing different types and administration methods of NRT. NRT was found to significantly increase smoking cessation rates compared to non-use. Various NRT delivery methods, including patches, gum, inhalers, and nasal spray, were evaluated alone and in combination. Higher doses and longer duration of therapy generally resulted in better outcomes.
Accessories are added to surfaces and objects to make them more useful, attractive, or versatile. Accessories should be used sparingly and in a coordinated style or color scheme. During refurbishment or renovation of a property, housekeeping plays an important role in preparing rooms by removing furniture and accessories, deep cleaning, and replacing items after work is completed. When accommodating guests with disabilities, properties must provide accessible rooms, transportation, registration areas, and amenities like grab bars, appropriately sized bathrooms, and communication devices for hearing impaired guests.
Major tobacco-related-events-in-the-united-statesGeorgi Daskalov
This document provides a summary of major tobacco-related events in the United States from World War II to the 1980s. It outlines key milestones such as the first studies linking smoking to cancer in the 1950s, the 1964 Surgeon General's report that concluded smoking causes disease, restrictions on tobacco advertising and the introduction of warning labels on cigarette packs. It also discusses tobacco industry efforts to downplay health risks and market "safer" cigarettes while nicotine levels increased. The summary covers events that increased public awareness of tobacco's dangers and early policies to regulate tobacco use.
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
This document describes the methodology used to examine the availability, accessibility, usage and regulatory environment of novel and emerging tobacco, nicotine, and related products in the EU. The study involved a two-stage evidence review, key informant interviews, and a stakeholder survey. In the first stage, the researchers developed a typology of products by comprehensively searching various information sources. This typology guided a second, more targeted evidence review. Key findings of the evidence review, interviews, and survey are presented in subsequent chapters, with conclusions and options for addressing regulatory gaps discussed in the final chapter. The overall aim was to inform a possible revision of the EU Tobacco Products Directive.
The 7Tips of entering Japanese market for tech startups拓弥 宮田
This is the deck for my presentation at Japan Society event ( http://www.usajapan.org/event/big-in-japan-tak-miyata-founding-partner-scrum-ventures-how-silicon-valley-startups-can-enter-asian-markets/ )
This is to introduce "7 Tips" of entering the Japanese market for tech startups.
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.
The document provides information about smokeless tobacco fact sheets prepared for a conference on smokeless tobacco. It includes an introduction stating that smokeless tobacco has existed for thousands of years and is consumed orally or nasally without burning. It causes cancer and other health issues. The fact sheets cover various smokeless tobacco products from different regions of the world and provide information on brand names, ingredients, use, users, and manufacturing. Additional information is welcomed for developing future editions of the fact sheets.
This document discusses updates in the diagnosis and treatment of osteoporosis. It defines osteoporosis as a disease characterized by low bone mass and deterioration of bone structure. Osteoporosis increases the risk of fractures, with vertebral fractures being the most common. It can lead to pain, disability, and increased mortality. An estimated 8 million women and 2.5 million men in the US have osteoporosis, and these numbers are expected to increase by 40% by 2020. Osteoporosis poses a significant economic burden and reduces quality of life. Advances have been made in assessing fracture risk levels based on 10-year probability in addition to bone mineral density scores. Treatment involves lifestyle changes and medications
Este documento describe brevemente la anatomía de la cara y los músculos faciales. Explica la ubicación, origen, inserción e inervación de músculos como el epicraneano, corrugador de la ceja, procero, orbicular del ojo, nasal, elevador del labio superior y del ala de la nariz, cigomático mayor y menor, risorio y elevador del ángulo de la boca. También incluye imágenes ilustrativas y da instrucciones para pruebas musculares faciales.
Haiku Deck is a presentation tool that allows users to create Haiku style slideshows. The tool encourages users to get started making their own Haiku Deck presentations which can be shared on SlideShare. In just a few sentences, it pitches the idea of using Haiku Deck to easily create visual presentations.
Jaymie Larson seeks a dynamic position where she can utilize her 11 years of experience in restaurant management. She has a track record of developing strong customer relationships and learning new tasks quickly. Her skills include time management, operations analysis, social perceptiveness, and judgment/decision-making. She is ServSafe certified and has held assistant manager roles at HMShost and Woody's Grille, where she oversaw scheduling, inventory, and ensuring customer satisfaction.
This document provides information on smoke and tobacco cessation resources available at UC Davis for students, faculty, staff, and visitors. It outlines several helpline numbers that can help with quitting. Students can receive free nicotine replacement products and counseling through Student Health and Counseling Services. Faculty and staff have access to free or low-cost nicotine replacement options through their health plans. Rite Aid pharmacy provides a free two-week supply of nicotine replacements to students, faculty, and staff with a UC Davis ID. Additional online resources are available to support quitting smoking and tobacco use.
The article discusses the Indonesian government's plan to increase tax revenues by expanding the tax base. It notes that currently only around 30 million people pay taxes out of a population of around 250 million. The government aims to add around 20 million new taxpayers over the next five years by simplifying the tax system and increasing the income threshold for paying taxes. This would help boost state revenues to fund infrastructure projects and subsidies for the poor.
This document provides an equality impact assessment for a proposed policy on standardised packaging of tobacco products in the UK. It finds that the policy could have both negative and positive impacts on equality. Negatively, it may disproportionately affect people with visual impairments, low English literacy, or those relying on illicit tobacco. Positively, it may help reduce health inequalities since smoking disproportionately impacts poorer, less educated, and mental illness groups. More evidence is needed, and the impacts will be reassessed after public consultation. The goal of the policy is to reduce smoking initiation and increase quitting to ultimately improve public health.
E-cigarettes were invented in 2003 as a less harmful alternative to traditional cigarettes. They work by heating a liquid that contains nicotine and flavorings to produce an aerosol that is inhaled. While e-cigarettes may be less risky than smoking, they are not completely safe. Their long-term health impacts are still unknown, and some studies have found links between the particles in e-cigarette aerosol and cardiovascular problems. India has banned e-cigarettes due to concerns about rising youth addiction and unknown health risks. Violators of the ban can face imprisonment and fines.
E-cigarettes were invented in 2003 as a less harmful alternative to traditional cigarettes. They work by heating a liquid that contains nicotine and flavorings to produce an aerosol that is inhaled. While e-cigarettes may be less risky than smoking, they are not completely safe. Their long-term health impacts are still unknown, and some studies have found links between the particles in e-cigarette aerosol and cardiovascular problems. India has banned e-cigarettes due to concerns about rising youth addiction and unknown health risks. Violators of the ban can face imprisonment and fines.
The document is a consultation on standardised (or "plain") packaging of tobacco products. It outlines the objectives to discourage smoking uptake among youth, encourage quitting, and reduce exposure to secondhand smoke. It discusses requiring tobacco products to be sold in standardized packaging without branding or promotional information to reduce appeal and misleading of consumers. It seeks feedback on the potential public health benefits and other impacts of introducing standardized packaging.
This document discusses issues related to specialist tobacconists under UK health laws. It defines specialist tobacconists as shops that derive 50% of sales from cigars, snuff, pipe tobacco and accessories. Specialist shops are allowed to advertise tobacco and have designated smoking rooms for product sampling. However, the document argues that shisha bars do not qualify as specialist shops and are not exempt from smoke-free laws, as shisha is consumed rather than briefly sampled. It notes challenges in enforcing smoke-free laws against underground shisha bars and recommends giving enforcement agencies stronger prohibition powers.
This document discusses plain packaging requirements for tobacco products and the related rights of trademark owners. It provides an introduction to plain packaging, defines various types of tobacco products, and outlines the benefits of plain packaging such as reducing false beliefs about brand safety and decreasing appeal to youth. It also lists countries that have adopted plain packaging laws and discusses Australia's plain packaging legislation and its upholding by courts. The document examines arguments that plain packaging infringes on trademark rights and discusses responses from organizations like the WTO, WHO, and courts. It concludes that plain packaging can help consumers focus on health warnings by reducing misleading branding, which is especially important for protecting India's large vulnerable tobacco consuming population.
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.
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 discusses tobacco cessation and control. It outlines the diseases caused by smoking in both children and adults. It recommends offering help to quit tobacco use through cessation advice, legislation, and pharmacological therapy. Health professionals have an important role to play in tobacco control through advising patients, promoting tobacco-free policies, and building cessation infrastructure. Brief counseling and motivational interventions can help patients quit smoking. Government initiatives like the COTPA act have implemented various bans and warnings. Increasing tobacco taxes and prices is also effective for reducing consumption. The National Tobacco Control Programme aims to reduce tobacco use in India.
This document describes the methodology used to examine the availability, accessibility, usage and regulatory environment of novel and emerging tobacco, nicotine, and related products in the EU. The study involved a two-stage evidence review, key informant interviews, and a stakeholder survey. In the first stage, the researchers developed a typology of products by comprehensively searching various information sources. This typology guided a second, more targeted evidence review. Key findings of the evidence review, interviews, and survey are presented in subsequent chapters, with conclusions and options for addressing regulatory gaps discussed in the final chapter. The overall aim was to inform a possible revision of the EU Tobacco Products Directive.
The 7Tips of entering Japanese market for tech startups拓弥 宮田
This is the deck for my presentation at Japan Society event ( http://www.usajapan.org/event/big-in-japan-tak-miyata-founding-partner-scrum-ventures-how-silicon-valley-startups-can-enter-asian-markets/ )
This is to introduce "7 Tips" of entering the Japanese market for tech startups.
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.
The document provides information about smokeless tobacco fact sheets prepared for a conference on smokeless tobacco. It includes an introduction stating that smokeless tobacco has existed for thousands of years and is consumed orally or nasally without burning. It causes cancer and other health issues. The fact sheets cover various smokeless tobacco products from different regions of the world and provide information on brand names, ingredients, use, users, and manufacturing. Additional information is welcomed for developing future editions of the fact sheets.
This document discusses updates in the diagnosis and treatment of osteoporosis. It defines osteoporosis as a disease characterized by low bone mass and deterioration of bone structure. Osteoporosis increases the risk of fractures, with vertebral fractures being the most common. It can lead to pain, disability, and increased mortality. An estimated 8 million women and 2.5 million men in the US have osteoporosis, and these numbers are expected to increase by 40% by 2020. Osteoporosis poses a significant economic burden and reduces quality of life. Advances have been made in assessing fracture risk levels based on 10-year probability in addition to bone mineral density scores. Treatment involves lifestyle changes and medications
Este documento describe brevemente la anatomía de la cara y los músculos faciales. Explica la ubicación, origen, inserción e inervación de músculos como el epicraneano, corrugador de la ceja, procero, orbicular del ojo, nasal, elevador del labio superior y del ala de la nariz, cigomático mayor y menor, risorio y elevador del ángulo de la boca. También incluye imágenes ilustrativas y da instrucciones para pruebas musculares faciales.
Haiku Deck is a presentation tool that allows users to create Haiku style slideshows. The tool encourages users to get started making their own Haiku Deck presentations which can be shared on SlideShare. In just a few sentences, it pitches the idea of using Haiku Deck to easily create visual presentations.
Jaymie Larson seeks a dynamic position where she can utilize her 11 years of experience in restaurant management. She has a track record of developing strong customer relationships and learning new tasks quickly. Her skills include time management, operations analysis, social perceptiveness, and judgment/decision-making. She is ServSafe certified and has held assistant manager roles at HMShost and Woody's Grille, where she oversaw scheduling, inventory, and ensuring customer satisfaction.
This document provides information on smoke and tobacco cessation resources available at UC Davis for students, faculty, staff, and visitors. It outlines several helpline numbers that can help with quitting. Students can receive free nicotine replacement products and counseling through Student Health and Counseling Services. Faculty and staff have access to free or low-cost nicotine replacement options through their health plans. Rite Aid pharmacy provides a free two-week supply of nicotine replacements to students, faculty, and staff with a UC Davis ID. Additional online resources are available to support quitting smoking and tobacco use.
The article discusses the Indonesian government's plan to increase tax revenues by expanding the tax base. It notes that currently only around 30 million people pay taxes out of a population of around 250 million. The government aims to add around 20 million new taxpayers over the next five years by simplifying the tax system and increasing the income threshold for paying taxes. This would help boost state revenues to fund infrastructure projects and subsidies for the poor.
This document provides an equality impact assessment for a proposed policy on standardised packaging of tobacco products in the UK. It finds that the policy could have both negative and positive impacts on equality. Negatively, it may disproportionately affect people with visual impairments, low English literacy, or those relying on illicit tobacco. Positively, it may help reduce health inequalities since smoking disproportionately impacts poorer, less educated, and mental illness groups. More evidence is needed, and the impacts will be reassessed after public consultation. The goal of the policy is to reduce smoking initiation and increase quitting to ultimately improve public health.
E-cigarettes were invented in 2003 as a less harmful alternative to traditional cigarettes. They work by heating a liquid that contains nicotine and flavorings to produce an aerosol that is inhaled. While e-cigarettes may be less risky than smoking, they are not completely safe. Their long-term health impacts are still unknown, and some studies have found links between the particles in e-cigarette aerosol and cardiovascular problems. India has banned e-cigarettes due to concerns about rising youth addiction and unknown health risks. Violators of the ban can face imprisonment and fines.
E-cigarettes were invented in 2003 as a less harmful alternative to traditional cigarettes. They work by heating a liquid that contains nicotine and flavorings to produce an aerosol that is inhaled. While e-cigarettes may be less risky than smoking, they are not completely safe. Their long-term health impacts are still unknown, and some studies have found links between the particles in e-cigarette aerosol and cardiovascular problems. India has banned e-cigarettes due to concerns about rising youth addiction and unknown health risks. Violators of the ban can face imprisonment and fines.
The document is a consultation on standardised (or "plain") packaging of tobacco products. It outlines the objectives to discourage smoking uptake among youth, encourage quitting, and reduce exposure to secondhand smoke. It discusses requiring tobacco products to be sold in standardized packaging without branding or promotional information to reduce appeal and misleading of consumers. It seeks feedback on the potential public health benefits and other impacts of introducing standardized packaging.
This document discusses issues related to specialist tobacconists under UK health laws. It defines specialist tobacconists as shops that derive 50% of sales from cigars, snuff, pipe tobacco and accessories. Specialist shops are allowed to advertise tobacco and have designated smoking rooms for product sampling. However, the document argues that shisha bars do not qualify as specialist shops and are not exempt from smoke-free laws, as shisha is consumed rather than briefly sampled. It notes challenges in enforcing smoke-free laws against underground shisha bars and recommends giving enforcement agencies stronger prohibition powers.
This document discusses plain packaging requirements for tobacco products and the related rights of trademark owners. It provides an introduction to plain packaging, defines various types of tobacco products, and outlines the benefits of plain packaging such as reducing false beliefs about brand safety and decreasing appeal to youth. It also lists countries that have adopted plain packaging laws and discusses Australia's plain packaging legislation and its upholding by courts. The document examines arguments that plain packaging infringes on trademark rights and discusses responses from organizations like the WTO, WHO, and courts. It concludes that plain packaging can help consumers focus on health warnings by reducing misleading branding, which is especially important for protecting India's large vulnerable tobacco consuming population.
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.
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 discusses tobacco cessation and control. It outlines the diseases caused by smoking in both children and adults. It recommends offering help to quit tobacco use through cessation advice, legislation, and pharmacological therapy. Health professionals have an important role to play in tobacco control through advising patients, promoting tobacco-free policies, and building cessation infrastructure. Brief counseling and motivational interventions can help patients quit smoking. Government initiatives like the COTPA act have implemented various bans and warnings. Increasing tobacco taxes and prices is also effective for reducing consumption. The National Tobacco Control Programme aims to reduce tobacco use in India.
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
This document provides a guide for tobacco users who want to quit smoking. It discusses getting ready to quit by understanding the health risks of smoking, the rewards of quitting, and how to improve confidence in quitting. It also covers planning and making quit attempts, including developing a quit plan, strategies to overcome challenges, and preparing for relapse. Local cessation support resources are also mentioned. The overall document aims to educate tobacco users on the importance of quitting and provides guidance on how to plan and succeed in a quit attempt.
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.
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.
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.
Tobacco is a plant grown for its leaves, which contain the addictive drug nicotine. Nicotine causes the release of endorphins that make people feel good in the short term but is highly addictive. Tobacco use leads to serious health issues like cancer, heart disease, and death. The WHO Framework Convention on Tobacco Control aims to address the global tobacco epidemic. In India, the National Tobacco Control Programme was launched in 2007 to increase awareness, reduce tobacco use and production, and enforce tobacco control laws. It operates at national, state, and district levels to implement strategies like public education campaigns, enforcement of advertising bans, and increasing access to cessation resources.
The document discusses e-cigarettes and whether they can help smokers quit smoking conventional cigarettes. It explains that e-cigarettes consist of a cartridge containing nicotine solution, a vaporizer, and a battery. Studies have shown e-cigarettes still contain some cancer-causing substances, but remove harmful tar. Large health organizations like the FDA and WHO have not approved e-cigarettes as safer alternatives or for smoking cessation due to lack of long-term research on safety. The best way to quit smoking is to avoid all nicotine products entirely.
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
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1. December 2014
Age of Sale for Nicotine
Inhaling Products
Consultation on proposed regulations to be made
under the Children and Families Act 2014
2.
3. December 2014
Contents
1. Purpose of this consultation................................................................................................. 4
2. Background ......................................................................................................................... 6
E-cigarettes ..............................................................................................................................6
Licenced products ....................................................................................................................7
Use of e-cigarettes ...................................................................................................................7
Association with tobacco smoking............................................................................................8
The effects of nicotine ..............................................................................................................8
3. Detail of proposed regulations........................................................................................... 10
Defining nicotine inhaling products.........................................................................................10
Medicinal products or medical devices...................................................................................10
Proxy purchase of e-cigarettes...............................................................................................11
Offences and penalties...........................................................................................................11
Age of sale..........................................................................................................................11
Proxy purchasing ................................................................................................................12
Enforcement...........................................................................................................................12
4. Territorial scope of the regulations .................................................................................... 12
5. Impact assessment............................................................................................................ 12
6. How to get involved in the consultation ............................................................................. 13
7. Declaration of direct or indirect links to the tobacco industry by respondents ................... 14
8. Next steps.......................................................................................................................... 14
9. Comments on the consultation process............................................................................. 14
10. Confidentiality of information ............................................................................................. 15
Annex A ..................................................................................................................................... 16
Draft regulations to be made under the Children and Families Act 2014 ...............................16
Annex B ..................................................................................................................................... 19
Consultation questions about the proposed regulations and assessment of impact on
business .................................................................................................................................19
4. December 2014
1. Purpose of this consultation
1.1. The purpose of this consultation is to seek views on draft regulations to introduce a
minimum age of sale of 18 years for nicotine inhaling products, such as electronic
cigarettes (also known as e-cigarettes) and related parts of such devices.
1.2. Given the emergence of e-cigarettes in recent years, coupled with concerns about the
increased awareness and use of these products by children, the Government has
committed to setting an age of sale requirement for these products. Section 92 of the
Children and Families Act 2014 (‘the Act’) gives the Secretary of State the powers to
make regulations to introduce a minimum age of sale for nicotine products.
1.3. A ‘nicotine inhaling product’ for the purposes of the proposed regulations means any
device which is intended to enable nicotine to be inhaled through a mouthpiece. It
encompasses e-cigarettes (disposable and non-disposable) and certain component
parts such as nicotine refill cartridges and nicotine refill substances, often called ‘e-
liquids’.
1.4. The proposed regulations would not apply to tobacco products, because age of sale
laws already exist. As the regulations would only apply to nicotine inhaling products,
they would not cover other products where small amounts of nicotine occur naturally,
such as certain fruits and vegetables. Nevertheless, the regulation-making powers
enable the Government to make provision in the future for other nicotine delivery
products which may emerge in time.
1.5. The aims of the proposed regulations would be to:
• limit the sale of nicotine inhaling products such as e-cigarettes to adults only, with
certain limited exceptions for medicinal products
• protect children from the risk of nicotine addiction and the impact that nicotine can
have on the developing adolescent brain
• protect children and young people from any potential ‘gateway’ effect into smoking
tobacco that might come from the use of nicotine inhaling products
1.6. The proposed regulations would:
• make it an offence to sell nicotine inhaling products (such as e-cigarettes) and
related products to anyone under the age of 18 years
• extend the tobacco ‘proxy purchasing’ offence in the Act to also cover e-cigarettes,
so it would also be an offence for an adult to buy a nicotine inhaling products on
behalf of a person under 18 years
• exempt the sale of any nicotine inhaling product that is licensed as a medicine,
where it has been prescribed to the child or where the medicine is indicated for
use by children
1.7. The proposed regulations are explained in more detail in section 3.
1.8. The age of sale regulations proposed in this consultation will apply to England and
Wales, subject to the necessary consent being provided by Welsh Ministers.
1.9. The Government intends to proceed with the introduction of regulations to set an age of
sale for nicotine inhaling products. This consultation seeks views on the detail of
proposed regulations so that feedback from those with an interest can be considered
5. Age of Sale for Nicotine Inhaling Products
5
before regulations are finalised. Parliament will consider the regulations before they can
be made.
1.10. We are seeking views on the proposed regulations at Annex A and responses to the
specific consultation questions at Annex B.
1.11. We also seek views on our initial assessment of the impact on business and the equality
analysis which are published alongside this consultation document.
6. 6
2. Background
2.1. In summary, the Government is introducing an age of sale restriction because:
• children should be protected from the risk of addiction
• the use of nicotine in adolescence can alter brain development
• use and awareness of e-cigarettes among children is increasing
• e-cigarettes can be appealing to children
• we do not know conclusively whether e-cigarettes act as a ‘gateway’ into the use
of tobacco
• we do not know about the effect of the use of e-cigarettes on the developing lungs
of children
• the Government wishes to remove existing uncertainty on age of sale and provide
clarity and consistency to assist manufacturers and retailers
2.2. The Government recognises that responsible manufacturers already recommend that
their products are for use by adults only. Responsible retailers already voluntarily
restrict children from accessing e-cigarettes. However, some do not. A number of
manufacturers and retailers of e-cigarettes have called for a minimum age of sale to be
introduced.
2.3. To support retailers to implement age of sale requirements for nicotine inhaling products,
the proposed regulations have been developed to be consistent with existing age of sale
requirements relating to the sale of tobacco and other age restricted products.
E-cigarettes
2.4. In recent years, the market for e-cigarettes has developed rapidly. Today, a wide range
of different types and brands of e-cigarettes are on the market.
2.5. According to a report on e-cigarettes commissioned by Public Health England (PHE), e-
cigarettes were invented in China in 2003 to provide inhaled doses of vaporized nicotine.
E-cigarettes were first introduced to Europe in about 2005 and have become
increasingly popular since. The products have evolved considerably.1
Action on
Smoking and Health (ASH) provides the following description of electronic cigarettes:
Electronic cigarettes, also known as vapourisers or electronic nicotine delivery
systems (ENDS), are often, although not always, designed to look and feel like
cigarettes. They have been marketed as less harmful alternatives to cigarettes
and for use in places where smoking is not permitted since they do not produce
smoke.
There are three main types of electronic cigarettes or vapourisers:
• Disposable products (non-rechargeable)
• An electronic cigarette kit that is rechargeable with replaceable pre-filled
cartridges
• An electronic cigarette that is rechargeable and has a tank or reservoir which
has to be filled with liquid nicotine
7. Age of Sale for Nicotine Inhaling Products
7
The first two types of electronic cigarette are often known as “cigalike” products as
they resemble cigarettes and often have a light at the end that glows when the
user draws on the device to resemble a lit cigarette.2
2.6. Most e-cigarettes on the market are flavoured. A huge variety of flavours for e-
cigarettes are available, some of which may be appealing to children (such as cherry
cola, white chocolate, bubble gum, vanilla ice cream, energy drink and gummy bear
flavours).
Licenced products
2.7. Nicotine inhaling products can only be marketed as a smoking cessation aid if they have
been licensed as a medicine by the MHRA.3
While a number of e-cigarette companies
have said publicly that they have or will submit an application for a medicines licence for
their products, at present a license has been granted for only two products that would
meet the definition of nicotine inhaling products: Voke and the Nicorette Inhalator.
2.8. A nicotine inhaling product regulated as a medicine, such as a nicotine replacement
therapy, would be available to be sold to children under the age of 18 years if (a) it is
sold in accordance with a valid prescription (regardless of classification) or (b) the
product’s medicine marketing authorisation provides that it is indicated for use by
persons under 18 years.
2.9. Licensed medicines are subject to separate regulatory rules that cover aspects such as
advertising, product presentation, to whom medicines can be supplied and other aspects
relating to sale and supply.
Use of e-cigarettes
2.10. E-cigarettes are becoming increasingly popular and are now widely promoted. ASH
estimates that there are currently around 2.1 million adults in Great Britain using
electronic cigarettes, up from an estimated 700,000 users in 2012.4
While use of these
products by people under the age of 18 is not widespread in England and Wales,
international evidence suggests that it is plausible that usage of e-cigarettes by young
people may increase.
2.11. Emerging evidence suggests that awareness of e-cigarettes by British children is high.
A report commissioned by PHE on e-cigarette uptake and marketing found that two-
thirds (66%) of 11 to 18-year olds in Great Britain had heard of e-cigarettes. Some 7%
had tried e-cigarettes at least once and 2% reported using them sometimes or often. A
separate study found that over two-thirds of children in Wales reported that they have
heard of e-cigarettes.5
In a study conducted among children in Cheshire and
Merseyside, all participating children had heard of e-cigarettes or knew what they were.
This study also found:
There was an overwhelming sense across all groups that the majority of young
people who do use e-cigarettes do so not for the benefits proposed by those who
produce and market these products (e.g. for health benefits, to save money, to
allow users to intake nicotine in locations where tobacco smoking is prohibited),
but simply “for the sake of it”, to fit in with or impress their peers, or to portray a
certain desired image of themselves.6
2.12. The promotion of e-cigarettes is likely to be a key reason why awareness of these
products is high among children and young people. E-cigarettes are available for sale in
a wide range of retail outlets, including supermarkets, newsagents, specialist shops and
8. 8
pharmacies, and are often prominently displayed and promoted in store. E-cigarette
companies compete on price and invest in marketing and promotion, including through
social media such as Twitter.7
E-cigarettes are widely advertised, which has become a
cause of concern for some.
2.13. The Government recognises that responsible e-cigarette manufacturers will not seek
specifically to market e-cigarettes to children. However, while e-cigarette companies
may design much of their promotional activity to reach out to adults, there is a risk that
this promotion may also resonate with young people. Young people are also exposed to
increasing in-store marketing of e-cigarette products and it is plausible that the
increasing prominence of e-cigarette marketing in shops may increase the appeal of
these products.
Association with tobacco smoking
2.14. While e-cigarette use by children is currently strongly associated with existing tobacco
smoking, research published recently by the Welsh Government provides tentative
evidence that e-cigarette use may represent a new form of childhood experimentation
with nicotine.5
E-cigarette use might be more prevalent among 10-11 year olds than
smoking. Some 6% of children in this group reported to have ever used an e-cigarette,
compared with 2% who reported having ever smoked. Research in Cheshire and
Merseyside found that young people view e‐cigarettes as products in their own right,
rather than, for example, a substitute to smoking tobacco. This research suggests that
many young people say that they use e-cigarettes “simply for the sake of it”, “for fun”, or
to “try something new”, and that the main focus for young people was on the different
flavours and designs of e‐cigarettes and the opportunity for users to customise their
devices and show individuality. The researchers concluded that, with their colourful
designs and variety of flavours, e-cigarettes may provide a more accessible and
appealing way for young people who may not like the taste or sensation of tobacco
cigarettes to experiment with nicotine.8
E-cigarettes are likely to be easier to use than
smoking conventional cigarettes.
2.15. In her 2013 Annual Report, the Chief Medical Officer for England ‘raises concern that
there may be young people for whom e-cigarettes could be an entry point to use of
conventional tobacco products, including cigarettes’.9
As there have been no
longitudinal studies to examine whether e-cigarettes serve as a gateway to tobacco use,
we cannot be certain at this stage about whether there is a “gateway effect” from the use
of e-cigarettes into tobacco smoking, and further research is needed to answer the
question definitively. The World Health Organization has recently recommended that e-
cigarettes should not be sold to minors.
The effects of nicotine
2.16. It has long been established that nicotine is highly addictive. Nicotine is a potent and
powerfully addictive drug, which is five to ten times more potent than cocaine or
morphine in producing behavioural and psychic effects associated with addiction
potential in humans.10
The Government wants to protect children and young people
from addiction to any substance, particularly those that might be harmful.
2.17. Young people can rapidly develop nicotine dependence. With respect to nicotine from
smoking tobacco, symptoms can develop soon after a young person’s first puff on a
cigarette. Novice users often do not recognise the symptoms they experience as related
to nicotine dependence.11
Research shows that the adolescent brain continues to
9. Age of Sale for Nicotine Inhaling Products
9
develop during adolescence and that it is uniquely different from the adult brain. One of
the differences is that adolescents are more sensitive to the rewarding effects of
nicotine, which may be a reason that many people start to smoke during adolescence.12
The impact of nicotine on the developing adolescent brain, as delivered by e-cigarettes,
is also described by Dutra et al.
Although e-cigarettes deliver many fewer toxins and at much lower levels than
conventional cigarettes, they contain nicotine, a highly addictive substance, in
doses designed to mimic cigarettes. Animal models suggest that, through its
effect on cholinergic pathways, nicotine may have permanent effects on the brain
and behaviour such as dysregulation of the limbic system, which can lead to long-
term difficulties with behavioural regulation, attention, memory, and motivation,
among other functions. The adolescent human brain may be particularly
vulnerable to the effects of nicotine because it is still developing.13
10. 10
3. Detail of proposed regulations
3.1. Regulations would be made in accordance with Section 92 of the Act.14
The proposed
regulations are set out in Annex A and should be read in conjunction with the Act.
Defining nicotine inhaling products
3.2. The minimum age of sale of 18 years will apply to ‘nicotine inhaling products’. This
definition covers all e-cigarette devices (including disposable and rechargeable types)
and their refills (such as pre-filled refill cartridges and liquids). Within the proposed
regulations, a ‘nicotine inhaling device’ covers any device which is intended to enable
nicotine to be inhaled through a mouth piece. It would not matter whether the device
looks like a conventional cigarette or takes a different form if a device meets the
definition proposed. The regulations cover all nicotine inhaling products, regardless of
how they are powered. ‘Dual use’ refillable devices which might alternatively be filled
with either nicotine or non-nicotine liquid would also be subject to the age of sale
requirements.
3.3. Some e-cigarettes do not look like conventional tobacco cigarettes and contain a
reservoir or tank which is designed to be filled with a propylene glycol liquid. These
liquids may be sold separately and may or may not contain nicotine. Although, at the
point of sale, some devices may not contain nicotine, they would be covered by the
proposed regulations if they are intended to enable nicotine to be inhaled through a
mouthpiece.
3.4. The government does not intend for the proposed regulations to cover component parts
such as batteries, charging devices and electrical leads for nicotine inhaling products.
Medicinal products or medical devices
3.5. The regulations provide exemptions for any nicotine inhaling product that is licensed as
a medicine by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Nicotine inhaling products that are licensed medicines can be made available to children
and young people under the age of 18 years on prescription. The draft regulations also
propose an exemption for any nicotine inhaling product which has an indication for use
by people under the age of 18.
3.6. Regulation 4 would exempt the sale of nicotine inhaling products that are medicines or
medical devices sold in accordance with a valid prescription by a pharmacist (or in other
rare exceptional circumstances under which prescription only medicines could be sold).
Regulation 5 would exempt from age of sale requirements the sale of any nicotine
inhaling products that are authorised medicines with a licence as a non-prescription
medicine which specifies that they are indicated for the treatment of persons aged under
18 years. In such cases, the seller may not need to be a pharmacist, as general sale list
(GSL) medicines can be sold in any type of shop, subject to certain conditions being
met.
3.7. Children under 18 years trying to quit smoking would continue to be able to access
nicotine inhaling products that are licensed as medicines by way of a prescription, so the
product would be used under medical supervision. As is currently the case, a person
under 18 years would still be able to purchase certain nicotine inhaling products, such as
the Nicorette Inhalator, in a newsagent or a supermarket, so long as the marketing
11. Age of Sale for Nicotine Inhaling Products
11
authorisation for the medicine specifies that it is indicated for use by children under 18
years.
3.8. Other forms of nicotine replacement therapy medicines which are not intended to enable
nicotine to be inhaled through a mouth piece, such as nicotine gums and patches, are
not within the scope of these regulations.
Proxy purchase of e-cigarettes
3.9. The regulations would extend the existing offence of the proxy purchase of tobacco
products (at Section 91 of the Act) to cover nicotine inhaling products.
3.10. This would make it an offence for an adult to buy, or attempt to buy, a nicotine inhaling
product on behalf of a child aged under 18 years, unless it has been prescribed to the
child. This would bring the purchase of nicotine inhaling products such as e-cigarettes in
line with equivalent offences for the proxy purchase of tobacco and alcohol and would
bring consistency and clarity for retailers.
3.11. The proxy purchase offence could also apply to some nicotine inhaling products that are
licensed as medicines. For example, where a product was licensed as a non-
prescription medicine (i.e. as a GSL medicine) and was indicated for use only by people
over the age of 18 years, it would be an offence for a person to buy, or attempt to buy,
this product on behalf of a child under the age of 18.
3.12. As with the offence for tobacco, the adult making the purchase on behalf of the child
would be committing the offence, not the retailer.
Offences and penalties
3.13. The Act sets out the penalties which would apply where an offence is committed under
the age of sale or proxy purchasing regulations. A person who does not comply with the
law would be committing a criminal offence.
Age of sale
3.14. Under the proposed regulations, an offence would be committed where someone sells a
nicotine inhaling product to a person under the age of 18 years.
3.15. Under Section 91(5) of the Act, a person found guilty of an offence would be liable on
summary conviction to a fine not exceeding level 4 on the standard scale.15
This is
consistent with the existing penalty for selling tobacco to persons under the age of 18.
3.16. Section 93 of the Act integrates the sale of nicotine inhaling products into the existing
enforcement regime relating to the persistent sales of tobacco to children. A person or a
business found to be repeatedly selling nicotine inhaling products to people under the
age of 18 could receive a Restricted Sales Order or Restricted Premises Order from the
court. Such an order prohibits a named individual, or a retail outlet, from selling nicotine
inhaling products or tobacco to anyone for a period of up to one year.
3.17. Section 92(4) of the Act provides for a defence whereby the retailer is able to
demonstrate that all reasonable steps were taken to avoid committing the offence.
12. 12
Proxy purchasing
3.18. An offence will be committed by the adult who purchases, or attempts to purchase, a
nicotine inhaling product as defined by the regulations on behalf of a person under 18
years. The Government proposes that enforcement officers could issue a Fixed Penalty
Notice to an individual committing a proxy purchasing offence with respect to nicotine
inhaling products. The fixed penalty amount is proposed to be £90 (£60 if payable within
15 days), which is consistent with the offence of proxy purchasing of alcohol. A person
who receives a Fixed Penalty Notice could choose instead to have the matter dealt with
by a court. A person who refuses or does not otherwise pay a Fixed Penalty Notice,
may also be referred to court.
Enforcement
3.19. Local authority trading standards officers would be responsible for enforcement of the
proposed regulations, and they may be assisted by the police as necessary.
3.20. To facilitate effective and consistent enforcement, Regulation 6 would bring the age of
sale offence for nicotine inhaling products within the scope of the Primary Authority
Scheme. Further information on the Primary Authority arrangements can be found on
the internet at:
https://www.gov.uk/government/publications/primary-authority-overview
3.21. In addition, the age of sale and proxy purchase offences will be added to the list of
offences in the Regulation of Investigatory Powers Act (RIPA) 2000. This will enable
local authority enforcement officers to apply to use “directed surveillance” to facilitate
effective enforcement, subject to existing safeguards. Directed surveillance means
surveillance which is covert and is likely to result in the obtaining of private information.
4. Territorial scope of the regulations
4.1. The regulations would apply to England and Wales only.
5. Impact assessment
5.1. A consultation-stage impact assessment (IA) has been prepared and is published
alongside this consultation document. A number of consultation questions specifically
related to the IA are at Annex B. We would welcome comments on the IA and any
further evidence or information which would enable us to further elaborate the IA.
5.2. We have also published an initial assessment of the impact on equality, which is
published alongside this consultation document and we welcome any additional
information in relation to how these proposals can contribute to us fulfilling our public
sector duties under the Equality Act 2010.16
13. Age of Sale for Nicotine Inhaling Products
13
6. How to get involved in the consultation
6.1. The consultation questions are set out at Annex B. The consultation will run for 6
weeks, from 17 December 2014 to 23:45 on 28 January 2015. We welcome responses
from any interested person, organisation or business.
6.2. Respondents are encouraged to provide their views online but responses can be made
in any of the following ways:
• Completing the online form at:
http://consultations.dh.gov.uk/tobacco/age-of-sale-for-nicotine-products
• Filling in the response form by downloading it at:
www.gov.uk/government/consultations
• Emailing your response to: nicotineproductsageofsale@dh.gsi.gov.uk
• Posting your response to:
Age of Sale Consultation
Department of Health
6th Floor, Wellington House
133-155 Waterloo Road
London
SE1 8UG
6.3. The purpose of this consultation is to seek the views of interested people, organisations
and businesses on the draft regulations to introduce age of sale requirements for
nicotine inhaling products and how these provisions would work in practice. We ask that
you provide references to research or other evidence with your responses.
6.4. If you wish to get a copy of this consultation document in an alternative format, or need
to respond in an alternative format for accessibility reasons, please contact us using the
email or postal addresses given in paragraph 6.2.
6.5. The Department of Health will not be able to respond specifically to individual
consultation responses.
14. 14
7. Declaration of direct or indirect links to the
tobacco industry by respondents
7.1. As a Party to the World Health Organization’s Framework Convention on Tobacco
Control (FCTC), the United Kingdom has an obligation to protect the development of
public health policy from the vested interests of the tobacco industry. To meet this
obligation, we ask all respondents to disclose whether they have any direct or
indirect links to, or receive funding from, the tobacco industry. We will still
carefully consider all consultation responses from the tobacco industry and from those
with links to the industry, and include them in the published summary of consultation
responses.
8. Next steps
8.1. All responses received by 23:45 on the closing date of 28 January 2015 will be carefully
considered. A summary report of consultation responses will be published on the
Department of Health website in due course after the completion of the consultation.
8.2. A final decision will be made on the content of the regulations. Subject to Parliamentary
approval, we are planning for the regulations to come into force in 2015.
9. Comments on the consultation process
9.1. If you have concerns or comments which you would like to make relating specifically to
the consultation process itself please contact
Consultations Coordinator
Department of Health
2E26, Quarry House
Leeds
LS2 7UE
e-mail: consultations.co-ordinator@dh.gsi.gov.uk
9.2. Please do not send consultation responses to this address.
15. Age of Sale for Nicotine Inhaling Products
15
10.Confidentiality of information
10.1. We will manage the information you provide in response to this consultation in
accordance with the Department of Health Information Charter.17
10.2. Please be aware that, under the Freedom of Information Act, there is a statutory Code of
Practice with which public authorities must comply and which deals, amongst other
things, with obligations of confidence. If you want the information that you provide to be
treated as confidential, it would be helpful if you could explain to us why you regard the
information you have provided as confidential. If we receive a request for disclosure of
the information we will take full account of your explanation, but we cannot give an
assurance that confidentiality can be maintained in all circumstances. An automatic
confidentiality disclaimer generated by your IT system will not, of itself, be regarded as
binding on the Department.
10.3. The Department will process your personal data in accordance with the Data Protection
Act and in most circumstances this will mean that your personal data will not be
disclosed to third parties.
16. 16
Annex A
Draft regulations to be made under the Children and Families Act 2014
Draft Regulations laid before Parliament under section 135(6) of the Children and Families Act 2014, for approval by
resolution of each House of Parliament.
D R A F T S T A T U T O R Y I N S T R U M E N T S
20xx No.xxx
PUBLIC HEALTH, ENGLAND AND WALES
The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing)
Regulations 20xx
Made - - - - ***
Coming into force
Regulations 1 and 2 …
Regulations 3 to 6 …
The Secretary of State makes the following regulations in exercise of the powers conferred by sections 92(1), (6) and (7)
and 93(8) of the Children and Families Act 2015(1
).
In accordance with section 135(6) of that Act, a draft of this instrument has been laid before Parliament and approved by
resolution of each House of Parliament.
In accordance with section 92(8) of that Act, the Secretary of State makes this instrument with the consent of the Welsh
Ministers.
Citation, commencement and interpretation
1.—(1) These Regulations may be cited as the Nicotine Inhaling Products (Age of Sale and Proxy Purchasing)
Regulations 20xx.
(2) Regulations 1 and 2 come into force on ….
(3) Regulations 3 to 6 come into force on …..
(4) In these Regulations—
“marketing authorisation” has the meaning given by regulation 8(1) of the Human Medicines Regulations 2012(2
);
(1
) 2014 c.6. See section 92(12) for the meaning of “specified”.
(2
) S.I. 2012/1916. Relevant amendments were made by S.I. 2013/235, 1855, 2593, 2014/490, 1878.
17. December 2014
“medical device” has the meaning given by regulation 2(1) of the Medical Devices Regulations 2002(3
);
“medicinal product” has the meaning given by regulation 2(1) of the Human Medicines Regulations 2012;
“nicotine cartridge” means a cartridge which—
(a) contains a substance which is not tobacco but consists of, or contains, nicotine; and
(b) is intended to form part of a nicotine inhaling device;
“nicotine inhaling device” means a device which—
(a) is intended to enable nicotine to be inhaled through a mouth piece (regardless of whether the device is also
intended to enable any other substance to be inhaled through a mouth piece); but
(b) is not tobacco(4
), cigarette papers or a device intended for the consumption of lit tobacco;
“nicotine inhaling product” means a nicotine inhaling device, nicotine cartridge or nicotine refill substance;
“nicotine refill substance” means a substance which—
(a) is not tobacco but consists of or contains nicotine; and
(b) is intended to be used to refill a nicotine inhaling device;
“parallel import licence” has the meaning given by regulation 48(2) of the Human Medicines Regulations 2012;
“prescription only medicine” has the meaning given by regulation 8(1) of the Human Medicines Regulations 2012.
Proxy purchase of nicotine products
2.—(1) Section 91 of the Children and Families Act 2014 (purchase of tobacco etc. on behalf of persons under 18) is
amended in accordance with paragraphs (2) to (4).
(2) In the heading, before “etc.” insert “nicotine products”.
(3) In subsection (1), for “or cigarette papers” substitute “cigarette papers or a relevant nicotine product”.
(4) After subsection (7) add—
“(8) In this section “relevant nicotine product” means a nicotine product within the meaning of section 92 the
sale of which at the same time and in the same circumstances to the individual aged under 18 would be prohibited
by regulations for the time being in force under subsection (1) of that section.”
Prohibition of sale of nicotine inhaling products to persons aged under 18
3. — The sale of nicotine inhaling products to persons aged under 18 is prohibited, except where regulation 4 or 5
applies.
Exception for sales of medicines and medical devices in accordance with a prescription etc.
4.—(1) This regulation applies to the sale of a nicotine inhaling product where—
(a) the nicotine inhaling product is a medicinal product or a medical device; and
(b) the circumstances of the sale are such that it would be permitted under Part 12 of the Human Medicines
Regulations 2012 (dealings with medicinal products) if the nicotine inhaling product were a prescription only
medicine.
(2) For the purposes of sub-paragraph (1)(b), Part 12 of the Human Medicines Regulations 2012 is to be read as if
regulation 244 (exemption in cases involving another’s default) were omitted.
Exception for medicines indicated for the treatment of persons aged under 18
5.—(1) — This regulation applies to the sale of a nicotine inhaling product which—
(3
) S.I. 2002/618. Relevant amendments were made by S.I 2008/2936.
(4
) See the definition of “tobacco” at section 92(12) of the Children and Families Act 2014.
18. 18
(a) is an authorised medicinal product; and
(b) is indicated for the treatment of persons of the age of the person to whom the product is sold.
(2) For the purposes of this regulation—
(a) a product is indicated for the treatment of persons of a particular age if that indication is described in the
summary of the product characteristics for the product in accordance with paragraph 27 of Schedule 8 to the
Human Medicines Regulations 2012 (summary of the product characteristics) or Article 11 of Directive
2001/83/EC(5
);
(b) “the summary of the product characteristics” is to be construed in accordance with Article 11 of Directive
2001/83/EC;
(c) a medicinal product is “authorised” if one of the following is in force for the product—
(i) a marketing authorisation; or
(ii) a parallel import licence.
Amendment of Schedule 3 to the Regulatory Enforcement and Sanctions Act 2008
6. — In Schedule 3(6
) to the Regulatory Enforcement and Sanctions Act 2008(7
) (enactments specified for the
purposes of Part 1), at the appropriate place insert—
“Children and Families Act 2014 (c.6), section 92”.
Signed by authority of the Secretary of State
(5
) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use. OJ No L 311, 28.11.2001
(6
) Schedule 3 was amended by Part 4 of Schedule 22 to the Marine and Costal Access Act 2009 (c.23), paragraphs 97 and 99 of
Schedule 26 and Part 1 of Schedule 27 to the Equality Act 2010 (c. 15) (as amended by SI 2010/2279, Schedule 1, paragraph 6 and
Schedule 2), paragraph 130 of Schedule 7 to the Charities Act 2011 (c. 25), paragraph 4(1) and (2) of Schedule 6 and Part 1 of
Schedule 8 to S.I. 2010/2960, section 19(2) of the Scrap Metal Dealers Act 2013 (c.10), paragraphs 12 and 13 of Part 1 of the
Schedule to S.I. 2013/1575, regulation 2 of S.I. 2013/2215 and paragraph 10 of Schedule 4 to the Mobile Homes (Wales) Act 2013
(anaw 6).
(7
) 2008 c.13.
19. Age of Sale for Nicotine Inhaling Products
19
Annex B
Consultation questions about the proposed regulations and assessment
of impact on business
1. Do you have any comments regarding the definition of nicotine inhaling products
proposed in the regulations?
2. Do you have any comments regarding the proposals for nicotine inhaling products that
are medicines or medical devices?
3. Do you have any comments regarding the enforcement arrangements proposed in the
regulations, or any views or evidence on enforcement costs?
4. Do you have any comments on the proposal to extend the current proxy purchase
offence for tobacco to cover nicotine inhaling products?
5. Do you have any additional evidence on the use of e-cigarettes by under 18s as a
gateway in or out of smoking? For example, how a minimum age of sale for e-cigarettes
would impact on current users aged under 18?
6. Do you have any additional evidence that restricting the sale of nicotine inhaling products
would contribute to reducing health inequalities and/or help us fulfil our duties under the
Equality Act 2010?
7. Do you have any information or evidence that would inform the consultation-stage impact
assessment? We particularly welcome any evidence or information which would improve
any of the assumptions or estimates we have made in terms of the impact on retailers,
manufacturers and distributers, including our assessment of any loss of profits.
8. Do you have any information or evidence that would improve any of the assumptions we
have made in terms of the impact of these proposed regulations on small and micro
businesses?
9. Is there anything else you wish to tell us that you think would improve the draft
regulations?
20. 20
1
Britton, J. and Bogdanovica, I. (2014). Electronic cigarettes: A report commissioned by Public Health England.
Available at:
www.gov.uk/government/uploads/system/uploads/attachment_data/file/311887/Ecigarettes_report.pdf
2
Action on Smoking and Health (2014). ASH briefing: E-cigarettes. Available at:
www.ash.org.uk/files/documents/ASH_715.pdf
3
The Stationery Office (2012). The Human Medicines Regulations 2012 (SI 2012/1916)
4
Action on Smoking and Health (2014). ASH briefing: Use of electronic cigarettes in Great Britain. Available at:
www.ash.org.uk/files/documents/ASH_891.pdf
5
Welsh Government (2014) Exposure to secondhand smoking in cars and e-cigarettes use among 10-11 year old
children in Wales:CHETS Wales 2 key findings report.
6
Hardcastle, K. and Bennett, A. (2014). “Most people I know have got one”: Young people’s perceptions and
experiences of electronic cigarettes. Centre for Public Health at Liverpool John Moores University, Liverpool.
7
Juang, J. et al. (2014). “A cross-sectional examination of marketing of electronic cigarettes on Twitter” in Tobacco
Control 2014; 23, pp.iii26-iii30.
8
Hardcastle, K. and Bennett, A. (2014). “Most people I know have got one”: Young people’s perceptions and
experiences of electronic cigarettes. Centre for Public Health at Liverpool John Moores University, Liverpool.
9
Davies, S. (2013). Annual Report of the Chief Medical Officer 2012 – Our Children Deserve Better: Prevention Pays.
Department of Health, London. Available at:
www.gov.uk/government/uploads/system/uploads/attachment_data/file/255237/2901304_CMO_complete_low_res_acc
essible.pdf
10
Royal College of Physicans. (2007). Harm Reduction in Nicotine Addiction: Helping People who can’t quit. RCP,
London.
11
Gervais, A., et al. (2006). “Milestones in the natural course of onset of cigarette use among adolescents”. Canadian
Medical Association Journal. 175(3), pp.255-261.
12
Counotte, D. et al. (2011). “Development of the motivational system during adolescence, and its sensitivity to disruption
by nicotine” in Developmental Cognitive Neuroscience; 2011; 1 (2011), pp.430-443.
13
Dutra, L. and Glantz, S. (2014). “Electronic Cigarettes and Conventional Cigarette Use Among US AdolescentsA
Cross-sectional Study” in JAMA Pediatrics 2014; 168(7), pp.610-617.
14
Available at: www.legislation.gov.uk/ukpga/2014/6/section/92
15
The value of the fine at level 4 is currently up to £2,500.
16
Bodies subject to the Equality Duty must, when delivering their services and performing their functions, have due
regard to the need to:
• Eliminate unlawful discrimination, harassment, victimisation and any other conduct prohibited by the Act;
• Advance equality of opportunity between people who share a particular protected characteristic and people who
do not share it; and
• Foster good relations between people who share a particular protected characteristic and people who do not share
it.
The public sector equality duty covers the protected characteristics of age, disability, gender reassignment, pregnancy
and maternity, race (includes ethnic or national origins, colour or nationality), religion or belief (includes lack of belief),
sex and sexual orientation. It also applies to marriage and civil partnership status, but only in respect of the
requirement to have due regard to the need to eliminate discrimination.
17
Available at: www.gov.uk/government/organisations/department-of-health/about/personal-information-charter