Regulation of e-cigarettes: the users' perspective

Abstract

We read with great interest the Comments1Hajek P Foulds J Le Houezec J Sweanor D Yach D Should e-cigarettes be regulated as a medicinal device?.Lancet Respir Med. 2013; 1: 429-431Summary Full Text Full Text PDF Scopus (22) Google Scholar, 2Cobb NK Cobb CO Regulatory challenges for refined nicotine products.Lancet Respir Med. 2013; 1: 431-433Summary Full Text Full Text PDF Scopus (7) Google Scholar in The Lancet Respiratory Medicine, which debated if, how, and by whom electronic cigarettes (e-cigarettes) should be regulated.E-cigarettes are increasingly used as substitutes for tobacco cigarettes,3Caponnetto P Russo C Bruno CM Alamo A Amaradio MD Polosa R Electronic cigarette: a possible substitute for cigarette dependence.Monaldi Arch Chest Dis. 2013; 79: 12-19PubMed Google Scholar with some suggestion that the rapidly increasing popularity of e-cigarettes brought about a decrease in tobacco cigarette sales in the USA at the start of 2013.4Adelman DJ Grainger M Ayala V Paxton K Tobacco: New Years' resolutions + e-cigs=weaker volumes? Morgan Stanley Research North America, New York2013Google Scholar The main reason for regulation of these products is said to be to ensure that consumers are protected. However, the consumers' perspective has been largely overlooked. For consumers, safety is a concern, but is secondary in view of the hazards of the product (ie, tobacco cigarette) being replaced.5Goniewicz ML Lingas EO Hajek P Patterns of electronic cigarette use and user beliefs about their safety and benefits: an Internet survey.Drug Alcohol Rev. 2013; 32: 133-140Crossref PubMed Scopus (236) Google Scholar Most consumers would be content with regulations that helped to ensure product consistency and prevent contamination, but see no need to apply the strict regulations used for pharmaceutical products that would lead to unnecessary increases in the price of e-cigarettes.6Farsalinos K, Romagna G, Tsiapras D, Kyrzopoulos S, Voudris V. Evaluating nicotine levels selection and patterns of electronic cigarette use in a group of “vapers” who achieved complete substitution of smoking. Subst Abuse (in press).Google Scholar Our experience suggests that many former smokers who transitioned to an e-cigarette believe that the main goal for regulators should be to keep e-cigarettes available and acceptable as a cigarette replacement. Excessive and ill-conceived regulation will conflict with these basic requirements; it will marginalise e-cigarettes by making them unattractive to smokers and less competitively priced compared with tobacco products.Future regulatory measures should primarily address quality standards of liquids used in e-cigarettes (e-liquids) and should require 1) evidence that good manufacturing practices have been followed; 2) official documentation reporting contents and concentrations in e-liquids to regulators; and 3) clear, accurate, and detailed labelling about the contents and possible dangers of inappropriate handling (eg, accidental poisoning) associated with e-cigarette use.Such a regulatory framework already exists; e-liquids can be marketed as dietary supplements, provided that no claims are made about prevention or treatment of disease. Under dietary supplement regulation, manufacturers must show that a product is not dangerous before introduction. Compliance with national good manufacturing practice policies would ensure that e-liquids are produced in a quality manner, do not contain contaminants or impurities, are accurately labelled, and are held under conditions to prevent adulteration. Additional restrictions could be implemented, including a rule requiring e-liquid manufacturers to submit a report to the relevant health authority of serious adverse events linked to the use of their products. With regard to marketing and safety of e-cigarettes' electronics, batteries, and spare parts, these components are already regulated by existing directives.Therefore, it should be easy to implement reasonable regulation that is in line with consumer's aspirations. However, introduction of such regulation will not be as easy as it seems. The rapidly expanding popularity of e-cigarettes is a threat to the interests of both the tobacco and pharmaceutical industry and to their associated stakeholders. The large revenues generated by tobacco excise taxes are needed by national governments to run their countries and sponsorship for the marketing of anti-smoking drugs and those intended to treat tobacco-related diseases are much needed by pharmaceutical regulatory bodies, health authorities, and medical societies for the running of their statutory activities.RP has received lecture fees and research funding from Pfizer and GlaxoSmithKline, manufacturers of stop smoking medications; has served as a consultant for Pfizer and Arbi Group Srl, the distributor of the categoria e-cigarette; and currently serves as Chief Scientific Advisor for LIAF (the Italian Anti-Smoking League). PC declares that he has no conflicts of interest. We read with great interest the Comments1Hajek P Foulds J Le Houezec J Sweanor D Yach D Should e-cigarettes be regulated as a medicinal device?.Lancet Respir Med. 2013; 1: 429-431Summary Full Text Full Text PDF Scopus (22) Google Scholar, 2Cobb NK Cobb CO Regulatory challenges for refined nicotine products.Lancet Respir Med. 2013; 1: 431-433Summary Full Text Full Text PDF Scopus (7) Google Scholar in The Lancet Respiratory Medicine, which debated if, how, and by whom electronic cigarettes (e-cigarettes) should be regulated. E-cigarettes are increasingly used as substitutes for tobacco cigarettes,3Caponnetto P Russo C Bruno CM Alamo A Amaradio MD Polosa R Electronic cigarette: a possible substitute for cigarette dependence.Monaldi Arch Chest Dis. 2013; 79: 12-19PubMed Google Scholar with some suggestion that the rapidly increasing popularity of e-cigarettes brought about a decrease in tobacco cigarette sales in the USA at the start of 2013.4Adelman DJ Grainger M Ayala V Paxton K Tobacco: New Years' resolutions + e-cigs=weaker volumes? Morgan Stanley Research North America, New York2013Google Scholar The main reason for regulation of these products is said to be to ensure that consumers are protected. However, the consumers' perspective has been largely overlooked. For consumers, safety is a concern, but is secondary in view of the hazards of the product (ie, tobacco cigarette) being replaced.5Goniewicz ML Lingas EO Hajek P Patterns of electronic cigarette use and user beliefs about their safety and benefits: an Internet survey.Drug Alcohol Rev. 2013; 32: 133-140Crossref PubMed Scopus (236) Google Scholar Most consumers would be content with regulations that helped to ensure product consistency and prevent contamination, but see no need to apply the strict regulations used for pharmaceutical products that would lead to unnecessary increases in the price of e-cigarettes.6Farsalinos K, Romagna G, Tsiapras D, Kyrzopoulos S, Voudris V. Evaluating nicotine levels selection and patterns of electronic cigarette use in a group of “vapers” who achieved complete substitution of smoking. Subst Abuse (in press).Google Scholar Our experience suggests that many former smokers who transitioned to an e-cigarette believe that the main goal for regulators should be to keep e-cigarettes available and acceptable as a cigarette replacement. Excessive and ill-conceived regulation will conflict with these basic requirements; it will marginalise e-cigarettes by making them unattractive to smokers and less competitively priced compared with tobacco products. Future regulatory measures should primarily address quality standards of liquids used in e-cigarettes (e-liquids) and should require 1) evidence that good manufacturing practices have been followed; 2) official documentation reporting contents and concentrations in e-liquids to regulators; and 3) clear, accurate, and detailed labelling about the contents and possible dangers of inappropriate handling (eg, accidental poisoning) associated with e-cigarette use. Such a regulatory framework already exists; e-liquids can be marketed as dietary supplements, provided that no claims are made about prevention or treatment of disease. Under dietary supplement regulation, manufacturers must show that a product is not dangerous before introduction. Compliance with national good manufacturing practice policies would ensure that e-liquids are produced in a quality manner, do not contain contaminants or impurities, are accurately labelled, and are held under conditions to prevent adulteration. Additional restrictions could be implemented, including a rule requiring e-liquid manufacturers to submit a report to the relevant health authority of serious adverse events linked to the use of their products. With regard to marketing and safety of e-cigarettes' electronics, batteries, and spare parts, these components are already regulated by existing directives. Therefore, it should be easy to implement reasonable regulation that is in line with consumer's aspirations. However, introduction of such regulation will not be as easy as it seems. The rapidly expanding popularity of e-cigarettes is a threat to the interests of both the tobacco and pharmaceutical industry and to their associated stakeholders. The large revenues generated by tobacco excise taxes are needed by national governments to run their countries and sponsorship for the marketing of anti-smoking drugs and those intended to treat tobacco-related diseases are much needed by pharmaceutical regulatory bodies, health authorities, and medical societies for the running of their statutory activities. RP has received lecture fees and research funding from Pfizer and GlaxoSmithKline, manufacturers of stop smoking medications; has served as a consultant for Pfizer and Arbi Group Srl, the distributor of the categoria e-cigarette; and currently serves as Chief Scientific Advisor for LIAF (the Italian Anti-Smoking League). PC declares that he has no conflicts of interest. Should Australia reconsider its ban on the sale of electronic nicotine delivery systems?In the past 30 years, steep increases in tobacco taxes, advertising bans, and bans on smoking in public places have reduced the daily smoking rate in Australian adults from 35% in 1983 to 13% in 2013.1,2 Australia was an early adopter of graphic health warnings on cigarette packs and mandatory plain packaging of cigarettes.2 In 2011, Australia joined Brazil, Canada, and several European countries in banning the sale of e-cigarettes or electronic nicotine delivery systems.3 Full-Text PDF E-cigarettes: a harm-reduction strategy for socioeconomically disadvantaged smokers?Smokers are rarely seen in Ann Arbor (MI, USA). The University of Michigan, the city's largest employer, embraced a smoke-free campus policy in 2011, relegating smokers to designated areas away from building entrances and out of sight. The city council followed suit in 2014, when it enacted an ordinance banning smoking in many public spaces, including the local transit centre, bus stops, and 77 of its 158 parks. A casual stroller through downtown might be easily fooled into believing that the “smoking issue” is a thing of the past; however, it is not so. Full-Text PDF