Comment
Obtaining test results quickly is also important. Patients in sub-Saharan Africa often have to travel far to access diagnostic centres and might only receive their tests results after several days. Specimens were collected in a single visit in the study by Peter and colleagues, but they were processed elsewhere and patients had appointments to collect results 1 week later. Worryingly, more than 10% of patients failed to return for a doctor’s assessment or their results. Collection of specimens in 1 day is therefore insufficient to ensure that patients receive a diagnosis. Despite the advent of rapid tests, results are rarely available on the same day as samples are taken, and clinical decisions often have been made before the results are returned. Furthermore, the right balance must be struck between the use of newer and more sensitive tests—which still need laboratory infrastructure with stable electricity and are often only available at central clinics—and increasing access to a diagnostic result, which often precludes the use of these technologies at the point of care. Ideally, new diagnostic tests should enable specimens to be processed at the point of care, and a few early prototypes are being developed.5,6 Alternatively, health systems could collect specimens at the point of care, transport them to specialised diagnostic centres, and—crucially—bring the test results back to the patient. The location of the test might not be as important as the mechanisms to ensure that the patient receives the information. Such approaches are
promising, resulting in a much higher rate of tuberculosis case detection in some settings.7 To optimise diagnosis and treatment of tuberculosis in primary care will definitely require efficient methods to obtain suitable specimens, but also mechanisms to enable access to test results so that informed clinical decisions can be made on time. *Luis E Cuevas, Daniel G Datiko Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK (LEC); and REACH, Awasa, Ethiopia (DGD) [email protected] We declare that we have no conflicts of interest. 1
2
3
4 5
6
7
Peter JG, Theron G, Pooran A, Thomas J, Pascoe M, Dheda K. Comparison of two methods for acquisition of sputum samples for diagnosis of suspected tuberculosis in smear-negative or sputum-scarce people: a randomised controlled trial. Lancet Respir Med 2013; published online July 19. http://dx. doi.org/10.1016/S2213-2600(13)70120-6. Atiq-ur-Rehman M, Naseem A, Hussain T. Comparison of diagnostic yield of AFB with sputum induction to spontaneous sputum examination in suspected pulmonary tuberculosis. J Coll Physicians Surg Pak 2009; 19: 506–09. Brown M, Varia H, Bassett P, Davidson RN, Wall R, Pasvol G. Prospective study of sputum induction, gastric washing, and bronchoalveolar lavage for the diagnosis of pulmonary tuberculosis in patients who are unable to expectorate. Clin Infect Dis 2007; 44: 1415–20. Cobelens F, van den Hof S, Pai M, et al. Which new diagnostics for tuberculosis, and when? J Infect Dis 2012; 205 (suppl 2): S191–98. Genedrive. 2011. http://www.marketwire.com/press-release/genedrivepasses-first-in-field-tuberculosis-testing-lse-ehp-1566732.htm (accessed June 27, 2013). Lee H, Yoon TJ, Weissleder R. Ultrasensitive detection of bacteria using core-shell nanoparticles and a NMR-filter system. Angew Chem Int Ed 2009; 48: 5657–60. Yassin MA, Datiko DG, Tulloch O, et al. Innovative community-based approaches doubled tuberculosis case notification and improve treatment outcome in southern Ethiopia. PLoS One 2013; 8: e63174.
There are more than 1 billion smokers worldwide. About half of individuals who continue smoking will die prematurely because of toxins in tobacco smoke. Over the past few years, smokers in economically developed countries have been showing growing interest in electronic cigarettes (ECs) that are designed to deliver nicotine without these toxins. Initial reactions to ECs focused on potential risks.1 Increasingly though, commentators are pointing out that there is little indication of harm, whereas the potential benefits are substantial.2–4 Research into switching from cigarettes to snus (Swedish smokeless tobacco)5,6 and into long-term use of nicotinereplacement treatments (NRTs)7,8 shows that, except in www.thelancet.com/respiratory Vol 1 August 2013
pregnancy, nicotine intake from a non-smoked source is associated with low or no health risks. The chemicals that make cigarettes dangerous are either absent in ECs or present only in trace concentrations.9–12 Europe is now at an important crossroad. One possible path ahead is to continue to regulate ECs as any other consumer product. The other path, currently under consideration by the proposed Updated Tobacco Products Directive of the European Commission is to regulate them as medicinal devices. The main arguments for such regulation include consumer safety, the need for precise product labelling, and equal terms on which to compete with NRTs. Strict controls would also restrict the development and
Sheila Terry/Science Photo Library
Should e-cigarettes be regulated as a medicinal device?
Published Online July 23, 2013 http://dx.doi.org/10.1016/ S2213-2600(13)70124-3
429
Comment
spread of ECs and alleviate a concern that if ECs flourish, this would renormalise smoking. If such medicinal regulation had no other consequence, these arguments might have some merit. The unintended consequences, however, could be severe and none of the above arguments are strong. One, in terms of the safety of ECs, there is no credible risk that normally used ECs can poison the user with nicotine. Much more dangerous chemicals such as bleach rely on packaging and common sense rather than on medicinal licensing. Another aspect of safety is the presence of unauthorised dangerous compounds. In Europe, EC users are already protected by general product and safety regulations and labelling requirements. For example, medicinal licensing is not needed to ensure toys do not contain lead. Of course, it is possible that some unexpected ill effects of ECs might emerge, but the key point is that compared with hypothetical risks that seem unlikely in view of current knowledge about ECs, we know the product ECs are replacing is seriously dangerous. If any new risks emerge, then appropriately tighter regulation can be implemented. Two, there are questions about the need for precise labelling of nicotine content. Nicotine delivery from ECs is determined not just by the nicotine content in the liquid of ECs, but also by characteristics of heating elements and other technical features and even more so by the individual’s frequency and depth of inhalations.13 Nicotine concentrations in liquid, therefore, have only a very rough relation to how much nicotine a user absorbs. As with cigarettes, such labelling conveys little useful information to users. Three, in terms of market competition, ECs are a consumer product competing with cigarettes. The success of ECs would be detrimental to sales not just of cigarettes but also of smoking cessation products. Protection of such markets, however, should not be high on the public health agenda. Four, regarding attracting non-smokers and renormalising smoking, so far there are very few cases of never smokers using ECs regularly whereas many smokers have switched to ECs.14 These electronic products have not been attracting children,15 and, although sales to children should be banned, medicinal licensing is not needed to achieve this aim. Many of the never smokers are likely to try smoking tobacco, so it 430
would be neither surprising nor a public health problem if some tried ECs instead. It is difficult to understand how use of ECs would imply that cigarettes are also acceptable. The two are clearly different. Availability of a safer alternative to cigarettes is likely to strengthen rather than weaken denormalisation of smoking. There are three main arguments against mandatory medicinal licensing of ECs, apart from the most obvious one that they are consumer products rather than medicines. One, medicinal licensing requirements would hinder further EC development, which is essential for ECs to become a full replacement for cigarettes. Small improvements would require new licensing applications, the innovation timescale would increase greatly and the costs of innovation would be prohibitive. NRTs represent a classic example of the stifling effect of medicinal regulation. There have been no major improvements since they were introduced 30 years ago. Two, the costs of ECs would increase because compliance with pharmaceutical standards for manufacturing and handling medicinal licensing are expensive processes, which cigarettes do not have to comply with. The large tobacco companies may become the only players with sufficient resources. Small agile innovators would go out of business. Tobacco companies might not want ECs to develop further because this would undermine sales of cigarettes. ECs would become more expensive than cigarettes, remain unattractive to most smokers, and would be sold in packaging emphasising unlikely dangers. Cigarettes would remain a more attractive and cheaper product. Three, standard consumer protection regulations exist in Europe and many other countries to ensure consumer products are safe, fit for purpose, and as described. Such frameworks also allow specific directives to address particular risks. For example, the requirements to make tamper-proof containers or prohibit sales to children are not restricted to medicines. In conclusion, since ECs are a recreational consumer product that are competing with much more dangerous cigarettes, which are not regulated as medicines, mandatory medicinal regulation is not required for public safety and can harm public health by restricting www.thelancet.com/respiratory Vol 1 August 2013
Comment
the ability of ECs to compete with cigarettes in the marketplace. Excessive regulation of ECs would protect the market monopoly of cigarettes and have the potential consequences of disease in and death of millions of smokers who were prevented from moving on to the next generation of ECs. For the first time in the history of the tobacco control movement, a realistic possibility is emerging that the tobacco problem might get resolved, and that this could happen with minimal or no government involvement or expenditure. Regulators of medicines should hold their fire.
or makers of ECs. DY has no conflicts of interest and specifically has no links with tobacco or the EC industry. 1 2 3 4
5
6 7
*Peter Hajek, Jonathan Foulds, Jacques Le Houezec, David Sweanor, Derek Yach
8
Wolfson Institute of Preventive Medicine, Queen Mary University of London, London E1 2AD, UK (PH); College of Medicine, Penn State University, Hershey, PA, USA (JF); Rennes, France (JLH); Faculty of Law, University of Ottawa, ON, Canada (DS); and Vitality Institute, New York, NY, USA (DY) [email protected]
9
PH received research funds and provided consultancy to manufacturers of medications for smoking cessation including Pfizer, GlaxoSmithKline, and McNeill; he has no links with the EC industry. JF has provided paid consulting for pharmaceutical companies marketing smoking cessation products (eg Pfizer, Johnson and Johnson) but has never had any paid or financial connection with current EC or tobacco manufacturers. JL provided consultancy to manufacturers of stop-smoking medications including Pfizer, Johnson and Johnson, Novartis, and Pierre Fabre; he has no links with the EC industry. DS has consulted for law firms involved in litigation against tobacco companies and for makers of smoking cessation products; he received no payments from tobacco companies
10
11
12 13 14 15
Cobb NK, Abrams DB. E-cigarette or drug-delivery device? Regulating novel nicotine products. New Engl J Med 2011; 365: 193–95. Borland R. Electronic cigarettes as a method of tobacco control. BMJ 2011; 343: d6269. Wagener TL, Siegel M, Borrelli B. Electronic cigarettes: achieving a balanced perspective. Addiction 2012; 107: 1545–48. Bates C. The counterfactual. Reasonable people saying sensible things about low-risk alternatives to smoking (2013); http://www.clivebates. com/?p=853 (accessed June 12, 2013). Foulds J, Ramstrom L, Burke M, Fagerstrom K. Effect of smokeless tobacco (snus) on smoking and public health in Sweden. Tob Control 2003; 12: 349–59. Lund I, Scheffels J. The relative risk to health from snus and cigarettes: Response to Grimsrud et al. Nicotine Tob Res 2013; 15: 304–05 Murray R, Bailey W, Daniels K, et al. Safety of nicotine polacrilex gum used by 3,094 participants in the lung health study. Chest 1996; 109: 438–45. Murray R, Connett J, Zapawa L. Does nicotine replacement therapy cause cancer? Evidence from the Lung Health Study. Nicotine Tob Res 2009; 11: 1076–82. Westenberger B. Evaluation of e-cigarettes. St Louis, MO: US Food and Drug Administration, 2009. Goniewicz M, Gawron M, Peng M, Jacob III P, Benowitz N. Electronic cigarettes deliver similar levels of nicotine and reduce exposure to combustion toxicants after switching from tobacco cigarettes. Society for Research on Nicotine and Tobacco 18th Annual Meeting; Houston, TX, USA; March 13–16, 2012. McAuley T, Hopke P, Zhao J, Babaian S. Comparison of the effects of e-cigarette vapor and cigarette smoke on indoor air quality. Inhal Toxicol 2012; 24: 850–57. Laugesen M. Safety report on the Ruyan e-cigarette cartridge and inhaled aerosol. Christchurch: Health New Zealand Limited, 2008. Goniewicz M, Hajek P, McRobbie H. Electronic cigarette: nicotine content and consistency of its delivery. Report to MHRA. London: MHRA, 2012. Etter J-F, Bullen C. Electronic cigarettes: users profile, utilisation, satisfaction and perceived efficacy. Addiction 2011; 106: 2017–28. ASH. Use of e-cigarettes in Great Britain by adults and young people. London: Action on Smoking and Health, 2013.
Historically, refined nicotine has been sold in only two forms: a pesticide or a pharmaceutical grade medicinal product for tobacco addiction. Until recently, the US Food and Drug Administration (FDA) has consistently blocked the marketing of any non-pharmaceutical nicotine product designed for human consumption. The main exceptions to the rule are the electronic nicotine delivery systems (ENDS or electronic cigarettes): battery-powered devices that deliver refined nicotine in a humectant, usually propylene glycol. ENDS are a variant of past inhaler designs, including the FDA-regulated nicotine inhaler.1 Paradoxically, as a consequence of an unexpected interpretation of the 2009 Tobacco Control Act by the courts (ruling that unless marketed with therapeutic claims, refined nicotine is still tobacco and must be regulated as such), ENDS are widely and aggressively www.thelancet.com/respiratory Vol 1 August 2013
marketed without any apparent oversight.2 Further action by the FDA is pending. For years, the public health and medical community has stressed the need for greater availability and use of nicotine replacement therapy (NRT) to end the tobacco epidemic. However, the availability of refined nicotine has suddenly and by stealth become widespread, without guarantees of product safety or evident contribution to overarching public health interests. This odd US-specific situation has resulted in a fascinating, yet discouraging, market disruption. On the one hand is the unfettered commercial activity of ENDS; on the other hand are governmental restrictions on the manufacture, marketing, and sale of NRT products (eg, nicotine patch, gum, or inhaler). Although ENDS escape regulation in design, importation, and distribution, the FDA traditionally approves new NRT
Mark Sykes/Science Photo Library
Regulatory challenges for refined nicotine products
Published Online July 23, 2013 http://dx.doi.org/10.1016/ S2213-2600(13)70160-7
431
Obtaining test results quickly is also important. Patients in sub-Saharan Africa often have to travel far to access diagnostic centres and might only receive their tests results after several days. Specimens were collected in a single visit in the study by Peter and colleagues, but they were processed elsewhere and patients had appointments to collect results 1 week later. Worryingly, more than 10% of patients failed to return for a doctor’s assessment or their results. Collection of specimens in 1 day is therefore insufficient to ensure that patients receive a diagnosis. Despite the advent of rapid tests, results are rarely available on the same day as samples are taken, and clinical decisions often have been made before the results are returned. Furthermore, the right balance must be struck between the use of newer and more sensitive tests—which still need laboratory infrastructure with stable electricity and are often only available at central clinics—and increasing access to a diagnostic result, which often precludes the use of these technologies at the point of care. Ideally, new diagnostic tests should enable specimens to be processed at the point of care, and a few early prototypes are being developed.5,6 Alternatively, health systems could collect specimens at the point of care, transport them to specialised diagnostic centres, and—crucially—bring the test results back to the patient. The location of the test might not be as important as the mechanisms to ensure that the patient receives the information. Such approaches are
promising, resulting in a much higher rate of tuberculosis case detection in some settings.7 To optimise diagnosis and treatment of tuberculosis in primary care will definitely require efficient methods to obtain suitable specimens, but also mechanisms to enable access to test results so that informed clinical decisions can be made on time. *Luis E Cuevas, Daniel G Datiko Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK (LEC); and REACH, Awasa, Ethiopia (DGD) [email protected] We declare that we have no conflicts of interest. 1
2
3
4 5
6
7
Peter JG, Theron G, Pooran A, Thomas J, Pascoe M, Dheda K. Comparison of two methods for acquisition of sputum samples for diagnosis of suspected tuberculosis in smear-negative or sputum-scarce people: a randomised controlled trial. Lancet Respir Med 2013; published online July 19. http://dx. doi.org/10.1016/S2213-2600(13)70120-6. Atiq-ur-Rehman M, Naseem A, Hussain T. Comparison of diagnostic yield of AFB with sputum induction to spontaneous sputum examination in suspected pulmonary tuberculosis. J Coll Physicians Surg Pak 2009; 19: 506–09. Brown M, Varia H, Bassett P, Davidson RN, Wall R, Pasvol G. Prospective study of sputum induction, gastric washing, and bronchoalveolar lavage for the diagnosis of pulmonary tuberculosis in patients who are unable to expectorate. Clin Infect Dis 2007; 44: 1415–20. Cobelens F, van den Hof S, Pai M, et al. Which new diagnostics for tuberculosis, and when? J Infect Dis 2012; 205 (suppl 2): S191–98. Genedrive. 2011. http://www.marketwire.com/press-release/genedrivepasses-first-in-field-tuberculosis-testing-lse-ehp-1566732.htm (accessed June 27, 2013). Lee H, Yoon TJ, Weissleder R. Ultrasensitive detection of bacteria using core-shell nanoparticles and a NMR-filter system. Angew Chem Int Ed 2009; 48: 5657–60. Yassin MA, Datiko DG, Tulloch O, et al. Innovative community-based approaches doubled tuberculosis case notification and improve treatment outcome in southern Ethiopia. PLoS One 2013; 8: e63174.
There are more than 1 billion smokers worldwide. About half of individuals who continue smoking will die prematurely because of toxins in tobacco smoke. Over the past few years, smokers in economically developed countries have been showing growing interest in electronic cigarettes (ECs) that are designed to deliver nicotine without these toxins. Initial reactions to ECs focused on potential risks.1 Increasingly though, commentators are pointing out that there is little indication of harm, whereas the potential benefits are substantial.2–4 Research into switching from cigarettes to snus (Swedish smokeless tobacco)5,6 and into long-term use of nicotinereplacement treatments (NRTs)7,8 shows that, except in www.thelancet.com/respiratory Vol 1 August 2013
pregnancy, nicotine intake from a non-smoked source is associated with low or no health risks. The chemicals that make cigarettes dangerous are either absent in ECs or present only in trace concentrations.9–12 Europe is now at an important crossroad. One possible path ahead is to continue to regulate ECs as any other consumer product. The other path, currently under consideration by the proposed Updated Tobacco Products Directive of the European Commission is to regulate them as medicinal devices. The main arguments for such regulation include consumer safety, the need for precise product labelling, and equal terms on which to compete with NRTs. Strict controls would also restrict the development and
Sheila Terry/Science Photo Library
Should e-cigarettes be regulated as a medicinal device?
Published Online July 23, 2013 http://dx.doi.org/10.1016/ S2213-2600(13)70124-3
429
Comment
spread of ECs and alleviate a concern that if ECs flourish, this would renormalise smoking. If such medicinal regulation had no other consequence, these arguments might have some merit. The unintended consequences, however, could be severe and none of the above arguments are strong. One, in terms of the safety of ECs, there is no credible risk that normally used ECs can poison the user with nicotine. Much more dangerous chemicals such as bleach rely on packaging and common sense rather than on medicinal licensing. Another aspect of safety is the presence of unauthorised dangerous compounds. In Europe, EC users are already protected by general product and safety regulations and labelling requirements. For example, medicinal licensing is not needed to ensure toys do not contain lead. Of course, it is possible that some unexpected ill effects of ECs might emerge, but the key point is that compared with hypothetical risks that seem unlikely in view of current knowledge about ECs, we know the product ECs are replacing is seriously dangerous. If any new risks emerge, then appropriately tighter regulation can be implemented. Two, there are questions about the need for precise labelling of nicotine content. Nicotine delivery from ECs is determined not just by the nicotine content in the liquid of ECs, but also by characteristics of heating elements and other technical features and even more so by the individual’s frequency and depth of inhalations.13 Nicotine concentrations in liquid, therefore, have only a very rough relation to how much nicotine a user absorbs. As with cigarettes, such labelling conveys little useful information to users. Three, in terms of market competition, ECs are a consumer product competing with cigarettes. The success of ECs would be detrimental to sales not just of cigarettes but also of smoking cessation products. Protection of such markets, however, should not be high on the public health agenda. Four, regarding attracting non-smokers and renormalising smoking, so far there are very few cases of never smokers using ECs regularly whereas many smokers have switched to ECs.14 These electronic products have not been attracting children,15 and, although sales to children should be banned, medicinal licensing is not needed to achieve this aim. Many of the never smokers are likely to try smoking tobacco, so it 430
would be neither surprising nor a public health problem if some tried ECs instead. It is difficult to understand how use of ECs would imply that cigarettes are also acceptable. The two are clearly different. Availability of a safer alternative to cigarettes is likely to strengthen rather than weaken denormalisation of smoking. There are three main arguments against mandatory medicinal licensing of ECs, apart from the most obvious one that they are consumer products rather than medicines. One, medicinal licensing requirements would hinder further EC development, which is essential for ECs to become a full replacement for cigarettes. Small improvements would require new licensing applications, the innovation timescale would increase greatly and the costs of innovation would be prohibitive. NRTs represent a classic example of the stifling effect of medicinal regulation. There have been no major improvements since they were introduced 30 years ago. Two, the costs of ECs would increase because compliance with pharmaceutical standards for manufacturing and handling medicinal licensing are expensive processes, which cigarettes do not have to comply with. The large tobacco companies may become the only players with sufficient resources. Small agile innovators would go out of business. Tobacco companies might not want ECs to develop further because this would undermine sales of cigarettes. ECs would become more expensive than cigarettes, remain unattractive to most smokers, and would be sold in packaging emphasising unlikely dangers. Cigarettes would remain a more attractive and cheaper product. Three, standard consumer protection regulations exist in Europe and many other countries to ensure consumer products are safe, fit for purpose, and as described. Such frameworks also allow specific directives to address particular risks. For example, the requirements to make tamper-proof containers or prohibit sales to children are not restricted to medicines. In conclusion, since ECs are a recreational consumer product that are competing with much more dangerous cigarettes, which are not regulated as medicines, mandatory medicinal regulation is not required for public safety and can harm public health by restricting www.thelancet.com/respiratory Vol 1 August 2013
Comment
the ability of ECs to compete with cigarettes in the marketplace. Excessive regulation of ECs would protect the market monopoly of cigarettes and have the potential consequences of disease in and death of millions of smokers who were prevented from moving on to the next generation of ECs. For the first time in the history of the tobacco control movement, a realistic possibility is emerging that the tobacco problem might get resolved, and that this could happen with minimal or no government involvement or expenditure. Regulators of medicines should hold their fire.
or makers of ECs. DY has no conflicts of interest and specifically has no links with tobacco or the EC industry. 1 2 3 4
5
6 7
*Peter Hajek, Jonathan Foulds, Jacques Le Houezec, David Sweanor, Derek Yach
8
Wolfson Institute of Preventive Medicine, Queen Mary University of London, London E1 2AD, UK (PH); College of Medicine, Penn State University, Hershey, PA, USA (JF); Rennes, France (JLH); Faculty of Law, University of Ottawa, ON, Canada (DS); and Vitality Institute, New York, NY, USA (DY) [email protected]
9
PH received research funds and provided consultancy to manufacturers of medications for smoking cessation including Pfizer, GlaxoSmithKline, and McNeill; he has no links with the EC industry. JF has provided paid consulting for pharmaceutical companies marketing smoking cessation products (eg Pfizer, Johnson and Johnson) but has never had any paid or financial connection with current EC or tobacco manufacturers. JL provided consultancy to manufacturers of stop-smoking medications including Pfizer, Johnson and Johnson, Novartis, and Pierre Fabre; he has no links with the EC industry. DS has consulted for law firms involved in litigation against tobacco companies and for makers of smoking cessation products; he received no payments from tobacco companies
10
11
12 13 14 15
Cobb NK, Abrams DB. E-cigarette or drug-delivery device? Regulating novel nicotine products. New Engl J Med 2011; 365: 193–95. Borland R. Electronic cigarettes as a method of tobacco control. BMJ 2011; 343: d6269. Wagener TL, Siegel M, Borrelli B. Electronic cigarettes: achieving a balanced perspective. Addiction 2012; 107: 1545–48. Bates C. The counterfactual. Reasonable people saying sensible things about low-risk alternatives to smoking (2013); http://www.clivebates. com/?p=853 (accessed June 12, 2013). Foulds J, Ramstrom L, Burke M, Fagerstrom K. Effect of smokeless tobacco (snus) on smoking and public health in Sweden. Tob Control 2003; 12: 349–59. Lund I, Scheffels J. The relative risk to health from snus and cigarettes: Response to Grimsrud et al. Nicotine Tob Res 2013; 15: 304–05 Murray R, Bailey W, Daniels K, et al. Safety of nicotine polacrilex gum used by 3,094 participants in the lung health study. Chest 1996; 109: 438–45. Murray R, Connett J, Zapawa L. Does nicotine replacement therapy cause cancer? Evidence from the Lung Health Study. Nicotine Tob Res 2009; 11: 1076–82. Westenberger B. Evaluation of e-cigarettes. St Louis, MO: US Food and Drug Administration, 2009. Goniewicz M, Gawron M, Peng M, Jacob III P, Benowitz N. Electronic cigarettes deliver similar levels of nicotine and reduce exposure to combustion toxicants after switching from tobacco cigarettes. Society for Research on Nicotine and Tobacco 18th Annual Meeting; Houston, TX, USA; March 13–16, 2012. McAuley T, Hopke P, Zhao J, Babaian S. Comparison of the effects of e-cigarette vapor and cigarette smoke on indoor air quality. Inhal Toxicol 2012; 24: 850–57. Laugesen M. Safety report on the Ruyan e-cigarette cartridge and inhaled aerosol. Christchurch: Health New Zealand Limited, 2008. Goniewicz M, Hajek P, McRobbie H. Electronic cigarette: nicotine content and consistency of its delivery. Report to MHRA. London: MHRA, 2012. Etter J-F, Bullen C. Electronic cigarettes: users profile, utilisation, satisfaction and perceived efficacy. Addiction 2011; 106: 2017–28. ASH. Use of e-cigarettes in Great Britain by adults and young people. London: Action on Smoking and Health, 2013.
Historically, refined nicotine has been sold in only two forms: a pesticide or a pharmaceutical grade medicinal product for tobacco addiction. Until recently, the US Food and Drug Administration (FDA) has consistently blocked the marketing of any non-pharmaceutical nicotine product designed for human consumption. The main exceptions to the rule are the electronic nicotine delivery systems (ENDS or electronic cigarettes): battery-powered devices that deliver refined nicotine in a humectant, usually propylene glycol. ENDS are a variant of past inhaler designs, including the FDA-regulated nicotine inhaler.1 Paradoxically, as a consequence of an unexpected interpretation of the 2009 Tobacco Control Act by the courts (ruling that unless marketed with therapeutic claims, refined nicotine is still tobacco and must be regulated as such), ENDS are widely and aggressively www.thelancet.com/respiratory Vol 1 August 2013
marketed without any apparent oversight.2 Further action by the FDA is pending. For years, the public health and medical community has stressed the need for greater availability and use of nicotine replacement therapy (NRT) to end the tobacco epidemic. However, the availability of refined nicotine has suddenly and by stealth become widespread, without guarantees of product safety or evident contribution to overarching public health interests. This odd US-specific situation has resulted in a fascinating, yet discouraging, market disruption. On the one hand is the unfettered commercial activity of ENDS; on the other hand are governmental restrictions on the manufacture, marketing, and sale of NRT products (eg, nicotine patch, gum, or inhaler). Although ENDS escape regulation in design, importation, and distribution, the FDA traditionally approves new NRT
Mark Sykes/Science Photo Library
Regulatory challenges for refined nicotine products
Published Online July 23, 2013 http://dx.doi.org/10.1016/ S2213-2600(13)70160-7
431
