Scientific Errors in the Tobacco Products Directive
January 16, 2014
We are among the key scientists in the field of tobacco and e-cigarettes whose research is cited by the EU Commission and other public bodies interested in tobacco control. We understand that the Commission and MEPs want to ensure that safe e-cigarettes are easily available for smokers who wish to witch from smoking tobacco. With e-cigarettes proving popular among smokers, there is an ethical and intellectual imperative to build policy on robust science. The stakes are high, as smoking kills 700’000 citizens in the EU each year. Several of the recitals and provisions of Article 18 of the Tobacco Products Directive (TPD) which concerns e-cigarettes lack or misrepresent the scientific understanding of the relevant issues. This letter is to help you understand research findings relevant to the current TPD text.
1. TPD’s Comparison of Nicotine Delivery From Tobacco and Electronic Cigarettes TPD Text: Recital c) for Article 18 states: “Nicotine containing liquid should only be allowed under this Directive where the nicotine concentration does not exceed 20 mg/ml. This level of concentration is imilar to the dose of nicotine derived from a standard cigarette during the same duration of smoking.” The science: The Commission quotes (1) Dr. Farsalinos’ papers (2,3) to justify the claim that 20mg/ml of nicotine matches the average cigarette delivery. Dr. Farsalinos has written to the Commission stating that they have misinterpreted his findings. His research instead shows that 20 mg/ml e-liquid provides less than one-third of the nicotine delivered by one tobacco cigarette (4,5). 50mg/ml is needed to roughly match a tobacco cigarette. All other existing studies confirm this (6-9). Some 20 to 30% of electronic cigarette users use liquids above 20mg (8,10). Higher nicotine content liquids are typically used by the most dependent smokers, who have the highest risk of smoking-related damage, and who benefit most from switching to electronic cigarettes. Most such heavy smokers need more than 20mg/ml to switch from smoking to vaping.
2. TPD’s Assumption On Nicotine Toxicity TPD Text: Recital f) for Article 18 states: “Given that nicotine is a toxic substance…” and the Commission asserts that “The acute lethal dose of nicotine in an adult human is estimated to be about 60 mg” (11)
The science: One justification for limiting nicotine levels in electronic cigarette liquid to 20mg/ml rests on the claim that higher levels would be dangerously toxic. This is not the case. People have ingested doses 60 times higher, which only led to nausea and vomiting and no other adverse effects (12). The Commission’s contention that 60mg of nicotine is lethal has been traced to dubious self-experiments recorded in a pharmacology textbook of 1856 and not confirmed since then (13). Poisoning from tobacco, nicotine replacement medications or e-cigarette liquid is extremely rare. There is also no risk of overdosing through inhalation. As with conventional cigarettes, excessive doses cause nausea, so inhalation is stopped long before any overdosing or health damage is possible (for review of evidence, ee 14). Childproof caps are sufficient to protect young children from swallowing e-liquids.
3. TPD’s Requirement For Consistent Nicotine Delivery TPD Text: Article 18.3 says “Member States shall ensure that:… (f) electronic cigarettes deliver the nicotine doses consistently” The science: The medicinal concept of “consistent delivery” is inappropriate for a consumer product used freely. Users of cigarettes, oral tobacco and e-cigarettes spontaneously determine their nicotine intake according to individual and momentary needs. Individual users of the same electronic cigarette differ in their nicotine intake 20-fold (4,5,15). Quality control of individual brands is needed to ensure consistency of nicotine content but ensuring consistent delivery makes little sense. No such demands have been placed on tobacco cigarettes or oral tobacco.
4. TPD Requirement On Electronic Cigarette Manufacturers To Provide Data On Nicotine Absorption From Each Product TPD Text: Article 18.2 Requires manufacturers to notify 6 months before a product or substantial modification goes to market data including: “information on nicotine dosing and uptake “ The science: Bearing in mind the above comments on nicotine delivery, such data would be of no benefit to consumers, but would incur large unnecessary costs. No such data are required from cigarette or tobacco manufacturers, and this, along with other regulatory proposals, would create a market advantage for the much more dangerous tobacco cigarettes.
5. TPD Requirement To Limit Electronic Cigarette Refill Containers To 10ml And Tanks To 2ml TPD Text Article 18.3 a): “nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, disposable electronic cigarettes or in single use cartridges. The cartridges or tanks shall not exceed a volume of 2 ml” The science: This proposal seems motivated by the concern about e-liquid toxicity, which is misinformed (see above). Electronic cigarettes have an excellent safety record so far (16). Worldwide, only one
electronic cigarette fatality has been reported caused by a small child drinking electronic cigarette liquid from an open container (17). The Commission’s proposal for smaller containers would generate more handling of refill bottles, so a higher choking risk for small children and higher cost to users. The alternative approach used with much more toxic household chemicals such as bleach is for the risk to be mitigated by common sense, warning labels and child-proof containers.
6. TPD Assumption That Electronic Cigarettes Are A Gateway To Smoking TPD Text Recital h) of Article 18 states: “Electronic cigarettes can develop into a gateway to nicotine addiction and ultimately traditional tobacco consumption, as they mimic and normalize the action of moking. For this reason, it is appropriate to adopt a restrictive approach to advertising.” The science The gateway effect is given as one of the reasons for a restrictive approach. Existing data however do not suggest that electronic cigarettes are having any such effects. Daily use of electronic cigarette in never-smokers was assessed in two studies, which found no such use (18, 19). In the US, 1- 2% of children experimented with electronic cigarettes, with none shown to have become regular users (20). In contrast, 54% of 15-16 years old European adolescents have tried at least once smoking cigarettes, and 88% of adult smokers who smoke daily report that they started smoking by the age of 18 years (21, 22). The evidence is instead that the gateway effect is out of tobacco use, as at least some mokers of all ages reduce or end smoking when moving over to electronic cigarette. However, use in adolescent non-smokers should be closely monitored in the future.
In conclusion, electronic cigarettes have a very good safety profile and are likely to provide a gateway away from rather than into smoking. Users should be allowed to identify a product and dosage that suit them rather than have regulators decide what they must use. Evidence-based and proportionate regulation should be implemented, and all stakeholders should be involved in the regulatory process. If wisely regulated, electronic cigarettes have the potential to obsolete cigarettes and to save millions of lives worldwide. Excessive regulation, on the contrary, will contribute to maintain the existing levels of moking-related disease, death and health care costs.
References 1) European Commission (2013) Fact sheet on E-Cigarettes http://ec.europa.eu/health/tobacco/docs/fs_ecigarettes_en.pdf 2) Farsalinos et al. Evaluation of Electronic Cigarette Use (Vaping) Topography and Estimation of Liquid Consumption. Int J Environ Res Public Health. 2013;10: 2500-14. 3) Farsalinos et al. Evaluating nicotine levels selection and patterns of electronic cigarette use in a group of ‘Vapers’ who had achieved complete substitution of smoking. Substance Abuse: Research and Treatment. 2013; 7:139-146.
4) Farsalinos K. et al. Nicotine absorption from electronic cigarette use: comparison between first and new generation devices. Presented to the FDA, December 19, 2013 (submitted for publication). 5) Farsalinos K. et al. Nicotine absorption from electronic cigarette use: comparison between experienced and naive users. Presented to the FDA, December 19, 2013. 6) Vansickel AR, Eissenberg T. Electronic Cigarettes: Effective Nicotine Delivery After Acute Administration. Nicotine & Tobacco Research 2012. 7) Hajek P, Goniewicz M, Phillips A, Myers-Smith K, West O, McRobbie H. Nicotine intake from electronic cigarettes and effect of practice: Report to the MHRA. London: Wolfson Institute of Preventive Medicine, Queen Mary University of London, 2013. 8) Dawkins L, Corcoran O. Acute electronic cigarette use: nicotine delivery and subjective effects in regular users. Psychopharmacology (Berl). 2014 Jan;231(2):401-7. 9) Nides MA, Leischow SJ, Bhatter M, Simmons M. Nicotine Blood Levels and Short-term Smoking Reduction with an Electronic Nicotine Delivery System. American Journal of Health Behavior 2014; 38(2): 265-74. 10) Etter, J. F. & Bullen, C. (2011) Electronic cigarette: users profile, utilization, sa tisfaction and perceived efficacy, Addiction, 106, 2017-28. 11) SCENIHR Scientific Committee, 2010 p 29 http://ec.europa.eu/health/scientific_committees/opinions_layman/tobacco/documents/addictiveness _and_attractiveness_of_tobacco_additives.pdf 12) Christensen LB, van't Veen T, Bang J. Three cases of attempted suicide by ingestion of nicotine liquid used in e-cigarettes, Clinical Toxicology. 2013; 51: 290.Clinical
Toxicology vol. 51 no. 4 2013
13) Mayer B. How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century. Arch Toxicol. 2014 Jan;88(1):5-7. 14) See the literature review on slides 10 and 11 at http://www.e-cigarette-forum.com/infozone/Dr- Jacques-Le-Houezec 15) Etter JF. Levels of saliva cotinine in electronic cigarette users, Addiction. 2014 Jan 8. 16) Polosa R, Rodu B, Caponnetto P, Maglia M, Raciti C. A fresh look at tobacco harm reduction: the case for the electronic cigarette. Harm Reduct J. 2013 Oct 4;10(1):19. 17) Winer S (2013). Police investigating toddler’s death from nicotine overdose, Times of Israel, May 29. 18) Douptcheva N, Gmel G, Studer J, Deline S, Etter JF. Use of electronic cigarettes among young Swiss men. J Epidemiol Community Health. 2013; 67: 1075-1076.
19) Action On Smoking And Health (2013). ASH fact sheet on the use of e-cigarettes in Great Britain (London, ASH). http://www.ash.org.uk/information/facts-and-stats/ash-briefings 20) CDC (2013). Notes from the field: electronic cigarette use among middle and high school students - United States, 2011-2012, MMWR Morb Mortal Wkly Rep, 62, 729-30. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6235a6.htm 21) The 2011 ESPAD Report. Substance Use Among Students in 36 European Countries. http://www.espad.org/Uploads/ESPAD_reports/2011/The_2011_ESPAD_Report_FULL_2012_10_29.pdf 22) U.S. Department of Health and Human Services. Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2012. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm
Signatories Professor Jean-François ETTER, PhD, Associate Professor, Privat docent Institut de santé globale, Faculté de médecine, Université de Genève, Switzerland. Dr. Konstantinos Farsalinos, MD Researcher, Onassis Cardiac Surgery Center, Athens, Greece Researcher, University Hospital Gathuisberg, Leuven, Belgium. Professor Peter Hajek, PhD Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry Queen Mary University of London, London, UK. Dr. Jacques Le Houezec, PhD Consultant in Public Health, Tobacco dependence, Rennes, France & Honorary Lecturer, UK Centre for Tobacco Control Studies, University of Nottingham, UK. Dr. Hayden McRobbie, MB ChB PhD Reader in Public Health Interventions, Wolfson Institute of Preventive Medicine, Queen Mary University of London, UK. Professor Chris Bullen, MBChB, PhD Director, The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand. Professor Lynn T. Kozlowski, PhD Dean, School of Public Health and Health Professions, Professor of Community Health and Health Behavior, University at Buffalo, State University of New York, USA.
Dr. Mitchell Nides, PhD President, Los Angeles Clinical Trials, Director, Picture Quitting, the Entertainment Industry's, Quit Smoking Program, Burbank, CA 91505, USA. Professor Dimitris Kouretas, MD Professor and Deputy Rector University of Thessaly, Greece. Professor Riccardo Polosa, MD, PhD Director of the Institute for Internal Medicine and Clinical Immunology, University of Catania, Italy. Dr. Karl Fagerström, PhD President, Fagerström Consulting AB, Vaxholm, Sweden. Professor Martin Jarvis, Dsc Emeritus Professsor of Health Psychology, Department of Epidemiology & Public Health, University College London, UK. Dr. Lynne E. Dawkins, PhD Senior Lecturer in Psychology, School of Psychology, University of East London, Stratford, London, UK. Dr. Pasquale Caponnetto, Assistant Professor, Researcher Centro per la Prevenzione e Cura del Tabagismo, Azienda Ospedaliero-Universitaria “Policlinico-V. Emanuele”, Università di Catania, Catania, Italy. Professor Jonathan Foulds PhD Professor of Public Health Sciences & Psychiatry, Penn State University, College of Medicine, Cancer Institute, Cancer Control Program, Hershey, PA 17033-0850, USA.