European Commission Health and Consumers Directorate-General, Brussels,
Dear Dr Le Houezec and colleagues,
Subject: Scientific declaration on TPD
Thank you for your mail of 17 January addressed to Commissioner Borg. I reply in my function as responsible Deputy Director General.
Before I reply to the issues raised, let me underline that I appreciate your active
engagement in the discussions on e-cigarettes. Also I would like to clarify that the final text agreed is essentially the compromise found by the co-legislators, i.e. the European Parliament and the Council. The role of the Commission is limited to facilitating the negotiations, but we fully support the agreement reached. In particular we welcome the efforts to establish high quality and safety standards for electronic cigarettes.
In your mail you suggest that the established maximum nicotine threshold is not an
appropriate one for a smoker trying to give up smoking. In this respect I would like to
emphasise that various studies - including from scientists that signed the letter – indicate that electronic cigarettes with such a nicotine threshold or below help the vast majority of smokers. Also when setting the threshold, the co-legislators took other considerations into account, such as the need to protect children against exposure to nicotine etc.
In your letter you also argue that nicotine is less dangerous than often perceived.
However, the co-legislators considered that nicotine is not a harmless substance. As a matter of fact nicotine is classified as a toxic substance under existing EU law.11 would also point out that under the new Tobacco Products Directive (TPD) refill bottles containing up to 200 mg of nicotine will be allowed. This also explains the need for child and tamper proof opening mechanisms.
As regards the consistent nicotine dosing of electronic cigarettes, I would like to clarify that only puffs of the same strength would have to deliver the same amount of nicotine.
Diverging degrees of nicotine intake depending on the puff strength would thus remain possible - similar to normal cigarettes. The co-legislators wanted the consumers to be informed of the nicotine dose and uptake and wanted to provide the authorities with a basis to assess the risk profile of a product.
Last but not least I would like to point out that the consumption pattern for electronic
cigarettes seems to be rapidly changing. Already today we see that their consumption is no longer limited to established smokers. We also observe a high and increasing degree of experimentation by young people. This is why there was a consensus on the part of the co-legislators on the need to remain vigilant to prevent the product from developing into a gateway product.
For the sake of completeness we would like to ask for clarification whether the scientists that have signed the mail have undertaken research, provided consulting or received funding/travel support from electronic cigarettes companies. I think Honourable Members of the European Parliament would appreciate Ml transparency on potential conflicts of interest. Also they might be interested to know whether there are dissentįng views to the opinions expressed in your letter.
The scientists replied to the points made by Martin Seychell on 31 January 2014 with the following letter.
Scientific Errors in the Tobacco Products Directive
Dear Mr. Seychell
We do appreciate your response to our letter, and we thank you for your quick reply.
However, we do not think that our concerns were addressed. The legislation remains based on misunderstood or misinterpreted evidence and imposes restrictions which are not justifiable. A legislation that regulates e-cigarettes in a more restrictive way than tobacco cigarettes that are much more harmful by any standard of measurement will be damaging for public health.
We accept your clarification about the consistent dosing as concerning nicotine content in vapour rather than nicotine delivery to users as the wording implies. The wording could be made clearer.
Considering the rest of your response, this ignores our arguments that the statements concerning nicotine toxicity, nicotine threshold and use by non-smokers or adolescents, which form the basis of the proposed restrictions, are not substantiated by evidence and are therefore inappropriate.
You state that 'electronic cigarettes with such a nicotine threshold or below help the vast majority of smokers' and 'already today we see that their consumption is no longer limited to established smokers' but there is no evidence for these assertions that we are aware of.
As it stands, the proposed legislation is aiming to prevent negligible and mostly imaginary dangers while threatening to undermine much more likely and much more substantial benefits.
As per your request, please find below the CoI of the signatories.
Professor Jean-François ETTER, PhD
Institut de santé globale, Faculté de médecine, Université de Genève, Switzerland.
I was reimbursed by an e-cigarette manufacturer for travels to London and to China, but was not paid for these talks.
Dr. Konstantinos Farsalinos, MD
Researcher, Onassis Cardiac Surgery Center, Athens, Greece
Researcher, University Hospital Gathuisberg, Leuven, Belgium.
I have no financial interests in any e-cigarette company. Some of my studies were performed using funds provided to the institution by e-cigarette companies. My salary is paid by a scholarship grant from the Hellenic Society of Cardiology.
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.
I have no links with any e-cigarette companies.
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.
I have received no financial support from e-cigarette companies, nor received any other significant benefit (e.g. travel etc).
Dr. Hayden McRobbie, MB ChB PhD
Reader in Public Health Interventions, Wolfson Institute of Preventive Medicine, Queen Mary University of London, UK.
I have received no personal financial or non-financial support from any companies for research on ecigarettes. PGM International provided products at no cost for the public-good funded ASCEND ecigarette trial and I have undertaken research on Ruyan e-cigarettes, for which the University of Auckland was funded by Health New Zealand, independently of Ruyan.
Professor Chris Bullen, MBChB, PhD
Director, The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.
I have received no personal financial or non-financial support from any companies for research on ecigarettes.PGM International provided products at no cost for the public-good funded ASCEND ecigarette trial and I have undertaken research on Ruyan e-cigarettes, for which the University ofAuckland was funded by Health New Zealand, independently of Ruyan.
Professor Lynn T. Kozlowski, PhD
Dean, School of Public Health and Health Professions, Professor of Community Health and HealthBehavior, University at Buffalo, State University of New York, USA.
I have not undertaken research, provided consulting or received funding/travel support from electronic cigarettes companies.
Dr. Mitchell Nides, PhD
President, Los Angeles Clinical Trials, Director, Picture Quitting, the Entertainment Industry's, QuitSmoking Program, Burbank, CA 91505, USA.
I have received research funding from NJOY Inc, Scottsdale, AZ.
Professor Dimitris Kouretas, MD
Professor and Deputy Rector University of Thessaly, Greece.
The University of Thessaly signed a research proposal between University and The Greek Chamber of ecigarettes importers to test the toxicity of the liquids that are sold in the Greek market. I have not received money from any e-cigarette company.
Professor Riccardo Polosa, MD, PhD
Director of the Institute for Internal Medicine and Clinical Immunology, University of Catania, Italy.
I have been serving as a consultant for Arbi Group Srl (Milano, Italy), the Italian distributor for 'Categoria' e-Cigarettes.
Dr. Karl Fagerström, PhD
President, Fagerström Consulting AB, Vaxholm, Sweden.
I have no links with any e-cigarette companies.
Professor Martin Jarvis, Dsc
Emeritus Professsor of Health Psychology, Department of Epidemiology & Public Health, University College London, UK.
I have no financial links with any electronic cigarette company, and have not consulted for or received travel support or research resources from any such company.
Dr. Lynne E. Dawkins, PhD
Senior Lecturer in Psychology, School of Psychology, University of East London, Stratford, London, UK.
I have no personal financial or non-financial interests in the e-cigarette industry. My university (University of East London, UEL) has received funding from Skycig Ltd for a research project that I coordinated as well as travel funds and hospitality from Totally Wicked and E-Lites.
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.
PC declares no conflict of interest.
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.
I have not received any financial compensation of any kind from an electronic cigarette company, nor received any other significant benefit (e.g. travel etc).